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April 1, 2021
NEW YORK &
MAINZ, Germany--(BUSINESS WIRE)--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.
“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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