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-- The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of
SARS-CoV-2 and is recommended for individuals 6 months of age and older

-- Recommendation is based on pre-clinical and epidemiological data showing
that the JN.1-adapted monovalent COVID-19 vaccine generates an improved
immune response against multiple JN.1 sublineages

-- Doses will be ready to ship to applicable EU member states immediately
upon authorization by the European Commission
===
NEW YORK and MAINZ, Germany, June 27, 2024 -- https://www.globenewswire.com/Tracker?data=Jn7NBrSXKeL3yVAa43ncWrYpHXqnvJA6pzO0y-2i91ESF8swKelCmLHTytmsBlRVz9XVRM1Kq9SAzduy3US-nA== Pfizer Inc. (NYSE: PFE, "Pfizer") and https://www.globenewswire.com/Tracker?data=UkQxI5Thn3CFpK7gxXftHRfQ6gigt7mNnw37Ip59YEedjfhYrxqDK9SvOzW4c_VTxKEDaLqL4uwN5pOJceH-3w== 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 JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY(R) JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency's Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. ETF stated that "evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve." (1) , (2)

The European Commission (EC) will review the CHMP's recommendation and is expected to make a final decision soon. Following the EC decision, the updated vaccine will be available to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron JN.1-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.(3)

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. The application also included manufacturing and pre-clinical data showing that the JN.1-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages, compared with the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.(4)

Pfizer and BioNTech are starting rolling applications with the U.S. Food and Drug Administration (FDA), per recent FDA recommendation, requesting approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals 6 months of age and older. The companies will continue to monitor the evolving epidemiology of COVID-19 and make appropriate preparations to meet global public health needs.

The COVID-19 vaccines (COMIRNATY(R)) 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(R) and its adapted vaccines (COMIRNATY(R) Original/Omicron BA.4-5; COMIRNATY(R) Omicron XBB.1.5) in the United States, the European Union, the United Kingdom, 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(R) 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, in infants and children from 6 months to 4 years who have not had COVID-19 with the first two doses are given three weeks apart, followed by a third dose given at least 8 weeks after the second dose. 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 available.

In addition, COMIRNATY has also been granted standard MA for two adapted vaccines: 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; and COMIRNATY Omicron XBB.1.5, which contains mRNA encoding for the spike protein of the Omicron XBB.1.5 subvariant of SARS-CoV-2.

COMIRNATY Omicron XBB.1.5 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.4-5 or COMIRNATY Omicron XBB.1.5 and the last prior dose of a COVID-19 vaccine.

IMPORTANT SAFETY INFORMATION

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-- 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 indicate that most cases recover. Some cases required intensive care
support and fatal cases have been observed.

-- From post-marketing experience very rare adverse reactions of myocarditis
and pericarditis, uncommon incidence of insomnia, hyperhidrosis and night
sweats, dizziness; common incidence of vomiting, very common diarrhoea
and unknown incidence (cannot be estimated from available data) of
anaphylaxis, paraesthesia, hypoaesthesia and erythema multiforme,
extensive swelling of vaccinated limb, facial swelling (in vaccine
recipients with a history of injection of dermatological fillers) and
heavy menstrual bleeding (most cases appeared to be non-serious and
temporary in nature) have been identified.

-- Anxiety-related reactions, including vasovagal reactions (syncope),
hyperventilation or stress--related reactions (e.g. dizziness,
palpitations, increases in heart rate, alterations in blood pressure,
paresthesia, hypoesthesia 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 Omicron XBB.1.5 may
be lower in immunosuppressed individuals.

-- As with any vaccine, vaccination with COMIRNATY Omicron XBB.1.5 may not
protect all vaccine recipients. Individuals may not be fully protected
until 7 days after their vaccination.

-- Adverse reactions observed during clinical studies and identified after
post authorization experience 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, fever, chills, fatigue, headache, muscle pain, joint
pain, diarrhea.

-- Common side effects: injection site redness, nausea, vomiting,
enlarged lymph nodes (more frequently observed after a booster
dose).

-- Uncommon side effects: feeling unwell, arm pain, insomnia,
dizziness, injection site itching, allergic reactions such as rash,
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
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June 27, 2024 10:30 ET (14:30 GMT)