Moderna submits its Covid vaccine for full FDA approval
Moderna's submission comes two days after the FDA granted full approval to Pfizer's Covid-19 vaccine
Moderna has finished filing its submission to the US Food and Drug Administration for full approval of its coronavirus vaccine.
The pharmaceutical company requested priority review for its Biologics License Application.
‘This BLA submission for our Covid-19 vaccine, which we began in June, is an important milestone in our battle against Covid-19 and for Moderna, as this is the first BLA submission in our company’s history,’ Moderna CEO Stéphane Bancel said in a statement on Wednesday.
Moderna’s announcement comes two days after the FDA granted full approval to Pfizer’s Covid-19 vaccine for people 16 years and older. Moderna was the second company to receive emergency use authorization from the FDA for its jab, after Pfizer.
The FDA gave emergency use authorization for Moderna’s jab for people ages 18 and older. Moderna has also applied for emergency use authorization of its jab for people 12 years and older.
A review for full approval usually takes months, but the FDA worked around the clock to license Pfizer’s vaccine ahead of schedule.
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