Moderna Inc. presented new safety data from an early trial that provides the first evidence that its covid-19 vaccine stimulates the immune systems of older people.
In a phase 1 trial, Moderna’s coronavirus vaccine produced “consistently high levels” of neutralizing antibodies — a key component of the body’s protective response — in older adults, the company said in a statement. Antibody levels in people more than 55 years old were comparable to those seen in younger adults, the company said.
The results from Moderna’s early-stage trial, which include data from 20 people in the older age group, were presented Wednesday to the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The findings are important because older adults often don’t respond as well to vaccines as younger adults.
The trial used the same dose of the vaccine that’s now being given to subjects in a final-stage trial. The dose elicited antibody levels higher than those typically seen in people recovering from the virus, Moderna said.
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The case for Moderna’s vaccine becoming one of the best shots to fight the coronavirus “got stronger today,” Moderna chief executive officer Stephane Bancel said in an interview. The findings in older people are “a big deal,” he said.
Moderna’s vaccine uses genetic material called messenger RNA to instruct the body’s own tissue to make viral proteins that induce the immune response. Bancel attributed the consistent effects of the vaccine, in part, to biodegradable coatings Moderna has developed that allow higher doses of messenger RNA while limiting side effects.
While the vaccine is associated with a variety of issues including chills, fatigue, fever, headache and muscle pain, there were no serious adverse events in the 100-microgram dose that’s being used in the final-stage trial, according to a copy of Moderna’s slide presentation from the meeting.
Moderna is “totally on track” for enrolling all 30,000 patients into its phase 3 trial by September, Bancel said. “Now we are really going at full speed.”
The company said on August 21 that it had already enrolled more than 13,000 patients in the trial. Results are possible by late fall.
An emergency use authorization, which allows medical products to be deployed without final safety and efficacy data, might make sense for a coronavirus vaccine, but only for limited groups of high-risk people, Bancel said. Those might include health-care workers or elderly people with pre-existing conditions, Bancel said, noting that federal regulators will ultimately decide what to do.
Broad emergency authorization of an experimental vaccine for healthy Americans wouldn’t be appropriate, Bancel said. Regulators need time to review all the data to make sure the vaccine gives sufficient benefit without unexpected risks, he said. He expects a review for full approval of a coronavirus vaccine to take months once the data is in.
Bancel said that Moderna plans to publish all its vaccine trial data in a major journal so that doctors can decide about the safety and efficacy of the vaccine for themselves. The company wants to produce the highest quality data so the public has confidence in its mRNA technology, he said.
“We don’t want to cut corners,” he said.
The company earlier published data from the same early-stage trial showing that the vaccine produced neutralizing antibodies against the coronavirus in younger adults. Triggering neutralizing antibodies in older patients is important as they are some of the most severely affected by covid-19.