'After a thorough and rigorous review process..': White House welcomes FDA's full approval for Pfizer's Covid-19 vaccine
The United States government on Monday welcomed the Food and Drug Administration’s (FDA) decision to award full approval to Pfizer-BioNTech SE’s vaccine against the coronavirus disease (Covid-19), calling it a “thorough and rigorous” scientific review process. It further said it is looking forward to the top regulator’s full approval for vaccines from Moderna and Johnson & Johnson as well.
“After a thorough, independent, and rigorous scientific review process that began more than a year ago, the FDA gave full approval to the Pfizer vaccine. Today’s announcement reaffirms the FDA’s findings that the vaccine is safe and effective,” the White House’s official Twitter handle said. “The Moderna and Johnson & Johnson vaccines remain safe and effective vaccine options. Both vaccines have undergone rigorous and methodical scientific testing before they were authorised for emergency use. We look forward for the FDA’s full approval of these vaccines soon,” it further stated.
Monday’s announcement by the United States’ top health agency follows reports from last week which stated that the Pfizer Covid-19 vaccine will receive full approval “next week.” The two-dose messenger RNA (mRNA) vaccine received Emergency Use Authorisation (EUA) from the FDA on December 11 last year, and, since then, more than 204 million Pfizer shots have been administered across the country, according to data complied by the Centers for Disease Control and Prevention (CDC).
The medical term for a full approval is “biologics license application” (BLA). The Pfizer jab becomes the first in the United States to receive BLA, and will now be manufactured as “Comirnaty.” The award of full approval was described by Janet Woodcock, the FDA’s acting commissioner, as a “milestone in the battle against the Covid-19 pandemic.”
According to Johns Hopkins University’s coronavirus tracker, the US has thus far seen more than 37 million cases of Covid-19, along with a related toll of nearly 630,000, both of which are highest globally.