A The trial of 30,000 patients for the Moderna coronavirus vaccine candidate, expected to begin next week, has been delayed, a potential obstacle to the company’s ambitious effort to deliver key data on Thanksgiving.
Moderna is making changes to the test plan, called the protocol, which has delayed the planned start date of the Phase 3 study, according to the researchers. The researchers, who spoke on condition of anonymity, emphasized that protocol changes are common, but said it is unclear how long the start will be delayed.
“I understood that they wanted to receive the first vaccines in July, and they say they are still committed to doing so,” said one researcher. “The best I can say is that they are close to being the target for that.”
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Researchers at the University of Illinois at Chicago had previously said that the Moderna trial would begin on July 9. On Thursday, NIH Director Francis Collins also told lawmakers in Washington that the study would begin this month.
Moderna did not respond to questions about how long the delay will last, the nature of the protocol changes, or whether it has anything to do with vaccine safety or manufacturing. After the post, CEO Stéphane Bancel told CNBC that Moderna still intends to start the trial in July.
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The intense focus on the exact timing of the test stems from the tight nature of the race to develop a vaccine against the new coronavirus, and the fact that any delay could jeopardize Moderna’s pole position. Pfizer, working with German firm BioNTech, plans to start a self-study of 30,000 patients later this month. AstraZeneca and the University of Oxford are slated to start a trial of similar size in August, followed by Johnson & Johnson in September.
All companies are working at unprecedented speed to advance their vaccines, and Moderna may not be the last to see its schedule delayed.
Developing and manufacturing vaccines at scale is always a challenging endeavor, with unexpected contingencies as the norm rather than the exception. Candidate vaccines that looked promising in animals may not offer the same results in people. Production problems arise.
During the 2009 H1N1 flu pandemic, US officials confidently predicted there would be a vaccine in early fall, in time to fend off a second wave of expected infections. But the new virus grew poorly in eggs, the substrate used in the production of the influenza vaccine. By the time the massive amounts of vaccines were ready for distribution, the peak of infection in the country had already passed.
Matthew Herper and Helen Branswell contributed reporting.
