This is the third COVID-19 vaccine that EMA has recommended for such authorization.
The EU agency’s Committee for Medicinal Products for Human Use (CHMP) said combined results from four clinical trials in the UK, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in people from 18 years of age.
These studies involved around 24,000 people altogether.
The safety of the vaccine has been demonstrated across the four studies, said the EMA.
However, the agency said it based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil).
“The other two studies had fewer than six COVID-19 cases in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine is to be given as two standard doses, and the second dose should be given between 4 and 12 weeks after the first, the agency concentrated on results involving people who received this standard regimen. These showed a 59.5% reduction in the number of symptomatic COVID-19 cases in people given the vaccine (64 of 5,258 got COVID-19 with symptoms) compared with people given control injections (154 of 5,210 got COVID-19 with symptoms).
“This means that the vaccine demonstrated around a 60% efficacy in the clinical trials.”
Efficacy in the elderly
Germany this week moved to block the use of the AstraZeneca vaccine in people aged over 65 years of age, but the EMA said it expects the jab to protect that cohort.
“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 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.”
The EU agency said the safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and by European authorities.
Reacting, Pascal Soriot, CEO, AstraZeneca, said: “Today’s recommendation underscores the value of AstraZeneca’s COVID-19 vaccine which is not only effective and well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalizations. We are deeply grateful to Oxford University, participants in the clinical trials and AstraZeneca colleagues for their unwavering commitment to providing this lifesaving vaccine to millions of Europeans.”
Professor Andrew Pollard, director of the Oxford Vaccine Group and chief investigator on the Oxford vaccine trials, also weighed in on the positive opinion: “The recommendation by the European Medicines Agency is an important milestone in extending access to the Oxford/AstraZeneca vaccine in our region and providing further endorsement that, after the rigorous scrutiny of regulators, the vaccine can be used to help protect populations from the coronavirus pandemic.”
AstraZeneca’s COVID-19 vaccine has already been granted a CMA or emergency use in 20 countries, spanning four continents including a number of Latin American countries, India, Morocco and the UK.
The company said that it is continuing to engage with governments, international organizations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.