Coronavirus vaccine could be deployed for public use in US before year-end, says Pfizer CEO Albert Bourla
New Delhi | Jagran Health Desk: Pfizer CEO Albert Bourla has claimed that the pharma company will likely deploy coronavirus vaccine in the US for public usage by the end of this year if trials succeed. BioNTech and Pfizer have sought FDA approval to expand the phase 3 clinical vaccine trial to up to 44,000 participants.
“I don’t know if they have to wait until 2021, because, as I said, our studies, we have a good chance that we will know if the product works by the end of October. And then, of course, it is the regulator’s job to issue a license or not,” he said.
The companies said in the press release that they were expecting a “conclusive readout” on the efficacy of their Coronavirus vaccine candidate BNT162 is likely to be available by October.
“We started already manufacturing and we have already manufactured hundreds of thousands of doses, so just in case we have a good study readout, conclusive and FDA, plus the advisory committee feels comfortable, that we will be ready,” Time Now quoted Albert Bourla, the chief executive of Phizer as saying.
In a joint press release, Pfizer-BioNTech also revealed that they are seeking approval for expanding the enrollment of their Phase 3 and submitted an amended protocol to the US FDA for the same. It would allow the companies to further increase trial population diversity and include adolescents as young as 16 years of age and people with Hepatitis C, stable HIV (human immunodeficiency viruses), chronic, or Hepatitis B infection, as well as provide additional safety and efficacy data.
“I don’t know if they have to wait until 2021, because, as I said, our studies, we have a good chance that we will know if the product works by the end of October. And then, of course, it is the regulator’s job to issue a license or not. I cannot say what the FDA will do. But I think it’s a likely scenario, and we are preparing for it,” Indian Express quoted Albert Bourla as saying.
Posted By: Srishti Goel