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EU Regulator Launches Rolling Review of Pfizer-BioNTech’s Variant Vaccine

The European Medicines Agency on Wednesday (June 15) launched a rolling review of a variant-adapted COVID-19 vaccine developed by Pfizer and BioNTech, as cases of new SARS-CoV-2 sub-variants of the Omicron lineage are on the 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, adding that they would also begin submitting data on the planned variant-adapted vaccine to the U.S. 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 regulators.

BioNTech and Pfizer had originally favored a vaccine that targets Omicron only but widened their development efforts after EMA urged them to also consider bivalent versions.

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