Interim results from a small sample of older participants in a Phase I study of a vaccine against the virus that causes Covid-19 have shown signs of efficacy consistent with those in younger adults, along with a favorable tolerability profile.
Cambridge, Massachusetts-based Moderna announced Tuesday the publication of data from its Phase I study of mRNA-1273 in The New England Journal of Medicine, including 10 participants each in the two dosing cohorts of participants aged 56-70 and 71 and older, for a total of 40.
Shares of Moderna (Nasdaq: MRNA) were up more than 2.5% on the Nasdaq in Wednesday afternoon trading.
The analysis evaluated the 25- and 100-microgram doses of mRNA-1273 and found that neutralizing antibody concentrations in the blood and T-cell responses in both the 56-70 and 71 and older age cohorts were consistent with the results that have previously been seen in younger adults. The paper reports results through day 57, or one month after participants have received the second dose of the vaccine.
“These interim Phase I data suggest that mRNA-1273, our vaccine candidate for the prevention of Covid-19, can generate neutralizing antibodies in older and elderly adults at levels comparable to those of younger adults,” Moderna Chief Medical Officer Tal Zaks said in a statement. “Given the increased morbidity and mortality of Covid-19 in older and elderly adults, these data give us optimism in demonstrating mRNA-1273’s protection in this population, which is being evaluated in the Phase III COVE study.”
Both dose levels were generally well-tolerated, with no serious adverse events through day 57. Headache, fatigue, myalgia, chills and injection site pain were the most common.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
COVE, which began enrolling participants in late July, is comparing the vaccine administered at 100 micrograms against placebo in 30,000 adults in the U.S. The company took the unusual step earlier this month of publishing the trial protocol and also said that by that time, about 10,000 participants had already received the first and second doses of the vaccine. Like most vaccines against SARS-CoV-2, mRNA-1273 is administered in two doses – the first on day 1, followed by a booster shot 29 days later. Johnson & Johnson’s vaccine is administered as a single shot.
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