Head nurse Sam Foster is holding a vial of Oxford University / AstraZeneca COVID-19 vaccine on January 4, 2021 at Churchill Hospital in Oxford, South West England.
Steve Parsons | AFP | Getty Images
LONDON – The coronavirus vaccine developed by AstraZeneca and Oxford University has been approved by the European Medicines Agency, the European Medicines Agency.
The EMA said on Friday that it had assessed the safety and effectiveness of the Covid vaccine and recommended that the European Commission, the EU’s executive branch, give formal conditional marketing authorization.
“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to fight the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA, in a statement on Friday.
“As in previous cases, the CHMP has rigorously evaluated this vaccine and the scientific basis of our work underpins our firm commitment to protecting the health of EU citizens,” said Cooke, referring to the EMA’s Committee on Medicinal Products for Human Use.
The vaccine is already being used in the UK, having received approval in late December, and now, along with the Pfizer BioNTech shot, which has already been approved for use in the UK, makes up most of the EU shocks administered in the country.
Approval comes at a difficult time for the EU as the vaccination program is at best sluggish and very prone to supply shortages.
He has been dealt two blows in the past few weeks, one from Pfizer, who announced that it would temporarily cut production while improving production capacity at its Belgian facility. Then last Friday it was reported that AstraZeneca would deliver far fewer cans to the block than originally expected due to production problems at its plants in the Netherlands and Belgium this spring.
The delays have sparked a crisis in the EU which said coronavirus vaccine exports from the bloc could be restricted to give citizens priority.
On Wednesday, the EU called on AstraZeneca to do whatever it takes to deliver its agreement to supply millions of coronavirus vaccines, suggesting that the company is diverting some supplies from its UK manufacturing facilities to the EU.
On Thursday, doubts arose about the possible approval of AstraZeneca’s vaccine after the German vaccine committee recommended that the vaccine only be offered to people between the ages of 18 and 64.
This is due to the fact that there is insufficient data to assess the effectiveness in people over 65 years of age.
Older study participants were later admitted to phase 3 clinical trials with the AstraZeneca shot, which took place in the UK and Brazil and earlier in South Africa. As a result, there are fewer data on effectiveness in those over 65.
AstraZeneca said this data would be collected when its study results were published in the medical journal The Lancet in December: “As older age groups were recruited later than younger age groups, there was less time to collect cases and, consequently, efficacy data in these cohorts The number of cases is currently limited, but additional data will be available in future analyzes, “it said.
On Friday when the AstraZeneca approval was announced, the EMA announced that older participants (over 55 years of age) had not yet had enough results to establish a number for the vaccine’s effectiveness in this group. However, it states that “protection is expected because an immune response is observed in this age group and is based on experience with other vaccines”.