NEW YORK, – Moderna Inc could have a COVID-19 recall targeting the Omicron variant tested and be ready to seek clearance in the United States as early as March, the company’s president said on Wednesday.
Moderna President Stephen Hoge said he believed that booster shots carrying genes specifically targeting mutations in the recently discovered Omicron variant would be the fastest way to address any anticipated reduction in vaccine effectiveness. that it might entail.
“We have already started this program,” he told Reuters.
The company is also working on a multivalent vaccine that would include up to four different coronavirus variants, including Omicron.
It could take several more months, he said.
The United States has identified its first case of COVID-19 caused by the Omicron variant in California, the United States Centers for Disease Control and Prevention said on Wednesday.
Omicron, dubbed a “variant of concern” by the World Health Organization, is being investigated to see if it is more contagious or causes more severe disease than the other variants, and if it can escape current vaccines .
Given advance directives from the U.S. Food and Drug Administration, which required mid-term clinical testing, Hoge said the process could take three or four months.
âOmicron-specific boosters, realistically, aren’t until March and maybe more in the second quarter,â Hoge said, unless the FDA changes its guidelines on the data needed for clearance.
Moderna would be able to manufacture the vaccine while it performs the tests, Hoge said, to have it ready for deployment as soon as possible.
He said the FDA is currently assessing the threat to vaccine protection posed by the Omicron variant. The agency could provide a faster turnaround time, similar to how it approves flu shots, by approving changes in flu strains, which would shorten the turnaround from three to four months.
In the United States, licensed influenza vaccines can be updated each season by substituting new strains of the virus that are believed to be most likely to cause illness in the next influenza season, without the need for further action. to large randomized clinical trials.
Based on the pattern of mutations seen in the Omicron variant, which include mutations that have already been shown to reduce the effectiveness of its vaccine in laboratory studies, Hoge said, “We would expect there to be has an impact “.
It is not yet clear how much the drop in efficacy of the Omicron variant will cause for current vaccines, but it could be important, Hoge surmised.
âThe mutations that previously led to the greatest drops in efficiency were seen in Delta and Beta. And all of these mutations appeared in Omicron,â Hoge said.
âAnd so the question here is, are we going to see a Delta-type performance? Are we going to see a Beta-type performance? Or are we going to see a cross multiple of the two? the people most concerned, âhe said.
Hoge said the company is testing to see whether fully vaccinated recipients of Moderna’s vaccine are protected against the variant, as well as those who received the 50 microgram and 100 microgram booster doses of the vaccine.
“I still believe that the existing vaccines can at least slow down, if not completely stop, the Omicron variant,” he said.
(Reporting by Michael Erman in New Jersey and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)