Pfizer and BioNTech have filed an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a booster dosage of an Omicron BA.4/BA.5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above.

The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted vaccine.

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The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution.

On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted bivalent vaccine will be made readily available for shipping.

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 variant spike protein.

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According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1, BA.2, BA.4/BA.5 and the wild-type viral strain.

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A clinical trial of the vaccine to assess its safety, tolerability and immunogenicity in people aged 12 years and above is anticipated to commence this month.

Pfizer chairman and CEO Albert Bourla said: “The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech Covid-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed.

“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorised, to help protect individuals and families as we prepare for potential fall and winter surges.”

The companies have also commenced rolling submission for conditional marketing authorization from the European Medicines Agency (EMA) for this Omicron BA.4/BA.5-adapted bivalent vaccine.

In July, the US FDA approved the companies’ supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for use in adolescents aged 12 to 15 years.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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