New York and Mainz, Germany, January 20,
2021 — Today, Pfizer Inc. (NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) announced results from an in vitro study that
provides additional data on the capability of sera from individuals
immunized with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 to
neutralize the SARS-CoV-2 U.K. strain, also known as B.1.1.7
lineage or VOC 202012/01. The results were published on the
preprint server bioRxiv and submitted to a peer-reviewed
journal.
The B.1.1.7 lineage is a rapidly spreading
variant of SARS-CoV-2 initially detected in the United Kingdom that
carries a larger than usual number of genetic changes with 10
mutations located in the spike protein. BioNTech and Pfizer have
previously published data from an in vitro study that evaluated one
of the key mutations (N501Y) in the U.K. strain, which is also
shared by the South African strain. That study showed efficient
neutralization of the N501Y mutated spike bearing virus by sera of
individuals who had received the Pfizer-BioNTech COVID-19
vaccine.
The current in-vitro study investigated the full
set of UK strain spike mutations. To this aim, a pseudovirus
featuring the UK strain spike protein was generated.
The pseudovirus recapitulates SARS-CoV-2 virus
binding and cell entry. Sera of participants from the previously
reported German Phase 1/2 trial inhibited pseudovirus bearing
the U.K. strain SARS-CoV-2 spike in a neutralization range that is
regarded as biologically equivalent to the unmutated Wuhan
SARS-CoV-2 spike.
While the pseudovirus system used is a surrogate
for authentic SARS-CoV-2, previous studies have shown excellent
concordance between pseudotype neutralization and SARS-CoV-2
neutralization assays.i The preserved neutralization of the
pseudovirus bearing the U.K. strain spike by BNT162b2-immune sera
makes it likely that COVID-19 caused by the UK virus variant will
also be prevented by immunization with BNT162b2.
Pfizer and BioNTech are encouraged by these
early in vitro study findings. Further data are needed to monitor
the Pfizer-BioNTech COVID-19 vaccine’s effectiveness in preventing
COVID-19 caused by new virus variants. So far, for COVID-19
vaccines it has not been established what reduction in
neutralization might indicate the need for a vaccine strain change.
Should a vaccine strain change be required to address virus
variants in the future, the Companies believe that the flexibility
of BioNTech’s proprietary mRNA vaccine platform is well suited to
enable such
adjustment.
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.
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 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 January 20, 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, the anticipated timing of regulatory submissions,
regulatory approval or authorization 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 clinical data (including the in vitro and Phase 3 data),
including the possibility of unfavorable new preclinical or
clinical trial data and further analyses of existing preclinical or
clinical trial 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 new 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 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; 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; whether and when any
other applications that may be pending or filed for BNT162b2
(including a potential Biologics License Application in the U.S.)
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, 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 and attendant storage,
distribution and administration requirements, including risks
related to handling after delivery by Pfizer; the risk that we may
not be able to successfully develop non-frozen formulations; the
risk that we may not be able to create or scale up manufacturing
capacity on a timely basis or have 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
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 potential
COVID-19 vaccine; our expectations regarding the potential
characteristics of BNT162b2 in our Phase 2/3 trial and/or in
commercial use based on data observations to date; the expected
time point for additional readouts on efficacy data of BNT162b2 in
our Phase 2/3 trial; the nature of non-clinical and 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:
Media RelationsAmy Rose+1 (212)
733-1226PfizerMediaRelations@pfizer.com
Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech:
Media RelationsJasmina Alatovic+49 89 62 81 75
46Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
iJ. B. Case et al., Neutralizing Antibody and Soluble ACE2
Inhibition of a Replication-Competent VSV-SARS-CoV-2 and a Clinical
Isolate of SARS-CoV-2. Cell host & microbe. 28, 475-485.e5
(2020)
A. B. Vogel et al., BNT162b vaccines are immunogenic and protect
non-human primates against SARS-CoV-2. bioRxiv (2020)
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