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Latest From Becton, Dickinson and Company
From Trial Hold To Post-EUA Surveillance: FDA Wants J&J To Monitor COVID-19 Vaccine Data For Clots
Safety data does not look to be a barrier J&J vaccine’s authorization, but FDA says it will recommend surveillance for further evaluation of thromboembolic events. The agency says it currently cannot rule out a causal relationship with the vaccine. One of these cases prompted a study hold last fall.
Novartis, Takeda See Industry Better Prepared For Next Pandemic
Novartis and Takeda’s R&D efforts saw an impact from the COVID-19 pandemic, but both Lutz Hegemann and Andrew Plump believe that when the next pandemic hits, the industry and regulators will be better prepared for it.
J&J's COVID-19 Vaccine May Face Efficacy Comparison Questions At US FDA Panel Review
Efficacy against moderate to severe/critical COVID-19 was 66%-67%, well above the FDA’s stated 50% efficacy threshold for an EUA but far short of the 94%+ efficacy rates posted by the Pfizer and Moderna vaccines against symptomatic disease; agency says efficacy against specific variants cannot be evaluated at this time because sequencing data are incomplete.
Trial Dropouts Illustrate Worries For J&J, Other Later Entrants To COVID Vaccine Space
More than 5% of participants in J&J’s vaccine trial chose to be unblinded because they were eligible to receive a vaccine that had already gained a US FDA emergency use authorization.
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