Pfizer and BioNTech announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 5/5-µg) is now recommended for marketing authorization by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for children 5 through 11 years of age. The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized in the European Union (EU) as a booster dose for individuals aged 12 years and older. Today’s CHMP recommendation to include children 5 through 11 years of age was based on safety and immunogenicity data from the companies’ Omicron BA.1-adapted bivalent vaccine in individuals 12 years and older, data from the initially approved 10-µg pediatric formulation of the companies’ original COVID-19 vaccine, manufacturing data from the companies’ pediatric formulation of the Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine.
Recent clinical data from an ongoing Phase 2/3 trial of the companies’ BA.4/BA.5-adapted bivalent booster in adults 18 years of age and older demonstrated a strong immune response against the BA.4 and BA.5 sublineages, measured 30 days after immunization, with a safety and tolerability profile similar to the companies’ original COVID-19 vaccine. In addition to this trial and the already submitted data, a Phase 1/2/3 pediatric study is ongoing that evaluates different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups. Data from both these trials will be shared with regulatory authorities around the world as soon as they become available.
COMIRNATY® and its adapted vaccine variations (COMIRNATY® Original/Omicron BA.1 and COMIRNATY® Original/Omicron BA.4-5) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (Original/Omicron BA.4-5) 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. 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 MA 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.
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