Pfizer and BioNTech seek FDA Emergency Use Authorisation for BA.4/BA.5 COVID-19 booster

Pfizer and BioNTech have completed a submission to the US Food and Drug Administration (FDA) requesting Emergency Use Authorisation (EUA) for a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older, the companies announced.

The companies outlined that they have rapidly increased production of the newly developed vaccine and ‘stand ready’ to deliver doses from September – pending authorisation – ahead of potential autumn and winter surges.

A conditional marketing authorisation application has also been initiated with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine, which the companies expect will be completed in the coming days.

The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein – present in the original Pfizer/BioNTech COVID-19 vaccine – together with mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant.

Pre-clinical data demonstrated a booster dose of the Pfizer/BioNTech Omicron BA.4/BA.5-adapted bivalent vaccine generated a ‘strong neutralising antibody response’ against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain.

A clinical study investigating the safety, tolerability and immunogenicity of the booster in individuals 12 years of age and older is anticipated to start this month.

Commenting on the application, Albert Bourla, chairman and chief executive officer, Pfizer, 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 previously announced safety, tolerability and immunogenicity data from a phase 2/3 trial of a 30µg booster dose of their Omicron BA.1-adapted bivalent vaccine candidate, which combines the existing vaccine and a vaccine targeting the Omicron BA.1 variant spike protein.

The Omicron BA.1-adapted bivalent vaccine demonstrated a superior immune response against the Omicron BA.1 variant compared to the companies’ current COVID-19 vaccine.