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 Last week, the U.S. Food and Drug Administration (FDA) said it
needed more data on the vaccine, delaying its decision for using the
vaccine in children 6 months through 4 years of age for at least two
months.
An early look at data showed the vaccine to be effective against the
Delta variant during testing while that was the dominant strain, but
some vaccinated children developed COVID-19 after Omicron emerged,
the report said, citing people familiar with the FDA's decision.
However, since the overall COVID-19 cases were low, the small number
of Omicron cases made the vaccine appear less effective in an early
statistical analysis, the report added.
The FDA did not respond to a Reuters request for comment.
Pfizer and BioNTech had submitted data on the first two doses of a
planned three-dose regimen earlier this month at the request of the
FDA. Pfizer did not disclose efficacy data.
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 The submission was surprising because in
December, the companies said early trial results
of the two low doses of the vaccine fell short
of expectations, and the clinical trial was
amended to test a three-dose version.
(Reporting by Manas Mishra in Bengaluru; Editing
by Devika Syamnath)
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