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.
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. 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.
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