CHICAGO (Reuters) – Modern Inc.
The study, published in the New England Journal of Medicine, presents a complete picture of the safety of the vaccine in older adults, a group in which COVID-19 increases the risk of serious complications.
The findings are reassuring as immunity weakens with age, Drs. Evan Anderson, one of the study’s lead researchers at Emory University in Atlanta, said in a phone interview.
The study was an extension of Modern’s Phase I safety test, previously conducted in individuals aged 18–55 years. It tested two doses of the modern vaccine – 25 micrograms and 100 micrograms – in which 60 adults from 54 and 60 adults aged 1 and older were placed.
Overall, the team found that in older adults who had received two injections of doses of 100 μg 28 days apart, the vaccine caused an immune response similar to those seen in younger adults.
Modern is already testing high doses in a large Phase III trial, the final stage before obtaining emergency authorization or approval.
Side effects, including headaches, fatigue, body aches, chills, and injection site pain, were mainly considered mild to moderate.
In at least two cases, however, volunteers had severe reactions.
One developed grade three fever, which is classified as 102.2 ° F (39 ° C) or above after receiving a low vaccine dose. Another developed fatigue was so severe that it temporarily halted daily activities, Anderson said.
Typically, side effects occurred soon after receiving the vaccine and resolving quickly, he said.
“This is similar to older adults experiencing high-dose influenza vaccines,” Anderson said. “They may feel or have fever.”
Norman Hulme, a 65-year-old senior multimedia developer at Emory who took a lower dose of the vaccine, said he felt compelled to participate in the trial after seeing the first reaction to fighting the virus in New York and Washington State.
“I really had no side effects,” said Hulme, who grew up in the New York area.
Hulme said he is aware that Modern’s vaccine employed a new technique, and there may be a risk in taking it, but added, “Somebody had to do it.”
(Reporting by Julie Stanhuysen; Editing by Bill Burcott)