Advisory Committee on Immunization Practices Recommends Pfizer’s PREVNAR 20® for Adults Previously Vaccinated with PREVNAR 13®
NEW YORK, October 20, 2022 - Pfizer Inc. (NYSE:PFE) today announced that that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend a single dose of PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) to help protect adults previously vaccinated with PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or both PREVNAR 13® and PPSV23 against invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in PREVNAR 20®.
Specifically, the ACIP voted to recommend the following:
• Adults who have received PCV13 only are recommended to receive a dose of PCV20 at least 1 year after the PCV13 dose or PPSV23 as previously recommended to complete their pneumococcal vaccine series.
• Adults with an immunocompromising condition, cochlear implant, or cerebrospinal fluid leak who have received both PCV13 and PPSV23 with incomplete vaccination status are recommended to complete their pneumococcal vaccine series by receiving either a dose of PCV20 at least 5 years after the last pneumococcal vaccine dose or PPSV23 as previously recommended.
• Shared clinical decision-making is recommended regarding administration of PCV20 for adults aged > 65 years who completed their vaccine series with both PCV13 and PPSV23. If a decision to administer PCV20 is made, a dose of PCV20 is recommended at least 5 years after the last pneumococcal vaccine dose.
“Today’s vote underscores the importance of PREVNAR 20® and it’s seven additional serotypes helping prevent invasive pneumococcal disease and pneumonia among adults,” said Luis Jodar, Infectious Disease and Evidence Generation, Chief Medical Affairs Officer, Pfizer. “We commend the ACIP and CDC for recognizing the public health benefit and further clarifying the adult pneumococcal pneumonia recommendations. We are confident this will help improve vaccination rates and ultimately reduce disease burden in this population.”
Details of ACIP’s recommendations will be available from the CDC. Provisional recommendations will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval, with final recommendations published in the CDC’s Morbidity and Mortality Weekly Report (MMWR).
“With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer. “With these recommendations, coupled with the previous recommendation for pneumococcal conjugate vaccine naive adults, providers now may help protect all of their eligible adult patients with a single dose of PREVNAR 20® – regardless of pneumococcal vaccination history.”
In October 2021, ACIP recommended for routine use one dose of Pfizer’s PREVNAR 20® in adults 65 years of age or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown, and adults aged 19 years of age or older with certain underlying medical conditions, such as asthma or diabetes, or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown.
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),4,5,6,7,8 and have been associated with high case-fatality rates,9,10,11,12 antibiotic resistance,13,14,15 and/or meningitis.16,17 PREVNAR 20™ contains the broadest serotype coverage of any available conjugate vaccine and helps protect against 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 disease and pneumonia in adults age 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 Quadrivalent) in adults aged 65 years or older.
On February 15, 2022, Pfizer announced the European Medicines Agency (EMA) approved the company’s 20-valent pneumococcal conjugate vaccine, which is marketed in the European Union (EU) under the brand name APEXXNAR.
INDICATIONS FOR PREVNAR 20®
• PREVNAR 20® is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
• This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
U.S. IMPORTANT SAFETY INFORMATION
• PREVNAR 20® should not be given to anyone with a history of severe allergic reaction to any component of PREVNAR 20® or any diphtheria toxoid–containing vaccine
• Some adults with weakened immune systems may have a lower response to PREVNAR 20®. Safety data are not available for these groups. Your healthcare provider can tell you if PREVNAR 20® is right for you
• In adults 18 years of age and older, the most common side effects were pain at the injection site, muscle pain, fatigue, and headache
• Ask your healthcare provider about the risks and benefits of PREVNAR 20®. Only a healthcare provider can decide if PREVNAR 20® is right for you
Please see full prescribing information for PREVNAR 20®.
INDICATIONS FOR PREVNAR 13®
• Prevnar 13® is a vaccine approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F)
• Prevnar 13® is not 100% effective and will only help protect against the 13 strains included in the vaccine
U.S. IMPORTANT SAFETY INFORMATION
• Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine
• Adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response
• In adults, the most common side effects (>5%) were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
• Ask your healthcare provider about the risks and benefits of Prevnar 13®. Only a healthcare provider can decide if Prevnar 13® is right for you
Please see full prescribing information for Prevnar 13®
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 more than 170 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 Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
The information contained in this release is as of October 20, 2022. 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® (Pneumococcal 20-valent Conjugate Vaccine), including its potential benefits, a recommendation by ACIP for a single dose of PREVNAR 20® to help protect adults previously vaccinated with PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or both PREVNAR 13® and PPSV23 against invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in PREVNAR 20®, 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 the prevention of invasive disease and pneumonia in adults age 18 years or older and in any jurisdictions for any other potential indications; whether and when any such other 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, 2021 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.
1 Alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other hemoglobinopathies, CSF leak, or cochlear implant.
2 Gierke R, Advisory Committee on Immunization Practices (ACIP). Current Epidemiology of Pneumococcal Disease and Pneumococcal Vaccine Coverage among Adults, United States. Centers for Disease Control and Prevention (CDC). February 25, 2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-02/24-25/02-Pneumococcal-Gierke.pdf.
3 Data on file. Pfizer Inc., New York, NY
4 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.
5 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.
6 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.
7 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.
8 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.
9 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.
10 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.
11 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.
12 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): e 1000081.
13 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.
14 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.
15 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.
16 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.
17 Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial Meningitis in the United States, 1998–2007. NEJM. 2011;364(21):2016-2025.
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