New Delhi: A phase 1 investigational trial has revealed that the Covid-19 vaccine developed by US-based pharmaceutical company Moderna elicited a strong immune response in older adults with no serious adverse effects, a study has claimed.
The vaccine, called mRNA-1273, is being developed by Moderna in partnership with the US government’s National Institutes of Health (NIH). For the trial, 40 adults over the age of 56 were inoculated with the vaccine.
The researchers involved in the study were drawn from a host of US institutes, including Emory University School of Medicine and the University of Maryland School of Medicine.
Moderna helped develop the protocol for the study and provided the vaccine, but had no role in funding. The NIH’s National Institute of Allergy and Infectious Diseases served as sponsor and decision-maker for study design and implementation.
According to the results of the study, published in the New England Journal of Medicine (NEJM) on 29 September, the vaccine produced high levels of both binding and neutralising antibodies in older adults.
The study noted that testing the vaccine on older participants was of “paramount importance” since “these persons account for the majority of serious Covid-19 cases and associated deaths”.
It added that the results are also significant because the “immune response to many other vaccines has been shown to decrease with increasing age”.
The participants of the study were divided into two subgroups — those between the ages of 56 and 70 and those who were 71 years and older. Both groups received two doses of either 25 micrograms or 100 micrograms of the vaccine, 28 days apart.
The vaccine produced both binding and neutralising antibody reactions in participants of both subgroups, but the “antibody and T-cell responses that were observed in this older population who received the 100-μg (microgram) dose exceeded the response to the 25-μg dose”.
Some participants experienced mild to moderate adverse effects, such as fatigue, chills, headache, myalgia (muscle pain), and pain at the injection site after being vaccinated.
“Such adverse events were dose-dependent and were more common after the second immunization,” the study said.
One of the participants in the 56-70 age group was not given a second dose of the vaccine because they developed an infection in a tissue close to the nail. But, according to the results, “No serious adverse events were reported, and no prespecified trial-halting rules were met.”
Race for Covid vaccine
Among the limitations of the study is that it was conducted on only 40 participants.
The study recommended the “continued evaluation of the 100-μg dose level and two-dose regimen in a large phase 3 trial with a more diverse population to ascertain the safety and efficacy of the mRNA-1273 vaccine and to assess its level of protection against Covid-19″.
Over 30 other vaccine candidates have entered the clinical trial stage to test for safety and efficacy against the novel coronavirus. Among the front-runners are the Oxford AstraZeneca vaccine, which is in phase 2 or 3 trials in various countries, and the RNA-based BioNTech-Pfizer vaccine, which is also in late-stage trials.
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