Drug giants, Pfizer and partner BioNTech have applied for an approval in the United States to roll out their coronavirus vaccine early, a first step towards relief as surging infections prompt a return to shutdowns that traumatized nations and the global economy earlier this year.
US Food and Drug Administration (FDA) said its vaccines committee would meet on December 10 to discuss the request for emergency use authorization.
“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines,” the organization’s head Stephen Hahn said in a statement.
“I want to assure the American people that the FDA’s process and evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible.”
He said he could not predict how long the review would take, but the federal government said earlier the final green light would probably come in December.
Pfizer chief executive Albert Bourla called the filing “a critical milestone in our journey to deliver a COVID-19 vaccine to the world.”
The BioNTech/Pfizer shot and another one being developed by the US firm Moderna have taken the lead in the global chase for a vaccine.
EU Commission president Ursula von der Leyen said the European bloc could also approve both before the end of the year.