NEW YORK and MAINZ, GERMANY, May 28, 2021 --
Pfizer Inc. (NYSE: PFE) and
BioNTech SE (Nasdaq: BNTX) today announced that the Conditional
Marketing Authorization (CMA) for COMIRNATY(R) in the European Union
(EU) has been expanded to include individuals 12 to 15 years of age.
This follows the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) positive opinion to authorize
the vaccine in this age group. The extended indication for the CMA for
COMIRNATY(R) is valid in all 27 EU member states.
COMIRNATY(R) was the first COVID-19 vaccine to receive authorization in
the EU and is the first to have its CMA extended to adolescents.
Distribution and administration of COMIRNATY(R) by the EU member states
will continue to be determined according to the populations identified
in the EU and per national guidance.
"Today's extension of our COVID-19 vaccine authorization in the European
Union is another critical milestone in our collective effort to broaden
vaccination programs to as many people as possible," said Ugur Sahin,
M.D., CEO and Co-founder of BioNTech. "Making vaccines available to
adolescents will help re-open schools and support the return to a normal
"This is a meaningful moment for adolescents, parents and entire
families who are seeking protection from this virus and a return to
normalcy," said Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. "We appreciate the agency's thorough and efficient review of the
data from our clinical trial, and look forward to seeing more people
across Europe immunized as a result of today's decision."
The EU decision is based on data from a pivotal Phase 3 clinical trial,
which enrolled 2,260 participants aged 12 to 15 years. Participants
received two 30 <MU>g doses of the COVID-19 vaccine. Results from this
trial, which were published in
The New England Journal of Medicine on May 27, 2021, showed a vaccine
efficacy of 100% in participants with or without prior SARS-CoV-2
infection and robust antibody responses. In the trial, the vaccine was
also generally well tolerated. Participants will continue to be
monitored for long-term protection and safety for an additional two
years after their second dose.
In addition, the pediatric study evaluating the safety and efficacy of
the COVID-19 vaccine in children 6 months to 11 years of age is ongoing.
Pfizer and BioNTech expect to have definitive readouts and, subject to
the data generated, submit for an Emergency Use Authorization (e.g., in
the U.S.) or a variation to Conditional Marketing Authorizations (e.g.,
in the EU) for two cohorts, including children 2-5 years of age and 5-11
years of age, in September. The readout and submission for the cohort of
children 6 months to 2 years of age are expected in the fourth quarter.
The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech
proprietary mRNA technology, was developed by both BioNTech and Pfizer.
BioNTech is the Marketing Authorization Holder in the European Union,
and the holder of emergency use authorizations or equivalents in the
United States (jointly with Pfizer), United Kingdom, Canada and other
countries in advance of a planned application for full marketing
authorizations in these countries.
AUTHORIZED USE IN THE EU:
COMIRNATY(R) (the Pfizer-BioNTech COVID-19 vaccine) has been granted
conditional marketing authorisation by the by the European Commission to
prevent coronavirus disease 2019 (COVID-19) in people from 12 years of
age. The European Medicines Agency's (EMA's) human medicines committee
(CHMP) has completed its rigorous evaluation of COMIRNATY(R) ,
concluding by consensus that sufficiently robust data on the quality,
safety and efficacy of the vaccine are now available.
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.
-- Syncope (fainting) may occur in association with administration of
injectable vaccines, in particular in adolescents. Procedures should be
in place to avoid injury from fainting.
-- The efficacy, safety and immunogenicity of the vaccine has not been
assessed in immunocompromised individuals, including those receiving
immunosuppressant therapy. The efficacy of COMIRNATY(R) may be lower in
-- As with any vaccine, vaccination with COMIRNATY(R) may not protect all
vaccine recipients. Individuals may not be fully protected until 7 days
after their second dose of vaccine.
-- In clinical studies, adverse reactions in participants 16 years of age
and older were injection site pain (> 80%), fatigue (> 60%), headache (>
50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and
injection site swelling (> 10%) and were usually mild or moderate in
intensity and resolved within a few days after vaccination. A slightly
lower frequency of reactogenicity events was associated with greater age.
-- The overall safety profile of COMIRNATY(R) in adolescents 12 to 15 years
of age was similar to that seen in participants 16 years of age and
older. The most frequent adverse reactions in clinical trial participants
12 to 15 years of age were injection site pain (> 90%), fatigue and
headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia
-- There is limited experience with use of COMIRNATY(R) in pregnant women.
Administration of COMIRNATY(R) in pregnancy should only be considered
when the potential benefits outweigh any potential risks for the mother
-- It is unknown whether COMIRNATY(R) is excreted in human milk.
-- Interactions with other medicinal products or concomitant administration
of COMIRNATY(R) with other vaccines has not been studied.
-- For complete information on the safety of COMIRNATY(R) 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
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
EudraVigilance or directly to BioNTech using email
email@example.com, telephone +49 6131 9084 0, or via the website
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) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals
12 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) and Full EUA Prescribing Information
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
(MORE TO FOLLOW) Dow Jones Newswires
May 28, 2021 15:45 ET (19:45 GMT)