- Based on topline data, three doses of the Pfizer-BioNTech
COVID-19 Vaccine met all immunobridging criteria required for
Emergency Use Authorization
- The third 3-µg dose was well tolerated among 1,678 children
under 5 years of age with a safety profile similar to placebo
- Vaccine efficacy of 80.3% was observed in descriptive analysis
of three doses during a time when Omicron was the predominant
variant
- The 3-µg dose level, which is one-tenth the dose for adults,
was selected for children under 5 years of age based on safety,
tolerability and immunogenicity
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced topline safety, immunogenicity and vaccine efficacy data
from a Phase 2/3 trial evaluating a third 3-µg dose of the
Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5
years of age. Following a third dose in this age group, the vaccine
was found to elicit a strong immune response, with a favorable
safety profile similar to placebo.
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Vaccine efficacy, a secondary endpoint in this trial, was 80.3%
in children 6 months to under 5 years of age. This descriptive
analysis was based on 10 symptomatic COVID-19 cases identified from
seven days after the third dose and accrued as of April 29, 2022.
The trial protocol specifies a formal analysis will be performed
when at least 21 cases have accrued from seven days after the third
dose. Final vaccine efficacy data will be shared once
available.
“Our COVID-19 vaccine has been studied in thousands of children
and adolescents, and we are pleased that our formulation for the
youngest children, which we carefully selected to be one-tenth of
the dose strength for adults, was well tolerated and produced a
strong immune response,” said Albert Bourla, Chairman and Chief
Executive Officer, Pfizer. “These topline safety, immunogenicity
and efficacy data are encouraging, and we look forward to soon
completing our submissions to regulators globally with the hope of
making this vaccine available to younger children as quickly as
possible, subject to regulatory authorization.”
“The study suggests that a low 3-ug dose of our vaccine,
carefully selected based on tolerability data, provides young
children with a high level of protection against the recent
COVID-19 strains,” said Prof. Ugur Sahin, M.D., CEO and co-founder
of BioNTech. “We are preparing the relevant documents and expect
completing the submission process to the FDA this week, with
submissions to EMA and other regulatory agencies to follow within
the coming weeks.”
In the Phase 2/3 trial, 1,678 children received a third dose of
the 3-µg formulation at least two months after the second dose at a
time when Omicron was the predominant variant. The immunogenicity
analysis of geometric mean titer (GMT) ratio and seroresponse rate
was conducted on a subset of study participants one month following
the third dose in children 6 months to under 5 years of age,
compared to the second dose in the 16- to 25-year-old population.
Non-inferiority was met for both the 6- to 24-month-old population
and the 2- to under 5-year-old population for both co-primary
endpoints. Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine
was well-tolerated in this age group, and no new safety signals
were identified. The majority of adverse events were mild or
moderate.
Studies in adults, adolescents, and children over 5 years of age
continue to indicate that three doses of the Pfizer-BioNTech
COVID-19 Vaccine enhances protection compared to two doses. The
safety, immunogenicity and vaccine efficacy data for three doses of
the vaccine in children under 5 years of age are consistent with
the data seen in adults, suggesting that a third dose will provide
similar benefit in children.
In February 2022, the companies initiated a rolling submission
for Emergency Use Authorization (EUA) of their COVID-19 vaccine in
children 6 months to under 5 years of age, following a request by
the U.S. Food and Drug Administration (FDA). At that time, a
two-dose series was determined to be well-tolerated in this age
group. Pfizer and BioNTech plan to submit these new safety,
immunogenicity, and vaccine efficacy data on three doses to the
rolling U.S. EUA application this week, with submissions to
regulators worldwide to follow.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on
BioNTech’s proprietary mRNA technology, was developed by both
BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder
in the United States, the European Union, the United Kingdom,
Canada and the holder of emergency use authorizations or
equivalents in the United States (jointly with Pfizer) and other
countries. Submissions to pursue regulatory approvals in those
countries where emergency use authorizations or equivalent were
initially granted are planned.
About the Phase 1/2/3 Trial in
Children
The Phase 1/2/3 trial has enrolled more than 10,000 children
ages 6 months to under 12 years of age in the United States,
Finland, Poland, and Spain from more than 90 clinical trial sites.
The trial evaluated the safety, tolerability, and immunogenicity of
three doses of the Pfizer-BioNTech COVID-19 Vaccine in three age
groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages
6 months to under 2 years. Based on the Phase 1 dose-escalation
portion of the trial, children ages 5 to under 12 years received a
two-dose schedule of 10 µg each while children under age 5 received
a lower 3 µg dose for each injection in the Phase 2/3 study. The
trial enrolled children with or without prior evidence of
SARS-CoV-2 infection.
U.S. Indication & Authorized
Use
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under
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 5
years of age and older.
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to
provide:
Primary Series
- a 2-dose primary series to individuals 5 years of age and
older
- a third primary series dose to individuals 5 years of age and
older with certain kinds of immunocompromise
Booster Series
- a single booster dose to individuals 5 through 11 years of age
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine
- a first booster dose to individuals 12 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
- a first booster dose to individuals 18 years of age and older
who have completed primary vaccination with a different authorized
or approved COVID-19 vaccine. The booster schedule is based on the
labeling information of the vaccine used for the primary
series
- a second booster dose to individuals 50 years of age and older
who have received a first booster dose of any authorized or
approved COVID-19 vaccine
- a second booster dose to individuals 12 years of age and older
with certain kinds of immunocompromise and who have received a
first booster dose of any authorized or approved COVID-19
vaccine
COMIRNATY® INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved
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.
- COMIRNATY® is administered as a 2-dose primary
series
COMIRNATY® AUTHORIZED USES
COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized
under Emergency Use Authorization (EUA) to provide:
Primary Series
- a 2-dose primary series to individuals 12 through 15 years of
age
- a third primary series dose to individuals 12 years of age and
older with certain kinds of immunocompromise
Booster Dose
- a first booster dose to individuals 12 years of age and older
who have completed a primary series with Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY®
- a first booster dose to individuals 18 years of age and older
who have completed primary vaccination with another authorized or
approved COVID-19 vaccine. The booster schedule is based on the
labeling information of the vaccine used for the primary
series
- a second booster dose to individuals 50 years of age and older
who have received a first booster dose of any authorized or
approved COVID-19 vaccine
- a second booster dose to individuals 12 years of age and older
with certain kinds of immunocompromise and who have received a
first booster dose of any authorized or approved COVID-19
vaccine
Emergency Use
Authorization
Emergency uses of the vaccine have not been approved or licensed
by FDA, but have been authorized by FDA, under an Emergency Use
Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19)
in either individuals 12 years of age and older, or in individuals
5 through 11 years of age, as appropriate. The emergency uses are
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.
INTERCHANGEABILITY
FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the
Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use
Authorization (EUA) for individuals 12 years of age and older can
be used interchangeably by a vaccination provider when prepared
according to their respective instructions for use.
The formulation of the Pfizer-BioNTech COVID-19 Vaccine
authorized for use in children 5 through 11 years of age differs
from the formulations authorized for individuals 12 years of age
and older and should therefore not be used interchangeably. The
Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5
through 11 years of age should not be used interchangeably with
COMIRNATY® (COVID-19 Vaccine, mRNA).
IMPORTANT SAFETY
INFORMATION
Tell your vaccination provider about all of your medical
conditions, including if you:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects the
immune system
- are pregnant, plan to become pregnant, or are
breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
- Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19
Vaccine, mRNA) may not protect all vaccine recipients
- You should not receive Pfizer-BioNTech COVID-19 Vaccine
or COMIRNATY® (COVID-19 Vaccine, mRNA) if you have had a
severe allergic reaction to any of its ingredients or had a severe
allergic reaction to a previous dose of Pfizer-BioNTech COVID-19
Vaccine or COMIRNATY®
- There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine
or COMIRNATY® (COVID-19 Vaccine, mRNA) could cause a severe
allergic reaction. A severe allergic reaction would usually occur
within a few minutes to 1 hour after getting a dose of the vaccine.
For this reason, your vaccination provider may ask you to stay at
the place where you received the vaccine for monitoring after
vaccination. If you experience a severe allergic reaction, call
9-1-1 or go to the nearest hospital
Seek medical attention right away if you have any of the
following symptoms:
- difficulty breathing, swelling of the face and throat, a fast
heartbeat, a bad rash all over the body, dizziness, and
weakness
- Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received the vaccine, more commonly in males
under 40 years of age than among females and older males. In most
of these people, symptoms began within a few days following receipt
of the second dose of the vaccine. The chance of having this occur
is very low
Seek medical attention right away if you have any of the
following symptoms after receiving the vaccine:
- chest pain
- shortness of breath
- feelings of having a fast-beating, fluttering, or pounding
heart
- Fainting can happen after getting injectable vaccines,
including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
(COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and
hurt themselves. For this reason, your vaccination provider may ask
you to sit or lie down for 15 minutes after receiving the
vaccine
- Some people with weakened immune systems may have reduced
immune responses to Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY® (COVID-19 Vaccine, mRNA)
- Additional side effects include rash, itching, hives, swelling
of the face, injection site pain, tiredness, headache, muscle pain,
chills, joint pain, fever, injection site swelling, injection site
redness, nausea, feeling unwell, swollen lymph nodes
(lymphadenopathy), decreased appetite, diarrhea, vomiting, arm
pain, and fainting in association with injection of the
vaccine
These may not be all the possible side effects of the vaccine.
Call the vaccination provider or healthcare provider about
bothersome side effects or side effects that do not go away.
- You should always ask your healthcare providers for medical
advice about adverse events. Report vaccine side effects to the US
Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC) Vaccine Adverse Event Reporting System
(VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report
online to www.vaers.hhs.gov/reportevent.html. You can also report
side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by
calling 1-800-438-1985
Click for Fact Sheets and Prescribing Information for
individuals 5 years of age and older:
Recipients and Caregivers Fact Sheet (5
through 11 years of age) Recipients and Caregivers Fact
Sheet (12 years of age and older) COMIRNATY® Full
Prescribing Information (16 years of age and older), DILUTE BEFORE
USE, Purple Cap COMIRNATY® Full Prescribing Information (16
years of age and older), DO NOT DILUTE, Gray Cap EUA Fact
Sheet for Vaccination Providers (5 through 11 years of age), DILUTE
BEFORE USE, Orange Cap EUA Fact Sheet for Vaccination
Providers (12 years of age and older), DILUTE BEFORE USE, Purple
Cap EUA Fact Sheet for Vaccination Providers (12 years of
age and older), DO NOT DILUTE, Gray Cap
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 May 23, 2022.
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 BNT162b2 mRNA vaccine
program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as
COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including potential
in children 6 months to under 5 years of age and planned regulatory
submissions, including a rolling EUA submission in the U.S.,
qualitative assessments of available data, potential benefits,
expectations for clinical trials, potential regulatory submissions,
the anticipated timing of data readouts, 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 Phase
1/2/3 or Phase 4 data), including the data discussed in this
release, for BNT162b2 or any other vaccine candidate in the BNT162
program in any of our studies in pediatrics, adolescents or adults
or real world evidence, including the possibility of unfavorable
new preclinical, clinical or safety data, and further analyses of
existing preclinical, clinical or safety data, including the risk
that final results from the Phase 2/3 trial, including the planned
formal vaccine efficacy analysis, could differ significantly from
the data included 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,
in real world data studies or in larger, more diverse populations
following commercialization; the ability of BNT162b2 or any future
vaccine 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 submissions to request emergency use or conditional marketing
authorizations for BNT162b2 in additional populations, for a
potential booster dose for BNT162b2 or any potential future
vaccines (including potential in children 6 months to under 5 years
of age or, potential future annual boosters or re-vaccinations)
and/or 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, including a
potential variant based, higher dose, or bivalent vaccine, and if
obtained, whether or when such emergency use authorizations or
licenses will expire or terminate; whether and when any
applications that may be pending or filed for BNT162b2 (including
potential applications in children 6 months to under 5 years of age
and any requested amendments to the emergency use or conditional
marketing authorizations) 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, clinical trial sites or third-party suppliers; the risk
that demand for any products may be reduced or no longer exist;
risks related to the availability of raw materials to manufacture a
vaccine; challenges related to our vaccine’s formulation, dosing
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, booster doses or
potential future annual boosters or re-vaccinations or new variant
based vaccines; the risk that we may not be able to maintain 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
advisory or technical committees and other public health
authorities and uncertainties regarding the commercial impact of
any such recommendations; challenges related to public vaccine
confidence or awareness; 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, 2021 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 including the program to develop a COVID-19 vaccine and
COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including the
potential in children 6 months to under 5 years of age and planned
regulatory submissions, including a rolling EUA submission in the
U.S., qualitative assessments of available data, potential
benefits, expectations for clinical trials, the anticipated timing
of regulatory submissions, regulatory approvals or authorizations
and anticipated manufacturing, distribution and supply); our
expectations regarding the potential characteristics of BNT162b2 in
our clinical trials, real world data studies, and/or in commercial
use based on data observations to date; preclinical and clinical
data (including Phase 1/2/3 or Phase 4 data), including the
descriptive data discussed in this release, for BNT162b2 or any
other vaccine candidate in the BNT162 program in any of our studies
in pediatrics, adolescents or adults or real world evidence,
including the possibility of unfavorable new preclinical, clinical
or safety data, including the risk that final or formal results
from the clinical trial could differ from the topline data; the
ability of BNT162b2 or a future vaccine 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; widespread use
of BNT162b2 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 timing for submission
of data for BNT162, or any future vaccine, in additional
populations (including in children 6 months to under 5 years of
age, potential future annual boosters or re-vaccinations), or
receipt of, any marketing approval or emergency use authorization
or equivalent, including or amendments or variations to such
authorizations, 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; the development of other vaccine
formulations, booster doses or potential future annual boosters or
re-vaccinations or new variant based vaccines; our contemplated
shipping and storage plan, including our estimated product shelf
life at various temperatures; the ability of BioNTech to supply the
quantities of BNT162 to support clinical development and market
demand, including our production estimates for 2022; challenges
related to public vaccine confidence or awareness; 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, clinical trial sites or third-party suppliers; the risk
that demand for any products may be reduced or no longer exist; the
availability of raw material to manufacture BNT162 or other vaccine
formulation; challenges related to our vaccine’s formulation,
dosing schedule and attendant storage, distribution and
administration requirements, including risks related to storage and
handling after delivery; and uncertainties regarding the impact of
COVID-19 on BioNTech’s trials, business and general operations. 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, 2021, filed with the SEC on March 30, 2022, 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.
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