Severe allergy side-effect of AstraZeneca coronavirus vaccine: EU drug regulator

WION Web Team
The Hague, Netherlands Published: Mar 12, 2021, 08:31 PM(IST)

AstraZeneca (UK) Photograph:( Reuters )

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AstraZeneca has also issued a statement assuring that its coronavirus vaccine is safe to be used and has dismissed blood clotting as a side effect

A few hours after several reports suggested that AstraZeneca's side effects include blood clotting, the EU drug regulator has asked to add severe allergies to the list of side-effects from this coronavirus vaccine.

On Friday, the EU drug regulator said that severe allergies should be added to the possible side effects of AstraZeneca's coronavirus vaccine as the regulator has found likely links of such cases in the UK.

Also read | 'Excellent vaccine': WHO backs use of AstraZeneca's coronavirus vaccine

The EMA said it had "recommended an update to the product information to include anaphylaxis and hypersensitivity (allergic reactions) as side effects".

This call for action has come a day after the European Medicines Agency (EMA) started an investigation of the claim that blood clots were formed in a handful of cases in Denmark after the patient got vaccinated with AstraZeneca's coronavirus vaccine.

Also read | WHO assessing reports on risks related to AstraZeneca Covid vaccine

In the highlights of the EMA committee assessing risks of medications, the EMA said, "the update is based on a review of 41 reports of possible anaphylaxis seen among around 5 million vaccinations in the United Kingdom."

It has also asserted that the declaration has been made after a review of the provided data. "After careful review of the data, (the committee) considered that a link to the vaccine was likely in at least some of these cases," it said.

Also read | Oxford-AstraZeneca Covid-19 vaccine can be used until probe results: EU regulator

This has also raised an important warning by AstraZeneca where the company has asked that the people receiving the jab should be kept under "close observation for at least 15 minutes" after getting inoculated, to monitor any allergic reactions.

Meanwhile, AstraZeneca has also issued a statement assuring that its coronavirus vaccine is safe to be used and has dismissed blood clotting as a side effect.

"An analysis of our safety data of more than 10 million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country," a spokesperson said.

"In fact, the observed number of these types of events are significantly lower in those vaccinated than would be expected among the general population."

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