Pfizer and German biotech firm BioNTech announced Saturday that they have submitted a proposal to the U.S. Food and Drug Administration to expand the phase-three trial of its coronavirus vaccine to include up to 44,000 participants, a significant increase from its previous target of 30,000.
The companies, which are developing the vaccine together, said in a statement that the trial is proceeding as planned and they expect to have enrolled 30,000 participants by 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,” the companies said.
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