Pfizer Receives Positive CHMP Opinion for RSV Vaccine Candidate to Help Protect Infants through Maternal Immunization and Older Adults
• Pfizer’s RSV vaccine candidate, RSVpreF, would help address substantial burden of RSV disease in individuals 60 years of age and older and in infants from birth through six months of age
• If approved, Pfizer’s RSV vaccine candidate would be first and only vaccine for both older adults and administration to pregnant individuals to help protect their infants
NEW YORK, July 21, 2023 – Pfizer Inc. (NYSE: PFE) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the granting of a marketing authorization for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, for both older adults and maternal immunization to help protect infants.
The CHMP’s positive opinion will now be reviewed by the European Commission (EC). The EC will take the CHMP’s recommendation under advisement to decide whether to approve RSVpreF, whose trade name in the European Union (EU) will be ABRYSVO®. The EC’s final decision is expected in the coming weeks and will apply to all 27 EU member states plus Iceland, Liechtenstein, and Norway.
“Today’s CHMP positive opinion represents a significant step forward in our efforts to help prevent RSV disease in older adults and infants,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “If approved, our RSV vaccine candidate for pregnant individuals would help protect infants immediately at time of birth through six months of age, when they are at highest risk of severe RSV disease and complications. This, along with an approval for older adults, would mark meaningful public health progress for RSV disease prevention throughout Europe.”
The CHMP positive opinion was issued based on evidence from Pfizer’s Phase 3 clinical trials RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease) and MATISSE (MATernal Immunization Study for Safety and Efficacy).
RENOIR (NCT05035212) is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older. The efficacy and safety results were recently published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.
MATISSE (NCT04424316) is a global, randomized, double-blinded, placebo-controlled Phase 3 study designed to evaluate the efficacy, safety, and immunogenicity of RSVpreF against medically attended lower respiratory tract illness (MA-LRT) and severe MA-LRTI due to RSV in infants born to healthy individuals vaccinated during pregnancy. The efficacy and safety results were also recently published in The New England Journal of Medicine.
Pfizer is currently the only company pursuing regulatory applications for an RSV investigational vaccine candidate for both an indication to help protect older adults, as well as an indication to help protect infants through maternal immunization.
On May 31, 2023, the U.S. Food and Drug Administration (FDA) approved RSVpreF under the name ABRYSVO™ for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older. Additionally, earlier this year, Pfizer announced that the FDA had granted priority review for a biologics license application for RSVpreF for the prevention of lower respiratory tract and severe lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in August 2023 is.
In May, Pfizer also announced it would be initiating multiple clinical trials evaluating RSVpreF in healthy children ages 2-5; children ages 5-18 with underlying medical conditions; adults ages 18-60 at high-risk for RSV disease due to underlying medical conditions; and adults ages 18 and older who are immunocompromised and at high-risk for RSV disease.1
In February 2023, Pfizer Japan announced an application was filed with the Ministry of Health, Labor and Welfare for RSVPreF as a maternal immunization to help protect infants against RSV. In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization to help protect infants against RSV.
U.S. INDICATION FOR ABRYSVO
ABRYSVO is a vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older.
U.S. IMPORTANT SAFETY INFORMATION FOR ABRYSVO
• ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
• Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury due to fainting
• Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
• Vaccination with ABRYSVO may not protect all people
• In adults 60 years of age and older, the most common side effects (≥10%) were pain at the injection site, fatigue, headache, and muscle pain
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 July 21, 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 PF-06928316 or RSVpreF, including its potential benefits, a marketing authorization pending in the EU for RSVpreF for both older adults and maternal immunization to help protect infants, an application pending in the U.S. for RSVpreF for the prevention of lower respiratory tract and severe lower respiratory tract disease caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals, applications pending for RSVpreF in other jurisdictions and plans to initiate clinical trials in other populations, 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 ABRYSVO; 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; risks associated with interim data, including the risk that final results from the Phase 3 trials could differ from the interim 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 biologic license applications may be filed in particular jurisdictions for ABRYSVO for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO 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 ABRYSVO for any such indications 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 ABRYSVO; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO 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, 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.
1Pfizer First Quarter 2023 Earnings Teleconference Presentation, May 2, 2023, page 22, https://s28.q4cdn.com/781576035/files/doc_financials/2023/q1/Q1-2023-Earnings-Charts-FINAL.pdf
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