Pfizer’s PENBRAYA™ Receives Recommendation for Prevention of Meningococcal Disease in Adolescents and Young Adults from Advisory Committee on Immunization Practices
- PENBRAYA recommended for adolescents and young adults to help protect against the five leading causes of meningococcal disease
- PENBRAYA provides the broadest serogroup coverage (meningococcal group A, B, C, W, and Y) of any licensed meningococcal vaccine available in the U.S.
NEW YORK, October 25, 2023 — Pfizer Inc. (NYSE:PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend PENBRAYA (meningococcal group A, B, C, W and Y vaccine) for the prevention of the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) in adolescents and young adults 16 through 23 years of age.
Specifically, the ACIP voted that:
Pfizer’s MenABCWY vaccine may be used when both MenACWY and MenB are indicated at the same visit.
These provisional recommendations will be reviewed and finalized by the director of the CDC and the Department of Health and Human Services.
“PENBRAYA, the first FDA approved 5-in-1 meningococcal vaccine, provides adolescents and young adults in the U.S. with the most comprehensive protection available against the leading causes of meningococcal disease,” said Luis Jodar, PhD, Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. “PENBRAYA helps simplify a complex meningococcal disease vaccination schedule and has the potential to increase vaccine coverage by providing the broadest protection in the fewest number of shots to help prevent this deadly disease.”
On October 20, the FDA approved PENBRAYA as a two-dose series given six months apart for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y for adolescents and young adults aged 10 through 25 years.
Potential U.S. Public Health Impact of a MenABCWY Vaccine
Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and, for survivors, can result in life-altering, significant long-term disabilities.1 Together, the five most common meningococcal serogroups account for 95 percent of all IMD cases worldwide, with serogroup B accounting for the majority of disease in adolescents and young adults in the U.S. and Europe.2
Up to today, the U.S. meningococcal vaccination platform for adolescents and young adults includes a routine recommendation for MenACWY vaccines (two doses) and a separate, shared clinical decision recommendation for MenB-specific vaccines (two doses) in order to achieve protection against the five leading meningococcal serogroups (A, B, C, W, and Y) that cause the majority of IMD. However, nearly 9 out of 10 older adolescents are missing CDC-recommended vaccinations against all five serogroups.3
Pfizer’s PENBRAYA reduces the total number of shots needed for individuals to be fully vaccinated against meningococcal serogroups A, B, C, W, and Y, thereby streamlining the standard of care.4 According to the CDC, combining vaccines into fewer shots may mean that more adolescents and young adults get their recommended vaccines on time, resulting in fewer delays in protection against serious diseases.5 Routine use of PENBRAYA could also reduce IMD cases and associated mortality, the rate of long-term consequences of infection in survivors, and costs associated with controlling outbreaks.6
About PENBRAYA Regulatory Review
In September 2022, Pfizer announced positive results from a randomized, active-controlled and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the PENBRAYA compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiority. The Phase 3 trial (NCT04440163) evaluated more than 2,400 participants from the U.S. and Europe. This trial was followed by the FDA’s acceptance of PENBRAYA’s Biologics License Application (BLA) in December 2022.
What is PENBRAYA?
PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.
PENBRAYA is administered as a two-dose series given six months apart.
Important Safety Information
- PENBRAYA should not be given to anyone with a history of a severe allergic reaction to any component of PENBRAYA
- Fainting may happen after getting injectable vaccines, including PENBRAYA. Precautions should be taken to avoid falling and injury due to fainting
- Some individuals with weakened immune system may have reduced immune responses to PENBRAY
- Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis groups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENBRAYA
- Vaccination with PENBRAYA may not protect all who receive the vaccine against N. meningitidis group A, B, C, W, and Y infections
- Vaccination with PENBRAYA does not substitute for vaccination with a tetanus toxoid–containing vaccine to prevent tetanus
- Guillain-Barré syndrome (GBS) has been reported following administration of other meningococcal vaccines. Ask your healthcare provider about the risks and benefits of PENBRAYA if you have a history of GBS
- The most common adverse reactions were pain at the injection site, fatigue, headache, injection site redness, muscle pain, injection site swelling, joint pain, and chills.
- Tell your healthcare provider if you are pregnant or plan to become pregnant
- Ask your healthcare provider about the risks and benefits of PENBRAYA. Only a healthcare provider can decide if PENBRAYA is right for you or your child
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.
DISCLOSURE NOTICE: The information contained in this release is as of October 25, 2023. 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 PENBRAYA, including its potential benefits and a vote by ACIP to recommend PENBRAYA for the prevention of the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease in adolescents 16 through 23 years of age, 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 PENBRAYA; 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 biologic license applications may be filed in particular jurisdictions for PENBRAYA; whether and when any such applications that may be pending or filed for PENBRAYA 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 such product candidate 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 PENBRAYA; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding PENBRAYA and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizer’s 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, 2022, 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 Borg J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of Meningococcal disease in adolescence: prospective, matched-cohort study. Pediatrics. 2009;123:e502-e509. Available at: https://pubmed.ncbi.nlm.nih.gov/19254985/. Accessed October 2023.
2 National Library of Medicine. Global estimate of Neisseria meningitidis serogroups proportion in invasive meningococcal disease: A systematic review and meta-analysis. September 2019. Available at: https://doi.org/10.1016/j.micpath.2019.103571. Accessed October 2023.
3 Vaccination coverage among adolescents aged 13-17 years – national … Available at: https://www.cdc.gov/mmwr/volumes/72/wr/pdfs/mm7234a3-H.pdf. Accessed October 2023.
4 National Library of Medicine. Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/35357651/. Accessed October 2023
5 Centers for Disease Control and Prevention. Combination Vaccines. Available at: www/cdc.gov/vaccines/parents/why-vaccinate/combination-vaccines.html. Accessed October 2023.
6 National Library of Medicine. Potential Public Health Impact of a Neisseria Meningitidis A, B, C, W, and Y Pentavalent Vaccine in the United States. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/33615973/. Accessed August 2023. https://www.cdc.gov/mmwr/volumes/69/rr/rr6909a1.htmhttps://pubmed.ncbi.nlm.nih.gov/19254985/
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