The vaccine still awaits emergency approval from the U.S. Food and Drug Administration (FDA), which plans to meet on Dec. 17 to discuss the company’s application. The FDA will meet on Dec. 10 to discuss Pfizer’s vaccine. In the meantime, state leaders and health officials have begun announcing that initial doses of coronavirus vaccines, namely that of Pfizer, are expected in the coming weeks pending the FDA’s approval.
A team of doctors involved with the clinical trial for Moderna’s vaccine published correspondence in the New England Journal of Medicine on Thursday, detailing findings among 34 healthy adult participants.
The jab involves a two-dose regimen, administered 28 days apart. At the 100-microgram (μg) dose, the vaccine “produced high levels of binding and neutralizing antibodies that declined slightly over time, as expected, but they remained elevated in all participants 3 months after the booster [second] vaccination,” the doctors wrote. The levels of antibodies among trial participants also “exceeded” that of 41 recovering COVID-19 patients in a control group.
Adults aged 18 to 55 saw the highest levels of antibodies, followed by the eldest participants (aged over 71), and finally, those aged 56 to 70. The team reported no serious adverse events, “and no new adverse events that were considered by the investigators to be related to the vaccine occurred after day 57.”
Researchers say it is “not yet established” whether the antibodies translate to protection against SARS-CoV-2 infection, but the results do imply that the vaccine has the potential to offer “durable immunity” against disease.
“Our findings provide support for the use of a 100-μg dose of mRNA-1273 in an ongoing phase 3 trial, which has recently shown a 94.5% efficacy rate in an interim analysis,” researchers concluded.