FILE PHOTO: Small bottles labeled with a “Vaccine COVID-19” sticker and a medical syringe are seen in this illustrationMore
(Reuters) – 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 initial target figure for the trial was up to 30,000 participants, which the companies said they expect to reach by next week.
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.
Drugmakers racing to develop a safe and effective coronavirus vaccine pledged in July to ensure their larger clinical