Moderna Inc. presented new safety data from an early trial providing the first evidence that its Covid-19 vaccine stimulates the immune system 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 over 55 years of age were comparable to those seen in younger adults, the company said.
The results of Moderna’s early stage trial, which includes data from 20 people in the older age group, were presented Wednesday to the U.S. Advisory Committee on Immunization Practices of the U.S. Centers for Disease Control and Prevention. The findings are important because older adults often do not respond as well to faxes as younger adults.
The trial used the same dose of vaccine that is now being given to subjects in a final phase trial. The dose generated antibody levels higher than those typically seen in humans recovering from the virus, Moderna said.
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‘Big deal’
The case for Moderna’s vaccine that became one of the best recordings to fight the coronavirus “got stronger today,” Moderna chief Stephane Bancel said in an interview. The findings in older people are “a big problem,” he said.
The Moderna vaccine uses genetic material called messenger RNA to instruct the body’s own tissues to make viral proteins that cause the immune response. Bancel attributed the consistent effects of the vaccine, in part, to biodegradable coatings that Moderna has developed that allow higher doses of messenger RNA while limiting side effects.
Photographer: Adam Glanzman / Bloomberg
While the vaccine is associated with a variety of problems, such as cold, fatigue, fever, headache and muscle aches, there were no serious adverse events at the 100-microgram dose used in the final phase, according to a copy of Moderna’s slide presentation of the meeting.
Moderna is “completely on track” for enrolling all 30,000 patients in September of the Phase 3 trial, Bancel said. “Now we’re 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.
Modern wants to turn the body into a vaccinating machine
An authorization for emergency use, with which medical products can be deployed without definitive safety and efficacy data, may make sense for a coronavirus vaccine, but only for limited groups of high-risk people, Bancel said. These could include health care workers as well as older 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 would not be appropriate, Bancel said. Regulators need time to review all data to ensure that the vaccine provides 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 Moderna has plans to publish all of its data on vaccine trials in a major journal so doctors can decide on the safety and effectiveness of the vaccine for themselves. The company wants to produce data of the highest quality so that the public has confidence in its mRNA technology, he said.
“We do not want to cut corners,” he said.
The company previously published data from the same early-stage trial showing that the vaccine produced neutralizing antibodies against the coronavirus in younger adults. Neutralizing antibodies in elderly patients is important because they are some of the most strongly influenced by Covid-19.
(Updates with CEO’s comments on trial output beginning in fifth paragraph.)
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