Pfizer ‘Within Days’ of Seeking Emergency Use for COVID-19 Vaccine

Pfizer plans to file within days with the Food and Drug Administration to allow emergency use of its COVID-19 vaccine

Pfizer Inc "didn't conspire with anyone" to delay release of efficacy results for the COVID-19 vaccine it developed with German partner BioNTech SE until after the USA presidential election, Chief Executive Albert Bourla said on Tuesday.

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.

On Monday, U.S. -based Moderna Inc. said that interim results from a Phase 3 study of its mRNA-1273 vaccine show that the vaccine is 94.5 per cent effective with no significant safety concerns.

Just two weeks ago, data verified by an independent monitor suggests Pfizer's drug was 90 per cent effective in stopping transmission of COVID-19 among people who have not been previously infected.

What were the results of the Pfizer-BioNTech trial?

Less than two weeks after releasing an interim data analysis, pharmaceutical companies Pfizer and BioNTech have announced their massive worldwide Phase 3 vaccine trial is complete.

Both vaccine candidates use a new technology known as messenger RNA, or mRNA.

The Moderna vaccine is likely to be authorised within seven to 10 days of Pfizer receiving an emergency use authorization (EUA).

© Jacquelyn Martin/AP, File In this August 2, 2018, file photo, the U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md.

Once it's applied, the MRHA will review all of the trial results and all the data collected through the trial for safety, quality and efficacy to ensure it is safe for use. Pfizer has now hit key milestones that will allow the company to apply for this limited authorization, which could happen in the coming days.

In terms of pricing, Wagh told that Pfizer is researching and developing the candidate vaccine to help address an urgent public health need. "If you want to get protection and want to have your life restored to normal, make sure you don't get COVID between now and then".

Even if Pfizer's vaccine is authorized, the company may face logistics hurdles. Health Canada is encouraging vaccine makers to submit for approval before their Phase 3 trials are done, so the approval process that normally takes up to a year can be finished faster.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over age 65, a particularly high-risk group. Moderna received about $1 billion in federal funds to support its vaccine development and has agreed to provide 100 million doses to the US for $1.5 billion. The only severe adverse events experienced by volunteers were fatigue (3.8%) and headaches (2%) after the second dose.

Both of those applications could come "within days", according to the press release.

In the latest analysis, the companies looked into the confirmed COVID-19 cases of 170 study participants, eight of whom had been vaccinated while 162 had received dummy shots.

Pfizer and BioNTech expect to be able to produce up to 50million vaccine doses globally in 2020 and up to 1.3billion in 2021.