EU medicine agency says decision on Pfizer-BioNTech COVID vaccine would be taken on Dec 29

European Medicine Agency (EMA) has announced that a decision for approval of Pfizer Vaccine would be made on December 29, reported the Daily Mail. The announcement comes two days after the organisations suffered a cyber-attack amid which attempts were made to steal critical data on various vaccine candidates. However, EMA announced that the attack would not affect its timeline to approve the vaccines.

Pfizer-BioNTech, which is one amongst the several companies hoping for approval, claimed that data related to their regulatory submission was illegally accessed as a part of the cyber-attack. Regardless, the Amsterdam based body reaffirmed that a decision on conditional approval of their vaccine candidate would be made on December 29. Apart from Pfizer-BioNTech, the organisation revealed that a decision on approval of Moderna’s vaccine candidate would be taken on January 12.  Meanwhile, AstraZeneca and Johnson &Johnson, both are expected to submit their application for marketing authorisation early next year, Daily Mail reported.

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The cyberattack

Speaking to the European parliament committee on December 9, EMA Chief Emer Cooke said that they have been subjected to cyberattacks over the last couple of weeks. In addendum, he confirmed that EMA was probing the hack 'in conjunction with experts from cybersecurity authorities across the EU, and with the criminal authorities and the Dutch police.' He also said that the attack would not hinder the organisation’s functioning and the timeline of vaccine approval.

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Earlier, EMA had warned against UK’s “hasty” emergency authorisation of COVID-19 shot developed by Pfizer and BioNTech. British regulator MHRA has announced that the mRNA-based vaccine that showed 95% efficacy, is safe for mass roll out with immunisations in the country starting among the high priority groups. Britain has reportedly already placed an order of 40 million doses of Pfizer-BioNTech's COVID-19 vaccine to provide the double-dose immunisation to at least 20 million people. 

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