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Advisory Committee on Immunization Practices Recommends PREVNAR 20® (20-Valent Pneumococcal Conjugate Vaccine) for Adults Aged 50 and Older

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Pfizer announced that the CDC's Advisory Committee on Immunization Practice (ACIP) voted to expand pneumococcal vaccine recommendations, including PREVNAR 20®, to all adults aged 50 and older. The vaccine protects against 20 serotypes responsible for the majority of invasive pneumococcal disease cases. In the U.S., these serotypes cause over 2,000 deaths and more than 65,000 cases of invasive pneumococcal disease annually in adults aged 50-64. The recommendation includes adults aged 19-49 with certain underlying conditions who haven't received a PCV or have unknown vaccination history.

Pfizer ha annunciato che il Comitato Consultivo sulle Pratiche di Immunizzazione (ACIP) dei CDC ha votato per ampliare le raccomandazioni sui vaccini contro il pneumococco, inclusi PREVNAR 20®, a tutti gli adulti di età pari o superiore a 50 anni. Il vaccino protegge contro 20 sierotipi responsabili della maggior parte dei casi di malattia pneumoococcica invasiva. Negli Stati Uniti, questi sierotipi causano oltre 2.000 decessi e più di 65.000 casi di malattia pneumoococcica invasiva ogni anno negli adulti di età compresa tra 50 e 64 anni. La raccomandazione include anche gli adulti tra i 19 e i 49 anni con determinate condizioni sottostanti che non hanno ricevuto un vaccino PCV o che hanno una storia vaccinale sconosciuta.

Pfizer anunció que el Comité Asesor sobre Prácticas de Inmunización (ACIP) de los CDC votó para ampliar las recomendaciones de la vacuna neumocócica, incluyendo PREVNAR 20®, a todos los adultos de 50 años o más. La vacuna protege contra 20 serotipos responsables de la mayoría de los casos de enfermedad neumocócica invasiva. En EE. UU., estos serotipos causan más de 2,000 muertes y más de 65,000 casos de enfermedad neumocócica invasiva anualmente en adultos de 50 a 64 años. La recomendación incluye a adultos de 19 a 49 años con ciertas condiciones subyacentes que no han recibido un PCV o que tienen un historial de vacunación desconocido.

화이자는 CDC의 예방접종 관행 자문 위원회(ACIP)가 50세 이상 모든 성인에게 PREVNAR 20®를 포함한 폐렴구균 백신 권장 사항을 확대하기 위해 투표했다고 발표했습니다. 이 백신은 침습성 폐렴구균 질병의 주요 원인인 20가지 세타입에 대해 보호합니다. 미국에서 이러한 세타입은 50세에서 64세 사이의 성인에게 매년 2,000명 이상의 사망자와 65,000명 이상의 침습성 폐렴구균 질병 사례를 초래합니다. 이 권장 사항은 PCV를 접종받지 않았거나 예방접종 이력이 불확실한 특정 기저 질환이 있는 19세에서 49세의 성인도 포함합니다.

Pfizer a annoncé que le Comité consultatif sur les pratiques d'immunisation (ACIP) des CDC a voté pour élargir les recommandations de vaccination contre le pneumocoque, y compris PREVNAR 20®, à tous les adultes âgés de 50 ans et plus. Le vaccin protège contre 20 sérotypes responsables de la majorité des cas de maladie invasive à pneumocoque. Aux États-Unis, ces sérotypes provoquent plus de 2 000 décès et plus de 65 000 cas de maladie invasive à pneumocoque chaque année chez les adultes âgés de 50 à 64 ans. La recommandation inclut également les adultes de 19 à 49 ans souffrant de certaines conditions sous-jacentes qui n'ont pas reçu de PCV ou qui ont un historique de vaccination inconnu.

Pfizer kündigte an, dass der Beratende Ausschuss für Impfpraktiken (ACIP) der CDC abgestimmt hat, um die Empfehlungen für Pneumokokken-Impfstoffe, einschließlich PREVNAR 20®, auf alle Erwachsenen ab 50 Jahren auszuweiten. Der Impfstoff schützt vor 20 Serotypen, die für die Mehrheit der invasiven Pneumokokkenkrankheitsfälle verantwortlich sind. In den USA verursachen diese Serotypen jährlich über 2.000 Todesfälle und mehr als 65.000 Fälle von invasiver Pneumokokkenkrankheit bei Erwachsenen im Alter von 50 bis 64 Jahren. Die Empfehlung umfasst auch Erwachsene im Alter von 19 bis 49 Jahren mit bestimmten Grunderkrankungen, die keinen PCV erhalten haben oder deren Impfgeschichte unbekannt ist.

Positive
  • Expansion of PREVNAR 20 recommendation to larger market (adults 50+)
  • Vaccine addresses serotypes causing over 65,000 annual disease cases
  • Targets rising serotype 4 disease in western U.S.
Negative
  • None.

Insights

The ACIP recommendation for PREVNAR 20 represents a significant market expansion for Pfizer's vaccine franchise. With over 65,000 cases of invasive pneumococcal disease annually in the 50-64 age group alone, this recommendation opens up a substantial new market segment. The vaccine's coverage of 20 serotypes, including the resurging serotype 4, positions it strongly against competitors.

The expansion to all adults aged 50+ removes previous restrictions and simplifies the vaccination recommendation, which should drive higher adoption rates. Based on current disease burden data and vaccination rates, this could translate to millions of additional doses annually. The timing is particularly relevant given the recent uptick in serotype 4 cases in western U.S., highlighting the vaccine's comprehensive coverage.

This regulatory development significantly enhances Pfizer's market position in the adult vaccine segment. The PREVNAR franchise, already a multi-billion dollar revenue generator, will likely see substantial growth from this expanded recommendation. The simplified age-based guidance (50+ years) versus the previous risk-based approach should improve implementation and boost vaccination rates.

The market opportunity is compelling - considering the U.S. population aged 50-64 is approximately 70 million people, even modest penetration rates could generate significant additional revenue. Healthcare providers are more likely to recommend vaccines with clear, age-based guidelines, which should accelerate adoption.

  • Millions of newly eligible U.S. adults aged 50 to 64 now recommended to receive vaccination against invasive pneumococcal disease (IPD) and pneumococcal pneumonia1

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) for all adults aged 50 and older. This recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services. With respect to PREVNAR 20, ACIP recommended:

  • Vaccination is recommended for all adults aged ≥50 years and for adults aged 19–49 years with certain underlying conditions or risk factors who have not received a PCV or whose vaccination history is unknown. 

“ACIP’s vote to expand adult pneumococcal vaccination to now include all adults aged 50 and older marks an important milestone in Pfizer’s long-standing commitment to reducing the burden of this life-threatening disease,” said Luis Jodar, PhD, Senior Vice President, Senior Vice President, Vaccines and Anti-Infectives Chief Medical Affairs Officers, Pfizer. “PREVNAR 20 offers protection against the serotypes responsible for the majority of invasive pneumococcal disease cases in this age group. Expanding its use also provides an opportunity to limit the re-emergence of disease-causing strains like serotype 4, which has recently affected certain U.S. adult populations and is covered by the vaccine.”

In the U.S., the 20 serotypes contained in PREVNAR 20 are estimated to cause over 2,000 deaths and more than 65,000 cases of invasive pneumococcal disease (IPD), including bacteremia and meningitis, and community-acquired pneumonia annually in adults aged 50 to 64.2 Between 2018 and 2022, more than half of IPD cases in people aged 50 to 64 were caused by these 20 serotypes.3 Vaccination with PREVNAR 20 helps prevent serotype 4 disease, which incidence has been rising in certain populations in the western U.S.4

About PREVNAR 20®
PREVNAR 20® is Pfizer’s next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) already included in Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD),5,6,7,8,9 and have been associated with high case-fatality rates,10,11,12,13 antibiotic resistance,14,15,16 and/or meningitis.17,18 PREVNAR 20 helps protect against disease caused by the 20 Streptococcus pneumoniae serotypes in the vaccine.

On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved PREVNAR 20 for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years or older. On September 30, 2022, the FDA approved the addition of information in the PREVNAR 20 prescribing information regarding coadministration with an influenza vaccine, adjuvanted (Fluad Quadrivalent19), in adults aged 65 years or older.

INDICATIONS FOR PREVNAR 20
PREVNAR 20® is a vaccine indicated for:

  • the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older.
  • the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years.
  • active immunization for the prevention of pneumonia caused by Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.
    • The indication of PREVNAR 20 for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved based on immune responses. Continued approval may depend on a supportive study

IMPORTANT SAFETY INFORMATION FOR PREVNAR 20

  • PREVNAR 20® should not be given to anyone who has had a severe allergic reaction to any component of PREVNAR 20 or to diphtheria–toxoid-containing vaccine.
  • Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups.
  • A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your doctor about the infant's medical status when deciding to get vaccinated with PREVNAR 20.
  • In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite and injection site redness, injection site swelling, and fever.
  • In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling and injection site redness, headache, and fever.
  • In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Also, injection site swelling was common in individuals 18 years through 59 years of age.
  • Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for you or your child.

View the full Prescribing Information.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE:
The information contained in this release is as of October 23, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine), including its potential benefits and a vote by ACIP to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20 for all adults aged 50 and older and for adults aged 19–49 years with certain underlying conditions or risk factors who have not received a PCV or whose vaccination history is unknown, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of PREVNAR 20 and uncertainties regarding the commercial impact of ACIP’s recommendation; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any biologics license applications may be filed in any other jurisdictions for PREVNAR 20 for any potential indications; whether and when any such applications that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether PREVNAR 20 will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PREVNAR 20; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding PREVNAR 20 and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

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1
U.S. Census Bureau. Population by age. https://data.census.gov/table?q=Population%20by%20age. Accessed October 2024.
2 Perdrizet J, Chilson E, Wasserman M, et al. Current and future pneumococcal conjugate vaccine serotype-specific burden in the United States adult population. Abstract No. ISP20-287 Presented at ISPPD-12, Toronto, June 21-25, 2020. Available at: https://cslide.ctimeetingtech.com/isppd20/attendee/confcal/presentation/list?q=Perdrizet.
3 U.S. Centers for Disease Control and Prevention. Summary of Work Group Interpretations of EtR and Policy Option on PCV21 Use in Adults. https://www.cdc.gov/acip/downloads/slides-2024-06-26-28/04-Pneumococcal-Kobayashi-508.pdf. Presented June 27, 2024. Accessed October 11, 2024.
4 U.S. Centers for Disease Control and Prevention. Summary of Risk-based Pneumococcal Vaccination Recommendations. https://www.cdc.gov/pneumococcal/hcp/vaccine-recommendations/risk-indications.html. Updated October 10, 2024. Accessed October 11, 2024.
5 Baisells E, Guillot L, Nair H, et al. Serotype distribution of Streptococcus pneumoniae causing invasive disease in children in the post-PCV era: A systematic review and meta-analysis. PlosOne. 2017;12(5): e0177113.
6 Hausdorff W & Hanage W. Interim results of an ecological experiment – conjugate vaccination against the pneumococcus and serotype replacement. Hum Vaccin Immunother. 2016;12(2):358-374.
7 Cohen R, Cohen J, Chalumeau M, et al. Impact of pneumococcal conjugate vaccines for children in high- and non-high income countries. Expert Rev Vaccines. 2017;16(6):625-640.
8 Moore M, Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent pneumococcal conjugate vaccine in children on invasive pneumococcal disease in children and adults in the USA: analysis of multisite, population-based surveillance. Lancet Infect Dis. 2015;15(3):301-309.
9 Metcalf B, Gertz RE, Gladstone RA, et al. Strain features and distributions in pneumococci from children with invasive disease before and after 13-valent conjugate vaccine implementation in the USA. Clin Microbiol Infect. 2016;22(1):60.e9-60.e29.
10 Oligbu G, Collins S, Sheppard CL, et al. Childhood deaths attributable to invasive pneumococcal disease in England and Wales, 2006–2014. Clin Infect Dis. 2017;65(2):308-314.
11 van Hoek, Andrews N, Waight PA, et al. Effect of serotype on focus and mortality of invasive pneumococcal disease: Coverage of different vaccines and insight into non-vaccine serotypes. PlosOne. 2012;7(7):e39150.
12 Stanek R, Norton N, Mufson M. A 32-years study of the impact of pneumococcal vaccines on invasive Streptococcus pneumoniae disease. Am J Med Sci. 2016;352(6):563-573.
13 Harboe ZB, Thomsen RW, Riis A, et al. Pneumococcal serotypes and mortality following invasive pneumococcal disease: A population-based cohort study. PlosOne. 2009;6(5):e1000081.
14 Azzari C, Cortimiglia M, Nieddu F, et al. Pneumococcal serotype distribution in adults with invasive disease and in carrier children in Italy: Should we expect herd protection of adults through infants’ vaccination? Hum Vaccin Immunother. 2016;12(2):344-350.
15 Tomczyk S, Lynfield R, Schaffner W, et al. Prevention of antibiotic-nonsusceptible invasive pneumococcal disease with the 13-valent pneumococcal conjugate vaccine. Clin Infect Dis. 2016;62(9):1119-1125.
16 Mendes RE, Hollingsworth RC, Costello A, et al. Noninvasive Streptococcus pneumoniae serotypes recovered from hospitalized adult patients in the United States in 2009 to 2012. Antimicrob Agents Chemother. 2015;59(9):5595-5601.
17 Olarte L, Barson WJ, Lin PL, et al. Impact of the 13-valent pneumococcal conjugate vaccine on pneumococcal meningitis in US children. Clin Infect Dis. 2015;61(5):767-775.
18 Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial meningitis in the United States, 1998–2007. NEJM. 2011;364(21):2016-2025.
19 Fluad Quadrivalent is not a Pfizer product

Category: Vaccines

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FAQ

What age group did ACIP recommend PREVNAR 20 (PFE) for in 2024?

ACIP recommended PREVNAR 20 for all adults aged 50 and older, as well as adults aged 19-49 with certain underlying conditions who haven't received a PCV or have unknown vaccination history.

How many cases of pneumococcal disease does PREVNAR 20 (PFE) target annually in adults 50-64?

The 20 serotypes in PREVNAR 20 cause over 65,000 cases of invasive pneumococcal disease and more than 2,000 deaths annually in adults aged 50-64 in the U.S.

What percentage of IPD cases did PREVNAR 20 (PFE) serotypes cause between 2018-2022?

More than half of invasive pneumococcal disease (IPD) cases in people aged 50-64 were caused by the 20 serotypes contained in PREVNAR 20 between 2018 and 2022.

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