pneumococcal vaccine#Worldwide

{{Short description|Vaccine to prevent infection by the bacteria Streptococcus pneumoniae}}

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| image = Pneumovax.jpg

| caption = 23-valent pneumococcal polysaccharide vaccine by MSD as it is marketed in Japan.

| type = vaccine

| target = Streptococcus pneumoniae

| vaccine_type = conjugate, polysaccharide

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| routes_of_administration = Intramuscular, subcutaneous injection

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Pneumococcal vaccines are vaccines against the bacterium Streptococcus pneumoniae. Their use can prevent some cases of pneumonia, meningitis, and sepsis. There are two types of pneumococcal vaccines: conjugate vaccines and polysaccharide vaccines. They are given by injection either into a muscle or just under the skin.

The World Health Organization (WHO) recommends the use of the conjugate vaccine in the routine immunizations given to children.{{cite journal | vauthors = ((World Health Organization)) | year = 2019 | title = Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper --February 2019 | journal = Weekly Epidemiological Record | volume = 94 | issue = 8 | pages = 85–103 | hdl = 10665/310970 | author-link = World Health Organization | hdl-access = free }}{{cite journal | vauthors = ((World Health Organization)) | year = 2021 | title = Pneumococcal vaccines: WHO position paper on their use in community outbreak settings | journal = Weekly Epidemiological Record | volume = 96 | issue = 13 | pages = 105–110 | hdl = 10665/340536 | author-link = World Health Organization | hdl-access = free }} This includes those with HIV/AIDS. The recommended three or four doses are between 71 and 93% effective at preventing severe pneumococcal disease. The polysaccharide vaccines, while effective in healthy adults, are not effective in children less than two years old or those with poor immune function.{{cite journal | vauthors = ((World Health Organization)) | year = 2008 | title = 23-valent pneumococcal polysaccharide vaccine : WHO position paper | journal = Weekly Epidemiological Record | volume = 83 | issue = 42 | pages = 373–384 | pmid = 18927997 | hdl = 10665/241217 | author-link = World Health Organization | hdl-access = free }}

These vaccines are generally safe. With the conjugate vaccine about 10% of babies develop redness at the site of injection, fever, or change in sleep. Severe allergies are very rare.

Whole-cell vaccinations were developed alongside characterisation of the subtypes of pneumococcus from the early 1900s.{{cite journal | vauthors = Grabenstein JD, Klugman KP | title = A century of pneumococcal vaccination research in humans | journal = Clinical Microbiology and Infection | volume = 18 | issue = Suppl 5 | pages = 15–24 | date = October 2012 | pmid = 22882735 | doi = 10.1111/j.1469-0691.2012.03943.x | s2cid = 25558809 | doi-access = free }} The first polysaccharide vaccine (tetravalent) was developed in 1945.{{cite journal | vauthors = Macleod CM, Hodges RG, Heidelberger M, Bernhard WG | title = Prevention of Pneumococcal Pneumonia by Immunization with Specific Capsular Polysaccharides | journal = The Journal of Experimental Medicine | volume = 82 | issue = 6 | pages = 445–465 | date = November 1945 | pmid = 19871511 | pmc = 2135567 | doi = 10.1084/jem.82.6.445 }} The current 23-valent polysaccharide vaccine was developed in the 1980s.{{cite journal | vauthors = ((World Health Organization)) | title = Pneumococcal vaccines WHO position paper--2012 | journal = Weekly Epidemiological Record | volume = 87 | issue = 14 | pages = 129–144 | date = April 2012 | pmid = 24340399 | hdl = 10665/241904 | author-link = World Health Organization | hdl-access = free }} The first conjugate vaccine (heptavalent) reached market in 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)}} It is on the World Health Organization's List of Essential Medicines.{{cite book | vauthors = ((World Health Organization)) | title = The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) | year = 2023 | hdl = 10665/371090 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access=free }}

Medical uses

Different pneumococcal vaccines provide protection against different serotypes. In particular, their coverage of antibiotic‐resistant serotypes varies. Early vaccines did not cover certain serotypes which later became a major contributor to antibiotic‐resistant infections. Subsequent vaccines are designed to address this gap.

class="wikitable"

|+Antibiotic-resistant serotype coverage{{cite web |title=Antibiotic-resistant Streptococcus pneumoniae |url=https://www.cdc.gov/pneumococcal/php/drug-resistance/index.html |publisher=Centers for Disease Control and Prevention |access-date=10 April 2025 |archive-url=https://web.archive.org/web/20240706000639/https://www.cdc.gov/pneumococcal/php/drug-resistance/index.html |archive-date=6 July 2024 |url-status=live}}{{cite web |title=About Pneumococcal Vaccines |url=https://www.cdc.gov/vaccines/vpd/pneumo/hcp/about-vaccine.html |publisher=Centers for Disease Control and Prevention |archive-url=https://web.archive.org/web/20250403103307/https://www.cdc.gov/vaccines/vpd/pneumo/hcp/about-vaccine.html |archive-date=3 April 2025 |url-status=live}}

rowspan=2 |Vaccine

!rowspan=2 |Rollout year

!colspan=7 |Resistant serotypes

6A6B9V1419A19F23F
PPSV23{{cite web |title=PNEUMOVAX 23 - Pneumococcal Vaccine, Polyvalent |url=https://www.fda.gov/vaccines-blood-biologics/vaccines/pneumovax-23-pneumococcal-vaccine-polyvalent |publisher=Food and Drug Administratio |access-date=10 April 2025 |archive-url=https://web.archive.org/web/20211115180446/https://www.fda.gov/vaccines-blood-biologics/vaccines/pneumovax-23-pneumococcal-vaccine-polyvalent |archive-date=15 November 2021 |url-status=dead}}1983{{no}}{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}
PCV13{{cite web |title=Prevnar 13 |url=https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-13 |publisher=Food and Drug Administration |access-date=10 April 2025 |archive-url=https://web.archive.org/web/20191211211828/https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-13 |archive-date=11 December 2019 |url-status=dead}}2010{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}
PCV202021{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}
PCV152022{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}{{yes}}
PCV212024{{yes}}{{no}}{{no}}{{no}}{{yes}}{{no}}{{yes}}

Recommendations

=Worldwide=

Pneumococcal vaccines Accelerated Development and Introduction Plan (PneumoADIP) is a program to accelerate the evaluation and access to new pneumococcal vaccines in the developing world. PneumoADIP is funded by the Global Alliance for Vaccines and Immunization (GAVI). Thirty GAVI countries have expressed interest in participating by 2010. PneumoADIP aims to save 5.4 million children by 2030.{{cite web |title = Vaccine Fund | work = PneumoADIP | publisher = Global Alliance for Vaccines and Immunization (GAVI); Johns Hopkins Bloomberg School of Public Health |url=http://www.pneumoadip.com |url-status=dead |archive-url=https://web.archive.org/web/20110208033345/http://pneumoadip.com/ |archive-date=8 February 2011}}

A pilot Advance Market Commitment (AMC) to develop a vaccine against pneumococcus was launched by GAVI in June 2009 as a strategy to address two of the major policy challenges to vaccine introduction: a lack of affordable vaccines on the market, and insufficient commercial incentives to develop vaccines for diseases concentrated in developing countries. Under the terms of an AMC, donors make a legally binding guarantee that, if a future vaccine is developed against a particular disease, they will purchase a predetermined amount at an agreed-upon price. The guarantee is linked to safety and efficacy standards that the vaccine must meet and is structured in a way to allow several firms to compete to develop and produce the best possible new product. AMCs reduce risk to donor governments by eliminating the need to fund individual research and development projects that may never produce a vaccine. If no company produces a vaccine that meets the predetermined standards, governments (and thus their taxpayers) spend nothing. For the bio-pharmaceutical industry, AMCs create a guaranteed market, with a promise of returns that would not normally exist. For developing countries, AMCs provide funding to ensure that those vaccines will be affordable once they have been developed. It is estimated that the pneumococcal AMC could prevent more than 1.5 million childhood deaths by 2020.{{cite web |title=Pneumococcal Advance Market Commitment (AMC) |url=http://www.gavialliance.org/funding/pneumococcal-amc |url-status=dead |archive-url=https://web.archive.org/web/20130607010319/http://www.gavialliance.org/funding/pneumococcal-amc/ |archive-date=7 June 2013 |website=GAVI}}{{third-party inline|date=May 2020}}

Doctors Without Borders has criticized GAVI's pneumococcal AMC for not encouraging innovation, discouraging competition from new market entrants, and raising vaccine costs. They said that it had allowed Pfizer and GlaxoSmithKline to maintain a duopoly while making it more difficult for the Serum Institute of India to sell their cheaper vaccine. The duopoly allowed price discrimination; somewhat higher prices for GAVI, and unaffordable prices (about ten time the GAVI price) for middle-income countries too rich for GAVI aid.{{cite web | author = Photography by Apostolia S |date=3 December 2019 |title=Gavi must stop giving millions in subsidies to Pfizer and GSK for pneumococcal vaccine |url=https://www.doctorswithoutborders.org/what-we-do/news-stories/news/gavi-must-stop-giving-millions-subsidies-pfizer-and-gsk-pneumonia |archive-url=https://web.archive.org/web/20220802123139/https://www.doctorswithoutborders.org/latest/gavi-must-stop-giving-millions-subsidies-pfizer-and-gsk-pneumonia-vaccine |archive-date=2 August 2022 |website=Doctors Without Borders |language=en}} The pneumococcal program (unlike previous market-shaping programs from GAVI{{cite journal | vauthors = Malhame M, Baker E, Gandhi G, Jones A, Kalpaxis P, Iqbal R, Momeni Y, Nguyen A | title = Shaping markets to benefit global health - A 15-year history and lessons learned from the pentavalent vaccine market | journal = Vaccine | volume = 2 | pages = 100033 | date = August 2019 | pmid = 31384748 | pmc = 6668221 | doi = 10.1016/j.jvacx.2019.100033 }}{{third-party inline|date=May 2020}}) did not include any mechanism for increasing competition.{{cite web | author = Photography by De Cock B |date=23 February 2011 |title=Pneumococcal Vaccine is Launched in Africa, But Are Donors Getting a Fair Deal from Companies? |url=https://www.doctorswithoutborders.org/what-we-do/news-stories/news/pneumococcal-vaccine-launched-africa-are-donors-getting-fair-deal |archive-url=https://web.archive.org/web/20220914205810/https://www.doctorswithoutborders.org/latest/pneumococcal-vaccine-launched-africa-are-donors-getting-fair-deal-companies |archive-date=14 September 2022 |website=Doctors Without Borders |language=en}}

The Humanitarian Mechanism makes the pneumococcal vaccine available to humanitarian actors (but not governments) at a lower-than-normal price during humanitarian emergencies.{{cite web | author = Photograph by Ekholm K | date = 2015 |title=Vaccination |url=https://www.doctorswithoutborders.org/what-we-do/medical-issues/vaccination |archive-url=https://web.archive.org/web/20220627200250/https://www.doctorswithoutborders.org/what-we-do/medical-issues/vaccination |archive-date=27 June 2022 |website=Doctors Without Borders |language=en}}

= Belgium =

The national vaccination program started vaccinating newborns in 2004 with the 7-valent pneumococcal conjugate vaccine (PCV 7). This was changed into the 13-valent conjugate (PCV 13) in 2011. The switch to the 10-valent conjugate (PCV 10) was made in July 2015 in Flanders and May 2016 in Wallonia.{{cite web |date=15 April 2019 |title=Pneumokokken - Nieuw advies Hoge Gezondheidsraad vaccinatie zuigelingen |trans-title=Pneumococcal: New advice from High Health Council concerning the vaccination of newborns |url=https://www.vaxinfopro.be/spip.php?rubrique44&lang=nl |archive-url=https://web.archive.org/web/20220201111838/https://www.vaxinfopro.be/spip.php?rubrique44&lang=nl |archive-date=1 February 2022 |access-date=5 September 2020 |website=vaxinfopro.be |language=nl}} In late 2020 a start was made with the vaccination of care home residents with the 23-valant pneumococcal polysaccharide vaccine (PPV 23).{{cite web |date=9 November 2020 |title=Gratis pneumokokkenvaccin voor bewoners van woonzorgcentra |trans-title=Free pneumococcal vaccination for the residents of care homes |url=https://www.laatjevaccineren.be/gratis-pneumokokkenvaccin-voor-bewoners-van-woonzorgcentra |archive-url=https://web.archive.org/web/20211028004412/https://www.laatjevaccineren.be/gratis-pneumokokkenvaccin-voor-bewoners-van-woonzorgcentra |archive-date=28 October 2021 |access-date=5 September 2021 |website=laatjevaccineren.be |language=nl}}

=Canada=

The Public Health Agency of Canada's general recommendations are 13-valent pneumococcal conjugate vaccine (PCV 13) vaccine for children aged 2 months to 18 years and 23-valent pneumococcal polysaccharide vaccine (PPV 23) vaccine for adults.{{cite web |date=16 February 2020 |title=Pneumococcal vaccine: Canadian Immunization Guide |url=https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-16-pneumococcal-vaccine.html |archive-url=https://web.archive.org/web/20220901065931/https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-16-pneumococcal-vaccine.html |archive-date=1 September 2022 |publisher=Public Health Agency of Canada | url-status=live }}

=India=

In May 2017, the Government of India decided to include the pneumococcal conjugate vaccine in its Universal Immunization Programme.{{cite news |date=14 May 2017 |title=Pneumonia vaccine to be part of immunisation drive |work=The Hindu |url=http://www.thehindu.com/todays-paper/tp-national/pneumonia-vaccine-to-be-part-of-immunisation-drive/article18449921.ece |access-date=18 September 2017 |archive-url=https://web.archive.org/web/20220818042101/https://www.thehindu.com/todays-paper/tp-national/pneumonia-vaccine-to-be-part-of-immunisation-drive/article18449921.ece |archive-date=18 August 2022 |issn=0971-751X}}

=The Netherlands=

The national vaccination program started including the pneumococcal vaccine for newborns in April 2006.{{cite news |date=3 December 2005 |title=Prik tegen pneumokokken; Alle baby's vanaf april volgend jaar tegen bacterie ingeënt |trans-title=Jab against pneumacoccal; All babies vaccinated against bacteria from April of next year |url=https://resolver.kb.nl/resolve?urn=KBPERS01:003288003:mpeg21:a00024 |url-access=subscription |access-date=4 September 2021 |website=Algemeen Dagblad |language=nl |via=Delpher}}

The Health Council advised in 2018 that those who are over the age of 60 should also be vaccinated on a 5-year recurring schedule. The resulting program from this, NPPV, started at the end of 2020.{{cite web | vauthors = van Twillert M |date=17 December 2020 |title=Gezondheidsraad: 'Doorgaan met pneumokokkenvaccinatie van ouderen' |trans-title=Health council: 'continue pneumococcal vaccination of elderly' |url=https://www.medischcontact.nl/nieuws/laatste-nieuws/nieuwsartikel/gezondheidsraad-doorgaan-met-pneumokokkenvaccinatie-van-ouderen.htm |archive-url=https://web.archive.org/web/20210515091004/https://www.medischcontact.nl/nieuws/laatste-nieuws/nieuwsartikel/gezondheidsraad-doorgaan-met-pneumokokkenvaccinatie-van-ouderen.htm |archive-date=15 May 2021 |access-date=4 September 2021 |website=Medisch Contact |language=nl }}

Health authorities reported in December 2020 that former COVID-19 patients also have an indication for this vaccine because of the damage their lungs incurred. Vaccinating this group is not part of the NPPV program.{{cite web |date=17 December 2020 |title=COVID-19 en vaccinatie tegen pneumokokken (2) |trans-title=COVID-19 and vaccination against pneumococcal (2) |url=https://www.gezondheidsraad.nl/documenten/adviezen/2020/12/17/covid-19-en-vaccinatie-tegen-pneumokokken-2 |archive-url=https://web.archive.org/web/20210919085437/https://www.gezondheidsraad.nl/documenten/adviezen/2020/12/17/covid-19-en-vaccinatie-tegen-pneumokokken-2 |archive-date=19 September 2021 |access-date=19 August 2021 |website=Health Council of the Netherlands (Gezondheidsraad) |language=nl}}

=South Africa=

The 7- and 13-valent pneumococcal conjugate vaccines (PCV7 and PCV13) were introduced into the National Expanded Program on Immunization (EPI) in South Africa in 2009 and 2011, respectively. South Africa became the first African country – and the first nation in the world with a high HIV prevalence – to introduce PCV7 into its routine immunization program.{{cite web |title=Critical decline in pneumococcal disease and antibiotic resistance in South Africa |url=http://www.nicd.ac.za/?page=alerts&id=5&rid=448 |url-status=live |archive-url=https://web.archive.org/web/20150723025857/http://www.nicd.ac.za/?page=alerts&id=5&rid=448 |archive-date=23 July 2015 |access-date=20 July 2015 |website=NICD}} Rates of invasive pneumococcal disease (IPD) – including cases caused by antibiotic-resistant bacteria – have fallen substantially in South Africa following the introduction of PCV7. Among children under two years of age, the overall incidence of IPD declined nearly 70% after PCV introduction, and rates of IPD caused by bacteria specifically targeted by the vaccine decreased nearly 90%.{{cite journal | vauthors = von Gottberg A, de Gouveia L, Tempia S, Quan V, Meiring S, von Mollendorf C, Madhi SA, Zell ER, Verani JR, O'Brien KL, Whitney CG, Klugman KP, Cohen C | title = Effects of vaccination on invasive pneumococcal disease in South Africa | journal = The New England Journal of Medicine | volume = 371 | issue = 20 | pages = 1889–1899 | date = November 2014 | pmid = 25386897 | doi = 10.1056/NEJMoa1401914 | doi-access = free }} Due to the indirect protection conferred by herd immunity, a significant decline in IPD in children and in unvaccinated adults has also been shown.

Pneumovax 23 is used for all ages and, according to the enclosed patient information leaflet, has a reported 76% to 92% protective efficacy (pneumococcal types 1, 2, 3, 4, 5, 6B**, 7F, 8, 9N, 9V**, 10A, 11A, 12F, 14**, 15B, 17F, 18C, 19A**, 19F**, 20, 22F, 23F** and 33F** are included, where ** indicates drug-resistant pneumococcal infections; these are the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae).{{medcn|date=December 2017}}

=United Kingdom=

It was announced in February 2006, that the UK government would introduce vaccination with the conjugate vaccine in children aged 2, 4 and 13 months.{{cite web |date=8 February 2006 |title=Children to be given new vaccine |url=http://news.bbc.co.uk/1/hi/health/4692908.stm |url-status=live |archive-url=https://web.archive.org/web/20060530173836/http://news.bbc.co.uk/1/hi/health/4692908.stm |archive-date=30 May 2006 |website=BBC News}}{{cite press release |title=Pneumococcal vaccine added to the childhood immunisation programme |date=8 February 2006 |publisher=Department of Health and Social Care |url=http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4128036&chk=PI8e57 |archive-url=https://web.archive.org/web/20061023094835/http://www.dh.gov.uk/PublicationsAndStatistics/PressReleases/PressReleasesNotices/fs/en?CONTENT_ID=4128036&chk=PI8e57 |archive-date=23 October 2006}} This included changes to the immunisation programme in general.{{cite web|url=http://www.meningitis.org/disease-info/vaccines/change-to-the-immunisation-programme-in-the-uk|title=Changes to the immunisation programme in the UK|publisher=Meningitis Research Foundation|archive-url=https://web.archive.org/web/20070713170218/http://www.meningitis.org/disease-info/vaccines/change-to-the-immunisation-programme-in-the-uk|archive-date=13 July 2007|access-date=6 May 2017}} In 2009, the European Medicines Agency approved the use of a 10 valent pneumococcal conjugate vaccine for use in Europe.{{cite press release |title=Synflorix, GlaxoSmithKline's pneumococcal vaccine receives European authorisation |date=31 March 2009 |publisher=GlaxoSmithKline |url=http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10039.htm |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}} The 13-valent pneumococcal vaccine was introduced in the routine immunization schedule of the UK in April 2010.{{citation needed|date=December 2017}}

=United States=

File:Pneumococcal% 20vaccine% 20guidelines.jpg (CDC)}}]]

In the United States, a heptavalent pneumococcal conjugate vaccine (PCV 7) (Prevnar) was recommended for all children aged 2–23 months and for at-risk children aged 24–59 months in 2000. The normal four-dose series is given at 2, 4, 6, and 12–14 months of age. In February 2010, a pneumococcal conjugate vaccine that protects against an additional six serotypes was introduced (PCV 13/brand name: Prevnar 13) and can be given instead of the original Prevnar.{{cite news | vauthors = Wilson D |title=Vaccine Approved for Child Infections |newspaper=The New York Times |date=24 February 2010 |url=https://www.nytimes.com/2010/02/25/business/25vaccine.html |url-status=live |archive-url=https://web.archive.org/web/20151104124227/http://www.nytimes.com/2010/02/25/business/25vaccine.html |archive-date=4 November 2015 }}{{cite web |title=Prevnar 13 |date=12 January 2012 |publisher=U.S. Food and Drug Administration (FDA) |url=https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-13 |url-status=dead |archive-url=https://web.archive.org/web/20110818230622/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667.htm |archive-date=18 August 2011 | id=STN: 125324}} In June 2021, a pneumococcal conjugate vaccine which protects against 20 serotypes was approved with the brand name Prevnar 20.{{cite web |date=10 June 2021 |title=Prevnar 20 |url=https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20 |archive-url=https://web.archive.org/web/20220906092547/https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20 |archive-date=6 September 2022 |access-date=20 June 2021 |publisher=Food and Drug Administration}} In April 2023, the FDA approved the use of Prevnar 20 vaccine to prevent pneumococcal disease in children aged six weeks to 17 years.{{Cite web |title=FDA Greenlights Pfizer's Pneumococcal Vaccine in Infants and Children |url=https://www.biospace.com/article/fda-greenlights-pfizer-s-pneumococcal-vaccine-prevnar-20-in-infants-and-children/ |access-date=3 May 2023 |website=BioSpace |date=28 April 2023 |archive-date=3 May 2023 |archive-url=https://web.archive.org/web/20230503190153/https://www.biospace.com/article/fda-greenlights-pfizer-s-pneumococcal-vaccine-prevnar-20-in-infants-and-children/ |url-status=live }}{{Cite web | vauthors = Hazarika I |date=28 April 2023 |title=FDA clears Pfizer's Prevnar 20 vaccine for IPD prevention |url=https://www.pharmaceutical-technology.com/news/fda-pfizer-prevnar-20/ |access-date=3 May 2023 |website=Pharmaceutical Technology |archive-date=3 May 2023 |archive-url=https://web.archive.org/web/20230503190153/https://www.pharmaceutical-technology.com/news/fda-pfizer-prevnar-20/ |url-status=live }}{{Cite web |url=https://www.fda.gov/media/167637/download |title= Supplemental Approval: 20-valent Pneumococcal Conjugate Vaccine (PREVNAR 20) | date = 27 April 2023 | publisher = Food and Drug Administration |access-date=12 May 2023 |archive-date=1 May 2023 |archive-url=https://web.archive.org/web/20230501203159/https://www.fda.gov/media/167637/download |url-status=live }}

Pneumovax 23 (pneumococcal vaccine polyvalent) was approved for medical use in the United States in 1983.{{cite web | title=Pneumovax 23 - Pneumococcal Vaccine, Polyvalent | website=U.S. Food and Drug Administration (FDA) | date=1 October 2024 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/pneumovax-23-pneumococcal-vaccine-polyvalent | archive-url=https://web.archive.org/web/20191112031149/https://www.fda.gov/vaccines-blood-biologics/vaccines/pneumovax-23-pneumococcal-vaccine-polyvalent | url-status=dead | archive-date=12 November 2019 | access-date=27 October 2024}}{{cite web | title=Pneumovax 23- pneumococcal vaccine polyvalent injection, solution | website=DailyMed | date=7 March 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb362a20-6d91-4ae8-bebb-9ee8b2591814 | access-date=27 October 2024}}

Vaxneuvance (pneumococcal 15-valent conjugate vaccine) was approved for medical use in the United States in June 2021.{{cite web | title=Vaxneuvance | website=U.S. Food and Drug Administration (FDA) | date=1 October 2024 | url=https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxneuvance | archive-url=https://web.archive.org/web/20210716204216/https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxneuvance | url-status=dead | archive-date=16 July 2021 | access-date=27 October 2024}}{{cite web | title=Vaxneuvance- pneumococcal 15-valent conjugate vaccine crm197 protein adsorbed injection, suspension | website=DailyMed | date=3 May 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1158fa93-ef41-4a29-8252-9251f94c53c8 | access-date=27 October 2024}}

Capvaxive (pneumococcal 21-valent conjugate vaccine) was approved for medical use in the United States in June 2024.{{cite web | title=Capvaxive | website=U.S. Food and Drug Administration (FDA) | date=1 October 2024 | url=https://www.fda.gov/vaccines-blood-biologics/capvaxive | archive-url=https://web.archive.org/web/20240618175712/https://www.fda.gov/vaccines-blood-biologics/capvaxive | url-status=dead | archive-date=18 June 2024 | access-date=27 October 2024}}{{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=27 October 2024}}

In October 2024, the Centers for Disease Control and Prevention (CDC) updated its recommendations for the pneumococcal vaccination and recommends routine pneumococcal vaccination for all children younger than 5 years of age and all adults 50 years of age or older.{{cite web | title=Pneumococcal Vaccine Recommendations | website=U.S. Centers for Disease Control and Prevention (CDC) | date=22 October 2024 | url=https://www.cdc.gov/pneumococcal/hcp/vaccine-recommendations/index.html | access-date=27 October 2024}}{{cite web | title=Pneumococcal Vaccination: For Providers | website=U.S. Centers for Disease Control and Prevention (CDC) | date=24 April 2019 | url=https://www.cdc.gov/vaccines/vpd/pneumo/hcp/index.html | access-date=27 October 2024}}

Mechanism

=Polysaccharide vaccine=

The pneumococcal polysaccharide vaccine most commonly used today {{Citation needed|date=October 2012}} consists of purified polysaccharides from 23 serotypes (1, 2, 3, 4, 5, 6b, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F).{{cite journal | vauthors = Pletz MW, Maus U, Krug N, Welte T, Lode H | title = Pneumococcal vaccines: mechanism of action, impact on epidemiology and adaption of the species | journal = International Journal of Antimicrobial Agents | volume = 32 | issue = 3 | pages = 199–206 | date = September 2008 | pmid = 18378430 | doi = 10.1016/j.ijantimicag.2008.01.021 | s2cid = 10514479 }} Immunity is induced primarily through stimulation of B-cells which release IgM without the assistance of T cells.{{cite journal | vauthors = Stein KE | title = Thymus-independent and thymus-dependent responses to polysaccharide antigens | journal = The Journal of Infectious Diseases | volume = 165 | issue = Suppl 1 | pages = S49–S52 | date = June 1992 | pmid = 1588177 | doi = 10.1093/infdis/165-supplement_1-s49 }}

This immune response is less robust than the response provoked by conjugated vaccines, which has several consequences. The vaccine is ineffective in children less than 2 years old, presumably due to their less mature immune systems. Non-response is also common amongst older adults. Immunity is not lifelong, so individuals must be re-vaccinated at age 65 if their initial vaccination was given at age 60 or younger. Since no mucosal immunity is provoked, the vaccine does not affect carrier rates, promote herd immunity, or protect against upper or lower respiratory tract infections. Finally, provoking immune responses using unconjugated polysaccharides from the capsules of other bacteria, such as H. influenzae, has proven significantly more difficult.

=Conjugated vaccine=

The pneumococcal conjugate vaccine (PCV) consists of capsular polysaccharides covalently bound to the diphtheria toxoid CRM197, which is highly immunogenic but non-toxic. This combination provokes a significantly more robust immune response by recruiting CRM197-specific type 2 helper T cells, which allow for immunoglobulin type switching (to produce non-IgM immunoglobulin) and production of memory B cells. Among other things, this results in mucosal immunity and the eventual establishment of lifelong immunity after several exposures.

For targeted serotypes, the PCV reduces colonization rates and provides herd immunity. It appears to also reduce the development of antimicrobial resistance among targeted serotypes.

The main drawbacks to conjugated vaccines are that they only protect against a subset of the serotypes covered by the polysaccharide vaccines.{{medcn|date=December 2017}}

Research

Due to the geographic distribution of pneumococcal serotypes, additional research is needed to find the most efficacious vaccine for developing-world populations. In a previous study, the most common pneumococcal serotypes or groups from developed countries were found to be, in descending order, 14, 6, 19, 18, 9, 23, 7, 4, 1, and 15. In developing countries, the order was 6, 14, 8, 5, 1, 19, 9, 23, 18, 15 and 7.{{cite journal | vauthors = Sniadack DH, Schwartz B, Lipman H, Bogaerts J, Butler JC, Dagan R, Echaniz-Aviles G, Lloyd-Evans N, Fenoll A, Girgis NI | title = Potential interventions for the prevention of childhood pneumonia: geographic and temporal differences in serotype and serogroup distribution of sterile site pneumococcal isolates from children--implications for vaccine strategies | journal = The Pediatric Infectious Disease Journal | volume = 14 | issue = 6 | pages = 503–510 | date = June 1995 | pmid = 7667055 | doi = 10.1097/00006454-199506000-00007 | url = https://zenodo.org/record/1234814 | archive-url = https://web.archive.org/web/20210828230558/https://zenodo.org/record/1234814/files/article.pdf?download=1 | archive-date = 28 August 2021 }} In order to further pneumococcal vaccine research and reduce childhood mortality, five countries and the Bill & Melinda Gates Foundation established a pilot Advance Market Commitment for pneumococcal vaccines worth US$1.5 billion. Advance Market Commitments are a new approach to public health funding designed to stimulate the development and manufacture of vaccines for developing countries.{{cite web |date=November 2012 |title=Saving Lives with New Vaccines: Advance Market Commitments |url=http://www.vaccineamc.org/files/AMC_FactSheet_v2.pdf |url-status=dead |archive-url= https://web.archive.org/web/20160306150623/http://www.gavi.org/library/gavi-documents/amc/fact-sheets/factsheet--advance-market-commitment/ |archive-date=6 March 2016 |website=Advance Market Commitments for Vaccines (vaccineAMC) |publisher=GAVI}}

There is research into producing vaccines that can be given into the nose rather than by injection.{{cite journal | vauthors = Hanniffy SB, Carter AT, Hitchin E, Wells JM | title = Mucosal delivery of a pneumococcal vaccine using Lactococcus lactis affords protection against respiratory infection | journal = The Journal of Infectious Diseases | volume = 195 | issue = 2 | pages = 185–193 | date = January 2007 | pmid = 17191163 | doi = 10.1086/509807 | doi-access = free }}{{cite journal | vauthors = Malley R, Lipsitch M, Stack A, Saladino R, Fleisher G, Pelton S, Thompson C, Briles D, Anderson P | title = Intranasal immunization with killed unencapsulated whole cells prevents colonization and invasive disease by capsulated pneumococci | journal = Infection and Immunity | volume = 69 | issue = 8 | pages = 4870–4873 | date = August 2001 | pmid = 11447162 | pmc = 98576 | doi = 10.1128/IAI.69.8.4870-4873.2001 }}

The development of serotype-specific anticapsular monoclonal antibodies has also been researched in recent years. These antibodies have been shown to prolong survival in a mouse model of pneumococcal infection characterized by a reduction in bacterial loads and a suppression of the host inflammatory response.{{cite journal | vauthors = Burns T, Abadi M, Pirofski LA | title = Modulation of the lung inflammatory response to serotype 8 pneumococcal infection by a human immunoglobulin m monoclonal antibody to serotype 8 capsular polysaccharide | journal = Infection and Immunity | volume = 73 | issue = 8 | pages = 4530–4538 | date = August 2005 | pmid = 16040964 | pmc = 1201218 | doi = 10.1128/IAI.73.8.4530-4538.2005 }}{{cite journal | vauthors = Fabrizio K, Groner A, Boes M, Pirofski LA | title = A human monoclonal immunoglobulin M reduces bacteremia and inflammation in a mouse model of systemic pneumococcal infection | journal = Clinical and Vaccine Immunology | volume = 14 | issue = 4 | pages = 382–390 | date = April 2007 | pmid = 17301214 | pmc = 1865609 | doi = 10.1128/CVI.00374-06 }} Additional pneumococcal vaccine research is taking place to find a vaccine that offers broad protection against pneumococcal disease.{{cite web |title=Acute Respiratory Infections (Update September 2009): Streptococcus pneumoniae |work=Initiative for Vaccine Research (IVR) |publisher=World Health Organization (WHO) |url=https://www.who.int/vaccine_research/diseases/ari/en/index3.html |url-status=dead |archive-url=https://web.archive.org/web/20120523221322/http://www.who.int/vaccine_research/diseases/ari/en/index3.html |archive-date=23 May 2012 }}

{{As of|2017}}, pneumonia vaccines target up to 23 forms of the bacterium that cause pneumonia with a new version under development covering 72 strains of the bacterium.{{cite journal | vauthors = Jones CH, Zhang G, Nayerhoda R, Beitelshees M, Hill A, Rostami P, Li Y, Davidson BA, Knight P, Pfeifer BA | title = Comprehensive vaccine design for commensal disease progression | journal = Science Advances | volume = 3 | issue = 10 | pages = e1701797 | date = October 2017 | pmid = 29057325 | pmc = 5647123 | doi = 10.1126/sciadv.1701797 | bibcode = 2017SciA....3E1797J }}; {{lay source |template=cite web |date=20 October 2017 |title=The end of pneumonia? New vaccine offers hope: Vaccine under development provides the 'most comprehensive coverage' to date and alleviates antimicrobial concerns, new study finds |url=https://www.sciencedaily.com/releases/2017/10/171020143811.htm |archive-url=https://web.archive.org/web/20220808015950/https://www.sciencedaily.com/releases/2017/10/171020143811.htm |archive-date=8 August 2022 |access-date=12 July 2018 |website=ScienceDaily}}{{update inline|date=December 2019}}

= Nonspecific effects =

A 2004 study reports that PCV reduces rates of RSV hospitalizations in children.{{cite journal | vauthors = Klugman KP, Chien YW, Madhi SA | title = Pneumococcal pneumonia and influenza: a deadly combination | journal = Vaccine | volume = 27 Suppl 3 | pages = C9–C14 | date = August 2009 | pmid = 19683658 | doi = 10.1016/j.vaccine.2009.06.007 }}

A 2024 British meta-analysis reports that the PCV appears provide some off-target protection from a number of viral respiratory infections. The evidence is strongest for influenza in children.{{cite journal | vauthors = Sepúlveda-Pachón IT, Dunne EM, Hanquet G, Baay M, Menon S, Jodar L, Gessner BD, Theilacker C | title = Effect of Pneumococcal Conjugate Vaccines on Viral Respiratory Infections: A Systematic Literature Review | journal = The Journal of Infectious Diseases | volume = 230 | issue = 3 | pages = e657–e667 | date = September 2024 | pmid = 38462672 | doi = 10.1093/infdis/jiae125 | pmc = 11420806 }}

References

{{reflist}}

Further reading

{{refbegin}}

  • {{cite web|vauthors=Kakade R|title=Global Pneumonia Vaccine Market Analysis 2016-2020 and Forecast 2021-2026 |url=https://industryresearchplace.com/report/MTcxNTY4|website=Industry Research Place}}{{Dead link|date=September 2022 |fix-attempted=yes }}
  • {{cite journal | vauthors = Moberley S, Holden J, Tatham DP, Andrews RM | title = Vaccines for preventing pneumococcal infection in adults | journal = The Cochrane Database of Systematic Reviews | volume = 1 | issue = 1 | pages = CD000422 | date = January 2013 | pmid = 23440780 | pmc = 7045867 | doi = 10.1002/14651858.CD000422.pub3 }}
  • {{cite book | vauthors=Käyhty H, Nurkka A, Soininen A, Väkeväinen M | title=The immunological basis for immunization series: module 12: pneumococcal vaccines | publisher=World Health Organization (WHO) | date=September 2009 | hdl=10665/44135 | isbn=9789241598217 | url=http://apps.who.int/iris/bitstream/handle/10665/44135/9789241598217_eng.pdf?sequence=1&isAllowed=y | archive-url=https://web.archive.org/web/20220914213706/http://apps.who.int/iris/bitstream/handle/10665/44135/9789241598217_eng.pdf?sequence=1&isAllowed=y | archive-date=14 September 2022 }}
  • {{cite book |url=https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/223734/Green-Book-updated-170713.pdf |title=Immunisation against infectious disease |date=November 2006 |publisher=Public Health England |veditors=Salisbury D, Ramsay M, Noakes K |chapter=Chapter 25: Pneumococcal |archive-url=https://web.archive.org/web/20220311225606/https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/223734/Green-Book-updated-170713.pdf |archive-date=11 March 2022 }}
  • {{cite book | vauthors = Gierke R, Wodi AP, Kobayashi M | chapter = Chapter 17: Pneumococcal Disease | veditors = Hall E, Wodi AP, Hamborsky J, Morelli V, Schillie S | title = Epidemiology and Prevention of Vaccine-Preventable Diseases | publisher = U.S. Centers for Disease Control and Prevention (CDC) | edition = 14th | location = Washington D.C. | year = 2021 | chapter-url = https://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html | url = https://www.cdc.gov/vaccines/pubs/pinkbook/index.html | access-date = 12 November 2019 | archive-date = 30 December 2016 | archive-url = https://web.archive.org/web/20161230001534/https://www.cdc.gov/vaccines/pubs/pinkbook/index.html | url-status = live }}

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