Severe allergies should be added to the list of possible side effects of the AstraZeneca Covid-19 vaccine, after probable links to such reactions in the UK were identified, the European Medicines Agency said on Friday ( EMA).
The European regulator announced Thursday to investigate a separate problem linked to bleeding disorders, which prompted Denmark, followed by other European countries, to suspend the use of the vaccine developed by the British laboratory AstraZeneca and the University of ‘Oxford. The EMA said, however, that it remains safe to use.
The EMA said in a statement Friday that it “recommended updating 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 UK,” the Amsterdam-based agency said, in the summary of its committee to assess the drug risks.
“After careful review of the data, (the committee) felt that a link to the vaccine was likely in at least some of these cases,” she added.
The EMA, however, clarified that anaphylaxis, or what it calls “severe allergic reactions”, was already a “known side effect that can occur very rarely with vaccines.”
Information on the AstraZeneca / Oxford vaccine already indicates that people receiving the injection should be kept under “close surveillance for at least 15 minutes” after its administration, in case of allergic reactions.
“No evidence of aggravated risk of clot” with the vaccine
British pharmaceutical group AstraZeneca said on Friday that there was “no evidence of an increased risk” of a blood clot caused by its Covid-19 vaccine, in reaction to the suspension of its use as a precaution in several countries.
“In fact, the figures for this type (of medical problem) are much lower in those who are vaccinated compared to what would be expected in the population as a whole,” the group added in a statement.