Europe Accelerates COVID-19 Vaccine Candidate 'Rolling Review'
The European Medicines Agency (EMA) announced it received an application for conditional marketing authorization for an experimental COVID-19 vaccine developed by AstraZeneca and Oxford University on January 12, 2021. An opinion on this authorization could be issued by January 29, 2021, during the meeting of EMA’s scientific committee for human medicines, stated in this press release.
'Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review, which began in 2020.'
During the review and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force, which brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.
If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID‑19, it will recommend granting conditional marketing authorization. The European Commission will then fast-track its decision-making process to grant a conditional marketing authorization valid in all EU and EEA Member States within days.
India recently followed the U.K. and granted emergency approval on January 1, 2021, for the AstraZeneca COVID-19 vaccine.