EU drug regulator says blood clots due to Astra-Zeneca "very rare"
18 Apr 2021

Photo: Massimo Pinca/Reuters
The European Medicines Agency (EMA) stated on Wednesday that the chance of women under the age of 60 developing blood clots due to Astra-Zeneca vaccination is higher than normal. The organization as well as Britain's regulatory body the Medicines and Healthcare products Regulatory Agency however, still maintain that the benefits of receiving the vaccination outweigh the risks.
The Oxford-Astra-Zeneca COVID-19 vaccine was developed in partnership with British-Swedish pharmaceutical and biotechnology giant, Astra-Zeneca and Oxford University. Verity Pharmaceuticals and Serum Institute of India (SII) collaborated with AstraZeneca to release the Covidshield Vaccine. Bhutan and Maldives became the very first recipients of this vaccine with the shipments landing at Velana International Airport in early 2021.
Dr Sabine Straus, chair of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said on Wednesday, “Our conclusion is that these clotting disorders are very rare side-effects of the vaccine,”.
34 million doses have already rolled out across the European Economic Area (EEA) - 27 EU Nations with Liechtenstein, Iceland and Norway. Out of these, 169 cases of blood clots have been reported to the EMA following March 2021 vaccinations. In addition to lower platelet levels, blood clots reportedly take place in veins of the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and arteries.
The PRAC committee of the European Medicines Agency (EMA) carried out an in-depth review of 62 cases of brain blood clots, and 24 cases of blood clots on the abdomen, reported through several outposts across the EU. 18 of these cases of blood clots were fatal.
EMA also reported that most cases have occured in women under the age of 60, about 2 weeks after receiving the vaccination. "At this time, it is not possible to identify specific risk factors'' the statement read.
Oxford university commented on Wednesday and stated that the discovery of possible blood clots with the vaccine shows that safety systems set in place have been proven as useful. “We are reassured to see that safety monitoring continues under the close scrutiny of regulators", said Andrew Pollard, the director of the Oxford Vaccine Group.
Italian authorities on Wednesday have also put out their recommendation that the Astra-Zeneca vaccine should be given to those above the age of 60. Authorities have also however stated that those that received the first shot can carry on with the second dose. While tens of millions have received the vaccine across Europe, some countries have resumed rolling out the shots -after a short hiatus- with recommended age restrictions in place. As such, France, the Netherlands and Germany, now do not recommend that those under 60 years of age receive the vaccine.
Christian Bogdan, a member of Germany’s vaccine committee, has also confirmed the formation of this rare blood clot in women under the age of 60. The committee recommended last week that recipients of the first dose of the vaccine should receive the second dose of another vaccine. Possible clots formed due to a mutation in Factor V Leiden, or taking birth control pills have been dismissed by the committee as well, citing the cause to be the activation of a rare antibody. This antibody is said to activate platelets in the blood and possibly cause clots.
Signs of this rare blood clot include shortness of breath, chest pain, leg swelling, and persistent abdominal pain. Additionally, the EMA also urged healthcare professionals at the forefront of rolling out vaccinations to advise recipients to report neurological symptoms such as blurred vision and severe headaches.
France and other nations have been forced into imposing lockdown amidst rising infection rates and battling the effects of new variants. While those that give out and receive these vaccinations have been left to choose between the 'better' of the two evils, it is apparent which is spreading faster and more deadly - the virus itself.