The EU regulatory body is “fully convinced” that the vaccine's benefits outweigh possible risks. Global health experts have been under growing pressure to answer questions over the safety of AstraZeneca's COVID-19 shot. “There is ”no indication'' that AstraZeneca vaccines are the cause of blood clots reported in some shot recipients, the European Medicines Agency's (EMA) chief said on Tuesday.
The regulatory agency responded after more than a dozen EU countries suspended the Oxford AstraZeneca coronavirus vaccine amid health concerns.
The agency is still firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19 with its associated risk of hospitalization and death outweigh the risk of these side effects, Executive Director Emer Cooke added.
Cooke said that an EMA evaluation of individual incidents is ongoing. It is expected to complete a full review on Thursday.
There are fears about the safety of the vaccine in some countries after several cases of blood clots or brain hemorrhages in people after receiving the inoculation. A small number of deaths have been reported.
The WHO, AstraZeneca, and the EMA have all insisted the AstraZeneca shot is safe, and that there is no link between the vaccine and reported blood clots. They say clots are not occurring in greater numbers or frequency than normally in the general population.
The vaccine was developed by British Swedish firm AstraZeneca and the University of Oxford in England. More than 11 million doses have been administered in the UK, without any major problems reported.
Emer stressed that trust in the safety and efficacy of these vaccines is paramount for us. She added it was the job of the agency to ensure the vaccines were safe.
On speculation that incidents of blood clots were related to a specific vaccine batch, Cooke said it was unlikely but the EMA was not ruling it out.
We are looking at adverse events associated with all vaccines, Cooke said when asked if it was probing the Pfizer-BioNTech and Moderna vaccines as well, following reports of clotting with those jabs in the United States.
A World Health Organization (WHO) committee of experts is also reviewing isolated cases of blood clots and low platelet counts in vaccinated individuals.