Pfizer and BioNTech announced that they have submitted an amended protocol to the US Food and Drug Administration (USFDA) to expand 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, Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.
The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.