- 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
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.
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the full release here:
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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. This study will evaluate up to 144 Phase 1
participants in two age cohorts, 18-55 and 65-85 years of age. The
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’
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 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 Notice
The 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 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210225005515/en/
Pfizer: 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: 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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