EMA to continue safety review into blood conditions related to the vaccine
NASSAU, BAHAMAS — The European Medicines Agency (EMA) has allayed fears over concerns over the AstraZeneca COVID-19 vaccine causing blood clots in recipients, finding in its review that the vaccine was “not associated” with the occurrence of blood clots in fewer than 40 people.
Cases of thrombosis and thrombocytopenia that have been reported in a small number of people who had received AstraZeneca mostly occurred within 14 days of vaccination.
The majority of reports involved women under 55, although the EMA said some of this may reflect greater exposure of such individuals due to targeting of particular populations for vaccine campaigns in different EU member states.
“The number of reported events exceeds those expected, and causality, although not confirmed, cannot, therefore, be excluded,” the report read.
“However, given the rarity of the events, and the difficulty of establishing baseline incidence since COVID-19 itself is resulting in hospitalizations with thromboembolic complications, the strength of any association is uncertain.
“EMA considers that the benefit-risk balance of the medicine remains positive, and there is no association with thromboembolic disorders overall.”
The EU regulator noted it will continue to review the possibility of an association.
The EMA conducted its review on a number of cases of thrombosis blood clots, following the decision of 13 European Union countries to suspend the use of the vaccine over fears there was a higher risk of blooding clotting in vaccine recipients.
The fears surrounding the possible link raised concerns in The Bahamas among some quarters of the public and healthcare professionals, including consultant physicians.
The batches of AstraZeneca being used in Europe differ from the 20,000 doses donated to The Bahamas last week Wednesday, which were manufactured and donated by India — one of the largest vaccine manufacturers in the world.
The government has said the doses met all World Health Organization (WHO) requirements and standards.
The WHO has called on countries to continue using the vaccines.
“At this time, WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue,” it said on Wednesday.
The health regulator is expected to release the result of its own review tomorrow.
It noted that if vaccine recipients of AstraZeneca experience breathlessness; pain in the chest or stomach; swelling or coldness in an arm or leg; severe or worsening headache or blurred vision; persistent bleeding or multiple small bruises, they should seek prompt medical assistance and mention their vaccination.
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