Europe Continues Reviewing AstraZeneca's COVID-19 Vaccine

The European Medicines Agency (EMA) announced on March 15, 2021, several authorities responsible for national vaccine campaigns in EU countries have temporarily paused vaccination programs with COVID-19 Vaccine AstraZeneca. These actions are a precaution taken in the light of their national situation.

Simultaneously, the EMA is investigating several events of blood clots in people who had received the vaccine, as previously reported. Events involving blood clots, some with unusual features, such as low numbers of platelets, have occurred in a very small number of people who received the AstraZeneca COVID-19 vaccine.

Many thousands of people develop blood clots annually in the EU for different reasons. The number of thromboembolic events overall in vaccinated people seems not to be higher than that seen in the general population.

The EMA said it is working closely with the company, with experts in blood disorders, and with other health authorities, including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), based on its experience with around 11 million administered doses of the vaccine.

Dr. Phil Bryan, MHRA Vaccines Safety Lead, stated: 'We are closely reviewing reports but the evidence available does not suggest the vaccine is the cause.'

EMA’s investigation has been continuing over the weekend, and rigorous analysis of all the data related to thromboembolic events will be carried out in the coming days. Experts are looking in great detail at all the available data and clinical circumstances surrounding specific cases to determine whether the vaccine might have contributed or if the event is likely to have been due to other causes.

The EMA’s safety committee will further review the information on March 16, 2021, and has called an extraordinary meeting for March 18th to conclude on the information gathered and any further actions that may need to be taken.

On January 29, 2021, the EMA stated it has recommended granting conditional marketing authorization for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age.