The US drugs regulator will grant emergency approval to a second coronavirus vaccine in the coming days, a decision that will make it the first country to have authorised two inoculations against the virus.
The US Food and Drug Administration decided on Thursday night to approve Moderna’s vaccine on an emergency basis, according to people close to the process, following the recommendation to do so by a panel of outside experts.
Stephen Hahn, the head of the FDA, and Peter Marks, the head of the regulator’s vaccine division, issued a statement on Thursday night that said they had informed Moderna they would work towards the “finalisation and issuance” of an emergency approval. Officials close to the process said they had made the decision to authorise the vaccine, and were now working on the written information to doctors and patients to accompany it.
The move will make the US the first country to have approved the vaccines from both Pfizer/BioNTech and Moderna, and will help the Trump administration meet its goal of producing enough doses to vaccinate 20m people by the end of the year.
Moderna’s vaccine, which will be the drug company’s first to gain any kind of regulatory approval, is similar to Pfizer/BioNTech’s, using the same technology and boasting a similar efficacy rate, at 94.1 per cent. An FDA report published earlier this week found it was “highly effective” and raised no significant safety concerns.
Unlike Pfizer’s vaccine however, which is available to anyone over the age of 16, Moderna’s inoculation is only being authorised for over-18s.
But the Moderna shot may prove more widely available in the US than the Pfizer/BioNTech jab, as the government has signed deals for 200m doses, twice many as it has secured from Pfizer so far. The Moderna vaccine also does not need to be kept in ultra-cold storage, so it may be able to be distributed more broadly.
FDA scientists met to make the decision on Thursday evening following the vote by a group of outside experts to move ahead with approval. All but one of the panel voted in favour of authorisation, with the other member abstaining.
An emergency use authorisation is not a full approval, which may follow in a matter of months, but it would allow widespread distribution of the vaccine, with only children excluded.
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