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 Advisers to the FDA will meet on Oct. 15 to assess the risks and
benefits of a booster shot of J&J's vaccine, which is currently
given as a single dose.
In its review, FDA scientists repeatedly noted the limitation of
small sample sizes of many of the company's studies.
They noted that data J&J used to support administering a booster six
months after the initial shot relied on a test to measure immune
response that has not been validated and was possibly not sensitive
enough.
That mismatch in assessment tools would make it challenging to make
meaningful comparisons with data from the company's larger two-dose
booster trial.
Agency scientists also noted that there were insufficient cases of
COVID-19 caused by the Delta variant to estimate how effective the
vaccine is against the coronavirus mutation now dominant globally in
that larger J&J trial evaluating two doses of the vaccine given
nearly two months apart.
U.S. health officials have been under pressure to offer advice on
booster doses of the J&J and Moderna COVID-19 vaccines after the
White House announced in August it planned to roll out boosters
beginning last month for most adults, pending approvals from the FDA
and the U.S. Centers for Disease Control and Prevention (CDC).
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The FDA and CDC last month signed off on boosters
https://www.reuters.com/world/
us/us-cdc-advisers-recommend-covid-19-vaccine-boosters-65-older-high-risk-2021-09-23
of the Pfizer Inc and BioNTech SE COVID-19 vaccine for certain
high-risk adults, but reviews of the Moderna and J&J shots were
delayed until the companies could produce more data.
The FDA on Tuesday released its assessment
https://www.reuters.com/business/
healthcare-pharmaceuticals/moderna-seeks-covid-19-vaccine-booster-clearance-older-adults-high-risk-2021-10-12
of Moderna's booster application ahead of a meeting of expert
advisers on the topic on Thursday. Neither assessment made a
recommendation to the panel on whether the data supports use of
booster shots.
Independent vaccine experts at the meeting on Friday will hear
presentations from the FDA and J&J scientists, and be asked whether
company data supports use of a booster dose at least two months
after the initial shot. They also will be asked to assess whether a
J&J booster given six months after the first shot may result in a
more robust immune response.
(Reporting by Julie Steenhuysen in Chicago and Manas Mishra in
Bengaluru; Editing by Anil D'Silva and Bill Berkrot)
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