In a recent statement, Pfizer and BioNTech announced filing an application to the United States (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.
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 for use in individuals aged 12 or older. Once authorized, the vaccine will be immediately available to ship. Additionally, an application for conditional marketing authorization is initiated with the European Medicines Agency for the BA.4/5-adapted vaccine that is expected to be completed soon.
Pfizer and BioNTech jointly developed the BNT162b2 vaccine based on the proprietary mRNA technology of BioNTech. BioNTech holds the marketing authorization for BNT162b2 in the US, the United Kingdom, the European Union, and other countries. BioNTech also has EUAs (jointly with Pfizer) in 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 development, 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 ready to be shipped in the US pending FDA authorization, less 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, along with the ancestral spike originally used in the BNT162b2 vaccine.
Data from pre-clinical studies showed that the bivalent booster had a robust neutralizing response against the ancestral strain and SARS-CoV-2 Omicron BA.1, BA.2, and BA.4/5 variants. However, a clinical trial assessing safety, immunogenicity, and tolerability could start by the end 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 compared to the current BNT162b2 vaccine. The adapted vaccine had a favorable safety profile and was well-tolerated.
Moreover, submissions are planned for regulatory approvals where EUAs were initially granted (for BNT162b2). Overall, the preliminary data support the EUA request, and companies have scaled production to deliver doses of the BA.4/5-adapted boosters from September 2022, pending authorization.