Pfizer and BioNTech have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment in their Phase III Covid-19 vaccine trial to up to 44,000 participants, according to a statement.
Enrollment in the trial has been proceeding as planned and the companies expect to reach their initial target of up to 30,000 participants next week
The proposed expansion would allow the companies to introduce more trial population diversity. The trail may include adolescents as young as 16 and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infections
Based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October
