Booster dose against omicron variant may come out in March, says president of Moderna

The pharmaceutical laboratory Moderna may have a booster vaccine against Covid-19 targeting the omicron variant tested and ready to request authorization from the United States in March, informed the company’s management on Wednesday (1).

Moderna president Stephen Hoge said he believes booster doses containing genes specifically targeting mutations of the newly discovered omicron variant would be the fastest way to deal with predicted reductions in vaccine effectiveness that the variant could cause.

“We have already started this program,” he told Reuters.

The company is also working on a polyvalent vaccine that would include up to four different variants of the coronavirus, including omicron.

That could take several more months, according to Hoge.

The United States identified its first case of Covid-19 caused by the omicron variant in California, the Centers for Disease Control and Prevention (CDC) said on Wednesday.

Omicron, considered a “variant of concern” by the World Health Organization, is being studied to see whether it is more contagious or causes more serious illness than other variants and whether it can escape current vaccines.

Given previous guidance from the Food and Drug Administration (FDA), which required intermediate clinical trials, Hoge said the process could take three to four months.

“The omicron-specific boosters, realistically, aren’t for until March, and maybe more in the second quarter,” said Hoge, unless the FDA changes guidance on what information will be needed to give authorization.

Moderna could manufacture the vaccine while it runs the tests, Hoge said, and then have it ready for release as soon as possible.

He explained that the FDA is evaluating the threat to vaccine protection posed by the new variant. The agency could come up with a faster timeline, similar to the way it approves flu vaccines, by approving flu strain changes, which would shorten the timeline by three to four months.

In the United States, licensed flu vaccines can be updated each season, replaced by new strains of the virus that are more likely to cause the illness in the next flu season, without the need for large randomized clinical trials.

Based on the pattern of mutations seen in the omicron variant, some of which have been shown to reduce the vaccine’s effectiveness in laboratory studies, Hoge said, “We hope there will be an impact.”

It’s still unclear how much reduced effectiveness of current vaccines for the omicron variant will be, but it could be significant, Hoge surmised.

“The mutations that previously led to the biggest drops in efficacy were seen in delta and beta. And all of these also showed up in omicron,” said Hoge.

“So the question here is, are we going to perform similar to the delta? Are we going to perform similarly to the beta? Or are we going to have a multiple crossover of the two? I think this last scenario is what worries people the most,” he said.

Hoge said the company is testing to see if people fully vaccinated with the Moderna vaccine are protected against the variant, as are those who received the booster doses of 50 micrograms and 100 micrograms of the immunizer.

“I still believe that existing vaccines will be able to at least slow down, or even completely stop, the omicron variant,” he said.

Translated by Luiz Roberto M. Gonçalves