US Grants Full Approval To Pfizer COVID-19 Vaccine

The US Food and Drug Administration on Monday fully approved Pfizer’s Covid-19 vaccine, a move expected to trigger a new wave of vaccine mandates as the Delta variant batters the country.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” acting FDA Commissioner Janet Woodcock said in a statement.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

In a statement, the FDA said its review for approval included data from approximately 44,000 people. The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.

The FDA gave emergency use authorization to the vaccine for people age 16 and older in December – making it the first shot to gain such backing – and then later gave further emergency use authorization for people age 12 and up in May. The new authorization does not give final approval for those between ages 12 and 15.