- The evaluation is part of the Phase
1/2/3 trial and will study a third dose of the Pfizer-BioNTech
COVID-19 vaccine, BNT162b2, at 30 µg that will be given to Phase 1
participants to evaluate the safety and tolerability of a booster
vaccine
- Discussions with regulatory
authorities are ongoing regarding an additional
registration-enabling study using an mRNA vaccine with a variant
sequence; this would provide a flexible solution for rapidly
adapting the vaccine for use against the B.1.351 lineage or other
new strains that may emerge as possible immune escape virus
variants
- Based on in-vitro studies conducted
to date and observations from real world evidence, the Companies
have not observed changes to neutralizing antibody levels that
would predict a significant reduction in protection provided by two
doses of BNT162b2
New York and Mainz, Germany,
February 25, 2021 — Pfizer Inc.
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today they
have begun an evaluation of the safety and immunogenicity of a
third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to
understand the effect of a booster on immunity against COVID-19
caused by the circulating and potential newly emerging SARS-CoV-2
variants. The study will draw upon participants from the Phase 1
study in the United States who will be offered the opportunity to
receive a 30 µg booster of the current vaccine 6 to 12 months after
receiving their initial two-dose regimen. The study is part of the
Companies’ clinical development strategy to determine the
effectiveness of a third dose against evolving variants.
Separately, in order to be prepared for any
potential future strain changes, Pfizer and BioNTech are in ongoing
discussions with regulatory authorities, including the U.S. Food
and Drug Administration (FDA) and the European Medicines Agency,
regarding a registration-enabling clinical study to evaluate a
variant-specific vaccine having a modified mRNA sequence. This
study would use a new construct of the Pfizer-BioNTech vaccine
based on the B.1.351 lineage, first identified in South Africa.
This could position the Companies to update the current vaccine
quickly if the need arises to protect against COVID-19 from
circulating strains. In alignment with the updated guidance issued
by the FDA regarding emergency use of vaccines to prevent COVID-19
which provides recommendations for evaluating a modified vaccine to
address variants, the Companies are hoping to pursue the validation
of future modified mRNA vaccines with a regulatory pathway similar
to what is currently in place for flu vaccines.
“While we have not seen any evidence that the
circulating variants result in a loss of protection provided by our
vaccine, we are taking multiple steps to act decisively and be
ready in case a strain becomes resistant to the protection afforded
by the vaccine. This booster study is critical to understanding the
safety of a third dose and immunity against circulating strains,”
said Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “At the same time, we are making the right
investments and engaging in the appropriate conversations with
regulators to help position us to potentially develop and seek
authorization for an updated mRNA vaccine or booster if
needed.”
“Our proactive clinical development strategy
aims to create the foundation today, that will enable us to address
the challenges of tomorrow. We want to be prepared for different
scenarios,” said Ugur Sahin, CEO and Co-founder of
BioNTech. “Therefore, we will be evaluating a second
booster in the current regimen as well as preparing for a potential
rapid adaption of the vaccine to address new variants which might
escape the current version of our mRNA-based vaccine. The
flexibility of our proprietary mRNA vaccine platform allows us to
technically develop booster vaccines within weeks, if needed. This
regulatory pathway is already established for other infectious
diseases like influenza. We take these steps in order to ensure a
long-term immunity against the virus and its variants.”
Administering a third dose will provide an early
assessment of the safety of a third dose of BNT162b2, as well as
its immunogenicity. The study will evaluate up to 144 Phase 1
participants in two age cohorts, 18-55 and 65-85 years of age. This
study will include trial participants who received the two doses in
the Phase 1 study 6 to 12 months ago in order to assess the
boostability of BNT162b2. Thus, the study will evaluate the safety
and tolerability of a third vaccination irrespective of the level
of antibody titers of the trial participant. Participants will be
assessed at the time they receive the third dose, then one week and
one month after, and Pfizer and BioNTech plan to study the ability
of the sera from those participants to neutralize SARS-CoV-2
strains of interest. The participants will continue being followed
in the study for up to 2 years as originally planned.
The Pfizer-BioNTech COVID-19 Vaccine 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 150 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 February 25, 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, the mRNA platform and
regulatory pathway and the Pfizer-BioNTech COVID-19 Vaccine
(BNT162b2) (including qualitative assessments of available data,
potential benefits, a potential booster dose and a potential new
variant-specific vaccine, expectations for clinical trials, the
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 in vitro and Phase 3 data),
including the possibility of unfavorable new preclinical, clinical
or safety data and further analyses of existing preclinical,
clinical or safety data; 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 upon 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
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 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 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 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, 2019 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 Quarterly Report for the Three and
Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its
Current Report on Form 6-K filed with the SEC on November 10, 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
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