US FDA Lowers Bar for Latest COVID Monoclonal Antibody Authorization
Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.
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Five of the six modeling scenarios in the FDA’s quantitative benefit-risk assessment on myocarditis with Moderna’s vaccine assumed Omicron as the dominant circulating strain, with assumed average vaccine effectiveness of only 30% against COVID-19 cases and 72% against hospitalizations.
Biden’s ‘Test To Treat’ Plan Will Include Merck And Pfizer COVID Pills, But Only One Gets Public Thanks
Hundreds of pharmacy-based clinics and community health centers will offer free COVID testing and treatment. Government has secured 20 million doses of Pfizer’s Paxlovid, deemed to be a ‘game changer,’ though Merck’s molnupiravir is expected to be important in long-term care facilities.
Sponsors seek clarity about the transition process, which could last a year or longer.