Dr. Anthony Fauci said the Phase 3 trial of Moderna’s experimental COVID-19 vaccine will begin in July and include study of 30,000 patients who will be as young as 18 and include elderly Americans as well.
In an interview Tuesday with the editor of JAMA, Fauci said the trial will include primarily U.S. sites, but also include international sites enrolling 30,000 individuals in a “randomized placebo” controlled trial of Moderna’s vaccine against the Coronavirus strain Covid-19. Moderna’s vaccine candidate is considered in the lead among several efforts by drug and vaccine makers in the battle against the deadly virus.
A phase 3 trial is considered the final stage before potential approval by the U.S. Food and Drug Administration, which would make it available for patients across the country. Moderna last week said it began enrolling 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 the work to begin a much larger phase 3 trial are well underway and will begin early next month.
“We are preparing the sites for the phase 3 study,” Fauci, who is the director of the National Institute of Allergy and Infectious Diseases, told Dr. Howard Bauchner, editor of JAMA during the interview, which was live Tuesday afternoon. “The real business end of this all is the phase three trial that starts in the first week in July.”
Fauci said those enrolled in the trial will primarily be between the ages of 18 and 55 but there also be elderly Americans including those who are at risk for serious illness if they become infected with Covid-19.
“We and the companies and the federal government, predominantly, is doing this at risk,” Fauci said, referring to the government’s agreement to fund production of dosages whether they end up working or not.
“We are going to start manufacturing doses of the vaccines way before we even know the vaccine works,” Fauci said of the manufacturing process. “We may know whether it’s efficacious by November or December. By that time, we hopefully would have close to 100 million (doses).”
By early 2021, a “couple hundred million” more dosages will be available, Fauci said. The manufacturing is “going to be done as we are testing the vaccine.”
Though Moderna’s vaccine candidate appears to be in the lead, Fauci was optimistic several other companies including AstraZeneca were developing potentially successful vaccines. “There’s an array 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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