The European Medicines Agency (EMA) said Wednesday it intends to approve a Pfizer/BioNTech vaccine against COVID-19 targeting two subvariants of the fast-spreading strain of Omicron as early as the fall.
• Also read: A massive vaccination campaign in the fall?
• Also read: The EU reserves 15 million doses of the modified Moderna vaccine
Omicron’s BA.4 and BA.5 sublines are leading to a surge in COVID-19 cases in Europe and the United States, prompting the WHO to declare last month that the pandemic was “far from over”.
The European regulator said it on Monday launched a review of an adapted version of Pfizer’s anti-COVID serum that targets those two subvariants, which are more easily transmissible and evade the immune system than previous strains.
“The EMA expects to receive an application for the adapted BA.4/5 vaccine developed by Pfizer/BioNTech, which will be reviewed for possible rapid approval in the autumn,” an EMA spokesman said in an email.
It should come “shortly after” the expected approval by Pfizer and rival Moderna of two more bespoke vaccines targeting the original Covid-19 strain and the earlier BA.1 subvariant of Omicron, the gatekeeper said.
Pfizer and Moderna filed separate regulatory submissions for those vaccines on July 22, the spokesman said.
EMA has previously said the first sera targeting Omicron could be approved as early as September.