Dr. Anthony Fauci said the Phase 3 study of Moderne̵
In an interview Tuesday with the editor of JAMA, Fauci said the trial will include primarily US websites, but also include international sites that register 30,000 individuals in a “randomized placebo” controlled trial of Moderna’s vaccine against the Covid-19 strain of Covid-19. The mother’s vaccine candidate is considered to be in the lead among several efforts by drug and vaccine manufacturers in the fight against the deadly virus.
A phase 3 study is considered to be the last step before potentially approving the US Food and Drug Administration, which would make it available to patients across the country. Modern last week said it began reporting 600 healthy participants in a Phase 2 clinical trial testing mRNA-1273, the company’s vaccine against the virus that causes Covid-19.
But Fauci confirmed Tuesday that work on launching a much larger Phase 3 trial is well under way and will begin early next month.
“We are preparing the sites for the Phase 3 study,” said Fauci, director of the National Institute of Allergy and Infectious Diseases. Howard Bauchner, editor of JAMA during the interview, which was live Tuesday afternoon. “The real end of all this is the phase three trial that begins in the first week of July.”
Fauci said those who participated in the trial will primarily be between the ages of 18 and 55, but there are also older Americans, including those at risk of serious illness if infected by Covid-19.
“We and the companies and the federal government primarily do this in the risk zone,” Fauci said, referring to the government’s agreement to fund the production of doses whether they stop working or not.
“We will start manufacturing doses of the vaccines before we even know the vaccine is working,” Fauci said of the manufacturing process. “We may know if it is effective in November or December. At that time, hopefully, we would have close to 100 million (doses). “
By the beginning of 2021, a few hundred million more doses will be available, Fauci said. Manufacturing “will be done when we test the vaccine.”
Although Moderne’s vaccine candidate appears to be in the lead, Fauci was optimistic several other companies including AstraZeneca were developing potentially successful vaccines. “There are a number of at least four and possibly five trials that I am aware of and directly or indirectly involved in,” Fauci said.
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