The European Medicines Agency (EMA) today confirmed that it had received an authorization request for the AstraZeneca / Oxford vaccine against the new coronavirus, saying that it could make its decision on January 29.
“The EMA has received a request for conditional marketing authorization for the Covid-19 vaccine developed by AstraZeneca and the University of Oxford,” the Amsterdam-based European body said in a statement posted on its website.
The EMA has already authorized the Covid-19 Pfizer / BioNTech vaccine on December 21 and the Moderna vaccine on January 6, for which the European Commission immediately gave the green light.
The agency said it would carry out an expedited review, the decision of which is expected on January 29, if the data presented is sufficiently “robust and complete.”
The European Union and the EMA are under pressure to speed up the approval of new vaccines against the virus, which has already claimed more than 620,000 lives across the continent.
Commission President Ursula von der Leyen hailed the submission of the AstraZeneca / Oxford vaccine application as “good news”.
“Once the vaccine has received a positive scientific opinion, we will work as quickly as possible to authorize its use in Europe,” he said on Twitter.
The AstraZeneca / Oxford vaccine is cheaper to produce than its rivals. It is also easier to store and transport, especially compared to the Pfizer / BioNTech vaccine which has to be stored at very low temperatures (-70 ° C).
It has been used massively in the UK since the beginning of Messin when major problems have been reported. However, the British Government is studying space the second dose to administer the first to more people and some experts consider it to be a significant risk.
No messenger RNA, attenuated virus, and buggy in clinical trials
The Oxford / AstraZeneca vaccine does not use the revolutionary genetic technology of mRNA or messenger RNA like Pfizer and Moderna, but the more traditional “virus-vector” type that takes as a carrier another virus (a chimpanzee adenovirus) although genetically modified and adapted to combat Covid-19.
However, it has been criticized due to the confusion in the interim results of clinical trials. The British laboratory announced in November that its vaccine had an average efficacy of 70%, compared to more than 90% for the Pfizer / BioNTech and Moderna vaccines.
The efficacy of the AstraZeneca / Oxford vaccine was 90% for volunteers who received a half dose first and then a full dose one month later, but only 62% for another group that was more frequently vaccinated with two full doses with a month difference.
The half-dose injection was, in fact, due to an error and only a small group had followed the second protocol, which had raised concern, and led the company to announce on November 26 that a “study additional “to verify these results.
“We believe that we have found the winning formula and how to achieve an efficacy that, with two doses, is as high as the others,” AstraZeneca President Pascal Soriot has since assured.
The EMA had also requested additional information related to the safety and efficacy of the vaccine. This information has been provided, according to the latest statement, and is currently being reviewed.