said Tuesday that it expects to have clinical data for a COVID-19 booster that protects against the original strain of the virus as well as omicron by the end of June, with the expectation that this would be the shot that is rolled out to Americans in the fall.
The company is working on several bivalent COVID-19 boosters, which essentially combine the original COVID-19 vaccine, which is based on the strain of the virus that was first identified in Wuhan, with different variants of concern. It’s also testing a standalone omicron booster.
“A bivalent booster vaccine, if authorized, would create a new tool as we continue to respond to emerging variants,” Moderna CEO Stéphane Bancel said in a news release.
One of Moderna’s booster candidates is a mix of the original vaccine with omicron. That shot is currently in a Phase 2/3 clinical trial, with data expected sometime in the second quarter.
Moderna said it expects that this vaccine will be the “lead candidate” for a booster rollout this fall in the Northern Hemisphere.
“Many countries are telling us this is the vaccine they want for fall of 2022,” Bancel said March 28 at its investor day, according to a FactSet transcript. “They understand that waning is happening, and that this is going to be required, especially for people at high risk.”
The company’s other booster candidate pairs the original wild-type vaccine with beta, a strain that was first identified in South Africa and declared a variant of concern in December 2020. Beta is no longer circulating.
What makes this combination important to understand is that beta and omicron share what are called “antibody escape site mutations,” though omicron is much more transmissible than beta. This is why people who are fully vaccinated or immune from a past infection can still get infected.
Preliminary research published last Friday found that this booster generated more than two times the antibody titers against omicron compared to Moderna’s currently approved booster at the six-month mark. The open-label Phase 2/3 study tested the experimental shot in people who had previously received the company’s primary series of shots.
“Cross-neutralization of multiple variants and the potency and durability of the antibody response appear to be advantages of bivalent booster vaccines that contain both the ancestral SARS-CoV-2 and variant spike sequences,” the Moderna scientists wrote. “Such vaccines may represent an important strategy as we respond to emerging SARS-CoV-2 variants.”
Another preprint that was published Friday further backs this line of thinking. The study, albeit very small and preliminary, examined 18 people in South Africa who had been infected with beta and later received two doses of BioNTech SE
and Pfizer Inc.’s
This combination “elicited neutralization with substantially lower omicron escape,” the researchers wrote.
Moderna’s stock has declined 41.3% so far this year, while the broader S&P 500
is down 7.8%.