Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have submitted an amended protocol to the FDA to expand enrollment in their Phase III Covid-19 vaccine trial to up to 44,000 participants, a significant increase from the previous target of 30,000.
“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,” the companies said in a statement.
The trial – which is expected to have enrolled a total of 30,000 participants by this week – is so far proceeding as planned, and it’s a possibility that the companies could have data reflecting whether the vaccine is effective or not by the end of October.
However, it could take longer to collect enough data to determine whether the vaccine is safe, due to months of follow-up work that will determine what kind of side effects, if any, the vaccine may cause.
Go deeper: Dr. Anthony Fauci remains confident there will be a vaccine available by the end of this year or early 2021, meaning “getting back to a degree of normality prior to Covid will be well into 2021.”