WASHINGTON, Nov 20, 2020 (BSS/AFP) – An emergency use authorization request
for the Covid-19 vaccine developed by Pfizer and BioNTech was expected to be
filed with the FDA on Friday, the US government and BioNTech’s co-founder
said.
This type of Food and Drug Administration authorization 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 authorization at the FDA,” health secretary Alex Azar told
a press conference Thursday in Washington.
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 percent 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.
– ‘This is really solid’ –
Both vaccines are based 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.
The speed at which the vaccines have been developed has raised alarm in
some quarters.
Traditional virus vaccines use actual viruses that can take months or years
to develop.
But top US infectious disease official Anthony Fauci sought to dispell
those concerns during a rare briefing by the White House task force Thursday.
“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 which allowed us to do things
in months that actually took years before,” Fauci said.
“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,” he continued.
“So we need to put to rest any concept that this was rushed in an
inappropriate way. This is really solid.”