BRIEF—EMA/CHMP backs approval of bivalent COVID-19 vaccine boosters

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended authorizing two vaccines adapted to provide broader protection against COVID-19, just a day after the US Food and Drug Administration did likewise.

Comirnaty Original/Omicron BA.1 and Spikevax Bivalent Original/Omicron BA.1 are for use in people aged 12 years and above who have received at least primary vaccination against COVID-19.

These vaccines are adapted versions of the original vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2.

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.

National authorities in the EU member states will determine who should receive which vaccines and when, taking into account factors such as infection and hospitalization rates, the risk to vulnerable populations, vaccination coverage and vaccine availability.