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EMA approves Pfizer-BioNTech vaccine for market authorisation

Image: NIAID [CC BY 2.0] via Flickr

Approval ‘milestone’ as Commission purchases 20 million Covid-19 rapid antigen tests

The European Medicines Agency has approved the Covid-19 vaccine by the companies Pfizer and BioNTech for conditional marketing authorisation in the EU.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards,” said EMA executive director Emer Cooke, who called the step a “milestone” in the fight against the pandemic.

The EMA made the highly anticipated announcement after a 21 December meeting of its human medicines committee, which made the call. The vaccine, named Comirnaty, has proven 95 per cent effective in large-scale clinical trials involving 44,000 people, the EMA said.

The European Commission will now fast-track Comirnaty, which has already been approved by the UK and Canada.

Sabine Straus, chair of the EMA’s Pharmacovigilance Risk Assessment Committee, which evaluated the vaccine data, said the committee was “very aware of our responsibility to EU citizens to collect and analyse every piece of information on the safety of the vaccine”, adding that based on data given to the EMA by Pfizer and BioNTech, the vaccine’s safety profile is “reassuring”.

On 15 December the EMA brought forward the meeting date for its human medicines committee from 29 December, saying its committee “will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks”.

Given the EMA’s approval, the European Commission is due to “fast-track its decision-making process with a view to granting a marketing authorisation valid in all EU and European Economic Area member states within days”, the EMA previously said.

On 18 December, European Commission suggested a common framework for the use, validation and mutual recognition of rapid antigen tests to determine whether patients are infected with Covid-19.

The Commission said its recommendation will “ensure the uniform use, validation and recognition of rapid antigen tests in the EU”, amid a fast pace in evolution of diagnostic testing.

On the same day, the Commission struck a deal with the companies Abbott and Roche allowing the purchase of over 20 million rapid antigen tests for up to €100 million, to be made available to EU member states from “early 2021”.

“Testing will remain fundamental in the coming months, even as we aim to start rolling out our vaccines in the EU from 27 December,” said EU health commissioner Stella Kyriakides.