Moderna files for US approval
Move comes as Pfizer and BioNtech seek EU nod
WASHINGTON: Moderna Inc says it has applied for US emergency authorisation for its Covid-19 vaccine after full results from a latestage study showed that it is 94.1% effective with no serious safety concerns.
The US Food and Drug Administration (FDA) said on Monday that an advisory committee would meet to discuss the request on Dec 17, making Moderna’s candidate the second highly effective vaccine likely to receive US regulatory backing and a potential roll-out this year.
Germany’s BioNTech and its US partner Pfizer yesterday said they had applied for EU regulatory approval for their Covid-19 vaccine, raising hopes that the first jabs could be administered in December.
The two companies said they had submitted an application to the European Medicines Agency on Monday “for Conditional Marketing Authorisation for their vaccine, after tests showed it was 95% effective against the coronavirus.
The FDA will decide on the emergency use authorisations after the advisers make their recommendations.
Moderna, which also plans to seek European approval, reported that its vaccine’s efficacy was consistent across age, race, ethnicity and gender demographics as well as having 100% success in preventing severe cases of the disease that has killed nearly 1.5 million people worldwide.
“We believe we have a vaccine that is highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Tal Zaks said. “We expect to play a major part in turning around this pandemic.”
Of the 196 people who contracted Covid-19 out of over 30,000 trial volunteers, 185 had received a placebo and 11 the vaccine. Moderna reported 30 severe cases, all in the placebo group.
Moderna shares rose 3% in extended trading after closing up 20%. They have gained about 700% this year.
“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.
In addition to filing its US application, Moderna said it would seek conditional approval from the European Medicines Agency and continue to talk with other regulators doing similar rolling reviews.