- First assessment from an RSV vaccine study in immunocompromised
adults show ABRYSVO was well-tolerated and generated strong
neutralizing responses after a single dose in adults ≥ 18 years of
age
- These results add to the growing body of evidence indicating a
single dose of ABRYSVO provides strong immune protection against
outcomes caused by RSV
Pfizer Inc. (NYSE: PFE) today announced positive top-line safety
and immunogenicity results from substudy B of the ongoing pivotal
Phase 3 clinical trial (NCT05842967) MONeT (RSV
IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness),
evaluating two doses of ABRYSVO vaccine in immunocompromised adults
aged 18 and older at risk of developing severe respiratory
syncytial virus (RSV)-associated lower respiratory tract disease
(LRTD).
Adults with immunocompromising conditions have an increased risk
of developing RSV-LRTD. Substudy B of the MONeT trial was conducted
to assess the safety and immunogenicity of two doses of ABRYSVO,
administered one month apart, in four groups of immunocompromised
adults: those with non-small cell lung cancer, those on
hemodialysis due to end-stage renal disease, those with autoimmune
inflammatory disorder receiving active immunomodulator therapy, and
solid organ transplant recipients. Of the 203 adults enrolled in
the substudy, approximately half were between the ages of 18 to 59,
and approximately half were 60 years or older.
ABRYSVO was well-tolerated during the trial, showing a safety
profile consistent with findings from other studies of the vaccine.
While the company evaluated two doses, a single 120 µg dose of
ABRYSVO generated a strong neutralizing response against both
subtypes of RSV, RSV-A and RSV-B, across all cohorts and age groups
in the study. Pfizer plans to share these findings at an upcoming
scientific conference and publish them in a peer-reviewed
scientific journal, as well as submit these data to the regulatory
agencies for review.
“Immunocompromised adults, such as patients with cancer or
autoimmune disorders, have a substantially increased risk of
experiencing severe complications from RSV, yet there are currently
no vaccines approved for those aged 18 to 59 in the U.S.,” said
Annaliesa Anderson, Ph.D., Senior Vice President and Chief
Scientific Officer, Vaccine Research and Development, Pfizer. “We
are encouraged by the positive top-line data from this study, which
provide important evidence that ABRYSVO has the potential to
address a significant unmet need in this vulnerable
population.”
These most recent data in immunocompromised adults build on the
body of evidence supporting the profile of ABRYSVO in high-risk
adults. In June of 2024 at the meeting of the Advisory Committee on
Immunization Practices (ACIP), Pfizer presented results from a
cohort of adults aged 18-59 with certain chronic medical
conditions. In the double-blinded study, 681 adults aged 18 to 59
with chronic conditions were randomized 2:1 to receive a single
dose of ABRYSVO or placebo. Participants demonstrated RSV-A and
RSV-B subgroup neutralizing responses non-inferior to the response
seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO, which
previously demonstrated ABRYSVO’s efficacy in a population of
adults aged 60 or older. These results support previous data
presented at the ACIP showing high ABRYSVO clinical effectiveness
against lower respiratory tract disease among a population of
adults age 60 years and older that included a substantial
proportion of immunocompromised persons.
Approval of ACT-O-VIAL®
Additionally and as previously announced, the U.S. Food and Drug
Administration (FDA) has approved Pfizer’s supplemental Biologics
License Application for the ACT-O-VIAL® presentation of ABRYSVO.
This approval allows Pfizer to bring a new option to market
alongside its existing needle-free reconstitution kits. The
ACT-O-VIAL System is a dual-component vial system that simplifies
the reconstitution of ABRYSVO within a single, compact device.
Designed to support safety, workflow improvements and storage
efficiency, the system offers significant storage space savings,
which may be appealing to retailers during peak vaccination
seasons.
ABOUT MONeT MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness) is a
Phase 3, multicenter clinical trial (NCT05842967) investigating the
safety, tolerability and immunogenicity of ABRYSVO in adults at
risk of RSV-associated disease, including adults with certain
chronic medical conditions (substudy A) and adults who are
immunocompromised (substudy B). Substudy A is a double-blinded
study that randomized 681 adults aged 18 to 59 with chronic
conditions, with 2:1 to receive a single dose of ABRYSVO or
placebo. Substudy B is an open-label study that enrolled
approximately 200 immunocompromised adults aged 18 or older,
roughly half of which were aged 60 or older, who received two doses
of ABRYSVO, one month apart.
ABOUT RSV Respiratory syncytial virus (RSV) is a
contagious virus and a common cause of respiratory illness.1 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.2,3,4 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.5,6,7,8,9,10,11,12,13 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 protection against RSV-LRTD, regardless of
the virus subgroup. In the prefusion state, the RSV fusion protein
(F) is a major target of neutralizing antibodies, serving as the
basis of Pfizer’s RSV vaccine. Variations in the F protein sequence
among RSV-A and RSV-B subgroups are clustered in a key antigenic
site, a target for potent neutralizing antibodies.
In May 2023, the FDA approved ABRYSVO for the prevention of LRTD
caused by RSV in individuals 60 years of age or older. The Advisory
Committee on Immunization Practices (ACIP) of the U.S. Centers for
Disease Control and Prevention recommends RSV vaccines as a single
dose for all adults 75 and older and for adults 60 and older at
increased risk of severe RSV disease. 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 in January 2024; the Pharmaceutical
Administration Bureau of Macau in February 2024; the Ministry of
Health, Labour, and Welfare of Japan for maternal immunization to
help protect infants in January 2024 and for older adults in March
2024; and the Therapeutic Goods Administration of Australia in
March 2024 for older adults.
In addition to MONeT, Pfizer has initiated a clinical trial
evaluating ABRYSVO in children ages two to less than 18 years who
are at higher risk for RSV disease.14
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
175 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 X 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 August 12, 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 share findings from an
RSV vaccine study in immunocompromised adults at an upcoming
scientific conference and publish them in a peer-reviewed
scientific journal, planned regulatory submissions, a potential new
indication for ABRYSVO and clinical trials initiated for ABRYSVO 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; 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 Centers for Disease Control and
Prevention. Respiratory Syncytial Virus Infection (RSV).
https://www.cdc.gov/rsv/index.html. Updated December 18, 2020. 2
Centers for Disease Control and Prevention. How RSV Spreads.
https://www.cdc.gov/rsv/causes/index.html. Updated May 30, 2024. 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. Updated April
2024. 4 Centers for Disease Control and Prevention. RSV in Infants
and Young Children.
https://www.cdc.gov/rsv/infants-young-children/index.html. Updated
June 5, 2024. 5 Centers for Disease Control and Prevention. RSV
Surveillance & Research.
https://www.cdc.gov/rsv/php/surveillance/. Updated June 5, 2024. 6
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. 7 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. 8 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. 9 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. 10 Centers for Disease Control and Prevention.
October 2022 ACIP Meeting Slides. ACIP Adult RSV Work Group
Considerations. Available at:
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-06-26-28/12-RSV-Adult-Melgar-508.pdf
11 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. 12 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. 13 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. 14 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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