“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” Emer Cooke, EU’s Medicines Agency executive director, said in a news release, adding, “this is the first vaccine which can be used as a single dose”.
The jab met criteria on efficacy, safety and quality during a “thorough evaluation,” the regulator said. The regulator cited a 67% efficacy in cutting symptomatic COVID-19 two weeks after vaccination, as well as mild-to-moderate side effects resolving within a few days post-vaccination.
The recommendation still awaits final approval from the European Commission, however. The commission took to Twitter Thursday to share news of the recommendation, writing in part, “we will now move quickly to grant marketing authorisation.”
The regulator announced last week it started a rolling review of Russia’s Sputnik V coronavirus vaccine ahead of a submitted application. EMA has attributed rapid decisions for previous COVID-19 vaccines to its rolling review process, and again, expects an expedited decision once an application is submitted.
Vaccines developed by Pfizer, Moderna and Oxford-AstraZeneca have already been authorized for use in Europe.