The Commission announced tonight that it has granted a conditional marketing authorization (CMA) for the COVID-19 vaccine developed by AstraZeneca, the third EU-approved COVID-19 vaccine, following a positive scientific recommendation based on a thorough safety assessment , the efficacy and quality of the vaccine by the European Medicines Agency (EMA) and the approval of the Member States.
The AstraZeneca vaccine will be given to adults 18 years of age and older to prevent COVID-19. The vaccine causes the immune system (the body's natural defenses) to produce antibodies and specialized white blood cells that work against the virus, thus providing protection against COVID-19. People who have been vaccinated will receive two injections of the AstraZeneca vaccine.
According to the EMA, most study participants were between 18 and 55 years old. There are not yet enough results in elderly participants (over 55 years old) to give an idea of how well the vaccine will work in this group. However, protection is expected, as an immune response is observed in this age group and is based on experience with other vaccines. Given the reliable safety information in this population, EMA scientists have suggested that the vaccine could be used in older adults. More information is expected from ongoing studies, which include a higher percentage of older participants.
Based on the positive opinion of the EMA, the Commission verified all the evidence supporting the marketing authorization and consulted the Member States before granting the conditional marketing authorization.
The AstraZeneca vaccine is based on an adenovirus, a harmless virus that delivers “instructions” from the virus that causes COVID-19. This allows the cells of the body itself to produce a protein unique to the COVID-19 virus. The individual's immune system recognizes that this unique protein must not be present in the body and responds by producing natural defenses against COVID-19 infection.
Commission President von der Leyen said: “Ensuring safe vaccinations for Europeans is our highest priority. “With the approval of the AstraZeneca vaccine, an additional 400 million doses will be available in Europe.”
“I expect the company to provide these doses as agreed, so that Europeans can be vaccinated as soon as possible,” he said.
“We will continue to do what we can to ensure more vaccines for Europeans, our neighbors and our partners worldwide,” he added.
Stella Kyriakidou, Commissioner for Health and Food Safety, noted that “with this recently approved vaccine, our portfolio continues to grow”.
“Our EU vaccine strategy has always aimed to have a wide and diverse portfolio of vaccines, with different technologies used, to maximize our chances of delivering safe and effective vaccines to citizens as soon as possible,” he said. “The approval of the European Medicines Agency today is another step towards fulfilling this promise.”
“The Commission is working around the clock to provide more vaccines for Europe and our international partners. “We are not leaving anything in our fight against this pandemic,” said Ms. Kyriakidou.
AstraZeneca: We are doing everything we can to deliver vaccines to the EU
AstraZeneca CEO Pascal Sorio said that every effort is being made to cover the shortfall in the quantities of the coronavirus vaccine that the company may make available in the EU in the near future.
Referring again to performance problems at a production facility on European soil as the reason the company will deliver fewer vaccines, Mr Sorio said: “We are really trying to fill the gap. “There is not much more we can do.”
Speaking during an online press conference on the approval of the company's coronavirus vaccine by the European Medicines Agency, Mr Sorio said most of the problems had been addressed and that “the productivity of the facility should improve rapidly in the coming months”. .
He added that the quantities that will be sent to the EU in the coming days and weeks are already “significant”, while he revealed that the company intends to transport the raw material of the vaccine from other production units around the world so that the final production stages take place in the EU. in order to increase the quantities available.
He declined to mention the conflict with the EU and the content of the agreement between the two sides that was made public, but commented that it was an “unfortunate and worrying” situation.
He said that the production of a vaccine in such a short period of time is a complicated case, despite the fact that some take it for granted.
The head of the vaccine research team at the University of Oxford, Professor Andrew Pollard, told the same press conference that there is certainty about the effectiveness of the vaccine over the age of 65, and that all companies are working to be able to treat new mutations with vaccines. of the coronavirus.