On Monday, the US Food and Drug Administration (FDA) granted full approval for the Pfizer-BioNTech COVID-19 vaccine for use in people aged 16 and up in the country.
Notably, the move by the American drug regulator elevates the Pfizer-BioNTech shot to the world’s first COVID-19 vaccination from emergency use authorization (EUA) to fully approved status.
In order to apply for a Biological License, the companies had to furnish the FDA with six months of safety and efficacy data on their vaccine. Before seeking for an emergency usage authorization, the agency merely required corporations to collect two months of data. Because of the shortened schedule, the agency was able to avoid some of the most time-consuming regulatory hurdles and get vaccines to individuals rapidly during the crisis.
This approval is based on volumes of evidence, including a clinical trial involving 20,000 patients who received the vaccination and 20,000 who received a placebo. After six months, the vaccine was found to be 91 per cent effective at preventing symptomatic COVID.
Approval is a milestone in the fight against COVID pandemic: Acting FDA Commissioner
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Janet Woodcock, acting Commissioner of the FDA, in a statement.
“While millions of people have already safely received COVID-19 vaccines,” she continued, “We recognise that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated.”