Pfizer/BioNTech to Seek Emergency Vaccine Approval in US Friday

The request for emergency use of the Covid-19 vaccine developed by Pfizer and BioNTech was expected to be filed with the FDA on Friday, said the US government and the co-founder of BioNTech.

This form of authorisation from the Food and Drug Administration is temporary or conditional and is granted in response to an emergency situation such as a pandemic reports AFP.  

“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 said earlier to AFP in a Zoom interview: "The documents will be finalized today and tomorrow and submitted to the FDA."

The FDA did not specify how long it would take to study the effectiveness and safety data of the vaccine, the two key criteria.

Moncef Slaoui, the technical head of the U.S. vaccine production operation, said Monday that the green light is likely to arrive in December—a timeline shared by Sahin.

He told AFP that there was a possibility that they could get green light from the U.S. "this year and even start distributing the vaccine by December.

BioNTech/Pfizer shot and another developed by the US firm Moderna have taken the lead in the global vaccine search, after large-scale trial data this month showed that their jabs were about 95 per cent effective against Covid-19.

The twin breakthroughs boosted hopes for an end to the pandemic that has affected more than 56 million people and caused more than 1.3 million deaths worldwide since the first outbreak of the virus in China at the end of last year.

“We would expect to see Moderna filing soon also,” Azar said at the press conference.

The US the European Union and a host of other nations have already ordered hundreds of millions of doses of the top vaccine candidates in production.

Health staff, carers and individuals deemed to be at high risk for serious Covid-19 are set to be the first in line for 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 licensed for use.

The speed at which vaccines have been produced has caused concern in some quarters.

Traditional virus vaccines use real viruses that can take months or years to create.

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.”