A U.S. Food and Drug Administration (FDA) submission requesting an Emergency Use Authorization (EUA) for a 10 µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 pediatric vaccine aged 5 to 11 years old was made by BioNTech and Pfizer, it surfaced yesterday.
With a corresponding application for the extension of the marketing authorization to the European Medicines Agency (EMA), which is to be submitted in a few days, the EUA application will be supported by safety, immunogenicity and preclinical data of 10 µg Omicron BA.4/BA der company supported. 5-adapted bivalent vaccine.
Pfizer/BioNTech have also initiated a phase 1/2/3 pediatric study (NCT05543616, C4591048) of the safety, tolerability and immunogenicity of various doses and dosing regimens of the bivalent booster vaccine Omicron BA.4/BA.5 in children aged between 6 and 6 months months and 11 years.
A previous Phase 1/2/3 study in these two younger age groups, which took place during a period of high prevalence of the Omicron BA.2 strain, had shown that the original Pfizer/BioNTech COVID-19 vaccine (BNT162b2, comernaty). be well tolerated and offer a high level of protection against the coronavirus.
The upcoming Phase 1/2/3 pediatric clinical trial will consist of four sub-studies, with Sub-study A evaluating Phase 1 doses of 3 mcg, 6 mcg and 10 mcg in infants between six and 23 months of age through a Phase 2 primary series of three Doses and booster. Substudies B and C will evaluate up to four doses of the bivalent vaccine in previously vaccinated infants and children aged 6 months to 4 years; and sub-study D will similarly address the age range of five to eleven years.
Pfizer/BioNTech’s bivalent COVID-19 vaccine (both Original and Omicron BA.4/BA.5) is already approved by the FDA under an EUA for use as a single booster dose in individuals 12 years and older who are actively against immunized from the coronavirus. According to current guidelines, it is to be administered at least two months after either completion of a primary course of an approved or approved monovalent COVID-19 vaccine, or after receipt of the last booster dose of one.
EMA began recommending approval of Omicron spike protein booster shots earlier this month based on clinical data from studies of BA.1 booster shots.
Recently, Moderna sued Pfizer/BioNTech for alleged patent infringement on its Spikevax shot.
Image from iStock by FatCamera.