EU drugs agency could approve Covid-19 vaccine by early 2021

EU drugs agency could approve Covid-19 vaccine by early 2021
Illustration picture. Credit: Pxfuel

A Covid-19 vaccine may be approved for use in the European Union (EU) as soon as early next year, the European Medicines Agency (EMA) said on Monday.

The EU's top drug authority said that a rolling evaluation of Covid-19 vaccine candidates could conclude between late this year or early 2021.

The EMA said that a range of mechanisms to expedite the development of a coronavirus vaccine had been set in motion "in order to make them available as soon as possible."

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"At this stage, it is difficult to precisely determine the delays for vaccine approval, because we still do not have all of the data and rolling reviews are still ongoing," the agency said in a statement to the AFP news agency.

"Depending on the progress of the review, the EMA could indeed be in a position of concluding evaluation of the most advanced [vaccine] candidates towards the end of this year or the beginning of next year."

For standard medicines, the agency's timeline for evaluation and potential approval lasts a maximum of 120 days.

The accelerated procedure known as the rolling review, currently used for all Covid-19-related drugs, allows the EMA to assess data as it becomes available throughout the ongoing research and development stages and before manufacturers formally apply for a review.

The vaccine candidates of Pfizer/BioNTech, Oxford/AstraZeneca and Moderna, all three of whom have recently announced higher than average efficacy rates for their respective jabs, are all under the EMA's rolling review procedure.

AstraZeneca on Monday became the latest of the three manufacturers to announce that its vaccine was 70 to 90% effective.

While the efficacy rates announced by the multinational are lower than those of its competitors, AstraZeneca's shot offers the advantage of using conventional development method, making their vaccine cheaper and easier to stock and transport.

Both Pfizer/BioNTech and Moderna used experimental mRNA technology to develop their vaccine, and last week came out with news that their vaccine candidates were 90% effective against the new coronavirus.

Gabriela Galindo

The Brussels Times

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