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The agency received the latest package of clinical data on Dec. 21 and is currently under evaluation, the EMA reported Wednesday. For a conditional approval of the vaccine in the European Union, more information on its quality, safety and efficacy is necessary.
These were requested from the company. Also, more information is expected from ongoing clinical studies in January. Interim data from a large study in the US is expected in the first quarter of 2021.
An AstraZeneca spokesperson said the group had sent a complete data package to the EMA. In the US, if all goes well, the vaccine is expected to receive emergency approval sometime in April, said Moncef Slaoui, head of Operation Warp Speed, which is pushing and overseeing development of the vaccine in the US. USA
So far, only the crown vaccine from Biontech and Pfizer has been approved in the EU. On Tuesday, EMA deputy director Noel Wathion stated that approval of the AstraZeneca vaccine in January was unlikely.
The UK, on the other hand, went ahead on Wednesday and became the first country in the world to approve the vaccine developed by AstraZeneca and the University of Oxford. The EMA does not want to be pressured by this. The approval in Great Britain is an emergency approval. The European authority, for its part, is working on conditional approvals for corona vaccines, with all associated controls and obligations. Conditional approval ensures that corona vaccines meet the strict EU standards for safety, efficacy and quality that apply to all other vaccines and medicines.
With two full doses separated by several weeks, the AstraZeneca vaccine had only shown 62 percent effectiveness. In a subgroup that received only half the dose and then the full dose, the effectiveness increased to 90 percent. AstraZeneca and the University of Oxford have made mixed representations as to whether the initial administration of half a dose was accidental or deliberate.
Both vaccines are given in two doses several weeks apart. In Britain, however, an initial dose must now be given to as many people in risk groups as possible. A second dose will be vaccinated at a maximum of twelve weeks, according to a statement from the Ministry of Health.
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