- 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.
Pfizer Inc. (NYSE: PFE) today announced top-line ABRYSVO®
vaccine efficacy and safety data for respiratory syncytial virus
(RSV) in adults 60 years of age and older following a second season
in the Northern and Southern Hemispheres from the ongoing pivotal
Phase 3 clinical trial (NCT05035212) RENOIR (RSV
vaccine Efficacy study iN Older adults
Immunized against RSV disease). Vaccine efficacy
against RSV-associated lower respiratory tract disease (LRTD),
defined by three or more symptoms, after disease surveillance in
season two was 77.8% (95.0% CI: 51.4, 91.1); vaccine efficacy
following season one was 88.9% (95.0% CI: 53.6%, 98.7%)1, which
demonstrates durable efficacy after two seasons.
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. Pfizer is conducting post-marketing
studies and surveillance programs to inform the safety profile of
ABRYSVO.
“We are encouraged by the level of protection that we observed
after two full RSV seasons for ABRYSVO,” said Annaliesa Anderson,
Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine
Research and Development, Pfizer. “This new data indicate that
broad and durable protection against both types of RSV that cause
disease, RSV A and RSV B, is the potential benefit to having a
bivalent vaccine.”
Pfizer intends to submit these data to regulatory authorities
and vaccine technical committees. The company also intends to
publish these findings in a peer-reviewed scientific journal and
share them at an upcoming scientific congress.
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 the United States
alone, among older adults, RSV infections account for approximately
60,000-160,000 hospitalizations and 6,000-13,000 deaths each
year.6,7,8,9,10,11,12,13,14 RSV disease is caused by the
respiratory syncytial virus. There are two major subgroups of RSV:
RSV A and RSV B. Both subgroups cause disease and can co-circulate
or alternate predominance from season to season.
ABOUT ABRYSVO Pfizer currently is the only company with
an RSV vaccine to help protect older adults, as well as infants
through maternal immunization. ABRYSVO is a bivalent vaccine that
was designed to provide broad protection against all RSV-LRTD,
regardless of the virus subgroup. The RSV fusion protein (F) in the
prefusion conformation is a major target of virus infection
blocking antibodies and is the basis of Pfizer’s RSV vaccine.
Sequence variability in F between RSV subgroup A and B strains
clusters in potent neutralizing antibody binding sites on prefusion
F.
In May 2023, the FDA approved ABRYSVO for the prevention of LRTD
caused by RSV in individuals 60 years of age or older. ABRYSVO is a
bivalent vaccine that was designed to provide broad protection
regardless whether strain. This was followed by the ACIP’s
recommendation of the vaccine for use in adults 60 years of age and
older with shared clinical decision making, which occurred in June
2023. In August 2023, the FDA approved ABRYSVO for the prevention
of LRTD and severe LRTD caused by RSV in infants from birth up to
six months of age by active immunization of pregnant individuals at
32 through 36 weeks gestational age. This was followed in September
2023 with ACIP’s recommendation for maternal immunization to help
protect newborns from RSV seasonally where the vaccine should be
administered from September through January in most of the
continental United States.
Also in August 2023, Pfizer announced that the European
Medicines Agency (EMA) granted marketing authorization for ABRYSVO
for both older adults and maternal immunization to help protect
infants. The vaccine has also received approvals from la
Administración Nacional de Medicamentos, Alimentos y Tecnología
Médica (ANMAT) of Argentina in September 2023; the Medicines and
Healthcare products Regulatory Agency (MHRA) of the United Kingdom
in November 2023; Health Canada of Canada in January 2024; the
Pharmaceutical Administration Bureau of Macau in February 2024; and
for maternal immunization to help protect infants by the Ministry
of Health, Labour, and Welfare of Japan in January 2024.
Pfizer has also initiated two additional clinical trials
evaluating ABRYSVO. One trial is being conducted in children ages
two to less than 18 years who are at higher risk for RSV disease.15
A second trial is evaluating adults ages 18 to 59 years at higher
risk for RSV due to underlying medical conditions such as asthma,
diabetes and chronic obstructive pulmonary disease (COPD), and
adults ages 18 and older who are immunocompromised and at high risk
for RSV.
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 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 February 29, 2024. 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,
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
December 31, 2023, 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 Walsh EE, Gonzalo PM, et al. “Efficacy and Safety of a
Bivalent RSV Prefusion F Vaccine in Older Adults.” The New England
Journal of Medicine. April 20, 2023.
https://www.nejm.org/doi/full/10.1056/NEJMoa2213836?query=featured_home
2 Centers for Disease Control and Prevention. Respiratory Syncytial
Virus Infection (RSV). https://www.cdc.gov/rsv/index.html. Updated
December 18, 2020. 3 Centers for Disease Control and Prevention.
RSV Transmission. https://www.cdc.gov/rsv/about/transmission.html.
Updated December 18, 2020. 4 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. 5 Centers for
Disease Control and Prevention. RSV in Infants and Young Children.
https://www.cdc.gov/rsv/high-risk/infants-young-children.html. 6
Centers for Disease Control and Prevention. RSV Surveillance &
Research. https://www.cdc.gov/rsv/research/index.html. 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 Centers for Disease Control and Prevention.
October 2022 ACIP Meeting Slides. ACIP Adult RSV Work Group
Considerations. Available at:
www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-10-19-20/04-RSV-Adults-Melgar-508.pdf.
12 Thompson WW, Shay DK, Weintraub E, et al. Mortality Associated
with Influenza and Respiratory Syncytial Virus in the United
States. JAMA. 2003; 289(2): 179.186. 13 Matias G, Taylor R,
Haguinet F, et al. Estimates of Mortality Attributable to Influenza
and RSV in the United States during 1997–2009 by Influenza Type or
Subtype, Age, Cause of Death, and Risk Status. Influenza Other
Respir Viruses. 2014; 8(5):507-15. 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 Feb
1;5(2):e220527. 15 Pfizer Second-Quarter 2023 Earnings
Teleconference Presentation, August 1, 2023, page, 24,
https://s28.q4cdn.com/781576035/files/doc_financials/2023/q2/Q2-2023-PFE-Earnings-Release.pdf
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