New York:
Pfizer and BioNTech mentioned Friday they have been launching an application requesting complete US regulatory approval for their game-altering Covid-19 vaccine for men and women 16 years and older.
The two pharma organizations program to submit information in assistance of the application “on a rolling basis over the coming weeks” to the Food and Drug Administration (FDA), they mentioned in a press release.
The FDA authorized the vaccine in December for emergency use, a designation permitted throughout public overall health emergencies. Since then, more than 170 million doses of the vaccine have been delivered in the United States.
The organizations are now in search of a “Biologics License Application” for permanent regulatory approval, which “requires longer-term follow-up data for acceptance and approval,” the organizations mentioned.
The info will incorporate information on the vaccine efficacy and security profile up to six months just after the second dose in a phase-3 clinical trial.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the US government,” mentioned Pfizer Chief Executive Albert Bourla.
“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
Pfizer and BioNTech have also submitted information to garner emergency use approval for men and women 12 to 15 years old. Pfizer mentioned earlier in the week that it expects imminent US approval for this application.
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