- Analysis of 927 confirmed symptomatic cases of COVID-19
demonstrates BNT162b2 is highly effective with 91.3% vaccine
efficacy observed against COVID-19, measured seven days through up
to six months after the second dose
- Vaccine was 100% effective in preventing severe disease as
defined by the U.S. Centers for Disease Control and Prevention and
95.3% effective in preventing severe disease as defined by the U.S.
Food and Drug Administration
- Vaccine was 100% effective in preventing COVID-19 cases in
South Africa, where the B.1.351 lineage is prevalent
- Vaccine safety now evaluated in more than 44,000 participants
16 years of age and older, with more than 12,000 vaccinated
participants having at least six months follow-up after their
second dose
- The companies plan to share these results with worldwide
regulatory agencies soon
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced updated topline results from analysis of 927 confirmed
symptomatic cases of COVID-19 observed in their pivotal Phase 3
study through March 13, 2021, showing the Pfizer-BioNTech COVID-19
vaccine, BNT162b2, was 91.3% effective against COVID-19, measured
seven days through up to six months after the second dose. The
vaccine was 100% effective against severe disease as defined by the
U.S. Centers for Disease Control and Prevention (CDC), and 95.3%
effective against severe COVID-19 as defined by the U.S. Food and
Drug Administration (FDA). Safety data from the Phase 3 study has
also been collected from more than 12,000 vaccinated participants
who have a follow-up time of at least six months after the second
dose, demonstrating a favorable safety and tolerability
profile.
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“These data confirm the favorable efficacy and safety profile of
our vaccine and position us to submit a Biologics License
Application to the U.S. FDA,” said Albert Bourla, Chairman and
Chief Executive Officer, Pfizer. “The high vaccine efficacy
observed through up to six months following a second dose and
against the variant prevalent in South Africa provides further
confidence in our vaccine’s overall effectiveness.”
“It is an important step to further confirm the strong efficacy
and good safety data we have seen so far, especially in a
longer-term follow-up,” said Ugur Sahin, CEO and Co-founder of
BioNTech. “These data also provide the first clinical results that
a vaccine can effectively protect against currently circulating
variants, a critical factor to reach herd immunity and end this
pandemic for the global population.”
About the Analysis
The updated analysis of the Phase 3 clinical trial was conducted
in accordance with guidance from the FDA for all companies
investigating COVID-19 vaccines to review safety and efficacy at
key milestones.
Results from this analysis of 46,307 trial participants build
upon and confirm previously released data and demonstrate strong
protection against COVID-19 through six months post-second dose.
From the 927 confirmed symptomatic cases of COVID-19 in the trial,
850 cases of COVID-19 were in the placebo group and 77 cases were
in the BNT162b2 group, corresponding to vaccine efficacy of 91.3%
(95% confidence interval [CI, 89.0, 93.2]).
Thirty-two cases of severe disease, as defined by the CDC, were
observed in the placebo group versus none in the BNT162b2
vaccinated group, indicating that the vaccine was 100% efficacious
in this analysis against severe disease by the CDC definition (95%
CI, [88.0,100.0]). Twenty-one severe cases, as defined by the FDA,
were observed in the placebo group versus one case in the BNT162b2
vaccinated group, indicating 95.3% efficacy by the FDA definition
(95% CI, [71.0, 99.9]).
Efficacy was generally consistent across age, gender, race and
ethnicity demographics, and across participants with a variety of
underlying conditions.
A total of 697 cases of COVID-19 were observed in the United
States; 647 cases of COVID-19 were observed in the placebo group
versus 50 in the vaccine group, indicating vaccine efficacy of
92.6% (95% CI, [90.1, 94.5]).
In South Africa, where the B.1.351 lineage is prevalent and 800
participants were enrolled, nine cases of COVID-19 were observed,
all in the placebo group, indicating vaccine efficacy of 100% (95%
CI, [53.5, 100.0]). In an exploratory analysis, the nine strains
were sequenced and six of the nine were confirmed to be of the
B.1.351 lineage. These data support previous results from
immunogenicity studies demonstrating that BNT162b2 induced a robust
neutralizing antibody response to the B1.351 variant, and although
lower than to the wild-type strain, it does not appear to affect
the high observed efficacy against this variant.i
No serious safety concerns were observed in trial participants
up to six months after the second dose. Side effects were generally
consistent with previously reported results. Vaccine safety has now
been evaluated in more than 44,000 participants aged 16 years and
older with more than 12,000 vaccinated participants having at least
six months of follow-up after their second dose.
Pfizer and BioNTech plan to submit detailed data for scientific
peer review and potential publication in the near future.
The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, has not been
approved or licensed by the U.S. Food and Drug Administration
(FDA), but has been authorized for emergency use by FDA under an
Emergency Use Authorization (EUA) to prevent Coronavirus Disease
2019 (COVID-19) for use in individuals 16 years of age and older.
The emergency use of this product is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of emergency use of the medical product under Section
564 (b) (1) of the FD&C Act unless the declaration is
terminated or authorization revoked sooner. Please see Emergency
Use Authorization (EUA) Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) including Full EUA
Prescribing Information available at www.cvdvaccine.com.
The vaccine, which is based on BioNTech proprietary mRNA
technology, was developed by both BioNTech and Pfizer. BioNTech is
the Marketing Authorizations Holder in the European Union, and the
holder of emergency use authorizations or equivalent in the United
States, United Kingdom, Canada and other countries in advance of a
planned application for full marketing authorizations in these
countries.
AUTHORIZED USE IN THE U.S.: The Pfizer-BioNTech COVID-19
Vaccine is authorized for use under an Emergency Use Authorization
(EUA) for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) in individuals 16 years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE
AUTHORIZATION PRESCRIBING INFORMATION:
- Do not administer Pfizer-BioNTech COVID-19 Vaccine to
individuals with known history of a severe allergic reaction (e.g.,
anaphylaxis) to any component of the Pfizer-BioNTech COVID-19
Vaccine
- Appropriate medical treatment used to manage immediate allergic
reactions must be immediately available in the event an acute
anaphylactic reaction occurs following administration of
Pfizer-BioNTech COVID-19 Vaccine
- Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the
occurrence of immediate adverse reactions according to the Centers
for Disease Control and Prevention guidelines
(https://www.cdc.gov/vaccines/covid-19/)
- Immunocompromised persons, including individuals receiving
immunosuppressant therapy, may have a diminished immune response to
the Pfizer-BioNTech COVID-19 Vaccine
- The Pfizer-BioNTech COVID-19 Vaccine may not protect all
vaccine recipients
- In clinical studies, adverse reactions in participants 16 years
of age and older included pain at the injection site (84.1%),
fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills
(31.9%), joint pain (23.6%), fever (14.2%), injection site swelling
(10.5%), injection site redness (9.5%), nausea (1.1%), malaise
(0.5%), and lymphadenopathy (0.3%)
- Severe allergic reactions, including anaphylaxis, have been
reported following the Pfizer-BioNTech COVID-19 Vaccine during mass
vaccination outside of clinical trials. Additional adverse
reactions, some of which may be serious, may become apparent with
more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
- Available data on Pfizer-BioNTech COVID-19 Vaccine administered
to pregnant women are insufficient to inform vaccine-associated
risks in pregnancy
- Data are not available to assess the effects of Pfizer-BioNTech
COVID-19 Vaccine on the breastfed infant or on milk
production/excretion
- There are no data available on the interchangeability of the
Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to
complete the vaccination series. Individuals who have received one
dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second
dose of Pfizer-BioNTech COVID-19 Vaccine to complete the
vaccination series
- Vaccination providers must report Adverse Events in accordance
with the Fact Sheet to VAERS at
https://vaers.hhs.gov/reportevent.html or by calling
1-800-822-7967. The reports should include the words
“Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section
of the report
- Vaccination providers should review the Fact Sheet for
Information to Provide to Vaccine Recipients/Caregivers and
Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine
Administration Under Emergency Use Authorization
- Please see Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers)
including Full EUA Prescribing Information available at
www.cvdvaccine-us.com
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.
Pfizer Disclosure Notice The information contained in
this release is as of April 1, 2021. 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
efforts to combat COVID-19, the collaboration between BioNTech and
Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine
program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2)
(including qualitative assessments of available data, potential
benefits, expectations for clinical trials, anticipated timing of
regulatory submissions, regulatory approvals or authorizations and
anticipated manufacturing, distribution and supply) involving
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 clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
risks associated with preclinical and clinical data (including the
topline data outlined in this release), including the possibility
of unfavorable new preclinical, clinical or safety data and further
analyses of existing preclinical, clinical or safety data
(including the topline data outlined in this release); the ability
to produce comparable clinical or other results, including the rate
of vaccine effectiveness and safety and tolerability profile
observed to date, in additional analyses of the Phase 3 trial and
additional studies or in larger, more diverse populations following
commercialization; the ability of BNT162b2 to prevent COVID-19
caused by emerging virus variants; the risk that more widespread
use of the vaccine will lead to new information about efficacy,
safety, or other developments, including the risk of additional
adverse reactions, some of which may be serious; the risk that
preclinical and clinical trial data (including the topline data
outlined in this release) are subject to differing interpretations
and assessments, including during the peer review/publication
process, in the scientific community generally, and by regulatory
authorities; whether and when additional data from the BNT162 mRNA
vaccine program (including the topline data outlined in this
release) will be published in scientific journal publications and,
if so, when and with what modifications and interpretations;
whether regulatory authorities will be satisfied with the design of
and results from these and any future preclinical and clinical
studies; whether and when a Biologics License Application for
BNT162b2 may be filed in the U.S. and whether and when other
biologics license and/or emergency use authorization applications
or amendments to any such applications may be filed in particular
jurisdictions for BNT162b2 or any other potential vaccines that may
arise from the BNT162 program, and if obtained, whether or when
such emergency use authorization or licenses will expire or
terminate; whether and when any applications that may be pending or
filed for BNT162b2 (including a potential Biologics License
Application in the U.S. or any requested amendments to the
emergency use authorization) or other vaccines that may result from
the BNT162 program may be approved by particular regulatory
authorities, which will depend on myriad factors, including making
a determination as to whether the vaccine’s benefits outweigh its
known risks and determination of the vaccine’s efficacy and, if
approved, whether it will be commercially successful; decisions by
regulatory authorities impacting labeling or marketing,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of a vaccine,
including development of products or therapies by other companies;
disruptions in the relationships between us and our collaboration
partners or third-party suppliers; risks related to the
availability of raw materials to manufacture a vaccine; challenges
related to our vaccine’s ultra-low temperature formulation,
two-dose schedule and attendant storage, distribution and
administration requirements, including risks related to storage and
handling after delivery by Pfizer; the risk that we may not be able
to successfully develop other vaccine formulations; the risk that
we may not be able to create or scale up manufacturing capacity on
a timely basis or maintain access to logistics or supply channels
commensurate with global demand for our vaccine, which would
negatively impact our ability to supply the estimated numbers of
doses of our vaccine within the projected time periods as
previously indicated; whether and when additional supply agreements
will be reached; uncertainties regarding the ability to obtain
recommendations from vaccine technical committees and other public
health authorities and uncertainties regarding the commercial
impact of any such recommendations; uncertainties regarding the
impact of COVID-19 on Pfizer’s 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, 2020 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.
About BioNTech Biopharmaceutical New Technologies is a
next generation immunotherapy company pioneering novel therapies
for cancer and other serious diseases. The Company exploits a wide
array of computational discovery and therapeutic drug platforms for
the rapid development of novel biopharmaceuticals. Its broad
portfolio of oncology product candidates includes individualized
and off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun
Pharma, and Pfizer. For more information, please visit
www.BioNTech.de.
BioNTech Forward-looking Statements This press release
contains “forward-looking statements” of BioNTech within the
meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements may include, but may not be
limited to, statements concerning: BioNTech’s efforts to combat
COVID-19; the collaboration between BioNTech and Pfizer to develop
a COVID-19 vaccine (including a potential second booster dose of
BNT162b2 and/or a potential booster dose of a variation of BNT162b2
having a modified mRNA sequence); our expectations regarding the
potential characteristics of BNT162b2 in our clinical trials and/or
in commercial use based on data observations to date; the ability
of BNT162b2 to prevent COVID-19 caused by emerging virus variants;
the expected time point for additional readouts on efficacy data of
BNT162b2 in our clinical trials; the nature of the clinical data,
which is subject to ongoing peer review, regulatory review and
market interpretation; the timing for submission of data for, or
receipt of, any marketing approval or Emergency Use Authorization;
our contemplated shipping and storage plan, including our estimated
product shelf life at various temperatures; and the ability of
BioNTech to supply the quantities of BNT162 to support clinical
development and market demand, including our production estimates
for 2021. Any forward-looking statements in this press release are
based on BioNTech current expectations and beliefs of future
events, and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in or implied by such forward-looking statements.
These risks and uncertainties include, but are not limited to: the
ability to meet the pre-defined endpoints in clinical trials;
competition to create a vaccine for COVID-19; the ability to
produce comparable clinical or other results, including our stated
rate of vaccine effectiveness and safety and tolerability profile
observed to date, in the remainder of the trial or in larger, more
diverse populations upon commercialization; the ability to
effectively scale our productions capabilities; and other potential
difficulties.
For a discussion of these and other risks and uncertainties, see
BioNTech’s Annual Report as Form 20-F for the Year Ended December
31, 2020, filed with the SEC on March 30, 2021, which is available
on the SEC’s website at www.sec.gov. All information in this press
release is as of the date of the release, and BioNTech undertakes
no duty to update this information unless required by law.
____________________________
i New England Journal of Medicine. Neutralizing Activity of
BNT162b2-Elicited Serum; March 8, 2021. Available at
https://www.nejm.org/doi/full/10.1056/NEJMc2102017
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Pfizer Contacts:
Media Relations Jerica Pitts +1 (347) 224-9084
Jerica.Pitts@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media Relations Jasmina Alatovic +49 (0)6131 9084 1513
Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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