Two months ago, Moderna trumpeted “positive” early data for its COVID-19 vaccine but didn’t offer the results in a scientific presentation or in a peer-reviewed study. Now, it’s showing us the receipts. The phase 1 study, being run by the National Institute of Allergy and Infectious Diseases (NIAID), is testing three dose levels of the vaccine, mRNA-1273, given in two injections a month apart in 45 adults. At day 43, about two weeks after they got the second dose, all evaluated patients had “robust” levels of neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19, according to a study published Tuesday in the New England Journal of Medicine. Three patients did not get a second dose: one because of a skin reaction and two because they were isolated while waiting for COVID-19 test results. Despite the ”robust” responses, the investigators noted that ”correlates of protection from SARS-CoV-2 infection have not been determined,” but if the new coronavirus works the way that other respiratory viruses do, it’s reasonable to expect high levels of neutralizing antibodies to correspond with protection. Sponsored by Clinical InkWhite Paper: Keep Your GI Trials Moving During COVID-19Clinical Ink’s intimate knowledge of and experience with GI trials enables a better deployment experience and improved trial conduct. Learn how our GI-specific data capture solutions can support virtual and hybrid trials during COVID-19. The investigators measured patients’ antibody levels using two different tests and compared them to results from 38 patients who had recovered from the disease. The bulk of those recovered patients had mild COVID-19, while 22% had moderate symptoms and 15% had severe disease and needed to be hospitalized or put on a ventilator. One measure found that patients who took the middle dose, 100 micrograms, had four times the antibody level that the recovered patients had. The second measure found those patients had twice the antibody level of the recovered patients. Whichever way you slice it, it’s good news, wrote Jefferies analyst Michael Yee in an investor note. RELATED: Moderna delay a snapshot of ‘squabbles’ with U. S. scientists over COVID-19 vaccine trials: Reuters“Rather than getting too analytical about the ratio, the level of neutralizing antibodies are high and well above convalescent sera, realizing that convalescent sera comparator antibody levels have a wide range for patients who resolve (e.g. we have seen levels between 50-200+). This is because severe patients could have more antibodies than milder patients,” Yee wrote. There were no serious side effects through day 57, about two months after the second dose. Half of the patients on the lowest dose, 25 mcg, experienced systemic side effects, including fatigue, headache, chills and muscle pain. All of the patients on the middle dose, 100 mcg, and the highest dose, 250 mcg, experienced these kinds of effects, but they were “transient and moderate or mile in severity.
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