UK and EU regulatory agencies confirm COVID-19 Vaccine AstraZeneca is safe and effective
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On March 18, the Medicines Health Regulatory Authority (MHRA) and European Medicines Agency (EMA) reaffirmed the benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks.
Earlier today, the MHRA announced their review of the small number of thromboembolic events in over 11 million people who received COVID-19 Vaccine AstraZeneca in the UK. The UK regulator confirmed that the benefits of the vaccine in preventing COVID-19 far outweigh the risks, and people should continue to get vaccinated when asked to do so. 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.
Subsequently, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded there was no increase in the overall risk of blood clots (thromboembolic events) with COVID-19 Vaccine AstraZeneca. 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. Furthermore, there was no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites.
“AstraZeneca will continue to work closely with health authorities to ensure the appropriate use of COVID-19 Vaccine AstraZeneca.”
AstraZeneca will continue to work closely with health authorities to ensure the appropriate use of COVID-19 Vaccine AstraZeneca. The Company recognises and will 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 for COVID-19 Vaccine AstraZeneca did not show that these events occurred any more commonly than would be expected in millions of people.
Ann Taylor, Chief Medical Officer, said: “Vaccine safety is paramount and we welcome the regulators’ decisions which affirm the overwhelming benefit of our vaccine in stopping the pandemic. We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe.”
Patient safety remains AstraZeneca’s highest priority and the Company has robust processes in place for the collection, analysis and reporting of adverse events and these are shared with regulatory authorities around the world.
Questions & Answers
Q.What was the MHRA's conclusion regarding blood clots in veins after vaccination?
What was the MHRA's conclusion regarding blood clots in veins after vaccination?
The MHRA concluded there is no evidence that blood clots in veins are occurring more than would be expected in the absence of vaccination. They confirmed the vaccine's benefits in preventing COVID-19 far outweigh the risks.
Q.What did the EMA's PRAC committee determine regarding the overall risk of blood clots with the AstraZeneca vaccine?
What did the EMA's PRAC committee determine regarding the overall risk of blood clots with the AstraZeneca vaccine?
The PRAC committee concluded there was no increase in the overall risk of blood clots (thromboembolic events) with COVID-19 Vaccine AstraZeneca. They did note a possible causal link for very rare serious events with thrombocytopenia, needing further analysis.
Q.What is AstraZeneca doing in response to the regulators' findings and recommendations?
What is AstraZeneca doing in response to the regulators' findings and recommendations?
AstraZeneca will continue to work closely with health authorities and implement the PRAC's recommendations, including updating product information. They are also continuing to understand these events to ensure the vaccine's safe delivery.
Q.Was there any evidence of problems with specific batches or manufacturing sites of the vaccine?
Was there any evidence of problems with specific batches or manufacturing sites of the vaccine?
No, there was no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites. This finding was part of the rigorous scientific review.
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