Pfizer and BioNTech apply for “emergency use authorisation” of Omicron booster vaccine for 5 to 11 year olds

Pfizer and BioNTech have submitted an application to the US FDA for Emergency Use Authorisation of its Omicron BA.4/BA.5-adapted bivalent vaccine booster in children five through 11 years of age.

Pfizer and BioNTech announced on Monday, September 26 that they have “completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorisation (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.

“The request for Emergency Use Authorisation of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies’ 10-µg bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from the companies’ Omicron BA.4/BA.5-adapted vaccine in their decision,” the companies said in a joint statement.

“An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years will be submitted to the European Medicines Agency (EMA) in the coming days.”

The news of Pfizer and BioNTech’s emergency use authorisation request for its vaccine booster comes after rival vaccine company Moderna sued Pfizer and BioNTech for copyright infringement over their Covid vaccines.

On Friday, August 26, Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that they had launched a lawsuit against Pfizer and BioNTech for copyright infringement of the Covid vaccine.

Pfizer’s CEO recently announced that he had tested positive for Covid, the second time in two months.

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