EMA okays Europe's second COVID vaccine

Regulatory NewsRegulatory News | 07 January 2021 |  By 

The European Commission has authorized a second vaccine against COVID-19 following a favorable review by the European Medicines Agency’s human medicines committee (EMA’s CHMP). On Wednesday, the messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health was given a conditional marketing authorization.
“With the Moderna vaccine, the second one now authorized in the EU, we will have a further 160 million doses. And more vaccines will come,” said European Commission (EC) President Ursula von der Leyen, adding that Europe now has made arrangements for “up to 2 billion” doses of COVID-19 vaccines. Of these, 460 million are either the Moderna vaccine or the Pfizer-BioNTech mRNA vaccine authorized by the EC in December 2020, which each require two doses.
To fulfill a contract signed in November 2020, Moderna will deliver 160 million doses of its vaccine to EU member countries by the end of the third quarter of 2021. Pfizer/BioNTech has committed to providing Europe with 300 million vaccine doses in 2021.
EMA has been using a rolling review process for COVID-19 vaccines and therapeutics, holding emergency meetings earlier in the week to review the Moderna vaccine after previously scheduling a 6 January review.  The conditional marketing authorization under which both the Moderna and Pfizer-BioNTech vaccines are being rolled out in Europe is one of the European Union’s mechanisms “for facilitating early access to medicines that fulfill an unmet medical need” in emergencies such as the COVID-19 pandemic.
A third vaccine, the adjuvanted chimpanzee adenovirus vector vaccine being developed by AstraZeneca and Oxford University, is also under rolling review by EMA. However, the regulator announced on 30 December 2020 that it still required “additional scientific information” from the sponsor to “support the rigor” required for a conditional marketing authorization. (RELATED: UK authorizes Oxford-AstraZeneca COVID-19 vaccine, Regulatory Focus 30 December 2020)
European Commission


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Tags: coronavirus, EMA, EUA

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