Severe allergies should be added to the possible side effects of AstraZeneca‘s coronavirus vaccine after likely links were found to a number of cases in Britain, the EU’s drug regulator said on Friday.
The development comes a day after the European Medicines Agency said it was investigating a separate issue of blood clots that prompted Denmark to suspend use of the jab, but said it remained safe to use.
The Amsterdam-based EMA said it had “recommended an update to 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 around 5 million vaccinations in the United Kingdom,” it said in the highlights of the EMA committee that assesses the risk of medications.
“After 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 “severe allergic reactions”, was already what it called a “known side effect that may occur, very rarely, with vaccines”.
The AstraZeneca vaccine’s product information already said that people should be kept under “close observation for at least 15 minutes” after getting the jab in case of allergic reactions.