Pfizer Announces Positive Top-Line Data for Full Season Two Efficacy of ABRYSVO® for RSV in Older Adults
- ABRYSVO, a bivalent vaccine, maintained consistently high protective efficacy for both RSV A and RSV B disease through two seasons after a single dose.
- ABRYSVO efficacy was 77.8% against RSV lower respiratory tract disease with three or more symptoms in a second full RSV season in adults 60 years of age or older.
Consistent vaccine efficacy was demonstrated for both RSV A and RSV B after season two with vaccine efficacy against each subtype of ≥80% for LRTD with three or more symptoms. Vaccine efficacy was also sustained against less severe LRTD, defined by two or more symptoms, from 65.1% (95.0%% CI: 35.9%, 82.0%)1 after season one to 55.7% (95.0% CI: 34.7%, 70.4%) after the end of season two. Vaccine efficacy against RSV-associated LRTD, defined by three or more symptoms, across both seasons after approximately 16.4 months of disease surveillance was 81.5% (95.0% CI: 63.3, 91.6).
No new adverse events were reported through the second RSV season beyond what was reported by subjects in the clinical trial during the first season.
“We are encouraged by the level of protection that we observed after two full RSV seasons for ABRYSVO,” said
ABOUT RSV
RSV is a contagious virus and a common cause of respiratory illness.2 The virus can affect the lungs and breathing passages of an infected individual and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.3,4,5 In
ABOUT ABRYSVO
In
Also in
INDICATIONS FOR ABRYSVO
ABRYSVO™ is a vaccine indicated in the US for:
- the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
- pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age
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
- For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
- Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during 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 fatigue, headache, pain at the injection site, and muscle pain
- In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea,
- In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo
View the full ABRYSVO Prescribing Information.
About
At
DISCLOSURE NOTICE:
The information contained in this release is as of
This release contains forward-looking information about ABRYSVO, including its potential benefits, plans to submit season two data to regulatory authorities and vaccine technical committees, clinical trials initiated for ABRYSVO in other populations and post-marketing studies and surveillance programs for ABRYSVO, 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; 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; intellectual property and other litigation; 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
1 Walsh EE, Gonzalo PM, et al. “Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults.”
2
3
4
5
6
7 Widmer K, Zhu Y, Williams JV, et al. Rates of Hospitalizations for Respiratory Syncytial Virus, Human Metapneumovirus, and Influenza Virus in Older Adults. J Infect Dis. 2012; 206(1):56-62.
8 Branche AR, Saiman L, Walsh EE, et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020. CID. 2022;74(6):1004-1011.
9 McLaughlin JM, Khan F, Begier E, et al. Rates of Medically Attended RSV among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022; 9(7): ofac300.
10 Zheng Z, Warren JL, Shapiro ED, et al. Estimated Incidence of Respiratory Hospitalizations Attributable to RSV Infections across Age and Socioeconomic Groups. Pneumonia. 2022;14(1):6.
11
12 Thompson WW, Shay DK, Weintraub E, et al. Mortality Associated with Influenza and Respiratory Syncytial Virus in
13 Matias G, Taylor R, Haguinet F, et al. Estimates of Mortality Attributable to Influenza and RSV in
14 Hansen CL, Chaves SS, Demont C, Viboud C. Mortality Associated With Influenza and Respiratory Syncytial Virus in the US, 1999-2018.JAMA Network Open. 2022
15 Pfizer Second-Quarter 2023 Earnings Teleconference Presentation,
View source version on businesswire.com: https://www.businesswire.com/news/home/20240229807323/en/
Media:
PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226
Investor:
IR@Pfizer.com
+1 (212) 733-4848
Source: