The European drug regulator has reiterated its support for AstraZeneca’s COVID-19 vaccine, saying that no particular age group, gender or previous medical history is particularly susceptible to blood clotting after receiving an injection. However, reiterating that the benefits of the vaccine outweigh the risks, he warned that people should be aware of the “remote possibilities” of the occurrence of rare blood clots and must urgently seek medical help in case of symptoms.
“A causal link to the vaccine has not been proven, but further analysis is possible and continues,” the European Medicines Agency (EMA) said in a statement. The EMA issued the statement after a hearing with a panel of independent external experts on Monday.
They spoke after several countries, including Canada, France, Germany and Spain, restricted the use of shots by drug manufacturers, following reports of a rare state of clotting after vaccination. Investigations by the EMA and several national authorities in the EU are continuing after initial probes assessed the vaccine as safe for use following a report of a coagulation disease known as cerebral venous sinus thrombosis (CVST).
The high proportion of reported cases affected young and middle-aged women, but this did not lead the EMA to conclude that this cohort was particularly at risk of AstraZeneca shooting. Women were generally more prone to CVST than men and twice as many women as men have received an AstraZeneca injection in the EU so far, said EMA head of security oversight Peter Arlett.
“Therefore, at this stage, it is difficult to separate why reporting of this very rare potential side effect prevailed, especially in younger women,” he added. The EMA has analyzed 62 such cases globally, in consultation with regulators in India, Brazil and the UK, and 44 cases have occurred in the European Economic Area (EEA).
It investigated 14 deaths, although not all were related to CVST, Arlett said. About 9.2 million people in the EEA received the bullet by the estimated date of March 22nd. Arlett admitted that the incidence rate of blood clotting is higher than what was usually expected in young and middle-aged people. Although he did not quantify the difference, he said it did not justify changing the recommendation.
“If we look at people under the age of 60, we see more cases (CVST) than we would expect from the background,” Arlett said. German vaccine monitoring body PEI announced on Tuesday that it had registered 31 cases of CVST, resulting in nine deaths, out of about 2.7 million people who received the AstraZeneca vaccine.
The European Medicines Agency (EMA) said several German cases occurred after the deadline and had not yet been included in its analysis.
Also read: COVID-19 vaccine: Germany to restrict AstraZenec to people over 60 due to blood clot reports