Coronavirus: EMA gives positive recommendation for AstraZeneca vaccine

date: 01/02/2021

The European Medicines Agency (EMA) issued a positive recommendation for AstraZeneca’s vaccine against COVID-19, named “COVID-19 Vaccine AstraZeneca”. It is the third vaccine to be authorised for marketing in the European Union. This recommendation has meanwhile been confirmed by the European Commission.

The Committee for Medicinal Products for Human Use (CHMP) of the EMA has thoroughly assessed the data on the quality, safety and efficacy of the AstraZeneca vaccine and recommended by consensus that the European Commission should grant a formal conditional marketing authorisation for the vaccine. European standards are met and allow for a vaccination campaign in line with European Union (EU) requirements.

The combined results of four clinical trials in the UK, Brazil and South Africa showed that AstraZeneca’s COVID-19 vaccine was safe and effective for the prevention of COVID-19 in people aged 18 years and older. The studies involved a total of about 24,000 people. Half of the participants received the vaccine and half received a control injection. The subjects did not know whether they received the vaccine or the control injection.

Most participants in these studies were between 18 and 55 years old. There are not yet enough results on participants older than 55 years to make a statement about the effectiveness of the vaccine for this group. The vaccine is expected to be protective, as an immune response was recorded in this age group. Based on experience with other vaccines and the reliable information on the safety of the vaccine, the EMA’s scientific experts consider that the vaccine can be used in older adults. Further information is expected from ongoing studies that include a larger proportion of elderly participants.

Post-marketing surveillance
As for all other medicinal products, the safety and efficacy of COVID-19 vaccines are followed up after they have been marketed. For example, all adverse events are monitored at national and European level. AstraZeneca’s vaccine has received conditional marketing authorisation: this means that the manufacturer has to provide additional information to the EMA at regular intervals which have been established according to a procedure. Moreover, for COVID-19 vaccines, the existing systems for monitoring safety have been extended, both at national and European level.

Already purchased by Belgium
Subject to market authorisation, AstraZeneca’s vaccine has already been purchased by the Belgian government on 21 August 2020. 7.5 million doses are planned for 2021. The vaccine has to be administered twice, the second dose being administered four to twelve weeks after the first dose.

How does the AstraZeneca vaccine work?
The vaccine developed by AstraZeneca and the University of Oxford is a viral vector vaccine. Viral vector vaccines use a known virus that does not cause disease in humans. This can be an innocuous virus or a live attenuated virus used in another vaccine. In AstraZeneca's case, it’s the adenovirus. An antigen (spike protein) or the genetic code of an antigen is added to this viral vector. Some viral vector vaccines can replicate in the host cell (replicating viral vector vaccines), others cannot (non-replicating viral vector vaccines), depending on the changes made to the vector genome. AstraZeneca's vaccine is a non-replicating viral vector vaccine.

More information
EMA press release on AstraZeneca's COVID-19 vaccine
COVID-19 vaccines
Questions & answers on COVID-19 vaccines (available in Dutch or French)

Last updated on 01/02/2021