- FDA’s decision is based on the data from the pivotal Phase 3
clinical trial in approximately 37,000 participants
- Each year in the U.S., it is estimated that between 60,000 and
160,000 older adults are hospitalized and between 6,000 and 10,000
die due to RSV infection1
- ABRYSVO’s approval will help offer older adults protection in
the anticipated RSV season this fall
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and
Drug Administration (FDA) has approved ABRYSVO™ (Respiratory
Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F
(RSVpreF) vaccine, for the prevention of lower respiratory tract
disease caused by RSV in individuals 60 years and older. ABRYSVO is
unadjuvanted and composed of two preF proteins selected to optimize
protection against RSV A and B strains and was observed to be safe
and effective.
“A vaccine to help prevent RSV had been an elusive public health
goal for more than half a century. Today’s approval is a monumental
step forward in delivering on Pfizer’s commitment to help alleviate
the significant burden of RSV in higher-risk populations, which
includes older adults,” said Annaliesa Anderson, Ph.D., Senior Vice
President and Chief Scientific Officer, Vaccine Research and
Development, Pfizer. “ABRYSVO will address a need to help protect
older adults against the potentially serious consequences of RSV
disease. We are extremely grateful to the clinical trial
participants, study investigator teams and our dedicated Pfizer
colleagues for their roles in making this vaccine available.”
The FDA’s decision is based on the data from the pivotal Phase 3
clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iN Older adults
Immunized against
RSV disease). RENOIR 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. RENOIR has
enrolled approximately 37,000 participants, randomized to receive
RSVpreF 120 μg or placebo in a 1:1 ratio. The 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.
“This past RSV season demonstrated the serious consequences and
potential health risks this virus poses for older adults,” said
Edward E. Walsh, MD, Professor of Medicine, University of Rochester
Medical Center, and principal RENOIR investigator. “Today’s FDA
approval of ABRYSVO recognizes significant scientific progress, and
importantly helps provide older adults potential protection against
RSV and an opportunity to improve community health by helping
prevent the disease.”
RSV is a contagious virus and a common cause of respiratory
illness worldwide.2 The virus can affect the lungs and breathing
passages of an infected individual, potentially causing severe
illness or death.3,4,5 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.6
The U.S. Centers for Disease Control and Prevention’s (CDC)
Advisory Committee on Immunization Practices (ACIP) will meet on
June 21, 2023, to discuss recommendations for the appropriate use
of RSV vaccines in older adults. Pending the outcome of this
meeting, Pfizer anticipates supply availability in Q3 2023 ahead of
the anticipated RSV season this fall.
Earlier this month, Pfizer reported positive top-line results
from the Phase 3 study evaluating the safety and immunogenicity of
ABRYSVO coadministered with seasonal inactivated influenza vaccine
(SIIV) in adults 65 years and older.7 Pfizer intends to publish
these results in a peer-reviewed scientific journal. Earlier this
month, 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 due to underlying medical conditions; and adults
ages 18 and older who are immunocompromised and at high-risk for
RSV.8
About ABRYSVO Regulatory Review On March 24, 2022, Pfizer
announced the FDA granted Breakthrough Therapy Designation for
ABRYSVO for the prevention of lower respiratory tract disease
caused by RSV in individuals 60 years of age and older. This
decision was followed by the FDA’s acceptance of ABRYSVO’s
Biologics License Application (BLA) under priority review for older
adults in November 2022.
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. Earlier this month, 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.
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. Also 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.
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 injections site, fatigue, headache,
and muscle pain
View the full Prescribing Information. If it is not currently
available via this link, it will be visible as soon as possible as
we work to finalize the document. Please check back for the full
information shortly.
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 May 31, 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 ABRYSVO
(RSVpreF), including its potential benefits, an approval in the
U.S. for the prevention of lower respiratory tract disease caused
by RSV in individuals 60 years and older, 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 (RSVpreF); 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;
whether and when any applications that may be pending or filed for
ABRYSVO (RSVpreF) 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 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); uncertainties regarding the ability to obtain
recommendations from vaccine advisory or technical committees and
other public health authorities regarding ABRYSVO (RSVpreF) 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 Centers for Disease Control and Prevention.
RSV in Older Adults and Adults with Chronic Medical Conditions.
https://www.cdc.gov/rsv/high-risk/older-adults.html. 2 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
3 Centers for Disease Control and Prevention. RSV Transmission.
https://www.cdc.gov/rsv/about/transmission.html. 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. Older Adults Are at
High Risk for Severe RSV Infection.
https://www.cdc.gov/rsv/factsheet-older-adults.html 7 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
8 Pfizer 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
Category: Vaccines
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Media Contact: PfizerMediaRelations@Pfizer.com +1 (212)
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Pfizer (NYSE:PFE)
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