14 September 2020 - - US-based drugmaker Pfizer Inc. (NYSE: PFE) and Germany-based BioNTech SE (NASDAQ: BNTX) have submitted an amended protocol to the US Food and Drug Administration 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, the companies said.

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.

The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

As reported previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.