The United States’ Food and Drug Administration (FDA) has authorised Pfizer and BioNTech’s COVID-19 vaccine for emergency use.
In a statement early Saturday morning, the FDA said the emergency use authorisation (EUA) allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the US.
“The FDA’s authorisation for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.
“The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
United States’ Food and Drug Administration (FDA)
The FDA said it determined that the Pfizer-BioNTech COVID-19 Vaccine met the statutory criteria for issuance of an EUA.
“The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19,” the administration said.
“The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.
“In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.”
Pfizer’s vaccine requires two doses administered three weeks apart.
The vaccine is expected to be distributed in phases with the most critical US workers and vulnerable people getting it first.
An EUA isn’t the same as a full approval, which can typically take months. Pfizer has only submitted two months of follow-up safety data, but the agency usually requires six months for full approval. The vaccine was authorised for people 16 years and older.
The authorisation comes at a time the pandemic has taken nearly 300,000 American lives in less than a year and wreaked havoc on the US economy.
The US reported 3,124 new COVID-19 deaths on Wednesday, the deadliest single-day tally of the pandemic so far. The country has also recorded over 15,000,000 cases of the disease.