Early-stage COVID-19 vaccine data provide ‘good news’ for older adults
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An expanded phase 1 trial assessing a SARS-CoV-2 vaccine co-developed by the National Institute of Allergy and Infectious Diseases and Moderna Inc. provided promising news for older adults, researchers said.
The vaccine, mRNA-1273, was tolerated in adults aged older than 55 years, with most associated adverse events being mild or moderate, and it produced antibody responses similar to those seen in younger patients, according to data published in The New England Journal of Medicine.
In March, mRNA-1273 became the first COVID-19 vaccine given to trial participants in the United States. It showed promise in early-stage testing and entered phase 3 development in July, but the authors of the new paper emphasized the importance of testing COVID-19 vaccines among older adults, who have been struck especially hard by the pandemic.
“We have seen a strong association between age and increased hospitalizations and deaths,” Evan J. Anderson, MD, associate professor of pediatrics and medicine at the Emory University School of Medicine, told Healio. “Evaluating the reactogenicity, safety, dose and immune response in those 56 years of age and older is critically important since this might differ from younger adults 18 to 55 years of age.”
Anderson and colleagues conducted a phase 1, dose-escalation, open-label trial of the mRNA-1273 vaccine candidate in healthy adults. The initial trial was expanded to include two subgroups of 40 older adults one group aged 56 to 70 years, and the other aged 71 years or older.
According to the study, all participants received two doses of either 25 g or 100 g of vaccine administered 28 days apart.
The study demonstrated that the 100 g dose — which is being tested in the phase 3 trial — was tolerated by participants, with mostly mild to moderate adverse events that included fatigue, chills, headache, myalgia and pain at the injection site. These events were more common after the second immunization.
The researchers added that vaccination among older adults with mRNA-1273 resulted in antibody responses that were similar to those observed in recipients aged 18 to 55 years. According to the study, by day 57, the anti-SARS-CoV-2 spike protein geometric mean titer (GMT) was 323,945 among those aged between 56 and 70 years and 1,128,391 among those aged 71 years of age or older who received the 25 g dose, whereas the GMTs in the two age subgroups were 1,183,066 and 3,638,522, respectively, among the participants who received the 100 g dose.
“This is good news that older adults did not require larger doses of vaccine to achieve similar immune responses to the younger adults,” Anderson said. “This study supports the use of the 100 µg dose in phase 3 clinical trials that evaluate the safety and efficacy in a larger and more diverse population, which includes older adults.”
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