The European Commission authorized the Omicron bivalent vaccines on Thursday, with the two vaccines adapted to provide broader protection against COVID-19.
The decision follows the US FDA’s move to grant emergency use authorization to Omicron vaccines on August 31.
Member states to decide roll out
Comirnaty Original/Omicron BA.1 (Pfizer/BioNTech) and Spikevax bivalent Original/Omicron BA.1 (Moderna) have been authorized in Europe for use in people aged 12 years and above who have received at least primary vaccination against COVID-19. The vaccines have been adapted to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2.
“As the pandemic evolves, the EU’s strategy is to have a broad range of adapted vaccines that target different SARS-CoV-2 variants so Member States have a plurality of options to meet their needs when they design their vaccination strategies,” notes the Commission.
“This is a key element in the overall strategy to combat the pandemic as it is not possible to predict how the virus will evolve in the future and which variants will be circulating this winter.
“Other adapted vaccines incorporating different variants, such as the Omicron subvariants BA.4 and BA.5, are currently under review by EMA or will be submitted soon, and, if authorized, will further extend the arsenal of available vaccines. The clinical data generated with the original/BA.1 bivalent vaccines recommended today will support the evaluation and authorisation of further adapted vaccines.
“The original vaccines, Comirnaty and Spikevax, are still effective at preventing severe disease, hospitalization and death associated with COVID-19 and will continue to be used within vaccination campaigns in the EU, in particular for primary vaccinations.”