Moderna says it is on track to apply for FDA approval to market the vaccine in early December
THURSDAY, Oct. 22, 2020 (HealthDay News) — The first company to start a phase 3 trial of a COVID-19 vaccine reached its target of enrolling 30,000 participants, CNN reported Thursday.
The company, Moderna, said that all 30,000 have received the first shot, and most have received the second. Half of the participants were given the vaccine and half received a placebo. Stephen Hoge, M.D., president of Moderna, told CNN that the company is on track to apply to the U.S. Food and Drug Administration for approval to market the vaccine in early December “if all the stars align.”
Moderna is one of four phase 3 trials of vaccines, each involving tens of thousands of people, CNN said. The Moderna trial and a trial of the Pfizer vaccine started in July. AstraZeneca began its U.S. trial in August.
Three things need to happen before Moderna applies to the FDA, Hoge told CNN. Of the 30,000 participants, 53 need to become sick with COVID-19. Second is that of the 53 participants who become ill with COVID-19, at least 40 need to have received the placebo. That would show the vaccine is 75 percent effective. Third, the FDA requires that enough time has passed to see if any side effects develop.
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