CHICAGO (Reuters) – Results from an early safety study of Moderna Inc’s adult coronavirus vaccine in adults showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger people, with side effects roughly equal to high doses of flu vaccines, researchers said Tuesday.
The study, published in the New England Journal of Medicine, offers a more complete picture of the safety of the vaccine in the elderly, a group at increased risk of severe complications from COVID-19.
The findings are reassuring, as immunity tends to weaken with age, said Dr. Evan Anderson, one of the study̵
The study is a continuation of Moderna’s Phase I safety test, conducted for the first time in people aged 18-55 years. He tested two doses of Moderna vaccine – 25 micrograms and 100 micrograms – in 40 adults aged 56 to 70 and 71 years and older.
Overall, the team found that in adult adults who received two injections of the 100 microgram dose at 28-day intervals, the vaccine elicited immune responses, roughly consistent with those seen in younger adults.
Moderna is already testing the higher dose in a large Phase III study, the final stage, before seeking emergency authorization or approval.
Side effects, which include headache, fatigue, body aches, chills and pain at the injection site, are generally considered to be mild to moderate.
In at least two cases, however, the volunteers had severe reactions.
One developed grade 3 fever, which was classified as 102.2 degrees Fahrenheit (39 ° C) or higher, after receiving the lower dose of vaccine. Another developed fatigue is so severe that it temporarily prevents daily activities, Anderson said.
Side effects usually appear soon after receiving the vaccine and resolve quickly, he said.
“This is similar to what many older people will experience with high doses of the flu vaccine,” Anderson said. “They may feel exhausted or have a fever.”
Norman Hill, a 65-year-old senior multimedia developer at Emory who took the lower dose of the vaccine, said he felt compelled to take part in the trial after watching the first responders in New York and Washington fight the virus.
“I really didn’t have any side effects,” said Hill, who grew up in the New York area.
Hill said he was aware that Moderna’s vaccine used a new technology and that there could be a risk of it being adopted, but said “someone has to do it”.
Report by Julie Stenhuisen; Edited by Bill Bercrot