The European Medicines Agency (EMA), which carefully reviewed the potential risks associated with the Oxford-AstraZeneca vaccine, concluded that “unusual blood clots with low platelets should be considered an extremely rare side effect of vaccination.
“The European regulatory authority states that reports of the combination of thrombosis with low platelets are extremely rare and that overall the benefits of the vaccine in preventing Covid-19 outweigh the risks of side effects.”
“Covid-19 is a very serious disease with high rates of hospitalization and mortality. Every day, the coronavirus continues to claim thousands of lives across Europe,” said EMA representative Emer Cooke. “And this vaccine has been shown to be highly effective. It prevents severe illness and hospitalisation and saves lives.
At the same time, Emma Cook confirmed that rare cases of thrombosis were observed in all age and gender groups, but no specific risk factors such as age, gender or predisposition to clot formation were identified. “Our safety committee confirms that the overall benefits of the AstraZeneca vaccine in preventing Covid-19 outweigh the risks of side effects,” she emphasized.
At the same time, the U.K.’s MHRA said on Wednesday that it was reasonable to offer an alternative vaccine to people under the age of 30 because of an increasing number of cases of thrombosis linked specifically to the AstraZeneca vaccine. According to MHRA representative Dr. June Rayne, public safety is a top priority.
According to the MHRA, as of March 31, 20 million injections of AstraZeneca’s vaccine had been administered and 79 cases (51 women, 28 men aged 18 to 79) of thrombosis had been observed, with 19 people dying as a result. As Dr. Rein noted, clinical trials can evaluate common side effects, but rare cases can only be identified through large-scale vaccination. Experts emphasize that they do not have precise evidence of what exactly causes such a condition with the vaccine, but the connection is becoming more apparent.
The majority of known cases of thrombosis have been observed in women under the age of 60 during the first two weeks after vaccination. According to specialists, one of the explanations for this combination of thrombosis and low platelets could be an immune system reaction that leads to a condition similar to that sometimes seen in patients taking heparin (known as heparin-induced thrombocytopenia).
Professor Wei Shen, Chairman of the Joint Committee on Vaccination and Immunization (JCVI), then made several important remarks. “We are not recommending that people in any age group stop vaccination,” Professor Wei Shen points out. “And the advice to replace AstraZeneca with an alternative vaccine is being given more as an extreme precautionary measure than for any real safety considerations.”
Earlier, speaking in Cornwall, Prime Minister Boris Johnson noted that whatever the regulators’ conclusions about the Oxford-AstraZeneca vaccine, it would not affect the established timetable for England’s exit from lockdown. “I believe it is important to listen to what scientists, doctors and medical experts have to say, but everything I have heard so far gives me no reason to believe that we should change or deviate from the path we have chosen,” Johnson said.