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{{Short description|Vaccine against Strep pneumoniae}}
{{Short description|Vaccine against Strep pneumoniae}}
{{Use dmy dates|date=November 2022}}
{{Use dmy dates|date=June 2024}}
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{{Drugbox
{{Drugbox
| image = Prevenar 13.jpg
| image = Prevenar 13.jpg
| caption = Prevenar 13
| caption = Prevenar 13
| drug_name =
| drug_name =


<!-- Vacine data -->
<!-- Vacine data -->
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<!-- Clinical data -->
<!-- Clinical data -->
| pronounce =
| pronounce =
| tradename = Prevnar 20, Prevnar 13, Synflorix, others; discontinued Prevnar (PCV7)
| tradename = Prevnar 20, Prevnar 13, Synflorix, others; discontinued Prevnar (PCV7)
| Drugs.com = {{drugs.com|monograph|pneumococcal-vaccine}}
| Drugs.com = {{drugs.com|monograph|pneumococcal-vaccine}}
| MedlinePlus = a607021
| MedlinePlus = a607021
| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| DailyMedID = Pneumococcal
| DailyMedID = Pneumococcal
| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
| pregnancy_AU = B1
| pregnancy_AU = B1
| pregnancy_AU_comment = <ref name="Vaxneuvance APMDS">{{cite web | title=Vaxneuvance APMDS | website=Therapeutic Goods Administration | date=24 January 2022 | url=https://www.tga.gov.au/resources/auspmd/vaxneuvance | access-date=5 February 2022 | archive-date=5 February 2022 | archive-url=https://web.archive.org/web/20220205045646/https://www.tga.gov.au/apm-summary/vaxneuvance | url-status=live }}</ref><ref>{{cite web | title=Updates to the Prescribing Medicines in Pregnancy database | website=Therapeutic Goods Administration | date=21 December 2022 | url=https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database | access-date=2 January 2023 | archive-date=3 April 2022 | archive-url=https://web.archive.org/web/20220403064059/https://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database | url-status=live }}</ref><ref name="Prevenar 20 APMDS">https://www.tga.gov.au/resources/auspmd/prevenar-20 {{Webarchive|url=https://web.archive.org/web/20230105011912/https://www.tga.gov.au/resources/auspmd/prevenar-20 |date=5 January 2023 }} {{bare URL inline|date=April 2023}}</ref>
| pregnancy_AU_comment = <ref name="Vaxneuvance APMDS">{{cite web | title=Vaxneuvance APMDS | website=Therapeutic Goods Administration | date=24 January 2022 | url=https://www.tga.gov.au/resources/auspmd/vaxneuvance | access-date=5 February 2022 | archive-date=5 February 2022 | archive-url=https://web.archive.org/web/20220205045646/https://www.tga.gov.au/apm-summary/vaxneuvance | url-status=live }}</ref><ref name="auto">{{cite web | title=Updates to the Prescribing Medicines in Pregnancy database | website=Therapeutic Goods Administration | date=21 December 2022 | url=https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database | access-date=2 January 2023 | archive-date=3 April 2022 | archive-url=https://web.archive.org/web/20220403064059/https://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database | url-status=live }}</ref><ref name="Prevenar 20 APMDS">{{cite web | title = Prevenar 20 | work = Therapeutics Goods Administration, The Department of Health and Aged Care | publisher = The Australian Government | url = https://www.tga.gov.au/resources/auspmd/prevenar-20 | archive-url = https://web.archive.org/web/20230105011912/https://www.tga.gov.au/resources/auspmd/prevenar-20 | archive-date=5 January 2023 }}</ref>
| pregnancy_category =
| pregnancy_category =
| routes_of_administration = [[Intramuscular]]
| routes_of_administration = [[Intramuscular]]
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| ATC_prefix = J07
| ATC_suffix = AL02
| ATC_suffix = AL02
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| ATC_supplemental =


<!-- Legal status -->
<!-- Legal status -->
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| legal_AU_comment = <ref name="Vaxneuvance APMDS" /><ref name="Prevenar 20 APMDS" /><ref>{{cite web | title=Prevenar 20 (Pfizer Australia Pty Ltd) | website=Therapeutic Goods Administration | date=13 January 2023 | url=https://www.tga.gov.au/resources/prescription-medicines-registrations/prevenar-20-pfizer-australia-pty-ltd | access-date=9 April 2023 | archive-date=27 March 2023 | archive-url=https://web.archive.org/web/20230327062424/https://www.tga.gov.au/resources/prescription-medicines-registrations/prevenar-20-pfizer-australia-pty-ltd | url-status=live }}</ref>
| legal_AU_comment = <ref name="Vaxneuvance APMDS" /><ref name="Prevenar 20 APMDS" /><ref>{{cite web | title=Prevenar 20 (Pfizer Australia Pty Ltd) | website=Therapeutic Goods Administration | date=13 January 2023 | url=https://www.tga.gov.au/resources/prescription-medicines-registrations/prevenar-20-pfizer-australia-pty-ltd | access-date=9 April 2023 | archive-date=27 March 2023 | archive-url=https://web.archive.org/web/20230327062424/https://www.tga.gov.au/resources/prescription-medicines-registrations/prevenar-20-pfizer-australia-pty-ltd | url-status=live }}</ref>
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| legal_BR_comment =
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| legal_CA = Rx-only
| legal_CA = Rx-only
| legal_CA_comment = /{{nbsp}}Schedule D<ref>{{cite web | title=Summary Basis of Decision (SBD) for Vaxneuvance | website=Health Canada | date=25 February 2022 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00579&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529193011/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00579&lang=en | url-status=live }}</ref><ref>{{cite web | title=Summary Basis of Decision - Prevnar 20 | website=Health Canada | date=31 August 2022 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00603&lang=en | access-date=22 September 2022 | archive-date=29 September 2022 | archive-url=https://web.archive.org/web/20220929045440/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00603&lang=en | url-status=live }}</ref>
| legal_CA_comment = /{{nbsp}}Schedule D<ref>{{cite web | title=Summary Basis of Decision (SBD) for Vaxneuvance | website=Health Canada | date=25 February 2022 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00579&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529193011/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00579&lang=en | url-status=live }}</ref><ref>{{cite web | title=Summary Basis of Decision - Prevnar 20 | website=Health Canada | date=31 August 2022 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00603&lang=en | access-date=22 September 2022 | archive-date=29 September 2022 | archive-url=https://web.archive.org/web/20220929045440/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00603&lang=en | url-status=live }}</ref><ref>{{cite web | title=Regulatory Decision Summary for Capvaxive | website=Drug and Health Products Portal | date=15 July 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722532649097 | access-date=27 December 2024}}</ref>
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| legal_NZ_comment =
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| legal_UK_comment =
| legal_UK_comment =
| legal_US = Rx-only
| legal_US = Rx-only
| legal_US_comment = <ref name="Prevnar 13 FDA label" /><ref name="Prevnar 20 FDA label" /><ref name="Vaxneuvance FDA label">{{cite web | title=Vaxneuvance- pneumococcal 15-valent conjugate vaccine crm197 protein adsorbed injection, suspension | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1158fa93-ef41-4a29-8252-9251f94c53c8 | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821081841/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1158fa93-ef41-4a29-8252-9251f94c53c8 | url-status=live }}</ref>
| legal_US_comment = <ref name="Prevnar 13 FDA label" /><ref name="Prevnar 20 FDA label">{{cite web | title=Prevnar 20- pneumococcal 20-valent conjugate vaccine injection, suspension | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4e2cf51-e6a8-4103-bb1d-6120c6474ff8 | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821081836/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4e2cf51-e6a8-4103-bb1d-6120c6474ff8 | url-status=live }}</ref><ref name="Vaxneuvance FDA label">{{cite web | title=Vaxneuvance- pneumococcal 15-valent conjugate vaccine crm197 protein adsorbed injection, suspension | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1158fa93-ef41-4a29-8252-9251f94c53c8 | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821081841/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1158fa93-ef41-4a29-8252-9251f94c53c8 | url-status=live }}</ref><ref name="Capvaxive FDA label">{{cite web | title=Capvaxive- pneumococcal 21-valent conjugate vaccine injection, solution | website=DailyMed | date=17 June 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a264c2f-d2f8-4ab5-bc5e-fbed0001ede6 | access-date=5 September 2024}}</ref>
| legal_EU = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Prevenar 13 EPAR" /><ref name="Synflorix EPAR" /><ref name="Vaxneuvance EPAR" /><ref name="Vaxneuvance EU" /><ref name="Apexxnar EPAR" />
| legal_EU_comment = <ref name="Prevenar 13 EPAR" /><ref name="Synflorix EPAR" /><ref name="Vaxneuvance EPAR" /><ref name="Vaxneuvance EU" /><ref name="Apexxnar EPAR" />
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| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
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| legal_status = Rx-only
| legal_status = Rx-only


<!-- Identifiers -->
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| PubChem =
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| DrugBank =
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| ChemSpiderID = none
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| synonyms = PCV, pneumococcal vaccine, capsular polysaccharides<ref name="auto"/>
| synonyms = PCV, pneumococcal vaccine, capsular polysaccharides<ref>{{cite web | title=Updates to the Prescribing Medicines in Pregnancy database | website=Therapeutic Goods Administration | date=21 December 2022 | url=https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database | access-date=2 January 2023 | archive-date=3 April 2022 | archive-url=https://web.archive.org/web/20220403064059/https://www.tga.gov.au/updates-prescribing-medicines-pregnancy-database | url-status=live }}</ref>

}}
}}


'''Pneumococcal conjugate vaccine''' is a [[pneumococcal vaccine]] and a [[conjugate vaccine]] used to protect [[infant]]s, young children, and adults against disease caused by the [[bacterium]] ''[[Streptococcus pneumoniae]]'' (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the [[pneumococcal polysaccharide vaccine]]. The [[World Health Organization]] (WHO) recommends the use of the conjugate vaccine in [[Vaccination schedule|routine immunizations]] given to children.<ref>{{cite journal | vauthors=((World Health Organization)) | title = Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper –February 2019 | journal = Wkly Epidemiol Rec | year = 2019 | volume = 94 | issue = 8 | pages = 85–104 | hdl = 10665/310970}}</ref><ref name="who.int 2019">{{cite web | title=Summary of WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age, February 2019 | website=who.int | date=April 21, 2019 | url=https://www.who.int/immunization/policy/position_papers/who_pp_pcv_2019_summary.pdf | archive-url=https://web.archive.org/web/20220308153642/https://www.who.int/immunization/policy/position_papers/who_pp_pcv_2019_summary.pdf | archive-date=March 8, 2022 | url-status=dead }}</ref>
'''Pneumococcal conjugate vaccine''' is a [[pneumococcal vaccine]] made with the [[conjugate vaccine]] method and used to protect [[infant]]s, young children, and adults against disease caused by the [[bacterium]] ''[[Streptococcus pneumoniae]]'' (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the [[pneumococcal polysaccharide vaccine]]. The [[World Health Organization]] (WHO) recommends the use of the conjugate vaccine in [[Vaccination schedule|routine immunizations]] given to children.<ref>{{cite journal | vauthors=((World Health Organization)) | title = Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper –February 2019 | journal = Wkly Epidemiol Rec | year = 2019 | volume = 94 | issue = 8 | pages = 85–104 | hdl = 10665/310970}}</ref><ref name="who.int 2019">{{cite web | title=Summary of WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age, February 2019 | website=[[World Health Organization]] (WHO) | date=21 April 2019 | url=https://www.who.int/immunization/policy/position_papers/who_pp_pcv_2019_summary.pdf | archive-url=https://web.archive.org/web/20220308153642/https://www.who.int/immunization/policy/position_papers/who_pp_pcv_2019_summary.pdf | archive-date=8 March 2022 | url-status=dead }}</ref>


Vaccine-mediated immunity is "conferred mainly by opsonophagocytic killing of ''S. pneumoniae''."<ref name=":0">{{cite web |date=June 2021 |year=2021 |title=PREVNAR 20- pneumococcal 20-valent conjugate vaccine injection, suspension: Wyeth Pharmaceutical Division of Wyeth Holdings LLC |url=https://labeling.pfizer.com/ShowLabeling.aspx?id=15428 |url-status=live |access-date=9 August 2022 |publisher=Wyeth Pharmaceuticals, LLC (A subsidiary of Pfizer Inc.) |page=11 |publication-place=Philadelphia, PA 19101, US |archive-date=5 September 2022 |archive-url=https://web.archive.org/web/20220905150823/https://labeling.pfizer.com/ShowLabeling.aspx?id=15428 }}</ref>
Vaccine-mediated immunity is "conferred mainly by opsonophagocytic killing of ''S. pneumoniae''."<ref name=":0">{{cite web |date=June 2021 |title=PREVNAR 20 pneumococcal 20-valent conjugate vaccine injection, suspension: Wyeth Pharmaceutical Division of Wyeth Holdings LLC |url=https://labeling.pfizer.com/ShowLabeling.aspx?id=15428 |url-status=live |archive-url=https://web.archive.org/web/20220905150823/https://labeling.pfizer.com/ShowLabeling.aspx?id=15428 |archive-date=5 September 2022 |access-date=9 August 2022 |publisher=Wyeth Pharmaceuticals, LLC (A subsidiary of Pfizer Incorporated) |page=11 |publication-place=Philadelphia, Pennsylvania}}</ref>


The most common side effects in children are decreased appetite, fever (only very common in children aged six weeks to five years), irritability, reactions at the site of injection (reddening or hardening of the skin, swelling, pain or tenderness), somnolence (sleepiness) and poor quality sleep.<ref name="Prevenar 13 EPAR" /><ref name=":0" /> In adults and the elderly, the most common side effects are decreased appetite, headaches, diarrhea, fever (only very common in adults aged 18 to 29 years), vomiting (only very common in adults aged 18 to 49 years), rash, reactions at the site of injection, limitation of arm movement, arthralgia and myalgia (joint and muscle pain), chills and fatigue.<ref name="Prevenar 13 EPAR" /><ref name=":0" />
The most common side effects in children are decreased appetite, fever (only very common in children aged six weeks to five years), irritability, reactions at the site of injection (reddening or hardening of the skin, swelling, pain or tenderness), somnolence (sleepiness) and poor quality sleep.<ref name="Prevenar 13 EPAR" /><ref name=":0" /> In adults and the elderly, the most common side effects are decreased appetite, headaches, diarrhea, fever (only very common in adults aged 18 to 29 years), vomiting (only very common in adults aged 18 to 49 years), rash, reactions at the site of injection, limitation of arm movement, arthralgia and myalgia (joint and muscle pain), chills and fatigue.<ref name="Prevenar 13 EPAR" /><ref name=":0" />


==Brands==
==Brands==
=== Capvaxive ===
Capvaxive is a pneumococcal 21-valent conjugate vaccine (PVC21) manufactured by Merck and was approved for medical use in the United States in June 2024.<ref name="FDA Capvaxive" /><ref>{{cite press release | title=U.S. FDA Approves Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults | publisher=Merck | via=Business Wire | date=17 June 2024 | url=https://www.businesswire.com/news/home/20240614126575/en/U.S.-FDA-Approves-CAPVAXIVE%E2%84%A2-Pneumococcal-21-valent-Conjugate-Vaccine-for-Prevention-of-Invasive-Pneumococcal-Disease-and-Pneumococcal-Pneumonia-in-Adults | access-date=18 June 2024}}</ref> It is indicated for the active immunization for the prevention of invasive disease caused by ''Streptococcus pneumoniae'' serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older; and the active immunization for the prevention of pneumonia caused by ''S. pneumoniae'' serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F,23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.<ref name="FDA Capvaxive">{{cite web | title=Capvaxive | website=U.S. Food and Drug Administration | date=17 June 2024 | url=https://www.fda.gov/vaccines-blood-biologics/capvaxive | access-date=18 June 2024 | archive-date=18 June 2024 | archive-url=https://web.archive.org/web/20240618224436/https://www.fda.gov/vaccines-blood-biologics/capvaxive | url-status=live }} {{PD-notice}}</ref>

===Pneumosil===
===Pneumosil===
Pneumosil is a decavalent pneumococcal conjugate vaccine produced by the [[Serum Institute of India]]. It contains the serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F, and was prequalified by WHO in January 2020.<ref>{{cite web |url=https://www.gavi.org/sites/default/files/document/pcv-profilespdf.pdf |title=Gavi-supported pneumococcal conjugate vaccines profiles to support country decision making |year=2019 |publisher=GAVI |access-date=8 April 2020 |archive-date=19 May 2020 |archive-url=https://web.archive.org/web/20200519081940/https://www.gavi.org/sites/default/files/document/pcv-profilespdf.pdf |url-status=live }}</ref><ref>{{cite press release |title=Pneumosil, the new pneumococcal vaccine, achieves WHO prequalification, a key step toward improving access and affordability |url=https://markets.businessinsider.com/news/stocks/pneumosil-the-new-pneumococcal-vaccine-achieves-who-prequalification-a-key-step-toward-improving-access-and-affordability-1028849941 |publisher=[[Serum Institute of India]] |agency=PR Newswire |date=28 January 2020 |access-date=8 April 2020 |archive-date=17 April 2021 |archive-url=https://web.archive.org/web/20210417183729/https://markets.businessinsider.com/news/stocks/pneumosil-the-new-pneumococcal-vaccine-achieves-who-prequalification-a-key-step-toward-improving-access-and-affordability-1028849941 |url-status=live }}</ref>
Pneumosil is a decavalent pneumococcal conjugate vaccine produced by the [[Serum Institute of India]]. It contains the serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F, and was prequalified by WHO in January 2020.<ref>{{cite web |url=https://www.gavi.org/sites/default/files/document/pcv-profilespdf.pdf |title=Gavi-supported pneumococcal conjugate vaccines profiles to support country decision making |year=2019 |publisher=GAVI |access-date=8 April 2020 |archive-date=19 May 2020 |archive-url=https://web.archive.org/web/20200519081940/https://www.gavi.org/sites/default/files/document/pcv-profilespdf.pdf |url-status=live }}</ref><ref>{{cite press release |title=Pneumosil, the new pneumococcal vaccine, achieves WHO prequalification, a key step toward improving access and affordability |url=https://markets.businessinsider.com/news/stocks/pneumosil-the-new-pneumococcal-vaccine-achieves-who-prequalification-a-key-step-toward-improving-access-and-affordability-1028849941 |publisher=[[Serum Institute of India]] |agency=PR Newswire |date=28 January 2020 |access-date=8 April 2020 |archive-date=17 April 2021 |archive-url=https://web.archive.org/web/20210417183729/https://markets.businessinsider.com/news/stocks/pneumosil-the-new-pneumococcal-vaccine-achieves-who-prequalification-a-key-step-toward-improving-access-and-affordability-1028849941 |url-status=live }}</ref>
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===Prevnar===
===Prevnar===
[[File:Vacuna-prevenar.jpg|thumb|Prevnar vaccine]]
[[File:Vacuna-prevenar.jpg|thumb|Prevnar vaccine]]
Prevnar 20 (PCV20) is the third version of a vaccine produced by the [[Wyeth]] subsidiary of [[Pfizer]]. In April 2023, the FDA approved Prevnar 20 for the prevention of invasive disease caused by the 20 different serotypes of ''S. pneumoniae'' contained in the vaccine (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) for individuals 6 weeks through 17 years of age; and for the prevention of otitis media (ear infection) caused by 7 of the serotypes of ''Streptococcus pneumoniae'' contained in the vaccine for children 6 weeks through 5 years of age.<ref name="FDA PR 20230428">{{cite web |date=28 April 2023 |title=FDA Roundup: April 28, 2023 |url=https://www.fda.gov/news-events/press-announcements/fda-roundup-april-28-2023 |url-status=live |archive-url=https://web.archive.org/web/20230429053758/https://www.fda.gov/news-events/press-announcements/fda-roundup-april-28-2023 |archive-date=29 April 2023 |access-date=29 April 2023 |website=U.S. Food and Drug Administration}} {{PD-notice}}</ref> In June 2023, the [[Advisory Committee on Immunization Practices]] (ACIP) approved PCV20 (Prevnar 20) for use in US children.<ref>{{Cite journal |date=September 2023 |title=ACIP Updates: Recommendations for Use of 20-Valent Pneumococcal Conjugate Vaccine in Children – United States, 2023 |url=https://www.cdc.gov/mmwr/volumes/72/wr/mm7239a5.htm |url-status=live |journal=MMWR. Morbidity and Mortality Weekly Report |volume=72 |issue=39 |page=1072 |doi=10.15585/mmwr.mm7239a5 |issn=0149-2195 |pmc=10545431 |pmid=37768876 |archive-url=https://web.archive.org/web/20231008182948/https://www.cdc.gov/mmwr/volumes/72/wr/mm7239a5.htm |archive-date=8 October 2023 |access-date=25 October 2023}}</ref><ref>{{Cite web |url=https://stacks.cdc.gov/view/cdc/133252 |title=ACIP Updates: Recommendations for the Use of 20-Valent Pneumococcal Conjugate Vaccine in Children ― United States, 2023 |date=22 September 2023 |volume=72 |access-date=10 March 2024 |archive-date=11 December 2023 |archive-url=https://web.archive.org/web/20231211002707/https://stacks.cdc.gov/view/cdc/133252 |url-status=live }}</ref>
Prevnar 13 (PCV13) is produced by the [[Wyeth]] subsidiary of [[Pfizer]] and it replaces Prevnar (PCV7), the pneumococcal 7-valent conjugate vaccine (PCV7).<ref name="FDA PR 20100224" /><ref>{{cite press release | title=Pfizer And Wyeth Become One: Working Together For A Healthier World | website=Pfizer | date=15 October 2009 | url=https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_wyeth_become_one_working_together_for_a_healthier_world | access-date=15 December 2022 | archive-date=15 December 2022 | archive-url=https://web.archive.org/web/20221215083304/https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_wyeth_become_one_working_together_for_a_healthier_world | url-status=live }}</ref> It is a tridecavalent vaccine because it contains thirteen serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).<ref name="Prevnar 13 FDA">{{cite web | title=Prevnar 13 | website=U.S. [[Food and Drug Administration]] (FDA) | date=1 March 2018 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-13 | archive-url=https://web.archive.org/web/20191127192849/https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-13 | archive-date=27 November 2019 | url-status=live | access-date=27 September 2019 | id=STN 125324}} {{PD-notice}}</ref><ref name="Prevnar 13 FDA label">{{cite web | title=Prevnar 13- pneumococcal 13-valent conjugate vaccine injection, suspension | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d49181b-b974-a5da-3b38-12a3a87bb96b | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821081836/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d49181b-b974-a5da-3b38-12a3a87bb96b | url-status=live }}</ref> Prevnar 13 was approved for use in the European Union in December 2009.<ref name="Prevenar 13 EPAR">{{cite web | title=Prevenar 13 EPAR | website=[[European Medicines Agency]] (EMA) | date=26 March 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-13 | access-date=26 March 2020 | archive-date=26 February 2021 | archive-url=https://web.archive.org/web/20210226205639/https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-13 | url-status=live }} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> In February 2010, Prevnar 13 was approved in the United States to replace Prevnar (PCV7), the pneumococcal 7-valent conjugate vaccine (PCV7).<ref name="FDA PR 20100224">{{cite press release |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm |title=FDA Approves Pneumococcal Disease Vaccine with Broader Protection |date=24 February 2010 | access-date=9 September 2010 |url-status=dead |archive-url=https://web.archive.org/web/20100911195649/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm |archive-date=11 September 2010 }} {{PD-notice}}</ref><ref>{{cite web | title=Prevnar 13 | website=U.S. [[Food and Drug Administration]] (FDA) | date=12 March 2010 | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667.htm | archive-url=https://web.archive.org/web/20100312165333/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667.htm | archive-date=12 March 2010 | url-status=unfit | access-date=27 November 2019}} {{PD-notice}}</ref> After waiting for the outcome of a trial underway in the Netherlands, the [[Centers for Disease Control and Prevention]] (CDC) recommended the vaccine for adults over age 65 in August 2014.<ref>{{cite web |url=http://www.marketwatch.com/story/advisory-committee-on-immunization-practices-votes-to-recommend-pfizers-prevnar-13-vaccine-in-adults-aged-65-years-and-older-2014-08-13 |title=Advisory Committee on Immunization Practices Votes to Recommend Pfizer's Prevnar 13 Vaccine in Adults Aged 65 Years and Older |website=MarketWatch.com |date=13 August 2014 |access-date=27 April 2017 |archive-date=4 March 2016 |archive-url=https://web.archive.org/web/20160304002106/http://www.marketwatch.com/story/advisory-committee-on-immunization-practices-votes-to-recommend-pfizers-prevnar-13-vaccine-in-adults-aged-65-years-and-older-2014-08-13 |url-status=live }}</ref>


Prevnar (PCV7) is a heptavalent vaccine, meaning that it contains the [[cell capsule]] sugars of seven [[serotype]]s of the bacteria ''S. pneumoniae'' (4, 6B, 9V, 14, 18C, 19F, and 23F) conjugated with [[diphtheria]] [[proteins]].<ref name="Prevnar FDA">{{cite web | title=Prevnar | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=25 May 2022 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar | access-date=22 September 2022 | archive-date=1 September 2022 | archive-url=https://web.archive.org/web/20220901043127/http://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar | url-status=live }}</ref> It was manufactured by [[Wyeth]].<ref name="Prevnar FDA 2">{{cite web | title=Prevnar | publisher=U.S. [[Food and Drug Administration]] (FDA) | date=24 August 2009 | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm180017.htm | access-date=29 September 2022 | archive-date=22 July 2017 | archive-url=https://wayback.archive-it.org/7993/20170722071713/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm180017.htm | url-status=dead }}</ref><ref name="Wyeth_Prevnar_Product_Flyer">{{cite web|url=http://www.wyeth.com/content/ShowLabeling.asp?id=134|title=Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM<sub>197</sub> Protein)|publisher=Wyeth|year=2006|url-status=dead|archive-url=https://web.archive.org/web/20060615072237/http://www.wyeth.com/content/ShowLabeling.asp?id=134|archive-date=15 June 2006}}</ref> Prevnar (PCV7) was approved for use in the United States in February 2000,<ref name="Prevnar FDA 2" /><ref>{{cite web | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm137057.htm | title=February 17, 2000 Approval Letter | publisher=U.S. [[Food and Drug Administration]] (FDA) | archive-url=https://web.archive.org/web/20090710171352/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm137057.htm | archive-date=10 July 2009 | url-status=dead}} {{PD-notice}}</ref><ref name="CDC In Depth">{{cite web | title=Pneumococcal Vaccination: What Everyone Should Know | publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) | date=24 January 2022 | url=https://www.cdc.gov/vaccines/vpd/pneumo/public/index.html | access-date=15 December 2022 | archive-date=12 November 2019 | archive-url=https://web.archive.org/web/20191112003154/https://www.cdc.gov/vaccines/vpd/pneumo/public/index.html | url-status=live }} {{PD-notice}}</ref> and vaccination with Prevnar was recommended for all children younger than two years and for unvaccinated children between 24 and 59 months old who were at high risk for pneumococcal infections.<ref name="aap">{{cite journal | vauthors = | title = American Academy of Pediatrics. Committee on Infectious Diseases. Policy statement: recommendations for the prevention of pneumococcal infections, including the use of pneumococcal conjugate vaccine (Prevnar), pneumococcal polysaccharide vaccine, and antibiotic prophylaxis | journal = Pediatrics | volume = 106 | issue = 2 Pt 1 | pages = 362–366 | date = August 2000 | pmid = 10920169 | doi = 10.1542/peds.106.2.362 | doi-access = | title-link = doi | s2cid = 33310899 }}</ref>
The second version, Prevnar 13 (PCV13), contained thirteen serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).<ref name="Prevnar 13 FDA">{{cite web | title=Prevnar 13 | website=U.S. [[Food and Drug Administration]] (FDA) | date=1 March 2018 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-13 | archive-url=https://web.archive.org/web/20191127192849/https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-13 | archive-date=27 November 2019 | url-status=live | access-date=27 September 2019 | id=STN 125324}} {{PD-notice}}</ref><ref name="Prevnar 13 FDA label">{{cite web |title=Prevnar 13 – pneumococcal 13-valent conjugate vaccine injection, suspension |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d49181b-b974-a5da-3b38-12a3a87bb96b |url-status=live |archive-url=https://web.archive.org/web/20210821081836/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d49181b-b974-a5da-3b38-12a3a87bb96b |archive-date=21 August 2021 |access-date=20 August 2021 |website=DailyMed}}</ref> It replaced Prevnar, the pneumococcal heptavalent conjugate vaccine (PCV7).<ref name="FDA PR 20100224" /><ref>{{cite press release | title=Pfizer And Wyeth Become One: Working Together For A Healthier World | website=Pfizer | date=15 October 2009 | url=https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_wyeth_become_one_working_together_for_a_healthier_world | access-date=15 December 2022 | archive-date=15 December 2022 | archive-url=https://web.archive.org/web/20221215083304/https://www.pfizer.com/news/press-release/press-release-detail/pfizer_and_wyeth_become_one_working_together_for_a_healthier_world | url-status=live }}</ref> Prevnar 13 was approved for use in the European Union in December 2009.<ref name="Prevenar 13 EPAR">{{cite web | title=Prevenar 13 EPAR | website=[[European Medicines Agency]] (EMA) | date=26 March 2020 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-13 | access-date=26 March 2020 | archive-date=26 February 2021 | archive-url=https://web.archive.org/web/20210226205639/https://www.ema.europa.eu/en/medicines/human/EPAR/prevenar-13 | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> In February 2010, Prevnar 13 was approved in the United States to replace Prevnar.<ref name="FDA PR 20100224">{{cite press release |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm |title=FDA Approves Pneumococcal Disease Vaccine with Broader Protection |date=24 February 2010 | access-date=9 September 2010 |url-status=dead |archive-url=https://web.archive.org/web/20100911195649/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201758.htm |archive-date=11 September 2010 }} {{PD-notice}}</ref><ref>{{cite web | title=Prevnar 13 | website=U.S. [[Food and Drug Administration]] (FDA) | date=12 March 2010 | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667.htm | archive-url=https://web.archive.org/web/20100312165333/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667.htm | archive-date=12 March 2010 | url-status=unfit | access-date=27 November 2019}} {{PD-notice}}</ref> After waiting for the outcome of a trial underway in the Netherlands, the [[Centers for Disease Control and Prevention]] (CDC) recommended the vaccine for adults over age 65 in August 2014.<ref>{{cite web |url=http://www.marketwatch.com/story/advisory-committee-on-immunization-practices-votes-to-recommend-pfizers-prevnar-13-vaccine-in-adults-aged-65-years-and-older-2014-08-13 |title=Advisory Committee on Immunization Practices Votes to Recommend Pfizer's Prevnar 13 Vaccine in Adults Aged 65 Years and Older |website=MarketWatch.com |date=13 August 2014 |access-date=27 April 2017 |archive-date=4 March 2016 |archive-url=https://web.archive.org/web/20160304002106/http://www.marketwatch.com/story/advisory-committee-on-immunization-practices-votes-to-recommend-pfizers-prevnar-13-vaccine-in-adults-aged-65-years-and-older-2014-08-13 |url-status=live }}</ref>


The first version, the heptavalent Prevnar (PCV7), was produced from the seven most prevalent strains of ''[[Streptococcus pneumoniae]]'' [[bacteria]] in the U.S. (4, 6B, 9V, 14, 18C, 19F, and 23F). Prevnar was approved for use in the United States in February 2000,<ref name="Prevnar FDA 2">{{cite web |date=24 August 2009 |title=Prevnar |url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm180017.htm |url-status=dead |archive-url=https://wayback.archive-it.org/7993/20170722071713/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm180017.htm |archive-date=22 July 2017 |access-date=29 September 2022 |publisher=U.S. [[Food and Drug Administration]] (FDA)}}</ref><ref>{{cite web |title=February 17, 2000 Approval Letter |url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm137057.htm |url-status=dead |archive-url=https://web.archive.org/web/20090710171352/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm137057.htm |archive-date=10 July 2009 |publisher=U.S. [[Food and Drug Administration]] (FDA)}} {{PD-notice}}</ref><ref name="CDC In Depth">{{cite web |date=24 January 2022 |title=Pneumococcal Vaccination: What Everyone Should Know |url=https://www.cdc.gov/vaccines/vpd/pneumo/public/index.html |url-status=live |archive-url=https://web.archive.org/web/20191112003154/https://www.cdc.gov/vaccines/vpd/pneumo/public/index.html |archive-date=12 November 2019 |access-date=15 December 2022 |publisher=U.S. [[Centers for Disease Control and Prevention]] (CDC) }} {{PD-notice}}</ref> and vaccination with Prevnar was recommended for all children younger than 2 years and for unvaccinated children between 24 and 59 months old who were at high risk for pneumococcal infections. The formulation resulted in a 98% probability of protection against the constituent strains, which caused 80% of the pneumococcal disease in infants in the U.S. PCV7 is no longer produced.<ref>{{Cite web |url=https://www.who.int/immunization/sage/meetings/2017/october/4_PCV_WG_MERGED_Evidence_to_Rec__SEPT_26.pdf |title=WHO SAGE evidence to recommendations table |access-date=6 April 2020 |archive-date=9 May 2021 |archive-url=https://web.archive.org/web/20210509140221/https://www.who.int/immunization/sage/meetings/2017/october/4_PCV_WG_MERGED_Evidence_to_Rec__SEPT_26.pdf |url-status=live | publisher=[[World Health Organization]] (WHO) }}</ref>
Prevnar (PCV7) was produced from the seven most prevalent strains of ''[[Streptococcus pneumoniae]]'' [[bacteria]] in the U.S. The bacterial capsule sugars, a characteristic of these pathogens, are linked (conjugated) to [[CRM197]], a nontoxic recombinant variant of [[diphtheria]] toxin (from cultures of ''[[Corynebacterium diphtheriae]]'').<ref name=":0" /> This produces a more robust immune response (in most healthy persons). Further, aluminum is also added to the vaccine serum because it is an adjuvant, meaning it further enhances the immune response.<ref name=":0" />


The vaccine's [[polysaccharide]] sugars are grown separately in soy peptone broths.<ref name=":0" /> Through [[reductive amination]], the sugars are directly conjugated to the protein carrier CRM<sub>197</sub> to form the [[glycoconjugate]].<ref name=":0" /> CRM<sub>197</sub> is grown in ''C. diphtheriae'' strain C7 in a medium of [[casamino acid]]s and [[yeast extract]]s.<ref>{{cite web |url=http://www.rxlist.com/cgi/generic/prevnar.htm |title=Prevnar (Pneumococcal 7-valent Conjugate) drug description - prescription drugs and medications at RxList |access-date=21 November 2007 |url-status=dead |archive-url=https://web.archive.org/web/20071211081606/http://www.rxlist.com/cgi/generic/prevnar.htm |archive-date=11 December 2007 }}</ref><ref name=":0" />
In the Prevnar vaccines, the bacterial [[cell capsule]] sugars, a characteristic of these pathogens, are linked (conjugated) through [[reductive amination]] to [[CRM197]], a nontoxic recombinant variant of [[diphtheria]] toxin. CRM197 is derived from the C7 strain of ''[[Corynebacterium diphtheriae]]'' grown in a medium of [[casamino acid]]s and [[yeast extract]]s.<ref name=":0" /><ref>{{cite web |title=Prevnar (Pneumococcal 7-valent Conjugate) drug description prescription drugs and medications at RxList |url=http://www.rxlist.com/cgi/generic/prevnar.htm |url-status=dead |archive-url=https://web.archive.org/web/20071211081606/http://www.rxlist.com/cgi/generic/prevnar.htm |archive-date=11 December 2007 |access-date=21 November 2007}}</ref> Bacteria bearing the vaccine's [[polysaccharide]] sugars are grown separately in soy peptone broths. The resulting [[glycoconjugate]]<ref name=":0" /> produces a more robust immune response in most healthy persons. Aluminum is also added to the vaccine as an [[Immunologic adjuvant|adjuvant]], further enhancing the immune response.<ref name=":0" />

The Prevnar (PCV7) seven-valent formulation (PCV7) contains [[serotype]]s 4, 6B, 9V, 14, 18C, 19F, and 23F, and resulted in a 98% probability of protection against these strains, which caused 80% of the pneumococcal disease in infants in the U.S. PCV7 is no longer produced.<ref>{{Cite web |url=https://www.who.int/immunization/sage/meetings/2017/october/4_PCV_WG_MERGED_Evidence_to_Rec__SEPT_26.pdf |title=WHO SAGE evidence to recommendations table |access-date=6 April 2020 |archive-date=9 May 2021 |archive-url=https://web.archive.org/web/20210509140221/https://www.who.int/immunization/sage/meetings/2017/october/4_PCV_WG_MERGED_Evidence_to_Rec__SEPT_26.pdf |url-status=live }}</ref>

Prevnar 13 (PCV13) was approved for medical use in the US in 2010.<ref>{{cite web | title=Prevnar 13 | website=U.S. [[Food and Drug Administration]] (FDA) | date=24 February 2010 | url=https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667.htm | access-date=15 December 2022 | archive-url=https://wayback.archive-it.org/7993/20170722071714/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667.htm | archive-date=22 July 2017 | url-status = dead }}</ref> PCV13 contains six additional strains (1, 3, 5, 6A, 19A and 7F).<ref>{{cite journal | title = Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children - Advisory Committee on Immunization Practices (ACIP), 2010 | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 59 | issue = 9 | pages = 258–261 | date = March 2010 | pmid = 20224542 | url = <!-- Official URL --> https://www.cdc.gov/mmwr/pdf/wk/mm5909.pdf | access-date = 29 September 2022 | url-status = live | archive-url = https://web.archive.org/web/20220618113957/https://www.cdc.gov/mmwr/PDF/wk/mm5909.pdf | archive-date = 18 June 2022 | author1 = Centers for Disease Control Prevention (CDC) }}</ref>

In June 2021, the U.S. [[Food and Drug Administration]] (FDA) approved the pneumococcal 20-valent conjugate vaccine, sold under the brand name Prevnar 20 (PCV20), for adults 18 years of age and older.<ref name="FDA Prevnar 20" /><ref name="Prevnar 20 FDA label" /> It is an icosavalent pneumococcal conjugate vaccine, which includes the serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.<ref name="FDA Prevnar 20">{{cite web |url=https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20 |title=Prevnar 20 |date=10 June 2021 |publisher=U.S. [[Food and Drug Administration]] (FDA) |access-date=20 June 2021 |archive-date=10 June 2021 |archive-url=https://web.archive.org/web/20210610025858/https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20 |url-status=live }} {{PD-notice}}</ref><ref name="Prevnar 20 FDA label">{{cite web | title=Prevnar 20- pneumococcal 20-valent conjugate vaccine injection, suspension | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4e2cf51-e6a8-4103-bb1d-6120c6474ff8 | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821081836/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4e2cf51-e6a8-4103-bb1d-6120c6474ff8 | url-status=live }}</ref> In February 2022, the European Medicines Agency approved PCV20 under the brand name Apexxnar.<ref name="Apexxnar EPAR" /><ref name="Apexxnar PR">{{cite press release | title=European Medicines Agency Approves Pfizer's 20-Valent Pneumococcal Conjugate Vaccine Against Invasive Pneumococcal Disease and Pneumonia in Adults (EU Apexxnar, U.S. Prevnar 20) | website=[[Pfizer]] | date=15 February 2022 | url=https://www.pfizer.com/news/press-release/press-release-detail/european-medicines-agency-approves-pfizers-20-valent | access-date=9 June 2022 | archive-date=7 June 2022 | archive-url=https://web.archive.org/web/20220607163656/https://www.pfizer.com/news/press-release/press-release-detail/european-medicines-agency-approves-pfizers-20-valent | url-status=live }}</ref>

In April 2023, the FDA approved Prevnar 20 for the prevention of invasive disease caused by the 20 different serotypes of Streptococcus pneumoniae contained in the vaccine for individuals six weeks through 17 years of age; and for the prevention of otitis media (ear infection) caused by 7 of the serotypes of Streptococcus pneumoniae contained in the vaccine for children six weeks through 5 years of age.<ref name="FDA PR 20230428">{{cite web | title=FDA Roundup: April 28, 2023 | website=U.S. Food and Drug Administration | date=28 April 2023 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-april-28-2023 | access-date=29 April 2023 | archive-date=29 April 2023 | archive-url=https://web.archive.org/web/20230429053758/https://www.fda.gov/news-events/press-announcements/fda-roundup-april-28-2023 | url-status=live }} {{PD-notice}}</ref>

On June 22, 2023, the [[Advisory Committee on Immunization Practices]] (ACIP) approved PCV20 (Prevnar 20) for use in U.S. children.<ref>{{Cite journal |last=CDCMMWR |date=2023 |title=ACIP Updates: Recommendations for Use of 20-Valent Pneumococcal Conjugate Vaccine in Children ― United States, 2023 |url=https://www.cdc.gov/mmwr/volumes/72/wr/mm7239a5.htm |journal=MMWR. Morbidity and Mortality Weekly Report |language=en-us |volume=72 |issue=39 |page=1072 |doi=10.15585/mmwr.mm7239a5 |issn=0149-2195 |pmc=10545431 |pmid=37768876}}</ref>


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===Vaxneuvance===
===Vaxneuvance===
Vaxneuvance is a pneumococcal 15-valent conjugate vaccine created by Merck that was approved for medical use in the United States in July 2021.<ref name="Vaxneuvance FDA label"/><ref name="FDA Vaxneuvance">{{cite web | title=Vaxneuvance | website=U.S. [[Food and Drug Administration]] (FDA) | date=30 July 2021 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxneuvance | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821080521/https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxneuvance | url-status=live }} {{PD-notice}}</ref> The vaccine was developed under the code name "V114".<ref>{{cite web |date=27 January 2022 |title=GRADE: 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal conjugate vaccine (PPSV23) for adults aged ≥65 years {{!}} CDC |url=https://www.cdc.gov/vaccines/acip/recs/grade/pneumo-PCV15-PPSV23-age-based.html |access-date=9 August 2022 |website=www.cdc.gov |language=en-us |archive-date=9 August 2022 |archive-url=https://web.archive.org/web/20220809141204/https://www.cdc.gov/vaccines/acip/recs/grade/pneumo-PCV15-PPSV23-age-based.html |url-status=live }}</ref> It is identical to PCV13, except that it adds serotypes 22F and 33F.<ref name=":1">{{cite journal | vauthors = Stacey HL, Rosen J, Peterson JT, Williams-Diaz A, Gakhar V, Sterling TM, Acosta CJ, Nolan KM, Li J, Pedley A, Benner P, Abeygunawardana C, Kosinski M, Smith WJ, Pujar H, Musey LK | display-authors = 6 | title = Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults | journal = Human Vaccines & Immunotherapeutics | volume = 15 | issue = 3 | pages = 530–539 | date = 2019 | pmid = 30648919 | pmc = 6605726 | doi = 10.1080/21645515.2018.1532249 }}</ref> These two serotypes are particularly important because, after "widespread use of the PCV13…[vaccine] in many countries," these two serotypes are now "among leading serotypes causing IPD in children and adults."<ref name=":1" />
Vaxneuvance is a pneumococcal 15-valent conjugate vaccine created by Merck that was approved for medical use in the United States in July 2021.<ref name="Vaxneuvance FDA label"/><ref name="FDA Vaxneuvance">{{cite web | title=Vaxneuvance | website=U.S. [[Food and Drug Administration]] (FDA) | date=30 July 2021 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxneuvance | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821080521/https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxneuvance | url-status=live }} {{PD-notice}}</ref> The vaccine was developed under the code name "V114".<ref>{{cite web |date=27 January 2022 |title=GRADE: 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal conjugate vaccine (PPSV23) for adults aged ≥65 years |url=https://www.cdc.gov/vaccines/acip/recs/grade/pneumo-PCV15-PPSV23-age-based.html |access-date=9 August 2022 |website=U.S. [[Centers for Disease Control and Prevention]] (CDC) |archive-date=9 August 2022 |archive-url=https://web.archive.org/web/20220809141204/https://www.cdc.gov/vaccines/acip/recs/grade/pneumo-PCV15-PPSV23-age-based.html |url-status=live }}</ref> It is identical to PCV13, except that it adds serotypes 22F and 33F.<ref name=":1">{{cite journal | vauthors = Stacey HL, Rosen J, Peterson JT, Williams-Diaz A, Gakhar V, Sterling TM, Acosta CJ, Nolan KM, Li J, Pedley A, Benner P, Abeygunawardana C, Kosinski M, Smith WJ, Pujar H, Musey LK | title = Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults | journal = Human Vaccines & Immunotherapeutics | volume = 15 | issue = 3 | pages = 530–539 | date = 2019 | pmid = 30648919 | pmc = 6605726 | doi = 10.1080/21645515.2018.1532249 }}</ref> These two serotypes are particularly important because, after "widespread use of the PCV13...[vaccine] in many countries," these two serotypes are now "among leading serotypes causing IPD in children and adults."<ref name=":1" />


Vaxneuvance is indicated for the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.<ref name="Vaxneuvance FDA label"/><ref name="FDA Vaxneuvance" /><ref>{{cite press release | title=Merck Announces U.S. FDA Approval of Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in individuals 6 weeks of age and older Caused by 15 Serotypes | publisher=Merck | via=Business Wire | date=16 July 2021 | url=https://www.businesswire.com/news/home/20210716005480/en/Merck-Announces-U.S.-FDA-Approval-of-VAXNEUVANCE%E2%84%A2-Pneumococcal-15-valent-Conjugate-Vaccine-for-the-Prevention-of-Invasive-Pneumococcal-Disease-in-Adults-18-Years-and-Older-Caused-by-15-Serotypes | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821083113/https://www.businesswire.com/news/home/20210716005480/en/Merck-Announces-U.S.-FDA-Approval-of-VAXNEUVANCE%E2%84%A2-Pneumococcal-15-valent-Conjugate-Vaccine-for-the-Prevention-of-Invasive-Pneumococcal-Disease-in-Adults-18-Years-and-Older-Caused-by-15-Serotypes | url-status=live }}</ref>
Vaxneuvance is indicated for the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.<ref name="Vaxneuvance FDA label"/><ref name="FDA Vaxneuvance" /><ref>{{cite press release | title=Merck Announces U.S. FDA Approval of Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in individuals 6 weeks of age and older Caused by 15 Serotypes | publisher=Merck | via=Business Wire | date=16 July 2021 | url=https://www.businesswire.com/news/home/20210716005480/en/Merck-Announces-U.S.-FDA-Approval-of-VAXNEUVANCE%E2%84%A2-Pneumococcal-15-valent-Conjugate-Vaccine-for-the-Prevention-of-Invasive-Pneumococcal-Disease-in-Adults-18-Years-and-Older-Caused-by-15-Serotypes | access-date=20 August 2021 | archive-date=21 August 2021 | archive-url=https://web.archive.org/web/20210821083113/https://www.businesswire.com/news/home/20210716005480/en/Merck-Announces-U.S.-FDA-Approval-of-VAXNEUVANCE%E2%84%A2-Pneumococcal-15-valent-Conjugate-Vaccine-for-the-Prevention-of-Invasive-Pneumococcal-Disease-in-Adults-18-Years-and-Older-Caused-by-15-Serotypes | url-status=live }}</ref>


On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vaxneuvance, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease.<ref name="Vaxneuvance: Pending EC decision" /> The applicant for this medicinal product is Merck Sharp & Dohme B.V.<ref name="Vaxneuvance: Pending EC decision">{{cite web | title=Vaxneuvance: Pending EC decision | website=[[European Medicines Agency]] (EMA) | date=13 October 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vaxneuvance | access-date=15 October 2021 | archive-date=18 October 2021 | archive-url=https://web.archive.org/web/20211018120605/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vaxneuvance | url-status=live }} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Vaxneuvance was approved for medical use in the European Union in December 2021.<ref name="Vaxneuvance EPAR">{{cite web | title=Vaxneuvance EPAR | website=[[European Medicines Agency]] (EMA) | date=12 October 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vaxneuvance | access-date=17 January 2022 | archive-date=18 January 2022 | archive-url=https://web.archive.org/web/20220118182730/https://www.ema.europa.eu/en/medicines/human/EPAR/vaxneuvance | url-status=live }} Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref name="Vaxneuvance EU">{{cite web | title=Vaxneuvance | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1591.htm | access-date=11 January 2022 | archive-date=11 January 2022 | archive-url=https://web.archive.org/web/20220111231101/https://ec.europa.eu/health/documents/community-register/html/h1591.htm | url-status=live }}</ref>
On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vaxneuvance, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease.<ref name="Vaxneuvance: Pending EC decision" /> The applicant for this medicinal product is Merck Sharp & Dohme B.V.<ref name="Vaxneuvance: Pending EC decision">{{cite web | title=Vaxneuvance: Pending EC decision | website=[[European Medicines Agency]] (EMA) | date=13 October 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vaxneuvance | access-date=15 October 2021 | archive-date=18 October 2021 | archive-url=https://web.archive.org/web/20211018120605/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vaxneuvance | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Vaxneuvance was approved for medical use in the European Union in December 2021.<ref name="Vaxneuvance EPAR">{{cite web | title=Vaxneuvance EPAR | website=[[European Medicines Agency]] (EMA) | date=12 October 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/vaxneuvance | access-date=17 January 2022 | archive-date=18 January 2022 | archive-url=https://web.archive.org/web/20220118182730/https://www.ema.europa.eu/en/medicines/human/EPAR/vaxneuvance | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref name="Vaxneuvance EU">{{cite web | title=Vaxneuvance | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1591.htm | access-date=11 January 2022 | archive-date=11 January 2022 | archive-url=https://web.archive.org/web/20220111231101/https://ec.europa.eu/health/documents/community-register/html/h1591.htm | url-status=live }}</ref>


==Schedule of vaccination==
==Schedule of vaccination==
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As with all immunizations, whether it is available or required, and under what circumstances, varies according to the decisions made by local public health agencies.
As with all immunizations, whether it is available or required, and under what circumstances, varies according to the decisions made by local public health agencies.


Children under the age of two years fail to mount an adequate response to the 23-valent adult vaccine, and so a pneumococcal conjugate vaccine is used. While this covers only seven strains out of more than ninety strains, these seven strains cause 80% to 90% of cases of severe pneumococcal disease, and it is considered to be nearly 100% effective against these strains.<ref>{{cite web|url-status=dead|url=http://www.health.vic.gov.au/immunisation/factsheets/pneumo_child.htm|title=Childhood Pneumococcal Disease|archiveurl=https://web.archive.org/web/20061025233540/http://www.health.vic.gov.au/immunisation/factsheets/pneumo_child.htm |archive-date=25 October 2006|date=21 March 2006}} - information on the disease and the Prevnar vaccine, from the Victoria State (Australia) government. Includes possible side effects.</ref>
Children under the age of two years fail to mount an adequate response to the 23-valent adult vaccine, and so a pneumococcal conjugate vaccine is used. While this covers only seven strains out of more than ninety strains, these seven strains cause 80% to 90% of cases of severe pneumococcal disease, and it is considered to be nearly 100% effective against these strains.<ref>{{cite web |date=21 March 2006 |title=Childhood Pneumococcal Disease |url=http://www.health.vic.gov.au/immunisation/factsheets/pneumo_child.htm |url-status=dead |archiveurl=https://web.archive.org/web/20061025233540/http://www.health.vic.gov.au/immunisation/factsheets/pneumo_child.htm |archive-date=25 October 2006}} Information on the disease and the Prevnar vaccine, from the Victoria State (Australia) government; includes possible side effects.</ref>


===United Kingdom===
===United Kingdom===
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===United States===
===United States===
In 2001, the [[Centers for Disease Control and Prevention]] (CDC), upon advice from its [[Advisory Committee on Immunization Practices]] (ACIP), recommended the vaccine be administered to every infant and young child in the United States. The resulting demand outstripped production, creating shortages not resolved until 2004. All children, according to the U.S. [[vaccination schedule]], should receive four doses, at two months, four months, six months, and again between one year and fifteen months of age.<ref>{{cite web | title=Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2019 | website=[[Centers for Disease Control and Prevention]] (CDC) | date=5 February 2019 | url=https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html | access-date=3 November 2019 | archive-date=6 March 2016 | archive-url=https://web.archive.org/web/20160306220930/http://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html | url-status=live }}</ref><ref>{{cite journal | vauthors = Nuorti JP, Whitney CG | title = Prevention of pneumococcal disease among infants and children - use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine - recommendations of the Advisory Committee on Immunization Practices (ACIP) | journal = MMWR. Recommendations and Reports | volume = 59 | issue = RR-11 | pages = 1–18 | date = December 2010 | pmid = 21150868 | doi = | url = https://www.cdc.gov/mmwr/pdf/rr/rr5911.pdf | access-date = 20 November 2021 | url-status = live | archive-url = https://web.archive.org/web/20210902235514/https://www.cdc.gov/mmwr/pdf/rr/rr5911.pdf | archive-date = 2 September 2021 }}</ref>
In 2001, the [[Centers for Disease Control and Prevention]] (CDC), upon advice from its [[Advisory Committee on Immunization Practices]] (ACIP), recommended the vaccine be administered to every infant and young child in the United States. The resulting demand outstripped production, creating shortages not resolved until 2004. All children, according to the U.S. [[vaccination schedule]], should receive four doses, at two months, four months, six months, and again between one year and fifteen months of age.<ref>{{cite web | title=Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2019 | website=[[Centers for Disease Control and Prevention]] (CDC) | date=5 February 2019 | url=https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html | access-date=3 November 2019 | archive-date=6 March 2016 | archive-url=https://web.archive.org/web/20160306220930/http://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html | url-status=live }}</ref><ref>{{cite journal |vauthors=Nuorti JP, Whitney CG |date=December 2010 |title=Prevention of pneumococcal disease among infants and children use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) |url=https://www.cdc.gov/mmwr/pdf/rr/rr5911.pdf |url-status=live |journal=MMWR. Recommendations and Reports |volume=59 |issue=RR-11 |pages=1–18 |doi= |pmid=21150868 |archive-url=https://web.archive.org/web/20210902235514/https://www.cdc.gov/mmwr/pdf/rr/rr5911.pdf |archive-date=2 September 2021 |access-date=20 November 2021}}</ref>


The CDC updated the pneumococcal vaccine guidelines for adults 65 years of age or older in 2019.<ref>{{cite journal | vauthors = Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T | title = Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 68 | issue = 46 | pages = 1069–1075 | date = November 2019 | pmid = 31751323 | pmc = 6871896 | doi = 10.15585/mmwr.mm6846a5 | url = https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6846a5-H.pdf | access-date = 20 November 2021 | url-status = live | archive-url = https://web.archive.org/web/20211120064309/https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6846a5-H.pdf | archive-date = 20 November 2021 }}</ref>
The CDC updated the pneumococcal vaccine guidelines for adults 65 years of age or older in 2019.<ref>{{cite journal | vauthors = Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T | title = Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 68 | issue = 46 | pages = 1069–1075 | date = November 2019 | pmid = 31751323 | pmc = 6871896 | doi = 10.15585/mmwr.mm6846a5 | url = https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6846a5-H.pdf | access-date = 20 November 2021 | url-status = live | archive-url = https://web.archive.org/web/20211120064309/https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6846a5-H.pdf | archive-date = 20 November 2021 }}</ref>


In October 2021, the CDC recommended that adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15).<ref name="ACIP Recommendations" /> If PCV15 is used, this should be followed by a dose of PPSV23.<ref name="ACIP Recommendations">{{cite web | title=ACIP Vaccine Recommendations and Schedules | website=[[Centers for Disease Control and Prevention]] (CDC) | url=https://www.cdc.gov/vaccines/acip/recommendations.html | access-date=19 November 2021 | archive-date=20 November 2021 | archive-url=https://web.archive.org/web/20211120063030/https://www.cdc.gov/vaccines/acip/recommendations.html | url-status=live }} {{PD-notice}}</ref> The CDC recommended that adults aged 19 to 64 years with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15).<ref name="ACIP Recommendations" />
In October 2021, the CDC recommended that adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15).<ref name="ACIP Recommendations" /> If PCV15 is used, this should be followed by a dose of PPSV23.<ref name="ACIP Recommendations">{{cite web | title=ACIP Vaccine Recommendations and Schedules | website=[[Centers for Disease Control and Prevention]] (CDC) | url=https://www.cdc.gov/vaccines/acip/recommendations.html | access-date=19 November 2021 | archive-date=20 November 2021 | archive-url=https://web.archive.org/web/20211120063030/https://www.cdc.gov/vaccines/acip/recommendations.html | url-status=live }} {{PD-notice}}</ref> The CDC recommended that adults aged 19 to 64 years with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15).<ref name="ACIP Recommendations" />

The CDC published revised and consolidated guidelines in September 2023, for adults aged 19 years of age and older.<ref>{{cite journal | vauthors = Kobayashi M, Pilishvili T, Farrar JL, Leidner AJ, Gierke R, Prasad N, Moro P, Campos-Outcalt D, Morgan RL, Long SS, Poehling KA, Cohen AL | title = Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023 | journal = MMWR. Recommendations and Reports | volume = 72 | issue = 3 | pages = 1–39 | date = September 2023 | pmid = 37669242 | pmc = 10495181 | doi = 10.15585/mmwr.rr7203a1 }}</ref>


==Efficacy==
==Efficacy==
[[File:US incidence of invasive streptococcal disease before and after vaccine introduction.jpg|thumb|left|alt=United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines.|United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines.<ref>{{cite web |url=https://www.cdc.gov/abcs/reports-findings/surv-reports.html |title=CDC - ABCs: Surveillance Reports main page - Active Bacterial Core surveillance |date=19 July 2021 |access-date=10 September 2017 |archive-date=1 December 2020 |archive-url=https://web.archive.org/web/20201201131012/https://www.cdc.gov/abcs/reports-findings/surv-reports.html |url-status=live }}</ref>]]
[[File:US incidence of invasive streptococcal disease before and after vaccine introduction.jpg|thumb|upright=1.2|left|alt=United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines.|United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines.<ref>{{cite web |date=19 July 2021 |title=CDC ABCs: Surveillance Reports main page Active Bacterial Core surveillance |url=https://www.cdc.gov/abcs/reports-findings/surv-reports.html |url-status=live |archive-url=https://web.archive.org/web/20201201131012/https://www.cdc.gov/abcs/reports-findings/surv-reports.html |archive-date=1 December 2020 |access-date=10 September 2017}}</ref>]]
Prevnar-7 is designed to stop seven of about ninety pneumococcal serotypes which have the potential to cause invasive [[pneumococcal disease]] (IPD). In 2010, a 13-valent vaccine was introduced. Each year, IPD kills approximately one million children worldwide.<ref>{{cite web | vauthors = Allen A |url= http://www.slate.com/id/2168854/pagenum/all/ |title=What if a vaccine makes room for a new strain of a disease? |website=Slate.com |date=21 June 2007 |access-date=27 April 2017 |archive-date=18 May 2011 |archive-url=https://web.archive.org/web/20110518204510/http://www.slate.com/id/2168854/pagenum/all |url-status=live }}</ref> Since approval, Prevnar's [[vaccine efficacy|efficacy]] in preventing IPD has been documented by a number of [[epidemiology|epidemiologic]] studies.<ref name="pmid12724479">{{cite journal | vauthors = Whitney CG, Farley MM, Hadler J, Harrison LH, Bennett NM, Lynfield R, Reingold A, Cieslak PR, Pilishvili T, Jackson D, Facklam RR, Jorgensen JH, Schuchat A | display-authors = 6 | title = Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine | journal = The New England Journal of Medicine | volume = 348 | issue = 18 | pages = 1737–1746 | date = May 2003 | pmid = 12724479 | doi = 10.1056/NEJMoa022823 | doi-access = free }}</ref><ref name="pmid16609088">{{cite journal | vauthors = Poehling KA, Talbot TR, Griffin MR, Craig AS, Whitney CG, Zell E, Lexau CA, Thomas AR, Harrison LH, Reingold AL, Hadler JL, Farley MM, Anderson BJ, Schaffner W | display-authors = 6 | title = Invasive pneumococcal disease among infants before and after introduction of pneumococcal conjugate vaccine | journal = JAMA | volume = 295 | issue = 14 | pages = 1668–1674 | date = April 2006 | pmid = 16609088 | doi = 10.1001/jama.295.14.1668 | doi-access = }}</ref><ref name="pmid17071283">{{cite journal | vauthors = Whitney CG, Pilishvili T, Farley MM, Schaffner W, Craig AS, Lynfield R, Nyquist AC, Gershman KA, Vazquez M, Bennett NM, Reingold A, Thomas A, Glode MP, Zell ER, Jorgensen JH, Beall B, Schuchat A | display-authors = 6 | title = Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study | journal = Lancet | volume = 368 | issue = 9546 | pages = 1495–1502 | date = October 2006 | pmid = 17071283 | doi = 10.1016/S0140-6736(06)69637-2 | url = https://zenodo.org/record/1259803 | access-date = 5 July 2019 | url-status = live | s2cid = 11834808 | archive-url = https://web.archive.org/web/20201205182840/https://zenodo.org/record/1259803 | archive-date = 5 December 2020 }}</ref> There is evidence that other people in the same household as a vaccinee also become relatively protected.<ref>{{cite journal | vauthors = Millar EV, Watt JP, Bronsdon MA, Dallas J, Reid R, Santosham M, O'Brien KL | title = Indirect effect of 7-valent pneumococcal conjugate vaccine on pneumococcal colonization among unvaccinated household members | journal = Clinical Infectious Diseases | volume = 47 | issue = 8 | pages = 989–996 | date = October 2008 | pmid = 18781875 | doi = 10.1086/591966 | doi-access = free }}</ref>
Prevnar-7 is designed to stop seven of about ninety pneumococcal serotypes which have the potential to cause invasive [[pneumococcal disease]] (IPD). In 2010, a 13-valent vaccine was introduced. Each year, IPD kills approximately one million children worldwide.<ref>{{cite web | vauthors = Allen A |url= http://www.slate.com/id/2168854/pagenum/all/ |title=What if a vaccine makes room for a new strain of a disease? |website=Slate.com |date=21 June 2007 |access-date=27 April 2017 |archive-date=18 May 2011 |archive-url=https://web.archive.org/web/20110518204510/http://www.slate.com/id/2168854/pagenum/all |url-status=live }}</ref> Since approval, Prevnar's [[vaccine efficacy|efficacy]] in preventing IPD has been documented by a number of [[epidemiology|epidemiologic]] studies.<ref name="pmid12724479">{{cite journal | vauthors = Whitney CG, Farley MM, Hadler J, Harrison LH, Bennett NM, Lynfield R, Reingold A, Cieslak PR, Pilishvili T, Jackson D, Facklam RR, Jorgensen JH, Schuchat A | title = Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine | journal = The New England Journal of Medicine | volume = 348 | issue = 18 | pages = 1737–1746 | date = May 2003 | pmid = 12724479 | doi = 10.1056/NEJMoa022823 | doi-access = free }}</ref><ref name="pmid16609088">{{cite journal | vauthors = Poehling KA, Talbot TR, Griffin MR, Craig AS, Whitney CG, Zell E, Lexau CA, Thomas AR, Harrison LH, Reingold AL, Hadler JL, Farley MM, Anderson BJ, Schaffner W | title = Invasive pneumococcal disease among infants before and after introduction of pneumococcal conjugate vaccine | journal = JAMA | volume = 295 | issue = 14 | pages = 1668–1674 | date = April 2006 | pmid = 16609088 | doi = 10.1001/jama.295.14.1668 | doi-access = }}</ref><ref name="pmid17071283">{{cite journal | vauthors = Whitney CG, Pilishvili T, Farley MM, Schaffner W, Craig AS, Lynfield R, Nyquist AC, Gershman KA, Vazquez M, Bennett NM, Reingold A, Thomas A, Glode MP, Zell ER, Jorgensen JH, Beall B, Schuchat A | title = Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study | journal = Lancet | volume = 368 | issue = 9546 | pages = 1495–1502 | date = October 2006 | pmid = 17071283 | doi = 10.1016/S0140-6736(06)69637-2 | url = https://zenodo.org/record/1259803 | access-date = 5 July 2019 | url-status = live | s2cid = 11834808 | archive-url = https://web.archive.org/web/20201205182840/https://zenodo.org/record/1259803 | archive-date = 5 December 2020 }}</ref> There is evidence that other people in the same household as a vaccinee also become relatively protected.<ref>{{cite journal | vauthors = Millar EV, Watt JP, Bronsdon MA, Dallas J, Reid R, Santosham M, O'Brien KL | title = Indirect effect of 7-valent pneumococcal conjugate vaccine on pneumococcal colonization among unvaccinated household members | journal = Clinical Infectious Diseases | volume = 47 | issue = 8 | pages = 989–996 | date = October 2008 | pmid = 18781875 | doi = 10.1086/591966 | doi-access = free }}</ref> There is evidence that routine childhood vaccination reduces the burden of pneumococcal disease in adults and especially high-risk adults, such as those living with [[HIV]]/[[AIDS]].<ref name="Siemieniuk 2011">{{cite journal | vauthors = Siemieniuk RA, Gregson DB, Gill MJ | title = The persisting burden of invasive pneumococcal disease in HIV patients: an observational cohort study | journal = BMC Infectious Diseases | volume = 11 | pages = 314 | date = November 2011 | pmid = 22078162 | pmc = 3226630 | doi = 10.1186/1471-2334-11-314 | doi-access = free }}</ref>
There is evidence that routine childhood vaccination reduces the burden of pneumococcal disease in adults and especially high-risk adults, such as those living with [[HIV]]/[[AIDS]].<ref name="Siemieniuk 2011">{{cite journal | vauthors = Siemieniuk RA, Gregson DB, Gill MJ | title = The persisting burden of invasive pneumococcal disease in HIV patients: an observational cohort study | journal = BMC Infectious Diseases | volume = 11 | pages = 314 | date = November 2011 | pmid = 22078162 | pmc = 3226630 | doi = 10.1186/1471-2334-11-314 | doi-access = free }}</ref>


The vaccine is, however, primarily developed for the U.S. and European epidemiological situation, and therefore it has only a limited coverage of serotypes causing serious pneumococcal infections in most developing countries.<ref name="pmid17324490">{{cite journal | vauthors = Barocchi MA, Censini S, Rappuoli R | title = Vaccines in the era of genomics: the pneumococcal challenge | journal = Vaccine | volume = 25 | issue = 16 | pages = 2963–2973 | date = April 2007 | pmid = 17324490 | doi = 10.1016/j.vaccine.2007.01.065 }}</ref>
The vaccine is, however, primarily developed for the U.S. and European epidemiological situation, and therefore it has a limited coverage of serotypes causing serious pneumococcal infections in most developing countries.<ref name="pmid17324490">{{cite journal | vauthors = Barocchi MA, Censini S, Rappuoli R | title = Vaccines in the era of genomics: the pneumococcal challenge | journal = Vaccine | volume = 25 | issue = 16 | pages = 2963–2973 | date = April 2007 | pmid = 17324490 | doi = 10.1016/j.vaccine.2007.01.065 }}</ref>


==Adverse reactions==
==Adverse reactions==


Local reactions such as pain, swelling, or redness occur in up to 50% of those vaccinated with PCV13; of these, 8% are considered severe. Local reactions are more likely after the 4th dose than the earlier doses.<ref name=Pink2017/> In clinical trials, fever greater than 100.4 F (38 C) was reported at a rate of 24-35% following any dose in the primary series and nonspecific symptoms such as decreased appetite or irritability occur in up to 80% of recipients.<ref name=Pink2017/> In a vaccine safety datalink study, [[febrile seizures]] occurred in roughly 1 in 83,000 to 1 in 6,000 children given PCV 13, and 1 in 21,000 to 1 in 2,000 of those who were given PCV13 and trivalent [[influenza vaccine]] at the same time.<ref name="Pink2017">{{cite web | vauthors = Gierke R, Wodi P, Kobayashi M, Hall E, Hamborsky J |title=Pinkbook Pneumococcal Epidemiology of Vaccine-Preventable Diseases |url=https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html#contraindications |archive-url=https://web.archive.org/web/20220901045810/https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html |archive-date=1 September 2022 |access-date=10 December 2017 |website=U.S. [[Centers for Disease Control and Prevention]] (CDC) |name-list-style=vanc}}</ref>
Local reactions such as pain, swelling, or redness occur in up to 50% of those vaccinated with PCV13; of these, 8% are considered severe. Local reactions are more likely after the 4th dose than the earlier doses.<ref name=Pink2017/> In clinical trials, fever greater than 100.4 F (38 C) was reported at a rate of 24–35% following any dose in the primary series and nonspecific symptoms such as decreased appetite or irritability occur in up to 80% of recipients.<ref name=Pink2017/> In a vaccine safety datalink study, [[febrile seizures]] occurred in roughly 1 in 83,000 to 1 in 6,000 children given PCV 13, and 1 in 21,000 to 1 in 2,000 of those who were given PCV13 and trivalent [[influenza vaccine]] at the same time.<ref name="Pink2017">{{cite web | vauthors = Gierke R, Wodi P, Kobayashi M, Hall E, Hamborsky J |title=Pinkbook Pneumococcal Epidemiology of Vaccine-Preventable Diseases |url=https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html#contraindications |archive-url=https://web.archive.org/web/20220901045810/https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html |archive-date=1 September 2022 |access-date=10 December 2017 |website=U.S. [[Centers for Disease Control and Prevention]] (CDC) }}</ref>


==Evidence supporting addition to routine vaccination schedules==
==Evidence supporting addition to routine vaccination schedules==


After introduction of the pneumococcal conjugate vaccine in 2000, several studies described a decrease in invasive pneumococcal disease in the United States. One year after its introduction, a group of investigators found a 69% drop in the rate of invasive disease in those of less than two years of age.<ref name="pmid12724479"/> By 2004, all-cause pneumonia admission rates had declined by 39% (95% CI 22–52) and rates of hospitalizations for pneumococcal meningitis decreased by 66% (95% CI 56.3-73.5) in children younger than 2.<ref name="pmid17416262">{{cite journal | vauthors = Grijalva CG, Nuorti JP, Arbogast PG, Martin SW, Edwards KM, Griffin MR | title = Decline in pneumonia admissions after routine childhood immunisation with pneumococcal conjugate vaccine in the USA: a time-series analysis | journal = Lancet | volume = 369 | issue = 9568 | pages = 1179–1186 | date = April 2007 | pmid = 17416262 | doi = 10.1016/S0140-6736(07)60564-9 | s2cid = 26494828 }}</ref><ref name="pmid18433334">{{cite journal | vauthors = Tsai CJ, Griffin MR, Nuorti JP, Grijalva CG | title = Changing epidemiology of pneumococcal meningitis after the introduction of pneumococcal conjugate vaccine in the United States | journal = Clinical Infectious Diseases | volume = 46 | issue = 11 | pages = 1664–1672 | date = June 2008 | pmid = 18433334 | pmc = 4822508 | doi = 10.1086/587897 }}</ref>
After introduction of the pneumococcal conjugate vaccine in 2000, several studies described a decrease in invasive pneumococcal disease in the United States. One year after its introduction, a group of investigators found a 69% drop in the rate of invasive disease in those of less than two years of age.<ref name="pmid12724479"/> By 2004, all-cause pneumonia admission rates had declined by 39% (95% CI 22–52) and rates of hospitalizations for pneumococcal meningitis decreased by 66% (95% CI 56.3–73.5) in children younger than 2.<ref name="pmid17416262">{{cite journal | vauthors = Grijalva CG, Nuorti JP, Arbogast PG, Martin SW, Edwards KM, Griffin MR | title = Decline in pneumonia admissions after routine childhood immunisation with pneumococcal conjugate vaccine in the USA: a time-series analysis | journal = Lancet | volume = 369 | issue = 9568 | pages = 1179–1186 | date = April 2007 | pmid = 17416262 | doi = 10.1016/S0140-6736(07)60564-9 | s2cid = 26494828 }}</ref><ref name="pmid18433334">{{cite journal | vauthors = Tsai CJ, Griffin MR, Nuorti JP, Grijalva CG | title = Changing epidemiology of pneumococcal meningitis after the introduction of pneumococcal conjugate vaccine in the United States | journal = Clinical Infectious Diseases | volume = 46 | issue = 11 | pages = 1664–1672 | date = June 2008 | pmid = 18433334 | pmc = 4822508 | doi = 10.1086/587897 }}</ref>


Rates of invasive pneumococcal disease among adults have also declined since the introduction of the vaccine.<ref name="pmid12724479"/><ref name="pmid18433334"/>
Rates of invasive pneumococcal disease among adults have also declined since the introduction of the vaccine.<ref name="pmid12724479"/><ref name="pmid18433334"/>


==Vaccination in low-income countries==
==Vaccination in low-income countries==
<!-- Deleted image removed: [[Image:WorldPneumoniaDeaths.gif|thumb|right|300px|Annual world deaths in children under 5 due to pneumococcal disease]] -->
<!-- Deleted image removed: [[Image:WorldPneumoniaDeaths.gif|thumb|right|300px|Annual world deaths in children under 5 due to pneumococcal disease]] -->[[File:Pneumococcal and rotavirus vaccine coverage (Gavi and non-Gavi countries).svg|thumb|upright=1.5|Evolution of pneumococcal and rotavirus vaccine coverage from 2006 to 2022 in Gavi and non-Gavi countries. Gavi countries are the 54 Gavi 5.0 eligible countries. Coverage data are WHO/UNICEF estimates of the percentage of infants who have received three doses of Pneumococcal conjugate vaccine.]]
Pneumococcal disease is the leading vaccine-preventable killer of young children worldwide, according to the [[World Health Organization]] (WHO). It killed more than 500,000 children younger than five years of age in 2008 alone.<ref name="Lancet 2009">{{cite journal | vauthors = O'Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, McCall N, Lee E, Mulholland K, Levine OS, Cherian T | display-authors = 6 | title = Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates | journal = Lancet | volume = 374 | issue = 9693 | pages = 893–902 | date = September 2009 | pmid = 19748398 | doi = 10.1016/S0140-6736(09)61204-6 | s2cid = 18964449 }}</ref> Approximately ninety percent of these deaths occur in the developing world.<ref name="Lancet 2009"/> Historically 15–20 years pass before a new vaccine reaches one quarter of the population of the developing world.<ref>{{cite web|url=http://www.pneumoadip.com/about_us/need_for_pneumoadip/|archive-url=https://web.archive.org/web/20210827050206/http://www.pneumoadip.com/about_us/need_for_pneumoadip/|url-status=dead|archive-date=27 August 2021|title=PneumoADIP - Need for PneumoADIP|website=Pneumoasdip.com|access-date=27 April 2017}}</ref>
Pneumococcal disease is the leading vaccine-preventable killer of young children worldwide, according to the [[World Health Organization]] (WHO). It killed more than 500,000 children younger than five years of age in 2008 alone.<ref name="Lancet 2009">{{cite journal | vauthors = O'Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, McCall N, Lee E, Mulholland K, Levine OS, Cherian T | title = Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates | journal = Lancet | volume = 374 | issue = 9693 | pages = 893–902 | date = September 2009 | pmid = 19748398 | doi = 10.1016/S0140-6736(09)61204-6 | s2cid = 18964449 }}</ref> Approximately ninety percent of these deaths occur in the developing world.<ref name="Lancet 2009" /> Historically 15–20 years pass before a new vaccine reaches one quarter of the population of the developing world.<ref>{{cite web |title=PneumoADIP – Need for PneumoADIP |url=http://www.pneumoadip.com/about_us/need_for_pneumoadip/ |url-status=dead |archive-url=https://web.archive.org/web/20210827050206/http://www.pneumoadip.com/about_us/need_for_pneumoadip/ |archive-date=27 August 2021 |access-date=27 April 2017 |website=Pneumoasdip.com}}</ref>


[[PneumoADIP|Pneumococcal vaccines Accelerated Development and Introduction Plan (PneumoADIP)]] was a [[Global Alliance for Vaccines and Immunization|GAVI Alliance (GAVI)]] funded project to accelerate the introduction of pneumococcal vaccinations into low-income countries through partnerships between countries, donors, academia, international organizations and industry. GAVI continues this work and as of March 2013, 25 GAVI-eligible and supported countries have introduced the pneumococcal conjugate vaccine. Further, 15 additional GAVI countries have plans to introduce the vaccine into their national immunization program and 23 additional countries have approved GAVI support to introduce the vaccine.<ref name="VIMS Report">{{cite journal|author=Johns Hopkins Bloomberg School of Public Health, International Vaccine Access Center|title=VIMS Report: Global vaccine introduction|year=2013|url=http://www.jhsph.edu/research/centers-and-institutes/ivac/vims/IVAC-VIMS-Report-2013-03.pdf|website=Jhsph.edu|access-date=27 April 2017|archive-date=3 March 2016|archive-url=https://web.archive.org/web/20160303233204/http://www.jhsph.edu/research/centers-and-institutes/ivac/vims/IVAC-VIMS-Report-2013-03.pdf|url-status=live}}</ref>
[[PneumoADIP|Pneumococcal vaccines Accelerated Development and Introduction Plan (PneumoADIP)]] was a [[Global Alliance for Vaccines and Immunization|GAVI Alliance (GAVI)]] funded project to accelerate the introduction of pneumococcal vaccinations into low-income countries through partnerships between countries, donors, academia, international organizations and industry. GAVI continues this work and as of March 2013, 25 GAVI-eligible and supported countries have introduced the pneumococcal conjugate vaccine. Further, 15 additional GAVI countries have plans to introduce the vaccine into their national immunization program and 23 additional countries have approved GAVI support to introduce the vaccine.<ref name="VIMS Report">{{cite journal|author=Johns Hopkins Bloomberg School of Public Health, International Vaccine Access Center|title=VIMS Report: Global vaccine introduction|year=2013|url=http://www.jhsph.edu/research/centers-and-institutes/ivac/vims/IVAC-VIMS-Report-2013-03.pdf|website=Jhsph.edu|access-date=27 April 2017|archive-date=3 March 2016|archive-url=https://web.archive.org/web/20160303233204/http://www.jhsph.edu/research/centers-and-institutes/ivac/vims/IVAC-VIMS-Report-2013-03.pdf|url-status=live}}</ref>
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===Economics===
===Economics===
Prevnar 13 is Pfizer's best-selling product.<ref name=10K>{{cite web | url=https://s21.q4cdn.com/317678438/files/doc_financials/2020/ar/PFE-2020-Form-10K-FINAL.pdf | title=Pfizer Inc. 2020 Form 10-K Annual Report | publisher=Pfizer | access-date=21 August 2021 | archive-date=23 March 2021 | archive-url=https://web.archive.org/web/20210323212110/https://s21.q4cdn.com/317678438/files/doc_financials/2020/ar/PFE-2020-Form-10K-FINAL.pdf | url-status=live }}</ref> It had annual sales of {{US$|5.85}}{{nbsp}}billion in 2020.<ref name=10K /><ref name="statnews-covid19">{{cite web | vauthors = Herper M |date=24 August 2020 |title=In the race for a Covid-19 vaccine, Pfizer turns to a scientist with a history of defying skeptics and getting results |url=https://www.statnews.com/2020/08/24/pfizer-edge-in-the-race-for-a-covid-19-vaccine-could-be-a-scientist-with-two-best-sellers-to-her-credit/ |access-date=2 December 2020 |website=[[Stat (website)|Stat News]] |archive-date=21 December 2020 |archive-url=https://web.archive.org/web/20201221043851/https://www.statnews.com/2020/08/24/pfizer-edge-in-the-race-for-a-covid-19-vaccine-could-be-a-scientist-with-two-best-sellers-to-her-credit/ |url-status=live }}</ref>
Prevnar 13 was Pfizer's best-selling product<ref name=10K>{{cite web | url=https://s21.q4cdn.com/317678438/files/doc_financials/2020/ar/PFE-2020-Form-10K-FINAL.pdf | title=Pfizer Inc. 2020 Form 10-K Annual Report | publisher=Pfizer | access-date=21 August 2021 | archive-date=23 March 2021 | archive-url=https://web.archive.org/web/20210323212110/https://s21.q4cdn.com/317678438/files/doc_financials/2020/ar/PFE-2020-Form-10K-FINAL.pdf | url-status=live }}</ref> with annual sales of {{US$|5.85}}{{nbsp}}billion in 2020.<ref name=10K /><ref name="statnews-covid19">{{cite web |date=24 August 2020 |title=In the race for a Covid-19 vaccine, Pfizer turns to a scientist with a history of defying skeptics and getting results |url=https://www.statnews.com/2020/08/24/pfizer-edge-in-the-race-for-a-covid-19-vaccine-could-be-a-scientist-with-two-best-sellers-to-her-credit/ |url-status=live |archive-url=https://web.archive.org/web/20201221043851/https://www.statnews.com/2020/08/24/pfizer-edge-in-the-race-for-a-covid-19-vaccine-could-be-a-scientist-with-two-best-sellers-to-her-credit/ |archive-date=21 December 2020 |access-date=2 December 2020 |website=[[Stat (website)|Stat News]] |vauthors=Herper M}}</ref>


== Research ==
== Research ==
Merck is investigating a 21-valent vaccine (code named V116) against pneumococcus serotypes.<ref name="NCT05393037" /> The vaccine is geared towards persons living with HIV.<ref name="NCT05393037">{{cite web | title=Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7) | website=ClinicalTrials.gov | date=26 May 2022 | url=https://clinicaltrials.gov/ct2/show/NCT05393037 | access-date=29 September 2022 | archive-date=9 August 2022 | archive-url=https://web.archive.org/web/20220809142346/https://clinicaltrials.gov/ct2/show/NCT05393037 | url-status=live }}</ref>
Merck is investigating a 21-valent vaccine (code named V116) against pneumococcus serotypes.<ref name="NCT05393037" /> The vaccine is geared towards persons living with HIV.<ref name="NCT05393037">{{cite web | title=Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7) | website=ClinicalTrials.gov | date=26 May 2022 | url=https://clinicaltrials.gov/ct2/show/NCT05393037 | access-date=29 September 2022 | archive-date=9 August 2022 | archive-url=https://web.archive.org/web/20220809142346/https://clinicaltrials.gov/ct2/show/NCT05393037 | url-status=live }}</ref>

The vaccine is recommended for people with [[immune-mediated inflammatory diseases]] in the UK.<ref>{{Cite web |title=CKS is only available in the UK |url=https://www.nice.org.uk/cks-uk-only |access-date=2024-12-19 |website=NICE |archive-date=18 September 2016 |archive-url=https://web.archive.org/web/20160918184246/http://cks.nice.org.uk/bronchiectasis |url-status=live }}</ref> A UK database study found that compared with not having a pneumococcal vaccine, being vaccinated was associated with a 30% reduced risk of hospitalisation due to pneumonia and a 40% reduced risk of death from pneumonia. Another database study found that vaccination was not associated with disease flare ups among people with [[lupus]], [[rheumatoid arthritis]] and [[Spondyloarthritis|spondylarthritis]], which is a common reason for vaccine hesitancy in this group.<ref>{{cite journal | vauthors = Nakafero G, Grainge MJ, Card T, Mallen CD, Nguyen Van-Tam JS, Abhishek A | title = Effectiveness of pneumococcal vaccination in adults with common immune-mediated inflammatory diseases in the UK: a case-control study | journal = The Lancet. Rheumatology | volume = 6 | issue = 9 | pages = e615–e624 | date = September 2024 | doi = 10.1016/S2665-9913(24)00128-0 | pmid = 39067457 | url = https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(24)00128-0/fulltext }}</ref><ref>{{cite journal | vauthors = Nakafero G, Grainge MJ, Card T, Mallen CD, Nguyen Van-Tam JS, Abhishek A | title = Uptake and safety of pneumococcal vaccination in adults with immune mediated inflammatory diseases: a UK wide observational study | journal = Rheumatology | pages = keae160 | date = March 2024 | pmid = 38479823 | doi = 10.1093/rheumatology/keae160 }}</ref><ref>{{Cite journal |date=17 December 2024 |title=Pneumonia vaccine is effective in people with inflammatory diseases |url=https://evidence.nihr.ac.uk/alert/pneumonia-vaccine-is-effective-in-people-with-inflammatory-diseases/ |journal=NIHR Evidence}}</ref>


== References ==
== References ==
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== External links ==
== External links ==
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* {{cite web | title=Pneumococcal Conjugate Vaccine Information Statement | website=U.S. [[Centers for Disease Control and Prevention]] (CDC) | date=11 May 2023 | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv.html }}

* {{cite web | title=Pneumococcal Conjugate Vaccine Information Statement | website=U.S. [[Centers for Disease Control and Prevention]] (CDC) | date=February 2022 | url=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv13.html }}


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Latest revision as of 12:29, 27 December 2024

Pneumococcal conjugate vaccine
Prevenar 13
Vaccine description
TargetStreptococcus pneumoniae
Vaccine typeConjugate
Clinical data
Trade namesPrevnar 20, Prevnar 13, Synflorix, others; discontinued Prevnar (PCV7)
Other namesPCV, pneumococcal vaccine, capsular polysaccharides[1]
AHFS/Drugs.comMonograph
MedlinePlusa607021
License data
Pregnancy
category
Routes of
administration
Intramuscular
ATC code
Legal status
Legal status
Identifiers
ChemSpider
  • none
KEGG

Pneumococcal conjugate vaccine is a pneumococcal vaccine made with the conjugate vaccine method and used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children.[17][18]

Vaccine-mediated immunity is "conferred mainly by opsonophagocytic killing of S. pneumoniae."[19]

The most common side effects in children are decreased appetite, fever (only very common in children aged six weeks to five years), irritability, reactions at the site of injection (reddening or hardening of the skin, swelling, pain or tenderness), somnolence (sleepiness) and poor quality sleep.[12][19] In adults and the elderly, the most common side effects are decreased appetite, headaches, diarrhea, fever (only very common in adults aged 18 to 29 years), vomiting (only very common in adults aged 18 to 49 years), rash, reactions at the site of injection, limitation of arm movement, arthralgia and myalgia (joint and muscle pain), chills and fatigue.[12][19]

Brands

[edit]

Capvaxive

[edit]

Capvaxive is a pneumococcal 21-valent conjugate vaccine (PVC21) manufactured by Merck and was approved for medical use in the United States in June 2024.[20][21] It is indicated for the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older; and the active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F,23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.[20]

Pneumosil

[edit]

Pneumosil is a decavalent pneumococcal conjugate vaccine produced by the Serum Institute of India. It contains the serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F, and was prequalified by WHO in January 2020.[22][23]

Prevnar

[edit]
Prevnar vaccine

Prevnar 20 (PCV20) is the third version of a vaccine produced by the Wyeth subsidiary of Pfizer. In April 2023, the FDA approved Prevnar 20 for the prevention of invasive disease caused by the 20 different serotypes of S. pneumoniae contained in the vaccine (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) for individuals 6 weeks through 17 years of age; and for the prevention of otitis media (ear infection) caused by 7 of the serotypes of Streptococcus pneumoniae contained in the vaccine for children 6 weeks through 5 years of age.[24] In June 2023, the Advisory Committee on Immunization Practices (ACIP) approved PCV20 (Prevnar 20) for use in US children.[25][26]

The second version, Prevnar 13 (PCV13), contained thirteen serotypes of pneumococcus (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).[27][8] It replaced Prevnar, the pneumococcal heptavalent conjugate vaccine (PCV7).[28][29] Prevnar 13 was approved for use in the European Union in December 2009.[12] In February 2010, Prevnar 13 was approved in the United States to replace Prevnar.[28][30] After waiting for the outcome of a trial underway in the Netherlands, the Centers for Disease Control and Prevention (CDC) recommended the vaccine for adults over age 65 in August 2014.[31]

The first version, the heptavalent Prevnar (PCV7), was produced from the seven most prevalent strains of Streptococcus pneumoniae bacteria in the U.S. (4, 6B, 9V, 14, 18C, 19F, and 23F). Prevnar was approved for use in the United States in February 2000,[32][33][34] and vaccination with Prevnar was recommended for all children younger than 2 years and for unvaccinated children between 24 and 59 months old who were at high risk for pneumococcal infections. The formulation resulted in a 98% probability of protection against the constituent strains, which caused 80% of the pneumococcal disease in infants in the U.S. PCV7 is no longer produced.[35]

In the Prevnar vaccines, the bacterial cell capsule sugars, a characteristic of these pathogens, are linked (conjugated) through reductive amination to CRM197, a nontoxic recombinant variant of diphtheria toxin. CRM197 is derived from the C7 strain of Corynebacterium diphtheriae grown in a medium of casamino acids and yeast extracts.[19][36] Bacteria bearing the vaccine's polysaccharide sugars are grown separately in soy peptone broths. The resulting glycoconjugate[19] produces a more robust immune response in most healthy persons. Aluminum is also added to the vaccine as an adjuvant, further enhancing the immune response.[19]

Synflorix

[edit]

Synflorix (PCV10) is produced by GlaxoSmithKline. It is a decavalent vaccine and thus contains ten serotypes of pneumococcus (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) which are conjugated to a carrier protein. Synflorix received a positive opinion from the European Medicines Agency (EMA) for use in the European Union in January 2009,[37] and GSK received European Commission authorization to market Synflorix in March 2009.[38][13]

Vaxneuvance

[edit]

Vaxneuvance is a pneumococcal 15-valent conjugate vaccine created by Merck that was approved for medical use in the United States in July 2021.[10][39] The vaccine was developed under the code name "V114".[40] It is identical to PCV13, except that it adds serotypes 22F and 33F.[41] These two serotypes are particularly important because, after "widespread use of the PCV13...[vaccine] in many countries," these two serotypes are now "among leading serotypes causing IPD in children and adults."[41]

Vaxneuvance is indicated for the active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.[10][39][42]

On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vaxneuvance, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease.[43] The applicant for this medicinal product is Merck Sharp & Dohme B.V.[43] Vaxneuvance was approved for medical use in the European Union in December 2021.[14][15]

Schedule of vaccination

[edit]

As with all immunizations, whether it is available or required, and under what circumstances, varies according to the decisions made by local public health agencies.

Children under the age of two years fail to mount an adequate response to the 23-valent adult vaccine, and so a pneumococcal conjugate vaccine is used. While this covers only seven strains out of more than ninety strains, these seven strains cause 80% to 90% of cases of severe pneumococcal disease, and it is considered to be nearly 100% effective against these strains.[44]

United Kingdom

[edit]

The UK childhood vaccination schedule for infants born after 31 December 2019, consists of a primary course of one dose at twelve weeks of age with a second dose at one year of age.[45][46] For infants born before 1 January 2020 and those in Scotland, the childhood vaccination schedule consists of a primary course of two doses at eight and sixteen weeks of age with a final third dose at one year of age.[46]

Children at special risk (e.g., sickle cell disease and asplenia) require as full protection as can be achieved using the conjugated vaccine, with the more extensive polysaccharide vaccine given after the second year of life:[46]

Vaccination schedule for children at special risk[46]
Age 2–6 months 7–11 months 12–23 months
Conjugated vaccine 3 × monthly dose 2 × monthly dose 2 doses, 2 months apart
Further dose in second year of life
23-valent vaccine Then after 2nd birthday single dose of 23-valent

United States

[edit]

In 2001, the Centers for Disease Control and Prevention (CDC), upon advice from its Advisory Committee on Immunization Practices (ACIP), recommended the vaccine be administered to every infant and young child in the United States. The resulting demand outstripped production, creating shortages not resolved until 2004. All children, according to the U.S. vaccination schedule, should receive four doses, at two months, four months, six months, and again between one year and fifteen months of age.[47][48]

The CDC updated the pneumococcal vaccine guidelines for adults 65 years of age or older in 2019.[49]

In October 2021, the CDC recommended that adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15).[50] If PCV15 is used, this should be followed by a dose of PPSV23.[50] The CDC recommended that adults aged 19 to 64 years with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive a pneumococcal conjugate vaccine (either PCV20 or PCV15).[50]

The CDC published revised and consolidated guidelines in September 2023, for adults aged 19 years of age and older.[51]

Efficacy

[edit]
United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines.
United States incidence of invasive pneumococcal disease before and after introduction of the 7-valent and 13-valent pneumococcal vaccines.[52]

Prevnar-7 is designed to stop seven of about ninety pneumococcal serotypes which have the potential to cause invasive pneumococcal disease (IPD). In 2010, a 13-valent vaccine was introduced. Each year, IPD kills approximately one million children worldwide.[53] Since approval, Prevnar's efficacy in preventing IPD has been documented by a number of epidemiologic studies.[54][55][56] There is evidence that other people in the same household as a vaccinee also become relatively protected.[57] There is evidence that routine childhood vaccination reduces the burden of pneumococcal disease in adults and especially high-risk adults, such as those living with HIV/AIDS.[58]

The vaccine is, however, primarily developed for the U.S. and European epidemiological situation, and therefore it has a limited coverage of serotypes causing serious pneumococcal infections in most developing countries.[59]

Adverse reactions

[edit]

Local reactions such as pain, swelling, or redness occur in up to 50% of those vaccinated with PCV13; of these, 8% are considered severe. Local reactions are more likely after the 4th dose than the earlier doses.[60] In clinical trials, fever greater than 100.4 F (38 C) was reported at a rate of 24–35% following any dose in the primary series and nonspecific symptoms such as decreased appetite or irritability occur in up to 80% of recipients.[60] In a vaccine safety datalink study, febrile seizures occurred in roughly 1 in 83,000 to 1 in 6,000 children given PCV 13, and 1 in 21,000 to 1 in 2,000 of those who were given PCV13 and trivalent influenza vaccine at the same time.[60]

Evidence supporting addition to routine vaccination schedules

[edit]

After introduction of the pneumococcal conjugate vaccine in 2000, several studies described a decrease in invasive pneumococcal disease in the United States. One year after its introduction, a group of investigators found a 69% drop in the rate of invasive disease in those of less than two years of age.[54] By 2004, all-cause pneumonia admission rates had declined by 39% (95% CI 22–52) and rates of hospitalizations for pneumococcal meningitis decreased by 66% (95% CI 56.3–73.5) in children younger than 2.[61][62]

Rates of invasive pneumococcal disease among adults have also declined since the introduction of the vaccine.[54][62]

Vaccination in low-income countries

[edit]
Evolution of pneumococcal and rotavirus vaccine coverage from 2006 to 2022 in Gavi and non-Gavi countries. Gavi countries are the 54 Gavi 5.0 eligible countries. Coverage data are WHO/UNICEF estimates of the percentage of infants who have received three doses of Pneumococcal conjugate vaccine.

Pneumococcal disease is the leading vaccine-preventable killer of young children worldwide, according to the World Health Organization (WHO). It killed more than 500,000 children younger than five years of age in 2008 alone.[63] Approximately ninety percent of these deaths occur in the developing world.[63] Historically 15–20 years pass before a new vaccine reaches one quarter of the population of the developing world.[64]

Pneumococcal vaccines Accelerated Development and Introduction Plan (PneumoADIP) was a GAVI Alliance (GAVI) funded project to accelerate the introduction of pneumococcal vaccinations into low-income countries through partnerships between countries, donors, academia, international organizations and industry. GAVI continues this work and as of March 2013, 25 GAVI-eligible and supported countries have introduced the pneumococcal conjugate vaccine. Further, 15 additional GAVI countries have plans to introduce the vaccine into their national immunization program and 23 additional countries have approved GAVI support to introduce the vaccine.[65]

Society and culture

[edit]
[edit]

On 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Apexxnar, intended for prophylaxis against pneumococcal pneumonia and associated invasive disease.[66] The applicant for this medicinal product is Pfizer Europe MA EEIG.[66] Apexxnar was approved for medical use in the European Union in February 2022.[16][67]

Economics

[edit]

Prevnar 13 was Pfizer's best-selling product[68] with annual sales of US$5.85 billion in 2020.[68][69]

Research

[edit]

Merck is investigating a 21-valent vaccine (code named V116) against pneumococcus serotypes.[70] The vaccine is geared towards persons living with HIV.[70]

The vaccine is recommended for people with immune-mediated inflammatory diseases in the UK.[71] A UK database study found that compared with not having a pneumococcal vaccine, being vaccinated was associated with a 30% reduced risk of hospitalisation due to pneumonia and a 40% reduced risk of death from pneumonia. Another database study found that vaccination was not associated with disease flare ups among people with lupus, rheumatoid arthritis and spondylarthritis, which is a common reason for vaccine hesitancy in this group.[72][73][74]

References

[edit]
  1. ^ a b "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration. 21 December 2022. Archived from the original on 3 April 2022. Retrieved 2 January 2023.
  2. ^ a b "Vaxneuvance APMDS". Therapeutic Goods Administration. 24 January 2022. Archived from the original on 5 February 2022. Retrieved 5 February 2022.
  3. ^ a b "Prevenar 20". Therapeutics Goods Administration, The Department of Health and Aged Care. The Australian Government. Archived from the original on 5 January 2023.
  4. ^ "Prevenar 20 (Pfizer Australia Pty Ltd)". Therapeutic Goods Administration. 13 January 2023. Archived from the original on 27 March 2023. Retrieved 9 April 2023.
  5. ^ "Summary Basis of Decision (SBD) for Vaxneuvance". Health Canada. 25 February 2022. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  6. ^ "Summary Basis of Decision - Prevnar 20". Health Canada. 31 August 2022. Archived from the original on 29 September 2022. Retrieved 22 September 2022.
  7. ^ "Regulatory Decision Summary for Capvaxive". Drug and Health Products Portal. 15 July 2024. Retrieved 27 December 2024.
  8. ^ a b "Prevnar 13 – pneumococcal 13-valent conjugate vaccine injection, suspension". DailyMed. Archived from the original on 21 August 2021. Retrieved 20 August 2021.
  9. ^ "Prevnar 20- pneumococcal 20-valent conjugate vaccine injection, suspension". DailyMed. Archived from the original on 21 August 2021. Retrieved 20 August 2021.
  10. ^ a b c "Vaxneuvance- pneumococcal 15-valent conjugate vaccine crm197 protein adsorbed injection, suspension". DailyMed. Archived from the original on 21 August 2021. Retrieved 20 August 2021.
  11. ^ "Capvaxive- pneumococcal 21-valent conjugate vaccine injection, solution". DailyMed. 17 June 2024. Retrieved 5 September 2024.
  12. ^ a b c d "Prevenar 13 EPAR". European Medicines Agency (EMA). 26 March 2020. Archived from the original on 26 February 2021. Retrieved 26 March 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. ^ a b "Synflorix EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 8 January 2021. Retrieved 13 July 2020.
  14. ^ a b "Vaxneuvance EPAR". European Medicines Agency (EMA). 12 October 2021. Archived from the original on 18 January 2022. Retrieved 17 January 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  15. ^ a b "Vaxneuvance". Union Register of medicinal products. Archived from the original on 11 January 2022. Retrieved 11 January 2022.
  16. ^ a b "Apexxnar EPAR". European Medicines Agency (EMA). 14 December 2021. Archived from the original on 3 March 2022. Retrieved 2 March 2022.
  17. ^ World Health Organization (2019). "Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper –February 2019". Wkly Epidemiol Rec. 94 (8): 85–104. hdl:10665/310970.
  18. ^ "Summary of WHO Position Paper on Pneumococcal conjugate vaccines in infants and children under 5 years of age, February 2019" (PDF). World Health Organization (WHO). 21 April 2019. Archived from the original (PDF) on 8 March 2022.
  19. ^ a b c d e f "PREVNAR 20 – pneumococcal 20-valent conjugate vaccine injection, suspension: Wyeth Pharmaceutical Division of Wyeth Holdings LLC". Philadelphia, Pennsylvania: Wyeth Pharmaceuticals, LLC (A subsidiary of Pfizer Incorporated). June 2021. p. 11. Archived from the original on 5 September 2022. Retrieved 9 August 2022.
  20. ^ a b "Capvaxive". U.S. Food and Drug Administration. 17 June 2024. Archived from the original on 18 June 2024. Retrieved 18 June 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  21. ^ "U.S. FDA Approves Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults" (Press release). Merck. 17 June 2024. Retrieved 18 June 2024 – via Business Wire.
  22. ^ "Gavi-supported pneumococcal conjugate vaccines profiles to support country decision making" (PDF). GAVI. 2019. Archived (PDF) from the original on 19 May 2020. Retrieved 8 April 2020.
  23. ^ "Pneumosil, the new pneumococcal vaccine, achieves WHO prequalification, a key step toward improving access and affordability" (Press release). Serum Institute of India. PR Newswire. 28 January 2020. Archived from the original on 17 April 2021. Retrieved 8 April 2020.
  24. ^ "FDA Roundup: April 28, 2023". U.S. Food and Drug Administration. 28 April 2023. Archived from the original on 29 April 2023. Retrieved 29 April 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  25. ^ "ACIP Updates: Recommendations for Use of 20-Valent Pneumococcal Conjugate Vaccine in Children – United States, 2023". MMWR. Morbidity and Mortality Weekly Report. 72 (39): 1072. September 2023. doi:10.15585/mmwr.mm7239a5. ISSN 0149-2195. PMC 10545431. PMID 37768876. Archived from the original on 8 October 2023. Retrieved 25 October 2023.
  26. ^ "ACIP Updates: Recommendations for the Use of 20-Valent Pneumococcal Conjugate Vaccine in Children ― United States, 2023". 22 September 2023. Archived from the original on 11 December 2023. Retrieved 10 March 2024.
  27. ^ "Prevnar 13". U.S. Food and Drug Administration (FDA). 1 March 2018. STN 125324. Archived from the original on 27 November 2019. Retrieved 27 September 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  28. ^ a b "FDA Approves Pneumococcal Disease Vaccine with Broader Protection" (Press release). 24 February 2010. Archived from the original on 11 September 2010. Retrieved 9 September 2010. Public Domain This article incorporates text from this source, which is in the public domain.
  29. ^ "Pfizer And Wyeth Become One: Working Together For A Healthier World". Pfizer (Press release). 15 October 2009. Archived from the original on 15 December 2022. Retrieved 15 December 2022.
  30. ^ "Prevnar 13". U.S. Food and Drug Administration (FDA). 12 March 2010. Archived from the original on 12 March 2010. Retrieved 27 November 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  31. ^ "Advisory Committee on Immunization Practices Votes to Recommend Pfizer's Prevnar 13 Vaccine in Adults Aged 65 Years and Older". MarketWatch.com. 13 August 2014. Archived from the original on 4 March 2016. Retrieved 27 April 2017.
  32. ^ "Prevnar". U.S. Food and Drug Administration (FDA). 24 August 2009. Archived from the original on 22 July 2017. Retrieved 29 September 2022.
  33. ^ "February 17, 2000 Approval Letter". U.S. Food and Drug Administration (FDA). Archived from the original on 10 July 2009. Public Domain This article incorporates text from this source, which is in the public domain.
  34. ^ "Pneumococcal Vaccination: What Everyone Should Know". U.S. Centers for Disease Control and Prevention (CDC). 24 January 2022. Archived from the original on 12 November 2019. Retrieved 15 December 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  35. ^ "WHO SAGE evidence to recommendations table" (PDF). World Health Organization (WHO). Archived (PDF) from the original on 9 May 2021. Retrieved 6 April 2020.
  36. ^ "Prevnar (Pneumococcal 7-valent Conjugate) drug description – prescription drugs and medications at RxList". Archived from the original on 11 December 2007. Retrieved 21 November 2007.
  37. ^ "EMEA Document" (PDF). Emea.europa.eu. Archived from the original (PDF) on 19 February 2009. Retrieved 27 April 2017.
  38. ^ "GSK Release". Gsk.com (Press release). Archived from the original on 4 August 2009. Retrieved 27 April 2017.
  39. ^ a b "Vaxneuvance". U.S. Food and Drug Administration (FDA). 30 July 2021. Archived from the original on 21 August 2021. Retrieved 20 August 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  40. ^ "GRADE: 15-valent pneumococcal conjugate vaccine (PCV15) in series with 23-valent pneumococcal conjugate vaccine (PPSV23) for adults aged ≥65 years". U.S. Centers for Disease Control and Prevention (CDC). 27 January 2022. Archived from the original on 9 August 2022. Retrieved 9 August 2022.
  41. ^ a b Stacey HL, Rosen J, Peterson JT, Williams-Diaz A, Gakhar V, Sterling TM, et al. (2019). "Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults". Human Vaccines & Immunotherapeutics. 15 (3): 530–539. doi:10.1080/21645515.2018.1532249. PMC 6605726. PMID 30648919.
  42. ^ "Merck Announces U.S. FDA Approval of Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in individuals 6 weeks of age and older Caused by 15 Serotypes" (Press release). Merck. 16 July 2021. Archived from the original on 21 August 2021. Retrieved 20 August 2021 – via Business Wire.
  43. ^ a b "Vaxneuvance: Pending EC decision". European Medicines Agency (EMA). 13 October 2021. Archived from the original on 18 October 2021. Retrieved 15 October 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  44. ^ "Childhood Pneumococcal Disease". 21 March 2006. Archived from the original on 25 October 2006. Information on the disease and the Prevnar vaccine, from the Victoria State (Australia) government; includes possible side effects.
  45. ^ "NHS vaccinations and when to have them". 31 July 2019. Archived from the original on 17 December 2021. Retrieved 3 September 2021.
  46. ^ a b c d Ramsay M, ed. (January 2020). "Chapter 25: Pneumococcal". Immunisation against infectious disease. Public Health England. Archived from the original on 12 November 2019. Retrieved 3 September 2021.
  47. ^ "Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2019". Centers for Disease Control and Prevention (CDC). 5 February 2019. Archived from the original on 6 March 2016. Retrieved 3 November 2019.
  48. ^ Nuorti JP, Whitney CG (December 2010). "Prevention of pneumococcal disease among infants and children – use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine – recommendations of the Advisory Committee on Immunization Practices (ACIP)" (PDF). MMWR. Recommendations and Reports. 59 (RR-11): 1–18. PMID 21150868. Archived (PDF) from the original on 2 September 2021. Retrieved 20 November 2021.
  49. ^ Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T (November 2019). "Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged ≥65 Years: Updated Recommendations of the Advisory Committee on Immunization Practices" (PDF). MMWR. Morbidity and Mortality Weekly Report. 68 (46): 1069–1075. doi:10.15585/mmwr.mm6846a5. PMC 6871896. PMID 31751323. Archived (PDF) from the original on 20 November 2021. Retrieved 20 November 2021.
  50. ^ a b c "ACIP Vaccine Recommendations and Schedules". Centers for Disease Control and Prevention (CDC). Archived from the original on 20 November 2021. Retrieved 19 November 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  51. ^ Kobayashi M, Pilishvili T, Farrar JL, Leidner AJ, Gierke R, Prasad N, et al. (September 2023). "Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023". MMWR. Recommendations and Reports. 72 (3): 1–39. doi:10.15585/mmwr.rr7203a1. PMC 10495181. PMID 37669242.
  52. ^ "CDC – ABCs: Surveillance Reports main page – Active Bacterial Core surveillance". 19 July 2021. Archived from the original on 1 December 2020. Retrieved 10 September 2017.
  53. ^ Allen A (21 June 2007). "What if a vaccine makes room for a new strain of a disease?". Slate.com. Archived from the original on 18 May 2011. Retrieved 27 April 2017.
  54. ^ a b c Whitney CG, Farley MM, Hadler J, Harrison LH, Bennett NM, Lynfield R, et al. (May 2003). "Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine". The New England Journal of Medicine. 348 (18): 1737–1746. doi:10.1056/NEJMoa022823. PMID 12724479.
  55. ^ Poehling KA, Talbot TR, Griffin MR, Craig AS, Whitney CG, Zell E, et al. (April 2006). "Invasive pneumococcal disease among infants before and after introduction of pneumococcal conjugate vaccine". JAMA. 295 (14): 1668–1674. doi:10.1001/jama.295.14.1668. PMID 16609088.
  56. ^ Whitney CG, Pilishvili T, Farley MM, Schaffner W, Craig AS, Lynfield R, et al. (October 2006). "Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study". Lancet. 368 (9546): 1495–1502. doi:10.1016/S0140-6736(06)69637-2. PMID 17071283. S2CID 11834808. Archived from the original on 5 December 2020. Retrieved 5 July 2019.
  57. ^ Millar EV, Watt JP, Bronsdon MA, Dallas J, Reid R, Santosham M, et al. (October 2008). "Indirect effect of 7-valent pneumococcal conjugate vaccine on pneumococcal colonization among unvaccinated household members". Clinical Infectious Diseases. 47 (8): 989–996. doi:10.1086/591966. PMID 18781875.
  58. ^ Siemieniuk RA, Gregson DB, Gill MJ (November 2011). "The persisting burden of invasive pneumococcal disease in HIV patients: an observational cohort study". BMC Infectious Diseases. 11: 314. doi:10.1186/1471-2334-11-314. PMC 3226630. PMID 22078162.
  59. ^ Barocchi MA, Censini S, Rappuoli R (April 2007). "Vaccines in the era of genomics: the pneumococcal challenge". Vaccine. 25 (16): 2963–2973. doi:10.1016/j.vaccine.2007.01.065. PMID 17324490.
  60. ^ a b c Gierke R, Wodi P, Kobayashi M, Hall E, Hamborsky J. "Pinkbook Pneumococcal Epidemiology of Vaccine-Preventable Diseases". U.S. Centers for Disease Control and Prevention (CDC). Archived from the original on 1 September 2022. Retrieved 10 December 2017.
  61. ^ Grijalva CG, Nuorti JP, Arbogast PG, Martin SW, Edwards KM, Griffin MR (April 2007). "Decline in pneumonia admissions after routine childhood immunisation with pneumococcal conjugate vaccine in the USA: a time-series analysis". Lancet. 369 (9568): 1179–1186. doi:10.1016/S0140-6736(07)60564-9. PMID 17416262. S2CID 26494828.
  62. ^ a b Tsai CJ, Griffin MR, Nuorti JP, Grijalva CG (June 2008). "Changing epidemiology of pneumococcal meningitis after the introduction of pneumococcal conjugate vaccine in the United States". Clinical Infectious Diseases. 46 (11): 1664–1672. doi:10.1086/587897. PMC 4822508. PMID 18433334.
  63. ^ a b O'Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, McCall N, et al. (September 2009). "Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates". Lancet. 374 (9693): 893–902. doi:10.1016/S0140-6736(09)61204-6. PMID 19748398. S2CID 18964449.
  64. ^ "PneumoADIP – Need for PneumoADIP". Pneumoasdip.com. Archived from the original on 27 August 2021. Retrieved 27 April 2017.
  65. ^ Johns Hopkins Bloomberg School of Public Health, International Vaccine Access Center (2013). "VIMS Report: Global vaccine introduction" (PDF). Jhsph.edu. Archived (PDF) from the original on 3 March 2016. Retrieved 27 April 2017.
  66. ^ a b "Apexxnar: Pending EC decision". European Medicines Agency (EMA). 15 December 2021. Archived from the original on 17 December 2021. Retrieved 18 December 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  67. ^ "Apexxnar Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
  68. ^ a b "Pfizer Inc. 2020 Form 10-K Annual Report" (PDF). Pfizer. Archived (PDF) from the original on 23 March 2021. Retrieved 21 August 2021.
  69. ^ Herper M (24 August 2020). "In the race for a Covid-19 vaccine, Pfizer turns to a scientist with a history of defying skeptics – and getting results". Stat News. Archived from the original on 21 December 2020. Retrieved 2 December 2020.
  70. ^ a b "Safety and Immunogenicity of V116 in Adults Living With Human Immunodeficiency Virus (HIV) (V116-007, STRIDE-7)". ClinicalTrials.gov. 26 May 2022. Archived from the original on 9 August 2022. Retrieved 29 September 2022.
  71. ^ "CKS is only available in the UK". NICE. Archived from the original on 18 September 2016. Retrieved 19 December 2024.
  72. ^ Nakafero G, Grainge MJ, Card T, Mallen CD, Nguyen Van-Tam JS, Abhishek A (September 2024). "Effectiveness of pneumococcal vaccination in adults with common immune-mediated inflammatory diseases in the UK: a case-control study". The Lancet. Rheumatology. 6 (9): e615 – e624. doi:10.1016/S2665-9913(24)00128-0. PMID 39067457.
  73. ^ Nakafero G, Grainge MJ, Card T, Mallen CD, Nguyen Van-Tam JS, Abhishek A (March 2024). "Uptake and safety of pneumococcal vaccination in adults with immune mediated inflammatory diseases: a UK wide observational study". Rheumatology: keae160. doi:10.1093/rheumatology/keae160. PMID 38479823.
  74. ^ "Pneumonia vaccine is effective in people with inflammatory diseases". NIHR Evidence. 17 December 2024.

Further reading

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