WASHINGTON – An emergency use authorisation request for the Covid-19 vaccine developed by Pfizer and BioNTech is expected to be filed with the Food and Drug Administration (FDA) today, said the US government and BioNTech’s co-founder.
This type of FDA authorisation is temporary or conditional, and is granted in response to an emergency situation such as a pandemic.
“Pfizer’s partner BioNTech has announced that tomorrow, they intend to file for emergency use authorisation at the FDA,” Health Secretary Alex Azar told a press conference here yesterday.
BioNTech co-founder Ugur Sahin earlier told AFP in a Zoom interview: “The documents will be finalised today and tomorrow, and submitted to the FDA.”
The agency did not say how long it will 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, on Monday said the green light will probably come next month – a time frame echoed by Sahin.
He told AFP that there is a chance the companies will get the go-ahead from the US “this year”, and even start 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 are around 95% effective against Covid-19.
Both vaccines are based on relatively new technology that uses a synthetic version of a molecule called “messenger RNA” to hack into human cells, and effectively turn them into vaccine-making factories.
No vaccine based on this platform has ever been approved.
But, top US infectious disease official Anthony Fauci sought to dispel concerns during a rare briefing by the White House task force yesterday.
“The process of the speed did not compromise at all safety, nor did it compromise scientific integrity. It was a reflection of the extraordinary scientific advances in these types of vaccines that allowed us to do things in months that actually took years before.
“It was actually an independent body of people who have no allegiance to anyone – not to the administration, not to me, not to the companies – that looked at the data and deemed it to be sound.
“So, we need to put to rest any concept that this was rushed in an inappropriate way. This is really solid.” – AFP, November 20, 2020
