Virus: an authorization request filed for the AstraZeneca vaccine (EMA)

Henrietta Brewer
January 13, 2021

The EU's drugs regulator said it would review a conditional approval application for AstraZeneca and Oxford University's Covid-19 vaccine this month under an accelerated timeline.

The European Medicines Agency (EMA) did not provide details on which documents or data were made available online, but said necessary action was being taken by law enforcement authorities.

The EMA approved the vaccine from Pfizer and BioNTech in December, and approved the Moderna COVID-19 vaccine earlier this month.

The agency said it would conduct an expedited review, with a decision that could be made on January 29, if the data reported is "robust and complete" enough.

"The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA Member States within days", the agency said.

The President of the European Commission, Ursula von der Leyen also welcomed the news on Twitter.

It is also easier to store and transport, especially that from Pfizer / BioNTech which must be stored at very low temperatures (-70 ° C).

Australia's peak immunology organisation has called for the federal government to halt its planned rollout of the AstraZeneca coronavirus vaccine, saying it might not be effective enough to eliminate the bastard virus in the community.

Moderna announced that deliveries to Europe were due to begin yesterday.

"We think that we have found the winning formula and how to achieve an efficiency which, with two doses, is high like that of the others", has since assured the managing director of AstraZeneca, Pascal Soriot.

Additional information was also provided by AstraZeneca at the request of CHMP and is now being studied.

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