- Standard marketing authorization recommendation applies to all
indications and formulations in the European Union, including
COMIRNATY® Original/Omicron BA.4-5 and COMIRNATY® Original/Omicron
BA.1 bivalent vaccines
- CHMP separately recommends approval of booster dose of
COMIRNATY® in children 5 through 11 years of age in the European
Union
NEW YORK and MAINZ, GERMANY, September
16, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has recommended converting the conditional Marketing
Authorization (cMA) for COMIRNATY® [COVID-19 Vaccine (nucleoside
modified)] to standard (also referred to as “full”) Marketing
Authorization (MA) for all authorized indications and formulations.
The European Commission (EC) will review the CHMP recommendation
and is soon expected to make a final decision.
The recommendation to convert the cMA to full MA
is based on the totality of available efficacy and safety data
provided by Pfizer and BioNTech, which confirm the benefits of the
vaccine continue to outweigh its potential risks.. The conversion,
if approved by the EC, applies to all existing COMIRNATY
indications and formulations authorized in the EU, including Pfizer
and BioNTech’s bivalent vaccines (COMIRNATY Original/Omicron BA.1
and COMIRNATY Original/Omicron BA.4-5) as booster doses for
individuals aged 12 and older in the EU.
In a separate action, the CHMP also recommended
approval for COMIRNATY as a 10-µg booster (third) dose given at
least six months after completion of a primary series for children
5 through 11 years of age. COMIRNATY 10-µg was authorized in the EU
in November 2021 as a two-dose primary series for children 5
through 11 years of age. Today’s recommendation is based on Phase
2/3 clinical data from participants 5 through 11 years of age who
received a 10-µg booster dose of COMIRNATY approximately 6 months
after completing the two-dose primary series. The third dose was
well tolerated with a favorable safety profile, and generated
neutralizing antibodies against both Omicron and the original
wild-type virus, regardless of prior COVID-19 diagnosis. The EC
will review the CHMP opinion and if MA is granted, the decision
will be immediately applicable to all 27 European Union member
states.
COMIRNATY, which is based on BioNTech’s
proprietary mRNA technology, was developed by both BioNTech and
Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2
(COMIRNATY) 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. Submissions to pursue regulatory
approvals in those countries where emergency use authorizations or
equivalent were initially granted are planned.
AUTHORIZED USE IN THE
EU:COMIRNATY® ▼ (the Pfizer-BioNTech COVID-19 vaccine) has
been granted standard marketing authorization (MA) by the European
Commission to prevent coronavirus disease 2019 (COVID-19) in people
aged 5 years and older. The vaccine is administered as a 2-dose
series, 3 weeks apart. 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. In addition, the cMA has been
expanded to include a booster dose (third dose) at least 3 months
after the second dose in individuals 12 years of age and older. A
third primary course dose may be administered at least 28 days
after the second dose to people aged 5 years and older with a
severely weakened immune system. 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 or
COMIRNATY Original/Omicron BA.4-5 may be administered as a booster
in people aged 12 years and older who have received at least a
primary vaccination course against 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, but very rare 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. Available data suggest that the course of
myocarditis and pericarditis following vaccination is not different
from myocarditis or pericarditis in general. The risk of
myocarditis after a booster dose of COMIRNATY, COMIRNATY
Original/Omicron BA.1 or COMIRNATY Original/Omicron BA.4-5 has not
yet been characterized.
-
Rare cases of acute peripheral facial paralysis; uncommon incidence
of insomnia, hyperhidrosis and night sweats; and unknown incidence
of paraesthesia, hypoaesthesia and erythema multiforme 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,
diarrhoea, 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 the Phase 3 study, 305 adults > 55 years of
age who had completed 3 doses of COMIRNATY, received a booster of
COMIRNATY Original/Omicron BA.1 after receiving Dose 3. The overall
safety profile for the COMIRNATY Original/Omicron BA.1 booster
(fourth dose) was similar to that seen after the COMIRNATY booster
(third dose). The most frequent adverse reactions in participants
greater than 55 years of age were injection site pain (> 50%),
fatigue (> 40%), headache 69 (> 30%), myalgia (> 20%),
chills and arthralgia (> 10%). No new adverse reactions were
identified for COMIRNATY Original/Omicron BA.1.
- 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 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 September 16, 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 the positive CHMP opinion for conversion of
COMIRNATY Conditional Marketing Authorization to Full Marketing
Authorization in the EU for all previously authorized indications
and formulations, the CHMP recommendation of a Marketing
Authorization for COMIRNATY as a 10-µg booster (third) dose given
at least six months after completion of a primary series for
children 5 through 11 years of age, 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, any
monovalent, bivalent or variant-adapted vaccine candidates 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; 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, any monovalent,
bivalent or variant-adapted vaccine candidates 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, any monovalent, bivalent or
variant-adapted vaccine candidates or any potential future vaccines
(including potential future annual boosters or re-vaccination)
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, any monovalent or bivalent
vaccine candidates 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 any requested amendments to the
emergency use or conditional marketing authorizations), any
monovalent, bivalent or variant-adapted vaccine candidates
(including the submissions pending with the EMA), 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 which may lead to
reduced revenues or excess inventory; 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 or next generation 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 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, bispecific
immune checkpoint 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, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.com.
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 including the program to
develop a COVID-19 vaccine and COMIRNATY® (COVID-19 vaccine, mRNA)
(BNT162b2) (including an Omicron-adapted bivalent COVID-19 vaccine
candidates based on the BA.1 and BA.4/BA.5 subvariants, planned
regulatory submissions, qualitative assessments of available data,
potential benefits, expectations for clinical trials, the
anticipated timing of regulatory submissions, regulatory approvals
or authorizations, including those based on the European
Commission’s review of recommendations and opinions of the
Committee for Medicinal Products of Human Use of the European
Medicines Agency, and anticipated manufacturing, distribution and
supply); our expectations regarding the potential characteristics
of BNT162b2, any monovalent or bivalent vaccine candidates or any
future vaccine, in our clinical trials and/or in commercial use
based on data observations to date; the ability of BNT162b2, any
monovalent or bivalent vaccine candidates or any future vaccine, to
prevent COVID-19 caused by emerging virus variants; 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, any monovalent or bivalent vaccine candidates
or any other vaccine candidate in 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; the expected time point for
additional readouts on efficacy data of BNT162b2, any monovalent or
bivalent vaccine candidates or any future vaccine, in our clinical
trials; 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 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; the ability of BioNTech
to supply the quantities of BNT162, any monovalent or bivalent
vaccine candidates or any future vaccine, to support clinical
development and market demand, including our production estimates
for 2022; that demand for any products may be reduced or no longer
exist which may lead to reduced revenues or excess inventory; 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 by Pfizer; the
ability to successfully develop other vaccine formulations, booster
doses or potential future annual boosters or re-vaccinations or new
variant-based vaccines; the ability 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; 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; 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’s 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 on Form 6-K for the
quarter ended June 30, 2022, filed with the SEC on August 8, 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.
CONTACTS
Pfizer: Media Relations +1 (212) 733-7410
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 Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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