Moderna doses 2nd arm of phase 2 booster study combining Spikevax with omicron-busting shot

The second arm of Moderna’s omicron booster trial has gotten underway with a first patient dosed in the phase 2 study testing a variant-specific vaccine against COVID-19.

The trial is combining Moderna’s booster candidate called mRNA-1273.214 with the approved COVID-19 vaccine known as Spikevax.

CEO Stéphane Bancel touted the speed of Moderna’s mRNA platform, which can respond to new variants to create new vaccine candidates. However, the trial is getting underway as the omicron wave has slowed.

"Our goal has been to remain ahead of the virus and we are committed to generating and sharing data with public health authorities as they prepare for the fall booster season,” Bancel said.

The study, which is an extension of an earlier one to evaluate the immunogenicity, safety and reactogenicity of the variant booster, will eventually enroll about 375 participants in the U.S. Adults aged 18 and older who previously received a primary course of the original vaccine plus a half-dose booster at least three months ago will receive a single omicron booster shot.

Moderna dosed an initial patient in another arm of the mid-stage trial, which includes patients who have not received a booster but got their primary course at least six months ago, in January.

A separate phase 2 study of the omicron booster is underway in the U.S., and the company is also conducting a phase 3 trial of the shot in the U.K. with the National Institute for Health Research. Dosing for the late-stage trial is expected to get underway soon.

The company is on the heels of Pfizer and BioNTech, which initiated a similar study for their own omicron booster candidate in January.