Blood clots to now be listed as a side effect of AstraZeneca vaccine-European Medicines Agency
London, April 7, 2021 (AltAfrica)-The unusual blood clots with low blood platelets should now be listed as very rare side effect od AstraZeneca vaccine according to the European Medicines Agency (EMA)
EMA executive director Emer Cooke said at a press conference that the determination comes after a review of 62 cases of blood clots in the sinuses that drain blood from the brain and 24 cases blood clots in abdominal veins in Europe as of March 22. Eighteen of these cases were fatal.
Cooke said the “very rare” blood clots should be listed as a possible side effect but emphasised that “the risk of mortality from COVID is much greater than the risk of mortality from these side effects.”
The reported cases of unusual blood clots were mostly observed in women under the age of 60 but the committee did not conclude that age and gender were clear risk factors.
“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 European Medicines Agency (EMA) said.
Most of the cases reported had occurred in women under 60 years of age within two weeks of vaccination.
The regulator said that one plausible explanation for the combination of blood clots and low blood platelets was an “immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT)”.
EMA nonetheless maintained that the benefits of the vaccine outweigh the risks of side effects, explaining that COVID-19 is a “very serious disease.”
The EMA press conference will be followed by an informal meeting of EU health ministers, the Portuguese Council presidency announced. It is ultimately up to individual countries who will be eligible for vaccination with the AstraZeneca jab.
Multiple countries had suspended the jab
Multiple European countries such as Denmark and Norway have maintained suspensions on vaccinations with the AstraZeneca/University of Oxford jab over concerns about the clots.
Other countries, including France, the Netherlands, and Germany, continued the use of the vaccine for individuals over a certain age, stating that blood clots were mostly observed in younger adults.
In an interview with a Rome newspaper on Tuesday, EMA official Marco Cavaleri, who is head of health threats and vaccine strategy, said that he thought there was an association between the vaccine and blood clots.
He said that the benefit-risk analysis would have to be reassessed for younger women, who were more affected by the blood clots.
Germany’s Paul-Ehrlich-Institut has said that approximately one case per 100,000 vaccinations with the AstraZeneca jab had been reported.
In the UK, which has not suspended use of the jab, a trial in children was halted amid concerns that the vaccine caused serious blood clots in some adults.
Additional report from Euronews