EU regulator starts real-time review of Moderna’s COVID-19 vaccine candidate By Reuters


© Reuters. Moderna’s logo is reflected in a drop on a syringe needle in this illustration

(Reuters) – Europe’s health regulator said on Monday it had launched a real-time review of U.S. drugmaker Moderna Inc’s (O:) experimental COVID-19 vaccine, following similar such reviews of rival vaccines from AstraZeneca (L:) and Pfizer (N:).

The European Medicines Agency’s human medicines committee has started a “rolling review” of Moderna’s mRNA-1273 vaccine candidate and is evaluating the first batch of data, the regulator said.

Rolling reviews allow drug companies to submit applications for COVID-19 medicinal products before development work is concluded and prior to the availability of complete supporting documentation, aimed at speeding up any approval process.

In October, Moderna had said it would apply for real-time reviews of its vaccine in Europe.

EMA’s announcement comes a week after Switzerland began a real-time review of data from Moderna’s vaccine candidate.

Moderna said earlier this month that it has enough data for a first interim analysis of its late-stage COVID-19 vaccine trial.

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