EU Medicines Agency green-lights adapted COVID-19 vaccines

The European Medicines Agency has given a positive opinion on the use of the first two variant-adapted COVID-19 booster vaccines, produced by BioNTech-Pfizer (Comirnaty) and Moderna (Spikevax) to protect against the Omicron BA.1 subvariant.

Following the EMA’s decision, EU Health Commissioner Stella Kyriakides said in a statement that “we will now proceed with an accelerated authorisation of these vaccines to ensure that they can be rolled out quickly across the EU.”

“[The vaccines] are developed to offer increased, broader protection against current and future variants. Subject to the scientific assessment of the EMA, we also expect an opinion on Omicron BA.4 and BA.5 adapted vaccines in the coming weeks as part of our broad vaccines portfolio approach that has characterised our work since the outset,” she added.

Her statement included a call for EU member states to include the adapted booster vaccines in their vaccination campaigns.

“To support member states’ efforts, the Commission will soon present actions for COVID-19 vaccination strategies and set out measures to help avoid a surge of COVID-19 this autumn and winter,” Kyriakides said, adding that the EMA and the European Centre for Disease Prevention and Control (ECDC) will publish their considerations on the roll-out of the adapted vaccines.

“We need to be ready to face another winter with COVID-19,” the EU’s health chief said.