EU regulator verdict on Moderna COVID booster shot next week

The European Union’s drug regulator expects to announce the results of its review of Moderna’s COVID-19 booster vaccine next week and also to start a rolling review of Merck’s (MRK.N)antiviral oral pill, a senior official said on Thursday.

The results of the Moderna review will be announced on Oct. 25, Marco Cavaleri, head of vaccines strategy for the European Medicines Agency (EMA), told a briefing.

Cavalerialso said it was not clear whether Russia would submit an application for its one-dose coronavirus vaccine, known as Sputnik Light, in addition to one already submitted for its two-dose Sputnik V shot.

“We don’t have really any clear understanding of whether (the Russian team) intends to submit an application also for this vaccine in the European Union, but we will continue the dialogue to get more clarity on this,” he said.

The start of a formal review of the two-dose Sputnik V was confirmed in March, but no decision has yet been announced.

Reuters reported on Thursday that the regulator was unlikely to decide whether to approve the Russian vaccine until at least the first quarter of 2022 because it still lacked some data required for the review.
This is in line with what the World Health Organization has said regarding delays in its Emergency Use Listing process. Reuters