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Moderna applies for EU vaccine authorization

Moderna applies for EU vaccine authorization
European Medicines Agency to conclude assessment of vaccine on Jan. 12

By Busra Nur Bilgic Cakmak

ANKARA (AA) - US biotechnology firm Moderna has applied for emergency EU authorization of its COVID-19 vaccine, the European Medicines Agency (EMA) announced on Tuesday.

“The Agency and its scientific committees will continue working on the assessment over the Christmas period,” said an EMA in a statement.

“If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, the EMA’s scientific committee for human medicines (CHMP) will conclude its assessment during an extraordinary meeting scheduled for 12 January at the latest,” it added.

The EMA said the timeframe is short because the agency has already reviewed some data on the vaccine.

“If EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID‑19, it will recommend granting a conditional marketing authorization,” said the statement.

“The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA Member States within days,” it added.

Moderna on Monday claimed its vaccine efficacy against the novel coronavirus is 94.1% after Phase 3 clinical trials, saying it is immediately filing for emergency use authorization for the vaccine.

The company's vaccine candidate also has the ability to prevent severe COVID-19, according to Moderna CEO Stephane Bancel.

Noting that Moderna is working with the US' Centers for Disease Control, Bancel said some 20 million doses of its vaccine will be available in the US by the end of 2020, and the company plans to manufacture 500 million to 1 billion doses globally in 2021.


source: News Feed
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