Pfizer and BioNTech’s New Bivalent Omicron Vaccine Lined Up for Authorization from the FDA

On August 22, Pfizer and BioNTech announced they submitted their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine to the United States Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA). The application includes data from the companies’ bivalent Omicron BA.1-adapted vaccine and pre-clinical and manufacturing data for the new variant. Should the FDA grant their request, the new vaccine 

Related Article: MHRA Grants Moderna’s Omicron Bivalent Vaccine Conditional Approval in UK

New Vaccine Protects against Two Omicron Strains

There is no one size fits all vaccine for protection against viruses. Often, viruses evolve, creating slightly altered versions of themselves called variants. Scientists categorized COVID-19 variants by Greek names, such as Alpha and delta. The most infectious one so far is the Omicron Variant, responsible for 80% of COVID-19 cases in the United States Alone.

However, these news variants produce more variation within themselves, resulting in subvariants. Of Omicron, the BA.4 and BA.5 are the most common. These new variants and subvariants pose a problem as their mutations differ just enough to slip by the protection afforded by earlier vaccines. 

That being said, developments have been made to update newer vaccines with extended protection against these variants. Bivalent vaccines protect against two different antigens of the same disease. Recently, regulatory boards like the FDA and European Medical Association (EMA) approved other types of bivalent omicron vaccines. For example, Moderna’s new version of Spikevax affords protection against the Alpha COVID-19 Variant and Omicron BA.4 and BA.5.

Similarly, Pfizer and BioNTech developed their own bivalent omicron vaccine. The new version contains both the mRNA spike protein encoding of the original COVID-19 strain and the encoding of the Omicron BA.4/BA.5 variant. A pre-clinical study of the new vaccine demonstrated a robust response to the Omicron BA.4/BA.5 variant, in addition to Omicron BA.1 and BA.2 and the original COVID-19 strain. Previously, a phase ⅔ clinical trial of a bivalent vaccine containing the Omicron BA.1 variant spike protein demonstrated safety, tolerability and immunogenicity in patients. 

The findings of both the pre-clinical and clinical trials support Pfizer and BioNTech’s submitted EUA. 

Pending Emergency Use Authorization and Upcoming Clinical Trial

EUAs are authorizations granted by the FDA to safeguard the public from various health concerns. Through them, the FDA authorizes the use of unapproved medical products or unapproved uses of approved medical products in situations deemed to be an emergency. 

Pfizer and BioNTech submitted their new Omicron bivalent vaccine for such authorization, citing prior studies’ data per FDA guidelines. In addition, the companies initiated a conditional marketing authorization application with the EMA. They expect the application’s completion soon. 

On the Omicron crisis, Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech, said, “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.”

Should the application gain approval, the companies claim, they are ready to ship the vaccine to the United States public immediately. 

Before the end of August, Pfizer and BioNTech have a clinical trial planned to further test their BA.4/BA.5 omicron bivalent vaccine. The study will investigate the safety, tolerability, and immunogenicity of the vaccine in individuals 12 years of age and older.

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Author

Max Heirich