If approved, RSVpreF would help address the
substantial burden of RSV disease in individuals 60 years of age or
older
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and
Drug Administration (FDA) accepted for priority review a Biologics
License Application (BLA) for its respiratory syncytial virus (RSV)
vaccine candidate, PF-06928316 or RSVpreF, as submitted for the
prevention of lower respiratory tract disease caused by RSV in
individuals 60 years of age and older.
Priority Review designation by the FDA reduces the standard BLA
review period by four months. The Prescription Drug User Fee Act
(PDUFA) goal date for a decision by the FDA on the RSVpreF
application is in May 2023. This decision follows the FDA’s
Breakthrough Therapy Designation of RSVpreF in older adults in
March 2022.
“With no RSV vaccines currently available, older adults remain
at-risk for RSV disease and potential severe outcomes, including
serious respiratory symptoms, hospitalization, and in some cases,
even death,” said Annaliesa Anderson, Ph.D., Senior Vice President
and Chief Scientific Officer, Vaccine Research & Development,
Pfizer. “The FDA’s acceptance of the BLA for our RSV vaccine
candidate is an important regulatory milestone in Pfizer’s efforts
to help protect older adults against RSV and demonstrates
additional progress toward what has been an elusive public health
goal – reducing the overall burden associated with this infectious
disease.”
The regulatory submission is supported by results of the 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 RSVpreF 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. In August 2022, Pfizer announced
positive top-line results of an interim efficacy analysis for
RENOIR.
Burden of RSV
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 60,000–120,000
hospitalizations and 6,000–14,000 deaths each year.5,6,7,8 Among
children younger than five years old in the U.S., RSV infections
account for approximately 2.1 million outpatient visits and
58,000–80,000 hospitalizations occur each year.9,10,11 RSV
incidence can vary dramatically from one year to the next, and this
year there has been a large resurgence in cases following an
evolution of masking and isolation measures.
RSV is a disease for which there are currently no prophylactic,
therapeutic, or vaccine options for older adults and the medical
community is limited to offering only supportive care for adults
with the illness.
About RSVpreF
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.
Pfizer is currently the only company with an investigational
vaccine being prepared for regulatory applications for both infants
through maternal immunization and older adults to help protect
against RSV. In November 2022, Pfizer announced a positive interim
analysis of its Phase 3 clinical trial (NCT04424316) MATISSE
(MATernal Immunization Study for Safety and Efficacy) investigating its bivalent RSV
prefusion vaccine candidate, RSVpreF or PF-06928316, when
administered to pregnant participants to help protect their infants
from RSV disease after birth.
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 December 7,
2022. 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 a BLA pending with the FDA for the
prevention of lower respiratory tract disease caused by RSV in
individuals 60 years of age and older, 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 BLA pending with the FDA for RSVpreF for the
prevention of lower respiratory tract disease caused by RSV in
individuals 60 years of age and older or any such other
applications 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, 2021 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 McLaughlin
JM, Khan F, Begier E, Swerdlow DL, Jodar L, Falsey AR. Rates of
Medically Attended RSV Among US Adults: A Systematic Review and
Meta-analysis. Open Forum Infect Dis. 2022;9(7):ofac300. Published
2022 Jun 17. doi:10.1093/ofid/ofac300. 6 Centers for Disease
Control and Prevention. CDC unpublished data from RSV-NET.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-10-19-20/04-RSV-Adults-Melgar-508.pdf.
Accessed November 22, 2022. 7 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.
doi:10.1001/jama.289.2.179 8 Hansen CL, Chaves SS, Demont C, Viboud
C. Mortality Associated With Influenza and Respiratory Syncytial
Virus in the US, 1999-2018. JAMA Netw Open. 2022;5(2):e220527.
Published 2022 Feb 1. doi:10.1001/jamanetworkopen.2022.0527 9 Hall
CB, Weinberg GA, Iwane MK, et al. The burden of respiratory
syncytial virus infection in young children. N Engl J Med.
2009;360(6):588-598. doi:10.1056/NEJMoa0804877 10 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 11 McLaughlin JM,
Khan F, Schmitt HJ, et al. Respiratory Syncytial Virus-Associated
Hospitalization Rates among US Infants: A Systematic Review and
Meta-Analysis. J Infect Dis. 2022;225(6):1100-1111.
doi:10.1093/infdis/jiaa752
Category: Vaccines
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