US biotechnology firm Moderna has applied for emergency EU authorization of its coronavirus vaccine, the European Medicines Agency (EMA) announced on Tuesday.
VACCINE CANDIDATE HAS ABILITY TO PREVENT SEVERE CORONAVIRUS
“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 coronavirus, 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.
The company’s vaccine candidate also has the ability to prevent severe coronavirus, 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.