"In July, Moderna started a 30,000-person study in the U.S. to test whether the vaccine safely protects people from symptomatic Covid-19 disease, and enrollment is nearly complete.
In the trial, half of the study subjects receive the vaccine and half receive a placebo, and researchers then count how many get symptomatic Covid-19.
The first interim analysis of the vaccine's efficacy will happen when 53 people in the entire study get symptomatic Covid-19. If there are significantly fewer vaccinated people than unvaccinated people among those 53 cases, the company may deem the results sufficient to seek government authorization of wider use.
That first analysis is likely to occur in November, but "it's hard to predict exactly which week because it depends on the cases, the number of people getting sick," Mr. Bancel said.
The company also must monitor the safety of at least half of the study subjects for two months after vaccination before it can seek an authorization for emergency use. Mr. Bancel said Moderna was likely to reach that threshold in late November. If Moderna files for an emergency use authorization soon after, the Food and Drug Administration may take a few weeks to review the application before deciding in December." [1]
1. U.S. News: Moderna Expects Interim Results Next Month
Loftus, Peter. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]20 Oct 2020: A.6.
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