EU regulator says AstraZeneca vaccine benefits outweigh risks despite 'possible links' of blood clots

Brussels [Belgium], April 8 : The European Medicines Agency (EMA) on Wednesday acknowledged a "possible link" between the AstraZeneca vaccine and "very rare cases of blood clots" but said the benefits of the vaccine, however, continue to outweigh the risks.
According to a statement from the European medical body, the Pharmacovigilance Risk Assessment Committee (PRAC) "concluded today (Wednesday) that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca)."
"In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group," it added.
EMA said that it is 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.
The body noted that so far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.
"The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding," it said.
The Committee carried out 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.
The cases came "mainly from spontaneous reporting systems" of the EEA (European Economic Area) and the UK, where around 25 million people had received the vaccine, it added.
"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... EMA's scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will also take into account the pandemic situation and vaccine availability in the individual Member State," the EMA said.
It also said that the PRAC stresses the importance of prompt specialist medical treatment. By recognising the signs of bloods clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications.
According to Sputnik, AstraZeneca said on Wednesday it was working to establish the causes of blood clots after vaccination against coronavirus with its drug, but emphasized that these were very rare cases.
The company also said it was actively working with regulators to amend the description of the drug and is already working to understand the existing cases, epidemiology and possible mechanisms that explain these extremely rare cases.
CNN also reported that the World Health Organization said it was "plausible" there was a link between the AstraZeneca vaccine and rare cases of blood clots.
Having reviewed the latest information from the EU and UK regulators among others, the WHO said "a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed."
"WHO is carefully monitoring the rollout of all COVID-19 vaccines and will continue to work closely with countries to manage potential risks, and to use science and data to drive response and recommendations," it read in a statement.
It also said that "whilst concerning, the events under assessment are very rare, with low numbers reported among the almost 200 million individuals" who have received the vaccine worldwide."