As leading coronavirus vaccines make their way through early stages of human testing, the NIH is plotting much larger efficacy studies this summer. U.S. researchers plan to run phase 3 trials of vaccines from Moderna, AstraZeneca and Johnson & Johnson in the coming months, the Wall Street Journal reports.
The NIH intends to start a phase 3 trial of Moderna’s vaccine in July, followed by an August trial of AstraZeneca’s vaccine and a September study of Johnson & Johnson’s shot, a U.S. government researcher told the newspaper.
All three of the shots are based on brand-new technologies, and they’re all reportedly among finalists in the Operation Warp Speed program. Former FDA chief Scott Gottlieb has publicly questioned the picks, pointing out the team’s reliance on new technologies.
Johnson & Johnson has not previously disclosed any human testing for its vaccine and the company has previously said it’s aiming to enter human studies in September. But on Wednesday, the company said it’s accelerating its timeline, with plans to start a phase 1/2a study in July.
AstraZeneca and Moderna, meanwhile, are already in phase 2 testing. A Moderna representative confirmed the phase 3 plan to the Journal, and an AstraZeneca spokesperson said the company’s recent contract with the U.S. government includes a late-stage test, but the company didn’t confirm timing. AstraZeneca scored a whopping $1.2 billion COVID-19 vaccine contract from the U.S. last month.
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Aside from the NIH plans, Pfizer could start a phase 3 trial as early as next month, a source told the WSJ. Down the road, the NIH could launch studies of other vaccines, John Mascola, the head of NIAID’s vaccine research center, told the publication. Anthony Fauci, head of the NIAID, said at BIO’s digital conference Tuesday he expects “more than one” vaccine to succeed.
The government-funded phase 3 studies will enroll about 30,000 people each, testing the vaccines against placebo in places where the virus is circulating, WSJ reports. The aim is to see whether the candidates can protect vaccinated individuals against infection. Researchers wouldn’t start the studies until earlier research confirms the candidates are safe and trigger an immune response.
About 6 months into the pandemic, 10 vaccines are in human testing and another 126 are in preclinical research, according to the World Health Organization. Vaccines are an essential part of restarting economies, so companies aren’t waiting to see data to scale up their manufacturing processes. Many pharma giants and smaller companies have already inked partnerships to help them mass produces vaccines ahead of seeing data.
