Placebo-Unblinding Should Be Uniform Across COVID Vaccine Trials, Advisory Committee Says
Executive Summary
US FDA’s outside advisors say Moderna should offer vaccine to placebo-arm patients when they are eligible, the same plan adopted for the Pfizer/BioNTech COVID-19 vaccine.
You may also be interested in...
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.
Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel
Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.
We Still Can’t Hear You: 11 Months Into Pandemic, Virtual US FDA Meetings Still Challenging
With J&J’s panel upcoming, it’s worth reflecting on last year’s COVID-19 vaccine advisory committee meetings. Moderna’s went a bit smoother than Pfizer’s, but hiccups still raise questions about whether agency is getting the advice it needs.