Europe’s drugs regulator said on Thursday its safety panel will call a meeting of experts on March 29 to further study the reported cases of blood clots linked to the COVID-19 vaccine developed by AstraZeneca and Oxford University.
External medical experts and two public representatives are expected to give their views on possible reasons for the clots, how they are occurring and other possible risks, the European Medicines Agency said https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-update-ongoing-evaluation-blood-clot-cases.
The EMA and World Health Organization backed the vaccine’s safety last week, but a poll showed European confidence had taken a hit after at least 17 countries suspended or delayed use following reports of hospitalisations with clotting issues and bleeding.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which looks into the safety of human medicines, has launched an ongoing, speedy review to assess these clots, including rare cases of blood clots in the brain.
An updated recommendation by the PRAC is expected between April 6 and 9 when the committee will be meeting.
AstraZeneca has said that its studies have found no higher risk of clots because of the vaccine.
Sweden said on Thursday it would resume use of AstraZeneca’s vaccine for people aged 65 and older, the health agency said, but keep the pause in place for younger Swedes as it continues to investigate a potential link between the shots and rare cases of blood clots.
“The vaccine is of great use for the elderly, among whom many fall seriously ill each day,” Director General Johan Carlson said in a statement on the agency’s new guidelines to the regional authorities administering the vaccinations in Sweden.
“At the same time, we haven’t seen these rare and serious side effects among our elderly. That is the background to why we are lifting the suspension for people older than 65.”
Most countries which temporarily suspended the vaccine have now resumed administering shots following recommendations from the European Union’s drug watchdog and the World Health Organization (WHO).