With COVID-19 cases surging in the U.S. and upwards of 65,000 new cases reported on a daily basis, according to Johns Hopkins data , the nation is sorely in need of some good news on the coronavirus front.
Researchers at U.S. biotech giant Moderna delivered some of that welcome news, reporting that the first stage of their COVID-19 vaccine trials provoked an immune response in all 45 participants, Reuters reported.
RELATED STORIES
Moderna’s Phase 1 trials began on March 16, 66 days after the genetic sequencing for the virus had been released.
The company was the first to start human trials, and just published the results in the New England Journal of Medicine. In the trials, which involved 45 participants, every person who received the vaccine saw an increased immune response, producing virus-killing antibodies at levels seen in those who have recovered from COVID-19.
“If your vaccine can induce a response comparable with natural infection, that’s a winner,” Dr. Anthony Fauci told Reuters. “That’s why we’re very pleased by the results.”
The volunteers in the trial did experience some side effects, but nothing researchers considered “serious adverse events.”
The participants in the study were split into three groups of 15, each of which were given different doses – one was given a 25-microgram dose, one a 100-microgram dose, and one a 250-microgram dose – and were administered two shots 28 days apart.
Seven of the volunteers who got the lowest dose experienced some side effects after the second shot, while all of the participants at the higher doses reported reactions including chills, headache, nausea, or pain around the injection site. One person reported a fever of 103 F. However, none of the side effects required hospitalization.
Moderna has already begun Phase 2 of its vaccine trials.
In Phase 1, a trial typically tries to determine whether a vaccine is safe and what dosage might trigger an immune response. In Phase 2, trials get expanded to a larger group, which includes those for whom a vaccine is intended. Phase 3 will expand the trials even further, with thousands of participants, and will test more for efficacy and safety, according to the CDC .
“We thought the immune responses look promising, but we don’t know whether the levels we’re seeing would actually protect against infection. It’s really hard to know that until you do the actual efficacy trial,” Dr. Lisa Jackson, a senior investigator at at Kaiser Permanente Washington Health Research Institute in Seattle who was involved in the study told CNN . “So we’re laying the groundwork for the trial that will provide those answers.”
The Phase 3 trial is due to begin later in July.
For that trial, Moderna will enlist as many as 30,000 volunteers, some of whom will receive the 100-microgram dose once on day one and again 28 days later. Some of the participants will receive a placebo for comparison.
All will be evaluated 14 days after the second dose, and the volunteers will be tracked for up to two years to determine things like how effective the vaccine is, how long the antibodies last, and whether any further side effects show up over time.
Moderna has aggressive plans to roll out the vaccine should the Phase 3 trial go well.
Should regulators approve of Moderna’s vaccine, the company said that, at the 100-microgram dose, it’s on pace “to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.”
In the meantime, more research is necessary, experts stress. “The safety and immunogenicity data in this preliminary report are promising, and they support continued development of this vaccine. However, we must bear in mind the complexity of vaccine development and the work still to be done before Covid-19 vaccines are widely available,” Dr. Penny Heaton of the Bill and Melinda Gates Foundation wrote in an editorial accompanying the study.
