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Results from an early safety study of Moderna Inc’s coronavirus vaccine candidate in older adults showed that it produced virus-neutralizing antibodies at levels similar to those found in younger adults, with side effects about on par with high-dose flu shots, researchers said on Tuesday.
The study, published in the New England Journal of Medicine, offers a more complete picture of the vaccine’s safety in older adults, a group at increased risk of severe complications in COVID-19.
The research was an extension of Moderna’s Phase I safety trial, first ran in people aged 18-55.
In general, the team found that in older adults who received two injections of the 100 microgram dose 28 days apart, the vaccine produced immune responses roughly consistent with those seen in younger adults.
Moderna is already testing the higher dose in a large Phase III trial, the final stage before seeking emergency authorization or approval.
Side effects, which included headache, fatigue, body aches, chills and injection site pain, were deemed mainly mild to moderate.
In at least two cases, however, volunteers had severe reactions.
One developed a grade three fever, which is categorized as 102.2 degrees Fahrenheit (39°C) or above, after receiving the lower vaccine dose. Another developed fatigue so severe that it briefly prevented daily activities, Anderson said.
Typically, side effects occurred soon after receiving the vaccine and resolved quickly, he said.
“This is similar to what a lot of older adults are going to experience with the high dose flu vaccine,” Anderson said. “They might feel off or have a fever.”
Norman Hulme, a 65-year-old senior multimedia programmer at Emory who took the lower dose of the vaccine, said he felt compelled to participate in the trial after watching first responders in New York and Washington State fight the virus.
“I actually had no side effects at all,” said Hulme, who grew up in the New York region.
Hulme said he was conscious Moderna’s vaccine used a new technology, which there might be a danger in taking it, but said,”someone had to do it.”