Health Desk- 13 September 2020: Pfizer Inc and BioNTech SE on Saturday proposed to the U.S Food and Drug Administration (FDA) to expand their Phase 3 pivotal COVID-19 vaccine trial to about 44,000 participants while increasing the diversity of the trial population.
The proposed expansion would also allow the companies to enroll people as young as 16 and people with chronic, stable HIV, hepatitis C and hepatitis B, they added.
Pfizer’s Chief Business Officer John Young in a U.S. congressional hearing in July said, “Diversity in clinical trials is a priority for Pfizer and is critical given that COVID-19 disproportionately impacts communities of color in the U.S”.
If the study is successful, the companies could submit the vaccine for regulatory approval as early as October, putting them on track to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.
Notable, drugmakers racing to develop a safe and effective coronavirus vaccine pledged in July to ensure their larger clinical trials would include diverse sets of volunteers.