The United States on Friday authorized Moderna’s Covid-19 vaccine for emergency use, paving the way for six million doses of a second vaccine to soon begin shipping across the hardest-hit country in the world.
Food and Drug Administration (FDA) chief Stephen Hahn said: “With the availability of two vaccines now for the prevention of Covid-19, the FDA has taken another crucial step in the fight against this global pandemic.”
The company said total 200 million doses have been ordered by the US government to date, and that it retains the option to purchase up to an additional 300 million doses. “Approximately 20 million doses will be delivered by the end of December 2020,” Moderna said.
The US FDA aprroval comes a day after a panel of outside advisers to the US drug regulators fully endorsed the vaccine candidate. Of the total 21 VRBPAC (Vaccines and Related Biological Products Advisory Committee) members, 20 voted in favour of authorising Moderna vaccine, while one abstained.
US President Donald Trump congratulated the nation on the approval of second vaccine, saying “the Moderna vaccine is now available!”.
The decision marks the first regulatory authorization in the world for Moderna’s vaccine and validation of its messenger RNA technology. It came less than a year after the first Covid-19 case was identified in the United States.
The biotech company has worked with the US government to prepare for the distribution of 5.9 million shots as early as this weekend.
The FDA decision is based on results from a late-stage study of 30,000 volunteers that found the vaccine was nearly 95% effective at preventing illness from Covid-19 with no serious safety concerns.