(The B) – Trial data indicates “we’re getting close” to having an answer in dealing with COVID-19. Moderna’s mRNA-1273 vaccine had led patients to produce antibodies that can neutralize the coronavirus that causes the disease. That’s according to the first published data from an early-stage trial of the experimental shot.
The results were published on July 14 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. “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 data roughly mirrors 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 beginning on July 27. Pfizer and BioNTech said they plan to start their own large study by the end of the month as well. In a statement, Moderna CEO Stéphane Bancel called the data “encouraging,” saying they “represent an important step forward” in the development of the vaccine. “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. “What we can say is that they made antibody that neutralized the virus, which is good.”
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. More results are expected to be reported later for older patients, who often mount a weaker immune response. The vaccine induced anti–SARS-CoV-2 immune responses in all participants.
Volunteers got a shot in the arm on Day 1, followed by a booster shot four weeks later. At the 100-microgram dose, the one Moderna is advancing into larger trials, all 15 patients experienced side effects, including fatigue, chills, headache, muscle pain, and pain at the site of injection. All side effects were considered mild or moderate. Patients had neutralizing antibody levels, measured in what are called geometric mean titers, of 231.8 at Day 57, compared to 109.2 in patients who recovered from Covid-19.
Researchers and drug companies have been racing with unprecedented speed to create a vaccine against the coronavirus. Moderna began its Phase 1 trial just 66 days after scientists first decoded the genome of SARS-CoV-2. “It’s amazing just how fast we’ve gotten to this point,” Penny Heaton, CEO of the Bill and Melinda Gates Research Institute in Cambridge, Mass., said in an interview. “It’s like six years of work has been compressed into six months.”
Researchers measured the efficacy of Moderna’s vaccine in multiple ways, all of which showed higher average antibody levels than were seen in patients who had recovered from Covid-19. It took time for antibody levels to rise. Only after the booster shot did volunteers compare favorably with recovered patients. Experts say that given the multiple types of tests, it is impossible to compare vaccines based on laboratory results between different vaccines. For its vaccine, Pfizer had said that neutralizing antibody levels were 267 at 28 days, but they were 94 (a lower level than Moderna reported) in recovered patients, apparently using a different test. Pfizer has not disclosed data beyond 28 days.
Several researchers said that seeing the results increased their hope not so much in Moderna’s vaccine, but in arriving at one or more vaccines that will help reduce the impact of the virus. “I am cautiously optimistic, based on the data that we’ve seen so far, that amongst the several different vaccine platforms that are being tested, there seem to be encouraging Phase 1 data to suggest that at least one of them is going to work,” said Francis Collins, director of the National Institutes of Health. “And maybe several of them.”
The Trump administration’s “Operation Warp Speed”, a program that encouraged private pharmaceutical companies, government agencies, and the military to fast track a vaccine, may have indeed cut the development time in combating COVID-19. In the midst of new cases surging across Texas, it is definitely promising and some needed good news. Again, Phase 3 of testing begins in a two weeks.
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