Pfizer/BioNTech to expand COVID-19 vaccine trial

14 September 2020

In a statement issued on Saturday, US pharma giant Pfizer (NYSE: PFE) and German partner BioNTech (Nasdaq: BNTX) announced they have submitted an amended protocol to the US Food and Drug Administration to expand the enrollment of their Phase III pivotal COVID-19 vaccine, dubbed BNT162, trial to up to around 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 (human immunodeficiency viruses), hepatitis C, or hepatitis B infection, as well as provide additional safety and efficacy data.

Still anticipate conclusive readout by end October

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