- 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
New York and Mainz, Germany, April 1,
2021 — 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 that 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 had a follow-up time of at least
six months after the second dose, demonstrating a favorable safety
and tolerability profile.
“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]).
32 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]). 21 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’ LivesAt 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 NoticeThe
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 BioNTechBiopharmaceutical
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
StatementsThis 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.
Pfizer Contacts:
Media RelationsJerica Pitts+1 (347)
224-9084Jerica.Pitts@pfizer.com
Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
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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