Pfizer and BioNTech file BLA for Omicron-targeting Covid-19 vaccine
Pfizer and BioNTech are seeking full approval for their Omicron-targeted bivalent Covid shot, and they’re following an FDA advisory committee’s advice on “harmonizing” vaccine compositions.
The partners have filed a supplemental BLA for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine as both a primary dose or a booster for patients over the age of 12. That means unvaccinated children and adults could skip the original primary series and receive a bivalent shot first.
The move is in response to an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) vote last month, intended to clear up confusion around varying primary and booster dose formulations and utilize vaccines that better target currently circulating strains of Covid.
Pfizer/BioNTech’s bivalent vaccine is available, but only under an emergency use authorization (EUA) as a single booster dose for ages 5 years and older and as the third dose in the three-dose primary series for children 6 months old through 4 years old.
In the EU, the bivalent vaccine already has full marketing authorization as a booster dose in patients five years and older who have completed a primary vaccination course against Covid-19.
The plan now for Pfizer/BioNTech is to submit applications to the European Medicines Agency for the marketing authorization to also include the bivalent vaccine as a primary vaccination in patients 5 years and older.
Moderna has its own Omicron-targeting vaccine boosters, but it’s unclear when the company plans on filing its own sBLA.
Novavax is also working on an updated vaccine, either monovalent or bivalent, for the 2023-2024 vaccination season, CMO Filip Dubovsky said last month.