- The positive vote is based on compelling scientific evidence
presented, including Phase 3 efficacy and safety data in pregnant
individuals and their infants
- FDA decision expected in August 2023
- If authorized, the vaccine candidate would help protect infants
at first breath through six months of life against RSV disease and
its potential complications
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and
Drug Administration’s (FDA) Vaccines and Related Biological
Products Advisory Committee (VRBPAC) voted that the available data
support the efficacy and safety of its unadjuvanted bivalent
respiratory syncytial virus (RSV) prefusion F vaccine candidate
RSVpreF or PF-06928316. The Committee voted 14 to 0 on
effectiveness and 10 to 4 on safety. The vaccine candidate is
currently under FDA review for the prevention of medically attended
lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused
by RSV in infants from birth up to six months of age by active
immunization of pregnant individuals.
“We are encouraged by the outcome of today’s VRBPAC meeting as
it is a critical step forward in the scientific community’s
long-sought-after goal to help prevent RSV disease in infants
during their most vulnerable first six months of life,” said
Annaliesa Anderson, Ph.D., Senior Vice President and Chief
Scientific Officer, Vaccine Research and Development, Pfizer. “If
approved, our RSV vaccine candidate has the potential to be the
first maternal immunization vaccine to help protect infants at
first breath through their first six months of life from this
potentially serious infection.”
The VRBPAC based its recommendation on the scientific evidence
shared by Pfizer, including primary analysis results from the
pivotal Phase 3 clinical trial (NCT04424316) MATISSE
(MATernal Immunization Study for Safety and Efficacy) announced in November 2022. These
results were also recently published in The New England Journal of
Medicine.
The role of the VRBPAC is to provide recommendations to the FDA;
however, these recommendations are not binding. The FDA’s decision
on the potential approval of RSVpreF for the prevention of MA-LRTD
and severe MA-LRTD caused by RSV in infants by active immunization
of pregnant individuals is expected by the Prescription Drug User
Fee Act (PDUFA) goal date in August 2023.
Burden of RSV in Infants 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, approximately 500,000 to 600,000 cases of
MA-LRTD due to RSV occur annually in infants less than 12 months of
age.5 Worldwide, there are an estimated 6.6 million cases of RSV
annually in infants less than six months of age, with approximately
45,000 dying each year from complications associated with the
infection, and the vast majority in developing countries.6,7,8
About RSVpreF Pfizer is currently the only company
pursuing regulatory applications for an RSV investigational vaccine
candidate for both an older adult indication, as well as a maternal
indication to help protect infants through maternal
immunization.
In December 2022, Pfizer announced that the FDA had granted
priority review to a biologics license application for RSVpreF for
the prevention of RSV disease in older adults with a decision on
whether or not to approve RSVpreF expected by thePDUFA goal date
later this month. This was followed by the February 2023 vote by
VRBPAC in support of the safety and effectiveness of RSVpreF in
adults 60 years of age and older. The FDA’s VRBPAC based its
recommendation on the scientific evidence shared by Pfizer,
including interim data from the pivotal Phase 3 clinical trial
(NCT05035212) RENOIR (RSV vaccine Efficacy study iN
Older adults Immunized against RSV disease). Top-line results for
RENOIR were previously announced by Pfizer in August 2022
and presented at IDWeek and the CDC’s Advisory Committee on
Immunization Practices (ACIP) in October 2022, as well as recently
published in The New England Journal of Medicine.
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.
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.9
Pfizer’s investigational RSV vaccine candidate builds on
foundational basic science discoveries including those made at the
National Institutes of Health (NIH), which detailed the crystal
structure of prefusion F, a key form of the viral fusion protein
(F) that RSV uses to enter human cells. The NIH research showed
that antibodies specific to the prefusion form were highly
effective at blocking virus infection, suggesting a prefusion
F-based vaccine may confer optimal protection against RSV. After
this important discovery, Pfizer tested numerous versions of a
stabilized prefusion F protein and identified a candidate that
elicited a strong anti-viral immune response in pre-clinical
evaluations. The bivalent vaccine candidate is composed of equal
amounts of recombinant RSV prefusion F from subgroups A and B.
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 18, 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 Pfizer’s
respiratory syncytial virus vaccine candidate (RSVpreF), including
its potential benefits and regulatory applications pending with the
FDA, the EMA, and other regulatory authorities for a maternal
indication to help protect infants through maternal immunization
and an older adult indication, 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, 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 RSVpreF for any potential indications; whether
and when the regulatory applications pending with the FDA and the
EMA, and other regulatory authorities and any such other
applications that may be pending or filed for any indications for
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
RSVpreF 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 RSVpreF; uncertainties regarding the
ability to obtain recommendations from vaccine advisory or
technical committees and other public health authorities regarding
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. Respiratory Syncytial Virus Infection (RSV).
https://www.cdc.gov/rsv/index.html. Updated December 18, 2020.
Accessed November 18, 2022. 2 Centers for Disease Control and
Prevention. RSV Transmission.
https://www.cdc.gov/rsv/about/transmission.html. Updated December
18, 2020. Accessed November 18, 2022. 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. Accessed
November 18, 2022. 4 Centers for Disease Control and Prevention.
RSV in Infants and Young Children.
https://www.cdc.gov/rsv/high-risk/infants-young-children.html.
Updated December 18, 2020. Accessed November 18, 2022. 5 Rainisch
G, Adhikari B, Meltzer MI, Langley G. Estimating the impact of
multiple immunization products on medically-attended respiratory
syncytial virus (RSV) infections in infants. Vaccine.
2020;38(2):251-257. doi:10.1016/j.vaccine.2019.10.023 6 Rha B,
Curns AT, Lively JY, et al. Respiratory Syncytial Virus-Associated
Hospitalizations Among Young Children: 2015-2016. Pediatrics.
2020;146(1):e20193611. doi:10.1542/peds.2019-3611 7 Li et al.
Global, regional, and national disease burden estimates of acute
lower respiratory infections due to respiratory syncytial virus in
children younger than 5 years in 2019: a systematic analysis.
Lancet 2022; 399: 2047-64. 8 Scheltema NM, Gentile A, Lucion F, et
al. Global respiratory syncytial virus-associated mortality in
young children (RSV GOLD): a retrospective case series [published
correction appears in Lancet Glob Health. 2017 Dec;5(12 ):e1190].
Lancet Glob Health. 2017;5(10):e984-e991.
doi:10.1016/S2214-109X(17)30344-3. 9 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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230518005725/en/
Media Contact: PfizerMediaRelations@Pfizer.com +1 (212)
733-1226
Investor Contact: IR@Pfizer.com +1 (212) 733-4848
Pfizer (NYSE:PFE)
過去 株価チャート
から 3 2024 まで 4 2024
Pfizer (NYSE:PFE)
過去 株価チャート
から 4 2023 まで 4 2024