US close to granting emergency approval to Moderna vaccine

A panel of experts at the US Food and Drug Administration has recommended the drugs regulator grant emergency approval to the Moderna coronavirus vaccine. AP - Hans Pennink

The American biotech company learned late Thursday the FDA was working towards the “finalisation and issuance” of an emergency approval for its product, developed alongside the National Institute of Allergy and Infectious Diseases.

The official decision, expected Friday, will make the US the first country to have authorised two coronavirus vaccines – after the Pfizer/BioNTech jab earlier won approval.

We just confirmed that the @US_FDA VRBPAC recommended that the FDA grant an Emergency Use Authorization for our COVID-19 vaccine candidate, mRNA-1273. 20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained. Read more: https://t.co/AmkdurMzQ2 pic.twitter.com/Ja4WAvb44Y

— Moderna (@moderna_tx) December 17, 2020

The move will boost the US’s national vaccination campaign and help the administration of Donald Trump meet its goal of producing enough doses to innoculate 20 million people by the end of the year.

Analysis by the FDA found Moderna’s vaccine to be more than 94 percent effective at preventing Covid-19 in a trial of more than 30,000 participants, adding it had a "favorable safety profile".

• Moderna asks health authorities in US, Europe to fast-track Covid vaccine

While there have been reports of severe allergic reactions to the Pfizer-BioNTech vaccine since it was rolled out in the UK, Moderna’s phase 3 clinical trial showed no cases of anaphylaxis.

Unlike the Pfizer-BioNTech vaccine, which requires ultracold storage, the Moderna shot can be stored at normal freezer temperatures, making distribution easier.