American pharmaceutical giant, Pfizer Inc., has said that a key safety milestone has been reached in the study of its Covid-19 vaccine with the drugmaker now set to file for an emergency use authorization from the US Food and Drug Administration (FDA), after collecting the necessary safety data.
According to Bloomberg, this disclosure was made by the Chief Executive Officer of Pfizer, Albert Bourla, while speaking at a virtual conference hosted by the New York Times on Tuesday, November 17, 2020.
Without being clear on when it hopes to file for an emergency use authorization, Bourla said, “We are preparing now for submissions.’’
However, he admitted that important questions about the vaccine still remain to be answered and disclosed that Pfizer would soon release more detailed efficacy results, “When it comes to how durable the protection could be, this is something we don’t know yet.’’
The FDA required drug makers to follow at least half of the people who received the vaccine in their phase 3 clinical trials for 2 months in order to make sure there is at least that amount of safety data before a vaccine is considered for use.
It is expected it will be the first Covid-19 vaccine to be cleared for use in the US and could start vaccinations sometime in December if everything works according to plan. It’s expected the company will be able to supply the US with enough vaccine in 2020 that will be used to vaccinate 20 million people.
Bourla at the conference with New York Times pointed out that Pfizer was not very specific when it reported over 90% efficacy, because that number might fluctuate as more cases going through the trial proves. He reiterated that the company was going to report additional number once it publishes a more comprehensive data.
He expressed relief to see that another vaccine was also successful and hoped there are many more to follow because the global need for Covid-19 vaccines exceeds the production capacity of any single company.
On how the company was able to move so swiftly, as no vaccine has ever been produced this fast, the Pfizer CEO said the pharmaceutical firm had to make zillions of decisions in the process and was blessed in making the right calls.
He said, “To get this done, the stars needed to be aligned and stay aligned.’’
What you should know
Nairametrics had reported that the coronavirus vaccine which was developed by Pfizer in collaboration with BioNTech SE, was certified over 90% effective in preventing symptomatic cases of the virus in an interim analysis. This was also followed by an announcement from Moderna, that its Covid-19 vaccine was certified 94.5% effective in its protection from the virus.