Regulators already use such benchmarks - known as correlates of protection - to evaluate flu vaccines without requiring large, lengthy clinical trials.
Such a benchmark is “urgently needed” to help overcome challenges faced by vaccine developers and boost availability of shots, Dr. Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York wrote this month in the journal Nature. Researchers at Oxford University late last month proposed a potential correlate of protection based on antibodies found in people who had received the AstraZeneca vaccine. The work awaits peer reviewed by other scientists. Results from a U.
“It doesn't have to be an established correlate of protection, but we have to ... arrive at the right pre-specified criteria, because we cannot risk that a second-generation vaccine ... is of low or modest vaccine efficacy," FDA vaccine official Dr. Marion Gruber told fellow regulators at a World Health Organization Meeting in May."That would undermine confidence in the vaccine enterprise.
Sanofi, with partner GlaxoSmithKline, and Canada’s Medicago are still opting for placebo-controlled trials involving thousands of participants, including in countries with high infection rates and fewer authorized vaccines available.
Great ... After injecting a billion humans Now only they wonder.
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