KUALA LUMPUR, April 7 — The European Medicines Agency (EMA) today concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of AstraZeneca-Oxford’s Covid-19 vaccine.
The European Union (EU) drug regulator said most of the cases reported have occurred in women aged below 60 within two weeks after receiving the first dose, based on a review of 62 cases of cerebral venous sinus thrombosis (CVST) and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database as of March 22 this year, 18 of which were fatal. CVST involves blood clots in the brain, while splanchnic vein thrombosis is blood clots in the abdomen.
These 86 blood clot cases mainly came from the UK and the European Economic Area (EEA) that comprises EU countries, Iceland, Liechtenstein, and Norway, where around 25 million people have received AstraZeneca’s Covid-19 vaccine.
“Based on the currently available evidence, specific risk factors have not been confirmed,” the EMA said in a statement.
EMA’s safety committee highlighted blood clots in the brain, abdomen, and arteries, together with low levels of blood platelets and sometimes bleeding, that occurred in the cases reported after receiving AstraZeneca’s Covid-19 vaccine.
“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,” said the EMA.
“EMA’s scientific assessment underpins the safe and effective use of Covid-19 vaccines.”
The drug regulator said one plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT). Heparin is a blood thinner that prevents the formation of blood clots.
EMA added that governments may provide additional guidance on the rollout of AstraZeneca’s Covid-19 vaccine based on their countries’ situation.
The EMA’s safety committee also stressed the importance of prompt specialist medical treatment, saying health care professionals can avoid complications in patients by recognising the signs of blood clots and low blood platelets and treating them early.
Vaccine Minister Khairy Jamaluddin told a webinar earlier today that Malaysia would decide whether to proceed with using AstraZeneca’s vaccine in the national Covid-19 inoculation programme after the EMA makes a finding on the shot, following reports of unusual blood clots in the UK and Germany among those who received the shot, some of whom had died.
He also said Malaysia expects first deliveries of AstraZeneca’s Covid-19 vaccine from the global vaccine sharing plan, COVAX, next month.