Pfizer, a pharmaceutical company, formally asked to allow emergency use for its COVID-19 vaccine candidate from the Food and Drug Administration (FDA). It has commenced on a process that can bring limited first shots as early as in December.
Pfizer Asks for Approval From FDA
From 170 novel coronavirus cases detected to date, a mere eight were among individuals who had received the actual vaccine. The others had gotten a dummy shot.
FDA, Scientists to Make Debate Public
The United States regulators who will deliberate on the fate of coronavirus vaccines took an uncommon step on Thursday: asking scientists beyond the FDA if their standards are sufficiently high.
The Food and Drug Administration could decide by the end of the year whether to enable usage of the initial vaccines against the respiratory illness, reported The Guardian.
Pfizer's announcement gets the ball rolling on the process that can bring limited first shots as early as in December and a probable end to the pandemic but not until after a long winter season.
The move comes days after Pfizer Inc. and BioNTech made a declaration that their vaccine appeared to be 95% effective at preventing mild to serious COVID-19 illness in a study underway, reported CBS News.
According to Pfizer Chief Executive Officer Albert Bourla in a video posted on Twitter on Friday, "It is with great pride and joy - and even a little relief - that I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA's hands. This is a historic day, a historic day for science and for all of us," reported Yahoo Life.
He added, "It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day."
The FDA is expected to deliberate within weeks on the request for the Emergency Use Authorization for the drug named BNT162b2. This means that vaccinations could start as soon as December.
The most recent data from Phase 3 clinical trials with almost 44,000 participants globally showed the 95% effectiveness of BNT162b2 at prevention of testing positive for COVID-19.
According to the companies, protection equipped with a good safety record meant the vaccine should be eligible for emergency use authorization. This could be granted by the FDA before the completion of its final testing.
Along with the FDA submission, they have already begun "rolling" applications in the United Kingdom and Europe with an intent to submit similar data soon.
"While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible," according to FDA Commissioner Stephen Hahn, reported The New Daily.
FDA scientists would now start the process of evaluating data and affirming the safety and effectiveness of the vaccine. If the agency approves the emergency use of the vaccine, a limited group of highly susceptible people would receive the shots within days.