The European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent COVID-19 disease in people from 18 years of age.
The human medicines committee (CHMP) at EMA has assessed the data on the quality, safety and efficacy of the vaccine that was approved by the European Commission on 29 January 2021.
Combined results from 4 clinical trials in the United Kingdom, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in adults. These studies involved around 24000 people altogether.
The safety of the vaccine has been demonstrated across these four studies. However, the EMA experts based the assessment on the vaccine efficacy on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases in each, which was not enough to measure the preventive effect of the vaccine.
These studies showed a 59.5% reduction in the number of symptomatic COVID-19 cases in people given the vaccine compared with people given control injections. This means that the vaccine demonstrated around a 60% efficacy in the clinical trials.
Most of the participants in these studies were between 18 and 55 years old. There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group. However, protection is expected, given that an immune response is seen in this age group and based on the experience with other vaccines. As there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults. More information is expected from ongoing studies, which include a higher proportion of elderly participants.
Regarding children, a Paediatric Investigational Plan was agreed with the company to test the vaccine in children from birth to less than 18 years of age. It includes 3 clinical trials to be conducted to gather evidence on the safety and immunogenicity of the vaccine in the paediatric population by July 2024.
COVID-19 Vaccine AstraZeneca is given as two injections into the arm, the second between 4 to 12 weeks after the first. The most common side effects were usually mild or moderate and got better within a few days after vaccination. The safety and effectiveness of the vaccine will continue to be monitored as it is used across Europe through the European pharmacovigilance system and additional studies by the company and by European authorities.
Keep updated by visiting our COVID-19 page where you can find further information about the COVD-19 treatments approved and under evaluation by the European authority.