NEW YORK, Dec 1 (Reuters) - Moderna Inc could have
a COVID-19 booster shot targeting the Omicron variant tested and
ready to file for U.S. authorization as soon as March, the
company's president said on Wednesday.
Moderna President Stephen Hoge said he believes booster
shots carrying genes specifically targeting mutations in the
newly-discovered Omicron variant would be the quickest way to
address any anticipated reductions in vaccine efficacy it may
"We've already started that program," he told Reuters.
The company is also working on a multi-valent vaccine that
would include up to four different coronavirus variants
That could take several more months, he said.
The United States identified its first COVID-19 case caused
by the Omicron variant in California, the U.S. Centers for
Disease Control and Prevention said on Wednesday.
Omicron, dubbed a "variant of concern" by the World Health
Organization, is being studied to see if it is more contagious
or causes more severe illness than other variants, and if it can
evade current vaccines.
Given prior guidance from the U.S. Food and Drug
Administration, which has required mid-stage clinical testing,
Hoge said the process could take three or four months.
"The Omicron-specific boosters, just realistically, are not
before March and maybe more in the second quarter," Hoge said,
unless the FDA changes its guidance for what data would be
needed for authorization.
Moderna would be able to manufacture the vaccine as it was
conducting the testing, Hoge said, to have it ready to roll out
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 timeline, akin to the way it approves vaccines
for influenza, by approving changes in the flu strains, which
would shorten the three- to four-month timeline.
In the United States, licensed flu vaccines can be updated
each season by substituting in new strains of the virus that are
believed to be most likely to cause illness in the upcoming flu
season, without the need for 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 efficacy of its vaccine in lab studies, Hoge said,
"we expect there will be an impact."
It is not clear yet how big of a drop in efficacy the
Omicron variant will cause for current vaccines, but it could be
significant, Hoge surmised.
"The mutations that had previously led to the biggest drops
in efficacy were seen in Delta and Beta. And all of those
mutations have shown up in Omicron," Hoge said.
"And so the question here is, are we going to see a
Delta-like performance? Are we going to see a Beta-like
performance? Or are we going to see some cross multiple of the
two? I think it's that last scenario that has people most
concerned," he 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 shot.
"I still believe that the existing vaccines will be able to
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)