Pfizer, BioNTech Apply to FDA for Emergency Use Authorization of Omicron-Adapted COVID-19 Booster Vaccine

Pfizer and BioNTech have submitted an application to the FDA for Emergency Use Authorization (EUA) for an Omicron-adapted bivalent COVID-19 vaccine, following positive data showing its efficacy.

Data support the request for an EUA of a 30-µg booster dose of an Omicron-adapted bivalent COVID-19 vaccine in individuals 12 years of age and older. The companies have rapidly scaled production and are prepared to deliver doses of the vaccine for September, and will begin shipping immediately pending authorization, according to a press release.

“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,” said Albert Bourla, chairman and CEO of Pfizer, in the press release. “Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges.”

The bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, in addition to mRNA encoding the spike protein of the Omicron BA.4/BA.5 variant. Pre-clinical data showed that a booster dose of the vaccine generated a strong neutralizing 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 vaccine in individuals aged 12 years and older is expected to start in August 2022.

The companies previously announced safety, tolerability, and immunogenicity data from a phase 2/3 trial of a 30-µg booster dose of the Omicron BA.1-adapted bivalent vaccine candidate, which combines the existing vaccine and a vaccine targeting the Omicron BA.1 variant spike protein. This vaccine elicited a superior immune response against the Omicron BA.1 variant compared to the companies’ current COVID-19 vaccine. It was also well-tolerated with a favorable safety profile.

According to the press release, the new EUA application follows guidance from the FDA to include clinical data from the Pfizer-BioNTech bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data from the companies’ bivalent Omicron BA.4/BA.5-adapted vaccine to address the continued evolution of SARS-CoV-2. A conditional marketing authorization application has also been initiated with the European Medicines Agency for the Omicron BA.4/BA.5-adapted bivalent vaccine and is expected to be completed soon.

“Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating Omicron lineages,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “In less than 3 months after the FDA provided its guidance for adapted vaccines in the US, we are ready to ship the first doses of our Omicron BA.4/BA.5-adapted bivalent vaccine, pending regulatory authorization, to provide people in the US with the possibility to get a booster adapted to the currently most dominant strain of the virus.”

REFERENCE

Pfizer and BioNTech Submit Application to US FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine. News release. Pfizer; August 22, 2022. Accessed August 23, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-fda-emergency-use