WASHINGTON,\u00a0United States\u00a0(AFP)\u2014 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.<\/p>\n
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.<\/p>\n
“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.<\/p>\n
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.”<\/p>\n
The FDA did not say how long it would take to review the data on vaccine efficacy and safety, the two main criteria.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
“We would expect to see Moderna filing soon also,” Azar said at the press conference.<\/p>\n
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.<\/p>\n
Health workers, carers and people considered at high risk for severe COVID-19 are set to be first in line for the jabs.<\/p>\n","protected":false},"excerpt":{"rendered":"
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