Pneumococcal conjugate vaccine#Prevnar

Capvaxive is a pneumococcal 21-valent conjugate vaccine (PCV21) manufactured by Merck and was approved for medical use in the United States in June 2024.{{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}} 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.{{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}}

In January 2025, 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 Capvaxive, a vaccine intended for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae.

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.{{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 }}{{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 }}

File:Vacuna-prevenar.jpg

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.{{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}} In June 2023, the Advisory Committee on Immunization Practices (ACIP) approved PCV20 (Prevnar 20) for use in US children.{{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/pdfs/mm7239a5-H.pdf |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}}{{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=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 }}

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).{{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}}{{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}} It replaced Prevnar, the pneumococcal heptavalent conjugate vaccine (PCV7).{{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 }} Prevnar 13 was approved for use in the European Union in December 2009.{{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. In February 2010, Prevnar 13 was approved in the United States to replace Prevnar.{{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}}{{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}} 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.{{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 }}

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,{{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)}}{{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}}{{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}} 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.{{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) }}

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.{{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}} Bacteria bearing the vaccine's polysaccharide sugars are grown separately in soy peptone broths. The resulting glycoconjugate 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.

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,{{cite web|url=http://www.emea.europa.eu/pdfs/human/opinion/Synflorix_1312009en.pdf|title=EMEA Document|website=Emea.europa.eu|access-date=27 April 2017|archive-url=https://web.archive.org/web/20090219223949/http://www.emea.europa.eu/pdfs/human/opinion/Synflorix_1312009en.pdf|archive-date=19 February 2009|url-status=dead}} and GSK received European Commission authorization to market Synflorix in March 2009.{{cite press release|url=http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10039.htm|title=GSK Release|website=Gsk.com|access-date=27 April 2017|url-status=dead|archive-url=https://web.archive.org/web/20090804042243/http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10039.htm|archive-date=4 August 2009}}{{cite web | title=Synflorix EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/synflorix | access-date=13 July 2020 | archive-date=8 January 2021 | archive-url=https://web.archive.org/web/20210108010508/https://www.ema.europa.eu/en/medicines/human/EPAR/synflorix | url-status=live }}

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

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.{{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 }}

In 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. The applicant for this medicinal product is Merck Sharp & Dohme B.V.{{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. Vaxneuvance was approved for medical use in the European Union in December 2021.{{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.{{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 }}

{{Further|Vaccination schedule}}

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.{{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.

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.{{cite web|url = https://www.nhs.uk/conditions/vaccinations/nhs-vaccinations-and-when-to-have-them/|title = NHS vaccinations and when to have them|date = 31 July 2019|access-date = 3 September 2021|archive-date = 17 December 2021|archive-url = https://web.archive.org/web/20211217103237/https://www.nhs.uk/conditions/vaccinations/nhs-vaccinations-and-when-to-have-them/|url-status = live}} 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.

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:

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.{{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 }}{{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 |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}}

The CDC updated the pneumococcal vaccine guidelines for adults 65 years of age or older in 2019.{{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 }}

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). If PCV15 is used, this should be followed by a dose of PPSV23.{{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}} 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).

The CDC published revised and consolidated guidelines in September 2023, for children.

The CDC published revised and consolidated guidelines in September 2024, for adults aged 19 years of age and older.{{cite journal | vauthors = Kobayashi M, Leidner AJ, Gierke R, Farrar JL, Morgan RL, Campos-Outcalt D, Schechter R, Poehling KA, Long SS, Loehr J, Cohen AL | title = Use of 21-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Recommendations of the Advisory Committee on Immunization Practices - United States, 2024 | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 73 | issue = 36 | pages = 793–798 | date = September 2024 | pmid = 39264843 | pmc = 11392227 | doi = 10.15585/mmwr.mm7336a3 | doi-access = free | url = https://www.cdc.gov/mmwr/volumes/73/wr/pdfs/mm7336a3-H.pdf }}

File:US incidence of invasive streptococcal disease before and after vaccine introduction.jpg

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.{{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 }} Since approval, Prevnar's efficacy in preventing IPD has been documented by a number of epidemiologic studies.{{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 }}{{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 = }}{{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 }} There is evidence that other people in the same household as a vaccinee also become relatively protected.{{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 }} 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.{{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 }}

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.{{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 }}

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. 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. 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.{{cite book | vauthors = ((Centers for Disease Control and Prevention)) | chapter = Chapter 17: Pneumococcal Disease | chapter-url = https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html | veditors = Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S | title = Epidemiology and Prevention of Vaccine-Preventable Diseases | edition = 14th | publisher = Public Health Foundation | location = Washington, D.C. | year = 2021 | url = https://www.cdc.gov/pinkbook/site.html }}

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. 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.{{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 }}{{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 }}

Rates of invasive pneumococcal disease among adults have also declined since the introduction of the vaccine.

File:Pneumococcal and rotavirus vaccine coverage (Gavi and non-Gavi countries).svg

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.{{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 }} Approximately ninety percent of these deaths occur in the developing world. Historically 15–20 years pass before a new vaccine reaches one quarter of the population of the developing world.{{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}}

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.{{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}}

In 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. The applicant for this medicinal product is Pfizer Europe MA EEIG.{{cite web | title=Apexxnar: Pending EC decision | website=European Medicines Agency (EMA) | date=15 December 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/apexxnar | access-date=18 December 2021 | archive-date=17 December 2021 | archive-url=https://web.archive.org/web/20211217113403/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/apexxnar | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Apexxnar was approved for medical use in the European Union in February 2022.{{cite web | title=Prevenar 20 (previously Apexxnar) EPAR | website=European Medicines Agency (EMA) | date=14 December 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/apexxnar | access-date=2 March 2022 | archive-date=3 March 2022 | archive-url=https://web.archive.org/web/20220303051238/https://www.ema.europa.eu/en/medicines/human/EPAR/apexxnar | url-status=live }}{{cite web | title=Apexxnar Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1612.htm | access-date=3 March 2023 | archive-date=4 March 2023 | archive-url=https://web.archive.org/web/20230304092724/https://ec.europa.eu/health/documents/community-register/html/h1612.htm | url-status=live }}

In January 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Capvaxive, a vaccine intended for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae. The applicant for this medicinal product is Merck Sharp & Dohme B.V.{{cite web | title=Capvaxive EPAR | website=European Medicines Agency (EMA) | date=30 January 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/capvaxive | access-date=16 February 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

Pfizer reported revenue of {{US$|6.44 billion}} for the Prevnar family of vaccines (Prevnar 20/Apexxnar (pediatric and adult) and Prevnar 13/Prevnar 13 (pediatric and adult)) in 2023.{{cite web | title=Pfizer's year in review | website=Pfizer 2023 Annual Report | date=31 December 2023 | url=https://www.pfizer.com/sites/default/files/investors/financial_reports/annual_reports/2023/ | access-date=30 December 2024}}

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

{{Reflist}}

• {{cite web | title=Pneumococcal Conjugate Vaccine Information Statement | website=U.S. Centers for Disease Control and Prevention (CDC) | url=https://www.cdc.gov/vaccines/hcp/current-vis/pneumococcal-conjugate.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv.html }}

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