Moderna Launches First Large-Scale US Virus Vaccine Trial


(Bloomberg) – The first major study of a Covid-19 vaccine in the US began with dosing of a single patient Monday morning in Savannah, Georgia, the initial shot for testing by Moderna Inc. and the National Institutes of Health that weigh the safety and efficacy of the vaccine in 30,000 people.

The Modern vaccine, backed by $ 955 million in government funding, will be tested at 89 sites in the US It uses messenger RNA, a synthetic form of the virus’ genetic material designed to push the body’s immune system into attack mode. If the trial is successful, the company is on track to produce 500 million doses of its vaccine in 2021, Moderna CEO Stephane Bancel said in a conference call with government officials.

The first results of the Moderna trial could be available in November or December, Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said in the call. But he called it “conceivable” that the results could come as early as October if the trial enrolls very quickly in places with a large number of cases.

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

Francis Collins, the head of the NIH, said making sure trial participants come from a variety of backgrounds is “essential.” The NIH will weekly track the diversity of the trial to make sure it attracts patients representative of those in the US who are most affected by the virus, he said.

“We are really going to rely on that sense of volunteering from people from all corners of society,” Collins said on the call.

Collins also said that a special panel from the National Academy of Medicine, a private nonprofit organization of doctors and researchers, will advise the government on the difficult question of who could get the vaccine first.

Collins said that at least three other Phase 3 trials are not far behind. The next three Phase 3 trials will be conducted with vaccines from the University of Oxford, Johnson & Johnson, and Novavax Inc., working within the government’s “Warp Speed” push. Separately, an upcoming trial by Pfizer Inc. and the injection of BioNTech SE is also approaching the study in the final stage.

Modern, based in Cambridge, Massachusetts, rose as much as 11% on Monday after announcing on Sunday that it will raise $ 472 million in a second round of US funding for its trial in the final stage. Shares rose 7.6% in New York at 11:58 am

The Moderna vaccine, developed jointly with the NIH, is one of more than 160 in development to prevent the spread of the disease, and the World Health Organization estimates that around 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 market, possibly before the end of the year.

(Add J&J Phase 1 trial in the ninth paragraph)

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