Pfizer and BioNTech are about to apply for vaccine approval

Saturday, 21 Nov, 2020

Pfizer says it hopes to produce up to 1.3 billion doses by the end of next year.

I am an infectious diseases specialist and professor at the University of Virginia. They're set to confer December 8-10, according to a person with knowledge of the situation.

Mr Hancock said the companies had already begun submitting data to the MHRA and would submit their full data in the coming days.

The scientific head of the United States operation to develop a vaccine, Moncef Slaoui said Monday that the green light would probably come in December - a timeframe echoed by Sahin.

An emergency authorization is a temporary or conditional authorization granted to respond to an emergency situation such as a pandemic.

EUA stands for emergency use authorization. Some treatments, such as certain cancer drugs, are cleared in just a couple of months.

A worker passes a line of freezers holding coronavirus disease (COVID-19) vaccine candidate BNT162b2 at a Pfizer facility in Puurs, Belgium in an undated photograph. This will offer some insight into whether the agency is leaning toward authorizing the vaccine.

Sahin estimates it could be "at least a year, if not longer" but he stressed that more data was needed to reach a final conclusion.

The vaccine trial will continue to follow all participants for two more years in order to collect detailed safety data. The agency and Pfizer will each summarize their findings for the advisory panel. The timing may make it hard for the FDA to fully vet the data before the meeting.

If the vaccine is authorized, Pfizer, health authorities and physicians will then face the arduous tasks of making enough shots to meet demand, distributing them and convincing individuals to take the vaccine.

He said the speed of the roll-out of a vaccine would depend on the speed it could be manufactured. It is also pointed out that the true effectiveness of a vaccine can only be determined once it moves out of trials and millions of people get it.

"I'm afraid we still haven't made those decisions", he said.

Before any vaccine is permitted in the US, it must be reviewed by the Food and Drug Administration, which requires study in thousands of people. The US FDA had set minimum bar for efficacy of 50%. This time it's really encouraging to know the Pfizer vaccine seems to work on older people as effectively as in younger ones. The timing of this meeting is unclear.

The Union health ministry had also said on Tuesday that the cold-chain requirements of Pfizer's coronavirus vaccine posed a big challenge to India's mass-vaccination campaign, but the government is examining all possibilities for its procurement. The FDA did not respond to requests for comment.

There will probably be enough vaccine for 25 million to 30 million people a month in early 2021, according to Moncef Slaoui, chief scientific adviser of Operation Warp Speed, the federal government initiative to speed up vaccine development. The objective is clear: to trigger a sufficient slowdown in the epidemic to allow the French to spend the end of the year holidays in a serene manner.

"We'll drill down on these data", said FDA adviser Dr. Paul Offit of the Children's Hospital of Philadelphia.

Moderna Inc. has reported similarly positive pivotal-trial data for its vaccine and is expected to seek FDA authorization in the next few weeks, after it finishes collecting all of its vaccine's safety data.

Combined phase-2 and phase-3 clinical trials of the Russian Covid-19 vaccine, Sputnik V, will be conducted soon in India by pharma major Dr Reddy's Laboratories.