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 "This is only one estimate, but we do believe this means as you look
toward the fall and winter, at minimum we expect the estimated
impact of waning immunity would be 600,000 additional cases of
COVID-19," Moderna President Stephen Hoge said on a conference call
with investors.
Hoge did not project how many of the cases would be severe, but said
some would require hospitalization.
The data stands in stark contrast with data from several recent
studies that suggested Moderna's vaccine protection lasts longer
than a similar shot from Pfizer Inc and German partner BioNTech SE.
Experts said the difference is likely due to Moderna's higher dose
of messenger RNA (mRNA) and the slightly longer interval between the
first and second shots.
Both vaccines proved to be exceedingly effective at preventing
illness in their large Phase III studies.
Wednesday's analysis, however, showed higher rates of infection
among people vaccinated roughly 13 months ago compared with those
vaccinated roughly eight months ago. The study period was from
July-August, when Delta was the predominant strain. It has yet to
undergo peer review.
Moderna on Sept. 1 submitted its application to the U.S. Food and
Drug Administration seeking authorization for a booster shot.
Hoge said data from its booster studies shows the vaccine could
increase neutralizing antibodies to levels even higher than were
seen after the second dose.
"We believe this will reduce COVID-19 cases," he said. "We also
believe that a third dose of mRNA-1273 has a chance of significantly
extending immunity throughout much of next year as we attempt to end
the pandemic."
Briefing documents from the FDA's analysis of Pfizer's booster
application, released earlier on Wednesday, suggest that a key issue
the agency will consider is whether vaccine protection is waning
https://www.reuters.com/business/
healthcare-pharmaceuticals/pfizer-says-third-covid-19-shot-warranted-fda-document-2021-09-15.
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 In its analysis, Moderna
compared the vaccine's performance in more than
14,000 volunteers vaccinated between July and
October of 2020 with some 11,000 volunteers
originally in the placebo group who were offered
the shot between December 2020 and March 2022
following its U.S. emergency use authorization.
In the two-month period from July-August, researchers identified 88
COVID-19 cases among those who got the two shots more recently,
compared with 162 cases among those vaccinated last year. Overall,
only 19 cases were considered severe, a key benchmark in assessing
waning protection.
Moderna said there was a trend toward a lower rate of severe cases
among the more recently vaccinated, although the finding was not
statistically significant.
Data from a separate study presented on Wednesday conducted with
Kaiser Permanente Southern California health system, meanwhile,
shows that Moderna's vaccine continued to perform well against the
Delta variant.
Researchers compared data on more than 352,000 people who got two
doses of the Moderna vaccine with the same number of unvaccinated
individuals and found the Moderna vaccine was 87% effective at
preventing a COVID-19 diagnosis, and 96% effective at preventing
hospitalization.
Hoge said the vaccine's initial performance is strong, but argued
that protection shouldn't be allowed to wane.
"The first six months are great, but you can't count on that being
stable out to a year and beyond," he said.
(Reporting by Julie SteenhuysenEditing by Bill Berkrot and Karishma
Singh)
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