FRANKFURT (Reuters) – The European Medicines Agency on Wednesday launched a rolling review of a variant-adapted COVID-19 vaccine developed by Pfizer and BioNTech, as cases of new sub-variants of the coronavirus’s Omicron lineage rise.
When available, clinical trial data will be added to the rolling submission, which is designed to speed up any approval, BioNTech and Pfizer said in a joint statement.
The pair added they would also begin submitting data on the planned variant-adapted vaccine to the U.S. Food and Drug Administration (FDA) over the next few weeks.
“The rolling review will continue until there is enough data for a formal application,” the EU regulator said in a separate statement.
The companies said they were still working on several variant-adapted vaccines and the final composition was subject to discussions with global regulators.
(Reporting by Ludwig Burger)
