EMA bumps up Moderna vaccine review

Regulatory NewsRegulatory News | 17 December 2020 |  By 

As it faces increasing pressure to authorize vaccines to prevent COVID-19, the European Medicines Agency (EMA) on Thursday said it would speed up its assessment of Moderna’s mRNA COVID-19 vaccine by nearly a week after receiving the last outstanding data it needed to decide on the application.
The agency had initially scheduled an extraordinary meeting of its Committee for Medicinal Products for Human Use (CHMP) to conclude its assessment of Moderna’s conditional marketing authorization application for 12 January, which will now be held on 6 January. The original meeting date will still be held as a precautionary measure.
The announcement comes just days after the agency announced it would move up its meeting to consider Pfizer and BioNTech’s COVID-19 vaccine by eight days to 21 December and follows news of a cyberattack that resulted in unlawful access of documents submitted in relation to both Pfizer-BioNTech and Moderna’s vaccines. (RELATED: EMA hit by cyberattack, Pfizer-BioNTech documents accessed, Regulatory Focus 9 December 2020; Despite data breach, CHMP set to consider Pfizer-BioNTech COVID vaccine, Regulatory Focus 15 December 2020).
“We have been able to revise the timetables for the evaluation of the COVID-19 vaccines due to the incredible efforts of everybody involved in these assessments,” said EMA Executive Director Emer Cooke. We have constantly revised our planning to further streamline all procedural aspects that need to be in place for a robust scientific assessment that leads to a marketing authorisation in all EU countries.”
On Twitter, European Commission President Ursula von der Leyen said she welcomed EMA’s decision to move up the meetings and said the bloc was “making good progress in securing vaccines.” With EMA’s recommendation for the Pfizer-BioNTech vaccine expected on 21 December, followed by a fast-tracked authorization decision by the European Commission in a matter of days, von der Leyen said that vaccinations campaigns across the EU could begin as early as 27 December.
Despite the authorization of the Pfizer-BioNTech vaccine in the US, UK, Canada and several other countries, EMA has sought to justify and differentiate its approach to getting the vaccines to market. Unlike other countries that have granted temporary or emergency authorizations to the vaccines, EMA is following its conditional marketing authorization pathway which will result in the full licensure of a vaccine for marketing across the EU. (RELATED: MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline, Regulatory Focus 2 December 2020; FDA authorizes Pfizer-BioNTech vaccine for emergency use, Regulatory Focus 11 December 2020).
“I have to stress that the authorizations that are granted in these contexts are for use or temporary supply of unlicensed vaccines, they are not marketing authorizations as such,” Cooke told the European Parliament’s health committee last week.
EMA continued that thread in its statement announcing the new meeting date, stressing that the marketing authorization would “meet the same high EU standards as for all vaccines and medicines.”


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