A top government regulator has said that Novavax’s spike protein-based COVID-19 vaccine listed severe allergies as a side effect, as the Food and Drug Administration (FDA) on Wednesday issued an emergency use authorization for the shot.
The European Medicines Agency on Thursday said that (pdf) severe allergic reactions could be potential side effects of the Novavax COVID-19 vaccine. In the United States, the vaccine’s product label warns against administering the shot to people with a history of allergic reactions to any of its components.
“The product information of Nuvaxovid will be updated with severe allergic reaction and unusual or decreased feeling in the skin as new side effects,” the EMA wrote, adding that “anaphylaxis (severe allergic reaction) will be included in the EU product information as a side effect of Nuvaxovid … together with an update of the existing advice for managing risk of anaphylaxis.”…