Pfizer’s ABRYSVO™ Receives Recommendation for Use in Older Adults from Advisory Committee on Immunization Practices

• ABRYSVO recommended for adults 60 years and older to help protect against Respiratory Syncytial Virus (RSV) disease 
• Pfizer presented initial data from mid- RSV season two in the Northern Hemisphere, which demonstrated ABRYSVO maintained efficacy against RSV-associated lower respiratory tract disease (LRTD)
• Additional data presented by Pfizer supports coadministration of ABRYSVO with flu vaccine in older adults 

NEW YORK, June 22, 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 ABRYSVO™ [Respiratory Syncytial Virus (RSV) Vaccine], the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for use in adults 60 years of age and older to help protect against lower respiratory tract disease caused by RSV.  

Specifically, the committee voted that: 

• Adults 65 years of age and older may receive a single dose of RSV vaccine, using shared clinical decision making.
• Individual adults aged 60-64 years may receive a single dose of RSV vaccine, using shared clinical decision making.

These provisional recommendations will be reviewed and finalized by the director of the CDC and the Department of Health and Human Services.

“We welcome the recommendations by ACIP as it underscores the important role ABRYSVO may have in helping to alleviate the significant burden of RSV in older adults,” said Luis Jodar, PhD, Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. “With more than 77 million individuals aged 60 and older in the U.S., the recommended use of this vaccine can help prevent the potentially serious consequences associated with RSV, which leads to the hospitalization of more than 60,000 of these adults each year.”

The ACIP recommendations follow the U.S. Food and Drug Administration’s (FDA) approval of ABRYSVO for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.

RSV is a contagious virus and a common cause of respiratory illness worldwide.¹ The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.^2,3,4 In the U.S., the burden RSV causes in older adults is considerable. The severity of RSV disease can increase with age and comorbidities, such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.⁵

MID- RSV SEASON TWO ABRYSVO EFFICACY AND FLU COADMINISTRATION DATA PRESENTED
During the meeting, Pfizer presented for the first time an analysis of initial vaccine efficacy data for mid- RSV season two in the Northern Hemisphere from the ongoing pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease). Vaccine efficacy after approximately six months of disease surveillance through mid-season two was 48.9% (95.0% CI: 13.7%, 70.5%) against RSV-associated LRTD defined by two or more symptoms; and 78.6% (95.0% CI: 23.2%, 96.1%) against more severe LRTD defined by three or more symptoms. At the end of the first RSV season, as published in The New England Journal of Medicine, the vaccine demonstrated efficacy against RSV-associated LRTD defined by two or more symptoms of 65.1% (95.0%% CI: 35.9%, 82.0%); and 88.9% (95.0% CI: 53.6%, 98.7%) against more severe LRTD defined by three or more symptoms. The comparison of data show that ABRYSVO maintained efficacy between the end of season one and mid-season two.

Following administration during the trial, the vaccine was generally well-tolerated and the most common side effects (≥10%) were pain at the injection site, fatigue, headache, and muscle pain. No adverse events were reported by subjects through mid- RSV season two. 

Additionally, Pfizer presented positive top-line results from the Phase 3 study evaluating the safety and immunogenicity of ABRYSVO when coadministered with seasonal inactivated influenza vaccine (SIIV) in adults 65 years and older. The results support coadministration of ABRYSVO with flu vaccine in older adults.⁶ Pfizer intends to publish these results in a peer-reviewed scientific journal. 

ADDITIONAL PFIZER VACCINES ACIP AGENDA ITEMS
Today, ACIP will discuss additional data, including cost effectiveness, and vote on the recommendations for the appropriate use of PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) in infants and children. 

Today and on Friday, June 23, respectively, ACIP will also review additional data, including cost-effectiveness, for Pfizer’s bivalent RSV prefusion vaccine candidate, RSVpreF or PF-06928316, when administered to pregnant individuals to help protect infants from RSV disease through maternal immunization, and Pfizer’s pentavalent meningococcal vaccine candidate (MenABCWY) when administered to individuals 10 through 25 years of age.

ABOUT ABRYSVO REGULATORY REVIEW
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. Previously Pfizer announced that the FDA had granted priority review for a BLA 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. In May, Pfizer announced that the FDA’s Vaccines and Related Biological Products Advisory Committee voted that available data support the efficacy and safety of RSVpreF for the maternal indication. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in August 2023. 

Pfizer Japan announced in May that its application with the Ministry of Health, Labor and Welfare for RSVpreF as a maternal immunization to help protect infants against RSV was accepted. 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. 

In February 2023, it was announced that the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) under accelerated assessment for RSVpreF, as submitted for both older adults and maternal immunization to help protect infants against RSV. The formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) currently is ongoing. 

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.

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

View the full Prescribing Information. 

INDICATIONS FOR PREVNAR 20

PREVNAR 20 is a vaccine approved 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.

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.
• Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for 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 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 June 22, 203. 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 ABRYSVO (RSVpreF), including its potential benefits, a vote by ACIP to recommend ABRYSVO for use in adults 60 years of age and older to help protect against lower respiratory tract disease caused by RSV, 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, and applications pending for RSVpreF in other jurisdictions; and certain of Pfizer’s other vaccines and vaccine candidates 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 (RSVpreF) and Pfizer’s other vaccines; 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 (RSVpreF) for any potential indications or for any of Pfizer’s other vaccines and vaccine candidates; whether and when any applications that may be pending or filed for ABRYSVO (RSVpreF) or any other vaccines or vaccine candidates 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 (RSVpreF) for any such indications or any other such vaccines 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 (RSVpreF) or any such other vaccines; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO (RSVpreF) or any such other vaccines 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.  

¹ World Health Organization. Respiratory Syncytial Virus (RSV) disease. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/respiratory-syncytial-virus-disease 
² Centers for Disease Control and Prevention. RSV Transmission.  https://www.cdc.gov/rsv/about/transmission.html. 
³ Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. https://www.cdc.gov/rsv/factsheet-older-adults.pdf. 
⁴ Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www.cdc.gov/rsv/high-risk/infants-young-children.html. 
⁵ Centers for Disease Control and Prevention. Older Adults Are at High Risk for Severe RSV Infection. https://www.cdc.gov/rsv/factsheet-older-adults.pdf
⁶ Pfizer First Quarter 2023 Earnings Press Release, May 2, 2023, page 11, https://s28.q4cdn.com/781576035/files/doc_financials/2023/q1/Q1-2023-PFE-Earnings-Release.pdf

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