EU Flags Severe Allergic Reaction Risk to Novavax’s COVID-19 Vaccine

The European Medicines Agency has updated the labeling of Novavax’s COVID-19 vaccine to include a warning about the risk of severe allergic reactions.

The warning was not listed in the initial label because the clinical development program did not detect any severe allergic reactions. But Novavax said that it had received reports of two cases of potentially life-threatening allergic reactions since the wider rollout of vaccinations.

Conditionally authorized in the EU since December 2021, the vaccine received emergency use authorization from the FDA on July 13. The U.S. government has ordered 3.2 million doses.