Moderna’s Covid-19 vaccine led patients to produce antibodies that can neutralize the novel coronavirus that causes the disease, though it caused minor side effects in many patients, according to the first published data from an early-stage trial of the experimental shot.
The results were published Tuesday in the New England Journal of Medicine. Moderna had previously released some results in a press release, but many experts said they were not sufficient to draw many conclusions. Even now, many are withholding judgment.
“It certainly is a good beginning,” said Betty Diamond, director at the Feinstein Institutes for Medical Research, who was not involved in the trial. “There are certainly lots of things we don’t know yet right now.”
The study, which was run by the National Institutes of Health, showed that volunteers who received the vaccine made more neutralizing antibodies than have been seen in most patients who have recovered from Covid-19. But a second injection, four weeks after the first, was required before the vaccine produced a dramatic immune response.
“The hallmark of a vaccine is one that can actually mimic natural infection and induce the kind of response that you would get with natural infection. And it looks like, at least in this limited, small number of individuals, that is exactly what’s happening,” said Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, the NIH branch that conducted the trial. “The data really look quite good,” he added. “There were no serious adverse events.”
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The data roughly mirror the results from a similar vaccine being produced by Pfizer and BioNTech, which were released July 1.
Moderna posted a listing on clinicaltrials.gov, a government registry, that says it will start a Phase 3 study in 30,000 patients on July 27. Pfizer and BioNTech said they plan to start their own large study by the end of the month. There are 23 vaccines in human clinical trials against the virus, SARS-CoV-2, according to the World Health Organization, with more set to begin testing soon.
In a statement, Moderna CEO Stéphane Bancel called the data “encouraging,” saying they “represent an important step forward” in the development of the vaccine, called mRNA-1273. “We are committed to advancing the clinical development of mRNA-1273 as quickly and safely as possible while investing to scale up manufacturing so that we can help address this global health emergency,” Bancel said.
One big question is whether producing antibodies predicts protection against infection — and how much protection. Another is whether the antibodies will last.
“We don’t know how much [antibody] we need to be protected, so we can’t say” all the participants “achieved a protective level,” Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program, said in an email to STAT. “What we can say is that they made antibody that neutralized the virus, which is good.”
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The study enrolled 45 healthy volunteers ages 18 to 55, testing three dose levels of Moderna’s vaccine. The trial participants were split roughly 50-50 between men and women. The population was 89% white, 13% Hispanic, 4% Black, 2% Asian, and 2% Native American. More results are expected to be reported later for older patients, who often mount a weaker immune response.
Source : statsnews.com