EMA: Overall Benefit-Risk for AZ Vaccine Remains Positive

After days of apprehension and intrigue, the EMA hasreleased its findingson the potential link between the AstraZeneca COVID-19 vaccine and blood clots. Select comments below:

• "EMA's safety committee (PRAC) has concluded today 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."
• "COVID-19 is associated with a risk of hospitalisation and death. 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."
• The EMA did not offer advice on what age groups should receive the vaccine, with the statement saying "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."
• Focus now shifts to the UK's MHRA, which is set to announce its findings on the vaccine later today.
• Should it recommend halting use among younger cohorts it would put a significant dent in the UK's ability to continue its vaccine programme as planned. However, with the EMA ruling the vaccine safe this seems unlikely.