Coronavirus vaccine news and update: On September 12, Pfizer and BioNTech have jointly issued a press release stating that both the companies were expecting a "conclusive readout" on the efficacy of their Coronavirus vaccine candidate
Coronavirus Vaccine latest: The Coronavirus vaccine could be available in the US before the end of this year, claimed American pharmaceutical company Pfizer CEO Albert Bourla. Bourla, however, said the availability of the COVID19 vaccine before 2020 would depend upon the safety data and approval from the US regulator Food and Drug Administration (FDA). Pfizer and BioNTech have already announced that a ‘conclusive’ data regarding the safety and efficacy of their Coronavirus vaccine candidate BNT162 is likely to be available by October.
“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.” Answering a question whether Pfizer-BioNTech could get the FDA to approve it as safe and distribute it across to the US before the end of 2021, Bourla said, “I cannot say what the FDA will do. But I think it’s a likely scenario, and we are preparing for it. For example, we started already manufacturing and we have already manufactured hundreds of thousands of doses.”
On September 12, Pfizer and BioNTech have jointly issued a press release stating that both the companies were expecting a “conclusive readout” on the efficacy of their Coronavirus vaccine candidate and it would likely be published by the end of October.
Pfizer-BioNTech also revealed that they submitted an amended protocol to the US FDA seeking approval for expanding the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. Enrollment in the trial has been proceeding as planned and the company expects to reach its initial target of up to 30,000 participants next week. The proposed expansion would allow the companies to further increase trial population diversity and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data, both the companies said.
Pfizer-BioNTech’s BNT162mRNA vaccine is an mRNA vaccine.