Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron
XBB.1.5-adapted COVID-19 Vaccine in the European Union
- The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5
sublineage of SARS-CoV-2 and is recommended for individuals 6
months of age and older
- Recommendation is based on pre-clinical data showing that the
Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates an
improved response against multiple XBB-related sublineages,
including XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris), which
continue to dominate globally1
- Doses will be ready to ship to applicable EU member states
immediately upon authorization by the European Commission
NEW YORK and MAINZ, Germany, August 30,
2023 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE
(Nasdaq: BNTX, “BioNTech”) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has recommended marketing authorization for the
companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine
(COMIRNATY® Omicron XBB.1.5) administered as a single dose for
individuals 5 years of age and older, regardless of prior COVID-19
vaccination history. The Committee has also recommended the updated
vaccine for children 6 months through 4 years of age as part or all
of the primary three-dose vaccination series, depending on how many
prior doses they received, or as single dose for those with a
history of completion of a COVID-19 primary vaccination course or
prior SARS-CoV-2 infection.
The European Commission (EC) will review the
CHMP’s recommendation and is expected to make a final decision
soon. Following a decision from the EC, the updated vaccine will be
ready to ship to applicable EU member states immediately. Pfizer
and BioNTech have been manufacturing the Omicron XBB.1.5-adapted
monovalent COVID-19 vaccine at risk to ensure supply readiness
ahead of the upcoming fall and winter season when the demand for
COVID-19 vaccination is expected to increase.2
“This season’s vaccine is ready to ship as soon
as the final regulatory decision is made, so that people across
Europe can better help protect themselves against COVID-19 illness
as the risk rises,” said Albert Bourla, Chairman and Chief
Executive Officer at Pfizer. “It’s been nearly a year since
many citizens in the European Union were vaccinated against
COVID-19 and the updated formulation provides the opportunity for
them to receive a vaccine more closely matched to current
sublineages.”
“As COVID-19 is expected to adopt a seasonal
pattern, similar to other respiratory viruses, we remain committed
to providing COVID-19 vaccines that are better matched to relevant
circulating variants or sublineages to people worldwide, to support
vaccinations in the upcoming fall and winter season,” said Prof.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Omicron
XBB-related sublineages are antigenically distant from prior
Omicron strains and continue to account for the vast majority of
COVID-19 cases globally. The updated COVID-19 vaccine aims to
further improve protection against severe illness and
hospitalization.”
The CHMP’s recommendation is based on the full
body of previous clinical, non-clinical, and real-world evidence
supporting the safety and efficacy of the COVID-19 vaccines by
Pfizer and BioNTech. Further, the application included pre-clinical
data showing that the Omicron XBB.1.5-adapted monovalent COVID-19
vaccine generates a substantially improved response against
multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, and
XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent
COVID-19 vaccine. Additional pre-clinical data demonstrate that
serum antibodies induced by the updated COVID-19 vaccine, when
compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19
vaccine, also effectively neutralize the globally dominant and
recently WHO-designated variant of interest EG.5.1 (Eris)3.
Pfizer and BioNTech have also filed an
application with the U.S. Food and Drug Administration (FDA)
requesting approval of their Omicron XBB.1.5-adapted monovalent
COVID-19 vaccine for individuals 6 months of age and older. A
decision is expected in the coming days. The companies have
submitted data for the updated COVID-19 vaccine to other regulatory
authorities around the world.
The COVID-19 vaccines (COMIRNATY®) by Pfizer and
BioNTech are based on BioNTech’s proprietary mRNA technology and
were developed by both companies. BioNTech is the Marketing
Authorization Holder for COMIRNATY and its adapted vaccines
(COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron
BA.4/BA.5) in the United States, the European Union, the United
Kingdom, Canada and other countries, and the holder of emergency
use authorizations or equivalents in the United States (jointly
with Pfizer) and other countries.
AUTHORIZED USE IN THE EU:COMIRNATY®
▼(Tozinameran) has been granted standard marketing authorization
(MA) by the European Commission to prevent coronavirus disease 2019
(COVID-19) in people from the age of 6 months. The vaccine is
administered as a single dose in people 5 years of age and older,
and as a three-dose series, 3 weeks apart, in infants and children
from 6 months to 4 years who have not had COVID-19. Adults and
adolescents from the age of 12 are given 30 micrograms per dose;
children aged 5 to 11 years are given 10 micrograms per dose;
infants and children aged 6 months to 4 years are given 3
micrograms per dose. Additional doses may be administered to
individuals aged 5 years and older who are severely
immunocompromised in accordance with national recommendations. The
European Medicines Agency’s (EMA’s) Committee for Medicinal
Products for Human Use (CHMP) has completed its rigorous evaluation
of COMIRNATY, concluding by consensus that sufficiently robust data
on the quality, safety and efficacy of the vaccine are now
available.
In addition, COMIRNATY has also been granted
standard MA for two adapted vaccines: COMIRNATY Original/Omicron
BA.1, which contains mRNA encoding for the spike protein of the
wild-type and of the Omicron BA.1 subvariant of SARS-CoV-2; and
COMIRNATY Original/Omicron BA.4-5, which contains mRNA encoding for
the spike protein of the wild-type and of the Omicron BA.4/BA.5
subvariant of SARS-CoV-2. COMIRNATY Original/Omicron BA.1 may be
administered as a single dose in people aged 12 years and older who
have received at least a primary vaccination course against
COVID-19. COMIRNATY Original/Omicron BA.4-5 may be administered as
a single dose regardless of prior vaccination status in people aged
5 years and older. Children from 6 months to 4 years of age may
have one or three doses depending on whether they have completed a
primary vaccination course or have had COVID-19. There should be an
interval of at least 3 months between administration of COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 and the
last prior dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION
- Events of anaphylaxis have been reported. Appropriate medical
treatment and supervision should always be readily available in
case of an anaphylactic reaction following the administration of
the vaccine.
- There is an increased risk (<1/10,000 cases) of myocarditis
and pericarditis following vaccination with COMIRNATY. These
conditions can develop within just a few days after vaccination and
have primarily occurred within 14 days. They have been observed
more often after the second vaccination, and more often in younger
males.
- Rare cases of acute peripheral facial paralysis; uncommon
incidence of insomnia, hyperhidrosis and night sweats; and unknown
incidence of paraesthesia, hypoaesthesia, erythema multiforme,
heavy menstrual bleeding, extensive swelling of limb and facial
swelling have been identified in post-marketing experience.
- Anxiety-related reactions, including vasovagal reactions
(syncope), hyperventilation or stress‐related reactions (e. g.
dizziness, palpitations, increases in heart rate, alterations in
blood pressure, tingling sensations and sweating) may occur in
association with the vaccination process itself. Stress-related
reactions are temporary and resolve on their own. Individuals
should be advised to bring symptoms to the attention of the
vaccination provider for evaluation. It is important that
precautions are in place to avoid injury from fainting.
- Vaccination should be postponed in individuals suffering from
acute severe febrile illness or acute infection. The presence of a
minor infection and/or low-grade fever should not delay
vaccination.
- As with other intramuscular injections, the vaccine should be
given with caution in individuals receiving anticoagulant therapy
or those with thrombocytopenia or any coagulation disorder (such as
haemophilia) because bleeding or bruising may occur following an
intramuscular administration in these individuals.
- The efficacy, safety and immunogenicity of the vaccine has not
been assessed in immunocompromised individuals, including those
receiving immunosuppressant therapy. The efficacy of COMIRNATY,
COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron
BA.4-5 may be lower in immunosuppressed individuals.
- As with any vaccine, vaccination with COMIRNATY, COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 may not
protect all vaccine recipients. Individuals may not be fully
protected until 7 days after their second dose of the vaccine.
- Adverse reactions observed during clinical studies are listed
below according to the following frequency categories: Very common
(≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to
< 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (<
1/10,000).
- Very common side effects: injection site pain, injection site
swelling, tiredness, headache, muscle pain, chills, joint pain,
diarrhea, fever
- Common side effects: injection site redness, nausea,
vomiting
- Uncommon side effects: enlarged lymph nodes (more frequently
observed after the booster dose), feeling unwell, arm pain,
insomnia, injection site itching, allergic reactions such as rash
or itching, feeling weak or lack of energy/sleepy, decreased
appetite, excessive sweating, night sweats
- Rare side effects: temporary one-sided facial drooping,
allergic reactions such as hives or swelling of the face
- Very rare side effects: inflammation of the heart muscle
(myocarditis) or inflammation of the lining outside the heart
(pericarditis), which can result in breathlessness, palpitations or
chest pain, anaphylaxis, extensive swelling of vaccinated limbs;
facial swelling, pins and needles/tingling, reduced sense of touch
or sensation, a skin reaction that causes red spots or patches on
the skin
- A large amount of observational data from pregnant women
vaccinated with the initially approved COMIRNATY vaccine during the
second and third trimester have not shown an increase in adverse
pregnancy outcomes. While data on pregnancy outcomes following
vaccination during the first trimester are presently limited, no
increased risk for miscarriage has been seen. COMIRNATY can be used
during pregnancy. No effects on the breast-fed newborn/infant are
anticipated since the systemic exposure of breast-feeding woman to
the initially approved COMIRNATY vaccine is negligible.
Observational data from women who were breast-feeding after
vaccination have not shown a risk for adverse effects in breast-fed
newborns/infants. COMIRNATY can be used during breast-feeding.
- No data are available yet regarding the use of COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 during
pregnancy. Since differences between products are confined to the
spike protein sequence, and there are no clinically meaningful
differences in reactogenicity between those COMIRNATY
variant-adapted vaccines that have been clinically evaluated,
COMIRNATY Original/Omicron BA.1 or COMIRNATY Original/Omicron
BA.4-5 can be used during pregnancy.
- No data are available yet regarding the use of COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 during
breast-feeding. Observational data from women who were
breast-feeding after vaccination with the initially approved
COMIRNATY vaccine have not shown a risk for adverse effects in
breast-fed newborns/infants. COMIRNATY Original/Omicron BA.1 or
COMIRNATY Original/Omicron BA.4-5 can be used during
breast-feeding
- Interactions with other medicinal products or concomitant
administration of COMIRNATY, COMIRNATY Original/Omicron BA.1 or
COMIRNATY Original/Omicron BA.4-5 with other vaccines has not been
studied.
- Animal studies with COMIRNATY Original do not indicate direct
or indirect harmful effects with respect to reproductive
toxicity.
- The safety of a COMIRNATY Original/Omicron BA.1 booster dose in
individuals from 18 to ≤ 55 years of age is extrapolated from
safety data from a subset of 315 adults 18 to ≤ 55 years of age who
received a booster (fourth dose) of Omicron BA.1 30 µg (monovalent)
after completing 3 doses of COMIRNATY. The most frequent adverse
reactions in these participants 18 to ≤ 55 years of age were
injection site pain (> 70%), fatigue (> 60%), headache (>
40%), myalgia (> 30%), chills (> 30%) and arthralgia (>
20%).
- In a subset from Study 4 (Phase 3), 305 adults > 55 years of
age who had completed 3 doses of Comirnaty, received a booster
(fourth dose) of Comirnaty 5 to 12 months after receiving Dose 3.
Participants who received a booster (fourth dose) of Comirnaty had
a median follow-up time of at least 1.7 months up to a data cut-off
date of 16 May 2022. The overall safety profile for the Comirnaty
booster (fourth dose) was similar to that seen after the Comirnaty
booster (third dose). The most frequent adverse reactions in
participants > 55 years of age were injection site pain (>
60%), fatigue (> 40%), headache (> 20%), myalgia and chills
(> 10%).
- The safety of a booster dose of COMIRNATY Original/Omicron
BA.4-5 is inferred from safety data for a booster dose of COMIRNATY
Original/Omicron BA.1, as well as for a booster dose of COMIRNATY
Original.
- The duration of protection afforded by the vaccine is unknown
as it is still being determined by ongoing clinical trials. As with
any vaccine, vaccination with Comirnaty Original/Omicron BA.1 or
COMIRNATY Original/Omicron BA.4-5 may not protect all vaccine
recipients
- For complete information on the safety of COMIRNATY, COMIRNATY
Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5, always
make reference to the approved Summary of Product Characteristics
and Package Leaflet available in all the languages of the European
Union on the EMA website.
The black equilateral triangle ▼ denotes that
additional monitoring is required to capture any adverse reactions.
This will allow quick identification of new safety information.
Individuals can help by reporting any side effects they may get.
Side effects can be reported to medinfo@biontech.de,
www.biontech.com or directly to BioNTech using email, telephone +49
6131 9084 0, or via the website.
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 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 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 August 30, 2023. 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 Pfizer and BioNTech's
COVID-19 vaccines, defined collectively herein as COMIRNATY
(including regulatory applications pending with the European
Commission and the U.S. Food and Drug Administration (FDA) for an
Omicron XBB.1.5-adapted monovalent COVID-19 vaccine , data
submitted for an Omicron XBB.1.5-adapted monovalent COVID-19
vaccine to other regulatory authorities, qualitative assessments of
available data, potential benefits, expectations regarding demand
for COVID-19 vaccination, 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 pre-clinical
and clinical data (including Phase 1/2/3 or Phase 4 or pre-clinical
data for COMIRNATY, or any vaccine candidate in the BNT162 program,
including the data discussed in this release) in any of our studies
in pediatrics, adolescents, or adults or real world evidence,
including the possibility of unfavorable new pre-clinical, clinical
or safety data and further analyses of existing pre-clinical,
clinical or safety data or further information regarding the
quality of pre-clinical, clinical or safety data, including the
risk that additional data against newer Omicron sublineages could
differ from previously reported data; the ability to produce
comparable clinical or other results for COMIRNATY, any vaccine
candidate or any other vaccines that may result from the BNT162
program or any other COVID-19 program, 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 COMIRNATY,
any vaccine candidate or any future vaccine to prevent COVID-19
caused by emerging virus variants; the risk that 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 pre-clinical 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 or other COVID-19 programs 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 existing or
future pre-clinical and clinical studies; whether and when
submissions to request emergency use or conditional marketing
authorizations for COMIRNATY or any future vaccines in additional
populations, for a potential booster dose for COMIRNATY, any
vaccine candidate or any potential future vaccines (including
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 COMIRNATY, any vaccine candidates or any other
potential vaccines that may arise from the BNT162 program, and if
obtained, whether or when such emergency use authorizations or
licenses, or existing emergency use authorizations, will expire or
terminate; whether and when any applications that may be pending or
filed for COMIRNATY (including any requested amendments to the
emergency use or conditional marketing authorizations and including
the applications pending with the FDA and the European Commission
for the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine), any
vaccine candidates or other vaccines that may result from the
BNT162 program or any other COVID-19 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 the authorization or
approval of products or therapies developed by other companies;
disruptions in the relationships between us and our collaboration
partners, clinical trial sites or third-party suppliers, including
our relationship with BioNTech; the risk that demand for any
products may be reduced, no longer exist or not meet expectations,
which may lead to excess inventory on-hand and/or in the channel or
reduced revenues; challenges related to and uncertainties regarding
the timing of a transition to the commercial market for any of our
products; uncertainties related to the public’s adherence to
vaccines and boosters; risks related to our ability to achieve our
revenue forecasts for COMIRNATY or any potential future COVID-19
vaccines; the risk that other companies may produce superior or
competitive products; risks related to the availability of raw
materials to manufacture or test 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 or next generation vaccines or
potential combination respiratory vaccines; the risk that we may
not be able to maintain manufacturing capacity or access to
logistics or supply channels commensurate with global demand for
our vaccines, which would negatively impact our ability to supply
our vaccines within the projected time periods; whether and when
additional supply or purchase agreements will be reached or
existing agreements will be completed or renegotiated;
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; pricing and access challenges; challenges
related to public confidence in, or awareness of COMIRNATY;
uncertainties around future changes to applicable healthcare
policies and guidelines issued by the U.S. federal government in
connection with the declared termination of the federal
government’s COVID-19 public health emergency as of May 11, 2023;
trade restrictions; potential third party royalties or other
claims; the uncertainties inherent in business and financial
planning, including, without limitation, risks related to Pfizer’s
business and prospects, adverse developments in Pfizer’s markets,
or adverse developments in the U.S. or global capital markets,
credit markets, regulatory environment or economies generally;
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, 2022 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 (BioNTech) 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 (CAR) T cells,
several protein-based therapeutics, including bispecific immune
checkpoint modulators, targeted cancer antibodies and antibody-drug
conjugate (ADC) therapeutics, as well as 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 DualityBio, Fosun
Pharma, Genentech, a member of the Roche Group, Genevant, Genmab,
OncoC4, Regeneron, Sanofi, and Pfizer.
For more information, please visit
www.BioNTech.com.
BioNTech Forward-looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not be limited to, statements concerning:
BioNTech’s efforts to combat COVID-19; the collaboration between
BioNTech and Pfizer; the rate and degree of market acceptance of
BioNTech’s COVID-19 vaccine, including the Omicron XBB.1.5-adapted
monovalent COVID-19 vaccine; qualitative assessments of available
data and expectations of potential benefits; regulatory submissions
and regulatory approvals or authorizations and expectations
regarding manufacturing, distribution and supply; expectations
regarding anticipated changes in COVID-19 vaccine demand, including
changes to the ordering environment; and expected regulatory
recommendations to adapt vaccines to address new variants or
sublineages. In some cases, forward-looking statements can be
identified by terminology such as “will,” “may,” “should,”
“expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,”
“estimates,” “predicts,” “potential,” “continue,” or the negative
of these terms or other comparable terminology, although not all
forward-looking statements contain these words. The forward-looking
statements in this press release are neither promises nor
guarantees, and you should not place undue reliance on these
forward-looking statements because they involve known and unknown
risks, uncertainties, and other factors, many of which are beyond
BioNTech’s control and which could cause actual results to differ
materially from those expressed or implied by these forward-looking
statements. These risks and uncertainties include, but are not
limited to: 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 data discussed in this release, and
including the possibility of unfavorable new preclinical, clinical
or safety data and further analyses of existing preclinical,
clinical or safety data; the nature of the clinical data, which is
subject to ongoing peer review, regulatory review and market
interpretation; BioNTech's pricing and coverage negotiations with
governmental authorities, private health insurers and other
third-party payors after BioNTech's initial sales to national
governments; the future commercial demand and medical need for
initial or booster doses of a COVID-19 vaccine; the availability of
raw materials to manufacture a vaccine; our vaccine’s formulation,
dosing schedule and attendant storage, distribution and
administration requirements, including risks related to storage and
handling after delivery; competition from other COVID-19 vaccines
or related to BioNTech's other product candidates, including those
with different mechanisms of action and different manufacturing and
distribution constraints, on the basis of, among other things,
efficacy, cost, convenience of storage and distribution, breadth of
approved use, side-effect profile and durability of immune
response; 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; the timing of and BioNTech's ability to
obtain and maintain regulatory approval for BioNTech's product
candidates; the ability of BioNTech’s COVID-19 vaccines to prevent
COVID-19 caused by emerging virus variants; BioNTech's and its
counterparties’ ability to manage and source necessary energy
resources; BioNTech's ability to identify research opportunities
and discover and develop investigational medicines; the ability and
willingness of BioNTech's third-party collaborators to continue
research and development activities relating to BioNTech's
development candidates and investigational medicines; the impact of
the COVID-19 pandemic on BioNTech's development programs, supply
chain, collaborators and financial performance; unforeseen safety
issues and potential claims that are alleged to arise from the use
of BioNTech's COVID-19 vaccine and other products and product
candidates developed or manufactured by BioNTech; BioNTech's and
its collaborators’ ability to commercialize and market BioNTech's
COVID-19 vaccine and, if approved, its product candidates;
BioNTech's ability to manage its development and expansion;
regulatory developments in the United States and other countries;
BioNTech's ability to effectively scale BioNTech's production
capabilities and manufacture BioNTech's products, including
BioNTech's target COVID-19 vaccine production levels, and
BioNTech's product candidates; risks relating to the global
financial system and markets; and other factors not known to
BioNTech at this time.
You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech’s Report on
Form 6-K for the period ended June 30, 2023, and in subsequent
filings made by BioNTech with the U.S. Securities and Exchange
Commission (“SEC”), which are available on the SEC’s website at
www.sec.gov. Except as required by law, BioNTech disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on BioNTech’s current
expectations and speak only as of the date hereof.
CONTACTS
Pfizer Media Relations +1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
BioNTech Media Relations Jasmina Alatovic +49 (0)6131
9084 1513 Media@biontech.de
Investor RelationsVictoria Meissner, M.D.+1 617 528
8293Investors@biontech.de
----
1 World Health Organization. COVID-19 Weekly Epidemiological
Update. Available at:
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports2
Wiemken TL, Khan F, Nguyen JL, Jodar L, McLaughlin JM. Is COVID-19
seasonal? A time series modeling approach. medRxiv.
2022:2022.06.17.22276570.3
https://www.who.int/docs/default-source/coronaviruse/09082023eg.5_ire_final.pdf?sfvrsn=2aa2daee_1
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