|
 The filing comes after the FDA last week scheduled an Oct. 15
meeting of its expert advisory committee to discuss whether to
authorize a second shot of J&J's single-dose vaccine.
J&J said its submission includes data from a late-stage study that
found a booster of its vaccine given 56 days after the primary dose
provided 94% protection against symptomatic COVID-19 in the United
States and 100% protection against severe disease, at least 14 days
after the booster shot.
The FDA has already authorized a booster dose of the vaccine
developed by Pfizer Inc and partner BioNTech for 65-year olds and
older, people at high risk of severe disease and others who are
regularly exposed to the virus.
[to top of second column] |
 Moderna also submitted its
application seeking authorization for a booster
shot of its two-dose vaccine last month.
J&J said it plans to submit the data to other
regulators, the World Health Organization and
National Immunization Technical Advisory Groups
to inform decision-making on local vaccine
administration strategies, as needed.
(Reporting by Manojna Maddipatla in Bengaluru;
Editing by Maju Samuel and Saumyadeb Chakrabarty)
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