The European Medicines Agency has received an application for conditional marketing authorization for the Covid-19 vaccine developed by AstraZeneca and Oxford University, it said in a statement Tuesday.
The EMA said it will proceed with the assessment “under an accelerated timeline” and an opinion on whether to issue an authorization could be made by January 29.
Conditional marketing authorization (CMA) is the process used to fast-track the authorization procedure and speed up approval of treatments and vaccines during public health emergencies.
“If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against Covid‑19, it will recommend granting a conditional marketing authorization. The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorization valid in all EU and EEA Member States within days,” the EMA said in a statement.
A decision could be made, “provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted,” the EMA said.
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