Daily Management Review

Application For Emergency Use Of Its Covid-19 Vaccine Filed With The US FDA By Pfizer


Application For Emergency Use Of Its Covid-19 Vaccine Filed With The US FDA By Pfizer
In what is being considered to be a major step toward providing protection against the novel coronavirus, an application for emergency use authorization (EUA) of its Covid-19 vaccine was filed with the United States health regulators on Friday by Pfizer Inc.
It was just day that final trial results were reported by Pfizer and German partner BioNTech SE which showed that the vaccine had 95 per cent efficacy and was effective in preventing Covid-19 infections with no major health or safety concerns. The companies filed for the EUA with the US Food and Drug Administration (FDA).
Confirming the news, the chief executive officer of Pfizer, Albert Bourla, said that the company had filed the application through a video posted on the company's website on Friday afternoon.
The announcement from Pfizer of the vaccine has raised hopes that CVoid-19 pandemic which has so far killed more than a quarter of a million people in the United States alone and more than 1.3 million people worldwide.
Safety data on about 100 children 12-15 years of age is also included in the application. $5 per cent the participants in the US trial are 56-85 years old, the company said.
US Health and Human Services secretary Alex Azar said in a television show that if the data is solid, "we literally could be weeks away from the authorization of a 95% effective vaccine".
It is expected that the FDA will grant the EUA by mid-December, the companies said and added that it is in a position to start shipping of the shot immediately. About 50 million doses of the vaccine will be ready by the end of this year which would be enough to protect 25 million people, Pfizer has said it expects.
According to reports quoting sources familiar with the situation, an advisory committee of the FDA is most likely to meet on December 8-10 for considering the vaccine, even though there are chances that the dates could get changed.
The Pfizer trials also revealed that its vaccine also provided the same level of protection to people from different ages and ethnicities which is an encouraging result since the disease has been more lethal for the elderly and the minorities.
Over 43,000 people participated in the Pfizer’s trial, out of which 170 volunteers had contracted Covid-19 and 162 of them had received only a placebo. That translated into the vaccine being 95 per cent effective which was much higher than what experts had initially hoped for.
A minimum efficacy level of 50 per cent was set by the US FDA.  
Participants who belonged to racially and ethnically diverse backgrounds comprised of almost 42% of global participants and 30% of US participants in the Phase 3 truals for its vaccine candidate, Pfizer said.
"Filing in the US represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine," Bourla said in a statement.