
Pfizer/BioNTech Bivalent Covid Booster Wins Approvals
UK health regulator Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Pfizer/BioNTech bivalent Covid-19 vaccine for use as a booster in people 12 years and older.
UK health regulator Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Pfizer/BioNTech bivalent Covid-19 vaccine for use as a booster in people 12 years and older.
The human medicines committee (CHMP) of EU drug regulator European Medicines Agency (EMA) has recommended approval of the updated Covid-19 vaccines of Pfizer-BioNTech and Moderna, combining protection against the original Omicron variant as well as the wild type that emerged in China in early 2020.
As had been widely expected, the US Food and Drug Administration (FDA) on Aug. 31 granted emergency use authorizations (EUAs) to the new Covid-19 shots developed by mRNA vaccine makers Pfizer-BioNTech and Moderna.
While Europe still deliberates, and municipalities monitor sewage to pinpoint the further spread of coronavirus subvariants, especially those evolving from the omicron variant, the US Food and Drug Administration’s advisory panel has voted 19-2 to recommend that the government’s autumn vaccination program be based on the second generation mRNA vaccines developed by Pfizer/BioNTech and Moderna.
Sanofi and GSK are touting their latecomer protein-based Covid-19 vaccine as a potential game changer in the fight against the Omicron variant.