Moderna applies for full approval of its Covid vaccine in US
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Currently, the vaccine is available under “emergency use authorization” in the US which allows life-saving medications to be made available for public use as quickly as possible
Moderna on Tuesday said that it was applying for full approval of its COVID-19 vaccine for people aged 18 and above. With this application, Moderna joins Pfizer which had made the same request in May.
Currently, the vaccine is available under “emergency use authorization” in the US which allows life-saving medications to be made available for public use as quickly as possible.
It was given the emergency use authorisation on December 18, 2020. So far, 124 million doses of the anti-Covid Moderna vaccine have been administered in the United States.
"We are pleased to announce this important step in the US regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine," Stephane Bancel, Moderna’s CEO was cited as saying by AFP.
"We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission”, Bancel added.
Last week, the company announced that its vaccine was highly effective among adolescents, while adding that it would seek authorisation among 12-to-17 year-olds soon.
Moderna’s two-shot vaccine is around 90 per cent effective against symptomatic COVID-19 infections and over 95 per cent effective against severe cases of Covid.
Also read: Moderna's single-dose vaccine in India likely next year; Pfizer ready with 50 mn doses for 2021
During a virtual investor event on Thursday, Moderna scientists and executives carved out plans to combat new strains. Company representatives claimed that they’re constantly undertaking testing of new variants and vaccines to keep up with mutants, while shedding light on the complexity of the process.
“New viral variants are coming, emerging constantly in real time” Guillaume Stewat-Jones, a scientist at Moderna was cited as saying by Barron’s.