The US medicines regulator has authorised the use of Moderna’s Covid-19 vaccine on an emergency basis, making a second jab available and boosting supplies at a critical crunch point as several states complain they cannot secure enough shots.
The second emergency use authorisation for a Covid-19 vaccine will mean that more than 5.9m Moderna shots will be delivered in the coming week.
Stephen Hahn, Food and Drug Administration commissioner, said it was “another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalisations and deaths in the United States each day”.
While Pfizer took only a US government pre-order for its first US approved vaccine, Operation Warp Speed — the Trump administration’s sprawling vaccine effort — poured funding into Moderna’s jab, contributing up to $4.1bn towards trials and the expansion of manufacturing capacity.
The Boston-based biotech has promised to deliver 200m doses to the US, twice as much as Pfizer. Alex Azar, health secretary complained this week that Pfizer had kept the government at “arm’s length” as the drugmaker rolled out its vaccine and said he would like more visibility into its production.
On Friday Mr Azar emphasised how the US government helped Moderna, including laying the groundwork in a partnership with the Biomedical Advanced Research and Development Authority since 2016, and collaborating on the Covid-19 vaccine with the National Institutes of Health.
“To have two vaccines against a novel virus authorised and distributed within a year is extraordinary, and to have one of these vaccines developed by scientists at the NIH should be a great source of pride,” he said.
President Donald Trump tweeted: “Congratulations, the Moderna vaccine is now available!”
The extra supplies come at a critical moment as Covid-19 rates and hospitalisations soar across the US, ahead of a holiday period expected to exacerbate an already desperate situation.
Moderna’s vaccine will also be easier to distribute, because it can be kept at 2C to 8C, whereas the Pfizer vaccine, which has been developed in a partnership with Germany’s BioNTech, must be stored at very cold temperatures.
The FDA issued the emergency use authorisation for people over 18 years of age and its decision comes a day after a group of outside experts met to discuss the Moderna vaccine, which they endorsed, with 20 people voting that the benefits of the Moderna vaccine outweighed its risks. There was one abstention.
Latest coronavirus news
Follow FT’s live coverage and analysis of the global pandemic and the rapidly evolving economic crisis here.
The vaccine 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 that there were no significant safety concerns.
Individuals will be warned that there is a “remote chance” of a “severe allergic reaction”, usually within a few minutes to an hour of being given the vaccine. The FDA said people who have had allergic reactions to the vaccine components should not take it.
Investors are hoping success with the Covid-19 vaccine bodes well for Moderna’s other vaccines. The lossmaking biotech has not had any products approved, and the pandemic may have brought forward its first approval by three to four years.
Shares in Moderna rose 2.2 per cent in after-hours trade to $143.37.