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CHICAGO: Results from an initial safety study of Moderna Inc’s coronavirus vaccine candidate in older adults showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults, with side effects roughly on par with those of High-dose flu shots, researchers said Tuesday (Sept. 29).
The study, published in the New England Journal of Medicine, provides a more complete picture of vaccine safety in older adults, a group at higher risk of serious complications from COVID-19.
The findings are reassuring because immunity tends to weaken with age, Dr. Evan Anderson, one of the lead investigators on the study from Emory University in Atlanta, said in a telephone interview.
The study was an extension of Moderna’s Phase I safety trial, which was conducted for the first time in people between the ages of 18 and 55. He tested two doses of Moderna’s vaccine, 25 micrograms and 100 micrograms, in 40 adults ages 56 to 70 and 71 years and older.
Overall, 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 in line with those seen in younger adults.
Moderna is already testing the highest dose in a large phase III trial, the final stage before seeking emergency clearance or approval.
Side effects, including headache, fatigue, body aches, chills, and injection site pain, were rated mostly mild to moderate.
However, in at least two cases, the volunteers had severe reactions.
One developed a grade three fever, which is classified as 102.2 degrees Fahrenheit (39 degrees Celsius) or higher, after receiving the lowest dose of the vaccine. Another developed fatigue so severe that it temporarily impeded daily activities, Anderson said.
Side effects typically occurred shortly after receiving the vaccine and resolved quickly, he said.
“This is similar to what many older adults are going to experience with the high-dose flu vaccine,” Anderson said. “They may feel sick or have a fever.”
Norman Hulme, a 65-year-old senior multimedia developer at Emory who took the lowest 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 didn’t really have any side effects,” said Hulme, who grew up in the New York area.
Hulme said he knew that Moderna’s vaccine employed a new technology and that there could be a risk in taking it, but said “someone had to do it.”
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