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The United Kingdom’s Medicines Health Regulatory Authority (MHRA) and the European Medicines Agency (EMA) have weighed in on the benefits of the AstraZeneca-OxfordUniversity vaccine.
After reviewing the small number of thromboembolic events in over 11 million people who received the AZ vaccine in the UK, the MHRA confirmed the benefits of the vaccine in preventing COVID-19 far outweigh the risks, and people should continue to get vaccinated, AZ said.
EU regulator reviews AstraZeneca shot and blood clot links
“Following the rigorous scientific review, the MHRA concluded there is no evidence that blood clots in veins are occurring more than would be expected in the absence of vaccination. A detailed review of five UK reports of a very rare and specific type of blood clot in the cerebral veins (sinus vein thrombosis) occurring together with lowered platelets (thrombocytopenia) is ongoing. This has been reported in fewer than one in a million people vaccinated so far in the UK, and can also occur naturally – a causal association with the vaccine has not been established,” it added.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has also concluded there was no increase in the overall risk of blood clots (thromboembolic events) with the AZ vaccine. “However, the PRAC also concluded that, for very rare cases of serious thromboembolic events with thrombocytopenia, a causal link with the vaccine is not proven, but is possible and deserves further analysis,” it added.
Furthermore, there was no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites, it clarified. Reports suggest that many of the countries who had suspended the use of the vaccine were back to using it.
How worried should we be about reports of blood clots and AstraZeneca’s vaccine?
AZ said it would implement the recommendations of the PRAC, including the update of the product information, whilst continuing to understand the nature and relevance of these events to ensure the safe delivery of the vaccine continues during this public health crisis.
Analysis of AstraZeneca’s safety database on tens of millions of records on those who took the vaccine did not show that these events occurred any more commonly than would be expected in millions of people.
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