EU medicines regulator finds ‘possible link’ between Astrazeneca vaccine and very rare blood clots
The EU’s medicines regulator has found a “possible link” between the Astrazeneca vaccine and rare blood clots, but said the benefits of receiving the vaccine outweigh potential risks.
The European Medicines Agency (EMA) this afternoon published its review into the vaccine, which found that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the Astrazeneca jab.
Those administered with the vaccine should be made aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within two weeks of vaccination, the EMA ruled.
However, it said the vaccine should continue to be used to all age groups.
“The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing Covid-19 outweigh the risks of side effects,” the EMA concluded.
The regulator said the cases came mainly from “spontaneous reporting systems” across the EU and UK, where around 25m people have received at least a first dose of the vaccine.
The EMA said it completed an in-depth review of 86 cases of thrombosis reported in the EU drug safety database, including 18 fatalities.
One plausible explanation for the combination of blood clots and low blood platelets is an immune response, the report ruled, which could lead to a condition similar to one seen sometimes in patients treated with heparin.
The committee said it would not recommend any specific measures to avoid the very rare potential side effects.
The EMA said it would continue to assess all evidence that becomes available on potential blood clots. It also urged people to make themselves aware of potential symptoms of blood clots, which it said usually occurred two weeks after receiving the jab.
Those include shortness of breath, stomach pains and headaches.
EMA executive director Emer Cooke said that the discovery of potential very rare blood clots “clearly demonstrates” the challenges of a large-scale vaccination programme.
“When millions of people receive these vaccines, very rare events can occur that were not identified during the clinical trials,” she said.
“The role of pharmacovigilance, the monitoring of the side effects, is to help us to rapidly detect and analyse these risks, and their impact on the benefit risk profile of the vaccine.”
It comes as the UK medicines afternoon this afternoon made the surprise move to recommend an alternative vaccine for under-30s.
A review by the Medicines and Healthcare products Regulatory Agency (MHRA) found that by the end of March, 79 people in the UK had suffered rare blood clots after taking the vaccine — 19 of whom died.
It said potential side effects were extremely rare, but that the risks remained greater amongst younger people. Nearly two-thirds of the cases were among women.
The review prompted the Joint Committee on Vaccination and Immunisation (JCVI), the government’s advisory group, to recommend that people aged between 18 and 29 be offered an alternative vaccine where possible.