In a recent statement, Pfizer and BioNTech announced filing an application to the USA (US) Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron BA.4/5-adapted bivalent vaccine.

Study: Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine. Image Credit: Dimitris Barletis/Shutterstock

Pfizer-BioNTech submitted an application to the FDA for the EUA of a 30 µg dose of a BA.4/5-adapted bivalent booster vaccine. The approval is requested to be used in individuals aged 12 or older. Once authorized, the vaccine will probably be immediately available to ship. Moreover, an application for conditional marketing authorization is initiated with the European Medicines Agency for the BA.4/5-adapted vaccine that is predicted to be accomplished soon.

Pfizer and BioNTech jointly developed the BNT162b2 vaccine based on the proprietary mRNA technology of BioNTech. BioNTech holds the marketing authorization for BNT162b2 within the US, the UK, the European Union, and other countries. BioNTech also has EUAs (jointly with Pfizer) within the US and other countries.

Pfizer’s Chairman and Chief Executive, Albert Bourla, added that the agility of the mRNA vaccine technology and the vast experience with the COVID-19 mRNA vaccine enabled the event, testing, and manufacturing of the updated vaccine for the circulating SARS-CoV-2 variants at an unprecedented pace.

Prof. Ugur Sahin, co-founder and Chief Executive of BioNTech, added that the Omicron-adapted booster was able to be shipped within the US pending FDA authorization, lower than three months after the FDA announced guidance for adapted vaccines. The BA.4/5-adapted bivalent booster consists of an mRNA encoding for the spike of the BA. 4/5 variant, together with the ancestral spike originally utilized in the BNT162b2 vaccine.

Data from pre-clinical studies showed that the bivalent booster had a sturdy neutralizing response against the ancestral strain and SARS-CoV-2 Omicron BA.1, BA.2, and BA.4/5 variants. Nonetheless, a clinical trial assessing safety, immunogenicity, and tolerability could start by the top of August 2022.

Previously, Pfizer-BioNTech released phase2/3 trial results on the immunogenicity, safety, and tolerability of a BA.1-adapted bivalent vaccine. Data suggested that the BA.1-adapted candidate vaccine elicited enhanced immune responses against Omicron BA.1 in comparison with the present BNT162b2 vaccine. The adapted vaccine had a good safety profile and was well-tolerated.

Furthermore, submissions are planned for regulatory approvals where EUAs were initially granted (for BNT162b2). Overall, the preliminary data support the EUA request, and firms have scaled production to deliver doses of the BA.4/5-adapted boosters from September 2022, pending authorization.