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Jul 27, 2020

Moderna, NIH launch first large-scale U.S. virus vaccine trial

Moderna vaccine wont hit market until 2021: Brian Bloom

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The first large study of a COVID-19 vaccine in the U.S. began with the dosing of a single patient Monday morning in Savannah, Georgia, the opening shot for testing by Moderna Inc. and the National Institutes of Health that will weigh the vaccine’s safety and efficacy in 30,000 people.

The Moderna vaccine, backed by US$955 million in government funding, will be tested at 89 U.S. sites. It uses messenger RNA, a synthetic form of genetic material from the virus designed to nudge the body’s immune system into attack mode.

If the trial is successful, the company is on track to make 500 million doses of its vaccine in 2021, Moderna Chief Executive Officer Stephane Bancel said on a conference call with government officials.

Early results from the Moderna trial could be available in November or December, Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, said on the call. But he called it “conceivable” that results could come as early as October if the trial enrolls very quickly in places with high case loads.

The trial is designed to show that the vaccine is at least 60 per cent effective in preventing COVID-19, Fauci said.

Francis Collins, the head of the NIH, said making sure the trial’s participants come from diverse backgrounds is “essential.” The NIH will be tracking the diversity of the trial weekly to make sure it is attracting patients representative of those in the U.S. who are being hit hardest by the virus, he said.

“We really are going to depend upon that sense of volunteerism from individuals from every different corner of society” Collins said on the call.

Collins also said the government will be advised on the tricky question of who might get the vaccine first by a special panel of the National Academy of Medicine, a private, nonprofit organization of doctors and researchers.

At least three other Phase 3 trials aren’t far behind, Collins said. The next three Phase 3 trials will be undertaken on vaccines from the University of Oxford, Johnson & Johnson and Novavax Inc. working within the government’s “Warp Speed” push. Separately, an upcoming trial of Pfizer Inc. and BioNTech SE’s shot is also nearing late-stage study.

J&J launched its Phase 1 clinical trials in the U.S. on Monday, and will start it in Belgium on Wednesday, according to the company.

Cambridge, Massachusetts-based Moderna climbed as much as 11 per cent Monday after announcing on Sunday that it’s getting US$472 million in a second round of U.S. funding for its late-stage trial. The shares were up 7.6 per cent in New York trading at 11:58 a.m.

Moderna’s vaccine, co-developed with the NIH, is one of more than 160 in development to prevent the spread of the disease, and the World Health Organization estimates about 25 different inoculations are currently in human trials.

Government support for the vaccine “increases our confidence in its success,” BMO analyst George Farmer wrote in a note to clients. Goldman analysts led by Salveen Richter called Moderna “a leading contender” to bring a vaccine to the market, potentially before the end of the year.

--With assistance from Riley Griffin.