Trial Dropouts Illustrate Worries For J&J, Other Later Entrants To COVID Vaccine Space
Executive Summary
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.
You may also be interested in...
US FDA Removes Minimum Efficacy Bar For COVID-19 Vaccines
Instead of the 50% threshold, the FDA in updated guidance says that efficacy confidence intervals and point estimates should be ‘appropriately justified.’
US FDA’s COVID Master Protocol Guidance To Maintain Influence Post-Pandemic
Agency seeking comment on document intended to replace the just-issued guidance on COVID-19 treatment development as FDA stresses the value of master protocols for developing clinical knowledge.
COVID-19 Vaccine Regulatory Strategy Evolving With The Pandemic
AstraZeneca and Novavax have not filed EUAs for their vaccines, and they never might. The pathway remains viable in the short-term, but as BLAs are approved and supplies are no longer short, the window may close.