There are developments in the European Union’s vaccine strategy with two recent announcements.
The European Medicines Agency (EMA) announced on Monday 3 October that it had started a ‘rolling review’ of the Pfizer-BioNTech messenger RNA vaccine Comirnaty against the original SARS-CoV-2 strain and the sub-variants of concern BA.4 and BA.5 (see EUROPE 13020/31) for use in children aged 5-11 years.
Furthermore, as the efficacy and safety of the two messenger RNA vaccines against SARS-CoV-2 validated in the EU (Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax) have been supported by scientific data, the European Commission has followed the EMA’s recommendations (see EUROPE 13023/15).
Comirnaty and Spikevax are therefore changing their authorisation process from a conditional marketing authorisation in the EU, which required annual renewal, to a standard marketing authorisation. (Original version in French by Émilie Vanderhulst)