Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected.
LONDON – A third COVID-19 vaccine has turned in positive results in the phase III interim analysis, with Astrazeneca plc/Oxford University reporting an average of 70.4% efficacy across two dose regimens for AZD-1222.
In what the FDA calls “an incremental step” in treating hospitalized COVID-19 patients, the agency has issued an emergency use authorization (EUA) for Eli Lilly and Co.’s baricitinib in combination with remdesivir.
Citing a lack of evidence that it improves survival, the need for ventilation or time to clinical improvement, the World Health Organization (WHO) has advised doctors against using Gilead Sciences Inc.’s antiviral Veklury (remdesivir) to treat COVID-19.
In a world more familiar with the 30% to 70% efficacy rates of seasonal flu vaccines, news of 95% efficacy rates for two of the major late-stage COVID-19 vaccines in development seems thrilling. But do such robust-sounding numbers, the product of relatively early analyses, really merit the enthusiasm they’ve garnered?
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