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Moderna chairman says COVID-19 vaccine could begin phase 2 trials in spring

Phase 1 trial was initiated in record time, after vaccine candidate fast-tracked by US government

Moderna Therapeutics

Moderna’s chairman Noubar Afeyan has said that phase 2 human trials of the company’s coronavirus vaccine could begin in spring, as pressure mounts for the successful development of a shot against the novel virus.

In March, Moderna launched a phase 1 human trial of its mRNA-based vaccine, named mRNA-1273, with the first patients having already been dosed. The study is being conducted by the US National Institutes of Health (NIH) at Kaiser Permanente Washington Health Research Institute in Seattle.

“It’s difficult to put a specific date on things just because it’s a very dynamic situation,” said Afeyan, according to CNBC.

“We’ve entered phase 1 trials. ... we’ll enter hopefully phase 2 trials, we expect that to happen in the spring, perhaps early summer,” he added.

The phase 1 trial will aim to recruit 45 health men and women aged between 18 and 55, and will test two doses of the vaccine administered 28 days apart, with 12 months of follow-up after the second dose.

The biotech company is already manufacturing large batches of mRNA-1273 to dose patients in the second, larger study, and is also increasing its production capacity to allow for millions of doses to be made if the vaccine proves safe and effective.

The phase 1 trial was initiated in record time, after the vaccine candidate was fast-tracked by the US government, which allowed Moderna to run some aspects of its development, such as non-

human primate challenge studies, in parallel with human trials.

Without the usual hurdles, due in large part to the urgency of the pandemic, Moderna has been able to develop and advance mRNA-1273 at a speed which is unprecedented in this research area – vaccines usually take at least a couple of years to bring through the clinic and into the market.

Article by
PMGroup

3rd April 2020

From: Research

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