Severe allergy added to side effects of AstraZeneca vaccine: EU regulator

Serious allergies must be added to the possible side effects of the AstraZeneca coronavirus vaccine, after likely links have been found in a number of cases in Britain, the EU drug regulator said on Friday.

The development comes a day after the European Medicines Agency said it was investigating a separate blood clot problem that prompted Denmark to stop using the jab, but said the use remains safe.

Amsterdam-based EMA said it “recommended an update of the product information to include anaphylaxis and hypersensitivity (allergic reactions) as side effects”.

“The update is based on a review of 41 reports of possible anaphylaxis seen among about 5 million vaccinations in the UK,” said the document in highlights from the EMA committee that assesses the risk of the drugs.

“After a careful review of the data, (the committee) considered that a link to the vaccine was likely in at least some of these cases.”

The EMA said, however, that anaphylaxis, or what it called “serious allergic reactions”, was what it called “a known side effect that can occur, very rarely, with vaccines”.

The product information for the AstraZeneca vaccine already said that people should be kept under “strict observation for at least 15 minutes” after receiving the vaccine in case of allergic reactions.

© 2021 AFP