- Vaccine efficacy of 81.8% was observed against severe medically
attended lower respiratory tract illness due to RSV in infants from
birth through the first 90 days of life with high efficacy of 69.4%
demonstrated through the first six months of life
- The RSVpreF investigational vaccine was well-tolerated with no
safety concerns for both vaccinated individuals and their
newborns
- Results met one of the study protocol’s pre-specified
regulatory success criteria, and Pfizer plans to submit its first
regulatory application by end of 2022
- If approved, Pfizer’s RSV vaccine candidate could be the first
maternal vaccine available to help prevent this common and
potentially life-threatening respiratory illness in young
infants
- Pfizer 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
Pfizer Inc. (NYSE: PFE) today announced positive top-line data
from the 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.
The pre-planned, interim efficacy analysis conducted by an
external and independent Data Monitoring Committee (DMC) met the
success criterion for one of two primary endpoints. The observed
efficacy for severe medically attended lower respiratory tract
illness (severe MA-LRTI) was 81.8% (CI: 40.6%, 96.3%) through the
first 90 days of life. Substantial efficacy of 69.4% (CI: 44.3%,
84.1%) was demonstrated for infants over the six-month follow-up
period.
Although the statistical success criterion was not met for the
second primary endpoint, clinically meaningful efficacy was
observed for MA-LRTI of 57.1% (CI: 14.7%, 79.8%) in infants from
birth through the first 90 days of life. Efficacy for MA-LRTI of
51.3% (CI: 29.4%, 66.8%) was observed over the six-month follow up
period.
Pre-planned safety reviews conducted at regular intervals
throughout the duration of the study by the DMC also indicate the
investigational vaccine is well-tolerated with no safety concerns
for both the vaccinated individuals and their newborns.
“We are thrilled by these data as this is the first-ever
investigational vaccine shown to help protect newborns against
severe RSV-related respiratory illness immediately at birth,” said
Annaliesa Anderson, Ph.D., Senior Vice President and Chief
Scientific Officer, Vaccine Research & Development, Pfizer.
“These data reinforce Pfizer’s resolve to bring our expertise in
the research and development of innovative vaccines to address
critical public health needs using new approaches and technologies.
We look forward to working with the FDA and other regulatory
agencies to bring this vaccine candidate to expectant mothers to
help protect their infants against severe RSV during their most
vulnerable first six months of life, which has the highest burden
of RSV illness in infants. We would like to thank the pregnant
women who volunteered for this trial, along with their infants, and
all the investigators around the world who participated in the
study for their contribution to this landmark research.”
At the recommendation of the DMC, and in consultation with the
U.S. Food and Drug Administration (FDA), Pfizer has stopped
enrollment in the study. Based on these positive results Pfizer
plans to submit a Biologics License Application (BLA) to the FDA by
the end of 2022 for the vaccine candidate followed by other
regulatory authorities in the coming months.
“Every year we see high levels of RSV cases among babies in the
U.S. with some regions reporting hospital admission rates higher
than normal this year,” said Eric A.F. Simões, M.D., Clinical
Professor, Pediatrics-Infectious Diseases, University of Colorado
School of Medicine and Children’s Hospital Colorado, Aurora. “A
maternal vaccine with high efficacy that can help protect infants
from birth could substantially reduce the burden of severe RSV
among newborns through six months of age, and, if approved by
regulatory authorities, will likely have a significant impact on
disease in the U.S. and globally.”
MATISSE is an ongoing randomized, double-blinded,
placebo-controlled Phase 3 study designed to evaluate the efficacy,
safety, and immunogenicity of RSVpreF against medically attended
lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in
infants born to healthy women vaccinated during pregnancy. The
study enrolled approximately 7,400 pregnant individuals. Maternal
participants ≤ 49 years of age were randomized in a 1:1 ratio to
receive a single dose of either 120 µg of Pfizer’s RSVpreF or
placebo during the late second to third trimester of their
pregnancy. The trial also assessed safety throughout the study and
immunogenicity of the vaccine in pregnant individuals and their
infants. Maternal participants were followed for safety through
vaccination and for six months after delivery. Infants were
followed for at least one year for safety and efficacy, with over
half of the infants followed for two years. This was a global study
in 18 countries and started in June 2020, so it spanned multiple
RSV seasons in both the northern and southern hemisphere.
Pfizer intends to submit these results for peer-review in a
scientific journal.
On March 2, 2022, Pfizer announced that its vaccine candidate
received Breakthrough Therapy Designation from the FDA for the
prevention of RSV-associated lower respiratory tract disease in
infants up to six months of age by active immunization of pregnant
women. The FDA designation was informed by the results of the Phase
2b proof-of-concept study of RSVpreF (NCT04032093), which evaluated
the safety, tolerability and immunogenicity of RSVpreF in
vaccinated pregnant women ages 18 through 49 and their infants.
This followed the FDA’s November 2018 decision to grant Fast Track
status to RSVpreF.
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 be
potentially life-threatening for young infants, persons with
certain chronic medical conditions, and older adults.2,3,4,5 In the
United States alone, approximately 2.1 million outpatient visits
and 58,000 hospitalizations due to RSV occur each year among
children younger than five years old.6,7 Worldwide, RSV results in
death of approximately 102,000 children annually, with about half
of those in infants less than 6 months old and the vast majority in
developing countries.8,9
RSV bronchiolitis is the leading cause of infant hospitalization
due to viral respiratory illness, characterized by respiratory
distress that can result in death. There is no specific treatment
for RSV, only supportive care measures like oxygen and fluids.
Currently there is no vaccine to prevent RSV. The only available
preventive agent is recommended for use in limited settings in the
highest-risk infants as a monthly injection with 5 doses
administered during the RSV season, leaving most infants without
protection.
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 August 2022, Pfizer announced positive top-line
results of an interim analysis for RENOIR (RSV vaccine Efficacy study iN Older
adults Immunized against
RSV disease), a Phase 3
clinical trial (NCT05035212) evaluating the efficacy,
immunogenicity, and safety of a single dose of RSVpreF, in adults
ages 60 years or older. This study was initiated in September 2021
and remains ongoing. RENOIR and MATISSE assessed severe LRTI
differently among the distinct study populations of older adults
and infants, respectively.
In March 2022, Pfizer announced RSVpreF received Breakthrough
Therapy Designation from the U.S. Food and Drug Administration
(FDA) for the prevention of RSV-associated lower respiratory tract
disease caused by RSV in individuals 60 years of age or older. The
FDA designation was primarily informed by the positive results of a
proof-of-concept, Phase 2a study evaluating the safety,
immunogenicity, and efficacy of a single dose of 120 µg RSVpreF in
a human viral challenge model in healthy adults 18 to 50 years of
age.
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 November 1, 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 planned regulatory submissions, 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 trial could differ from the interim data discussed
in this release; 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 any
jurisdictions for RSVpreF for any potential indications (including
the planned BLA submission in the U.S.); whether and when any such
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.
[Category: Vaccines]
___________________________ 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. Disease or Condition of
the Week - Respiratory Syncytial Virus Infection (RSV).
https://www.cdc.gov/dotw/rsv/index.html. Updated September 14,
2021. 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.
Updated December 18, 2020. 6 Hall CB, et al. The Burden of
Respiratory Syncytial Virus Infection in Young Children. N Engl J
Med. 2009; 360:588-598. DOI: 10.1056/NEJMoa0804877 7 Rha B, et al.
Respiratory Syncytial Virus-Associated Hospitalizations Among Young
Children: 2015-2016 Pediatrics. 2020 Jul;146(1):e20193611. doi:
10.1542/peds.2019-3611. Epub 2020 Jun 16. 8 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. 9 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.
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