Pfizer Inc. (NYSE: PFE, "Pfizer") and https://www.globenewswire.com/Tracker?data=nszWGAD-s8Kwh3AXFmnoQhf5wG71KUbSboLXclkoiHh-vbrb-E3SFCu3RX9qKmVWI97YwVFNBkYu6ZYdphsuyg== BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. If the EC grants the variation regarding a booster dose, the decision will be immediately applicable to all 27 EU member states.
The positive opinion by the CHMP is based on the clinical trial data shared by the companies, real world evidence as well as literature data. The data submitted by BioNTech and Pfizer include data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY(R) . A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for COMIRNATY.
Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the EC. The companies do not expect the introduction of booster doses in the United States and the EU, if authorized, to impact the existing supply agreements in place with governments and international health organizations around the world.
COMIRNATY, 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 ongoing.
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.
-- Very rare cases of myocarditis and pericarditis have been observed
following vaccination with Comirnaty. These cases have primarily occurred
within 14 days following vaccination, more often after the second
vaccination, and more often in younger men. Available data suggest that
the course of myocarditis and pericarditis following vaccination is not
different from myocarditis or pericarditis in general.
-- 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.
-- 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
immunosuppressed individuals.
-- 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 (>
20%).
-- 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
and fetus.
-- 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
website. https://www.marketscreener.com/quote/stock/BIONTECH-SE-66771992/news/Press-Release-Pfizer-and-BioNTech-Receive-CHMP-Positive-Opinion-for-COVID-19-Vaccine-Booster-in-th-36596823/
