The safety committee of the European Medicines Agency (EMA) has concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of the Oxford-AstraZeneca COVID-19 vaccine. However, it has stressed that the benefits of the vaccine continue to outweigh its risks.
In a press release on Wednesday, 7 April, the committee said that it had carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis. Out of these, 18 had been reported to be fatal.
“COVID-19 is associated with a risk of hospitalisation and death. 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 drug regulator said.
The committee said that one plausible explanation for the combination of blood clots and low blood platelets is an immune response, adding that it has requested new studies to provide more information. It will take further action if necessary, the body added.
The EMA said that it was reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within two weeks of vaccination.
It also said that based on the evidence available so far, specific risk factors have not been confirmed.
“As for all vaccines, EMA will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information,” the press release stated.
Meanwhile, the UK vaccine panel has urged alternatives to AstraZeneca for under-30s, AFP reported on Wednesday.
Causal Link Between Vaccine & Blood Clots: Official
On Tuesday, a senior EMA expert had said that there is a causal link between the coronavirus vaccine developed by AstraZeneca and very rare cases of blood clots, although it remains unclear what the connection is and the possible causes are likewise still unknown.
"It is clear that an association exists" between the vaccine and the dozens of reported blood clots, said Marco Cavaleri, head of the EMA's health threats and vaccines strategy, according to IANS.
"Such cases are extremely rare, and the benefits (of the vaccine) still largely outweigh the risks," he stressed.
(With inputs from IANS and AFP.)
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