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Moderna enrolls 30,000 for final stage coronavirus vaccine trial
Published : 23 Oct 2020, 01:08
American pharmaceutical company Moderna, the first to start clinical trials of a COVID-19 vaccine in the United States, finished enrolling all 30,000 of its participants for final stage trial on Thursday, reported Xinhua.
The Cambridge, Massachusetts-based company said it has officially enrolled all 30,000 participants in the third phase of the trial, which involves two shots of the vaccination.
All 30,000 participants have received their first shot, and currently 25,654 of them have received their second dose, according to Moderna.
Once everyone has the second vaccination, Moderna will take time to assess the safety of it. If the benefits outweigh the risks, the company will apply for emergency use authorization of the U.S. Food and Drug Administration (FDA).
Moderna's vaccine candidate mRNA-1273 is being tested at approximately 89 clinical research sites in the United States.
The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms, according to the U.S. National Institutes of Health (NIH).
The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives, said the NIH.
Moderna is one of four U.S. phase 3 trials of coronavirus vaccines, each involving tens of thousands of participants.
Moderna and another pharmaceutical company Pfizer started their phase 3 trials on July 27. AstraZeneca started its U.S. trial on Aug. 31 and paused it about a week later when a participant fell ill. Johnson & Johnson started its trial Sept. 23 and paused it less than three weeks later for the same reason.
Both of the two trials on hold are still in effect.
Moncef Slaoui, scientific head of Operation Warp Speed, a White House program designed to shorten the amount of time it takes to develop a coronavirus vaccine, said Wednesday Moderna and another pharmaceutical company Pfizer are likely to be the first with vaccine candidates to apply for FDA emergency use authorization, possibly as soon as November or December.
If a vaccine is authorized before the end of the year, Slaoui said approximately 20 to 40 million doses of it will be stockpiled and ready for distribution for a limited population.