WASHINGTON, United States (AFP)— An emergency use authorization request for the COVID-19 vaccine developed by Pfizer and BioNTech was expected to be filed with the FDA Friday, the US government and BioNTech’s co-founder said.
This type of authorization is temporary or conditional and is granted in response to an emergency situation such as a pandemic — and may be revoked or modified if new efficacy or safety data emerge later.
“Pfizer’s partner BioNTech has announced that tomorrow, they intend to file for emergency use authorization at the FDA,” health secretary Alex Azar told a press conference Thursday in Washington, referring to the Food and Drug Administration.
BioNTech co-founder Ugur Sahin earlier told AFP in a Zoom interview: “The documents will be finalized today and tomorrow and submitted to the FDA.”
The FDA did not say how long it would take to review the data on vaccine efficacy and safety, the two main criteria.
The scientific head of the US operation to develop a vaccine, Moncef Slaoui said Monday that the green light would probably come in December — a timeframe echoed by Sahin.
He told AFP there is a chance they could receive the green light from the US “this year,” and even starting delivering the vaccine by December.
The BioNTech/Pfizer shot and another one being developed by US firm Moderna have taken the lead in the global chase for a vaccine, after large-scale trial data this month showed that their jabs were around 95 per cent effective against COVID-19.
The twin breakthroughs have lifted hopes for an end to a pandemic that has infected more than 56 million people and caused over 1.3 million deaths worldwide since the virus first emerged in China late last year.
“We would expect to see Moderna filing soon also,” Azar said at the press conference.
The US, the European Union and a slew of other nations have already placed orders for hundreds of millions of doses of the top vaccine candidates in development.
Health workers, carers and people considered at high risk for severe COVID-19 are set to be first in line for the jabs.
