US Officials Hope To Identify Correlates of Protection For COVID-19 Vaccines Shortly
Executive Summary
Accelerated approval might soon be in the cards for COVID-19 vaccines if an immune correlate of protection can be identified through ongoing work by FDA and NIH. Meanwhile, to speed more vaccines to Americans, FDA is trying to help ramp up manufacturing. Sanofi is set to commence a Phase IIb trial with an active comparator.
You may also be interested in...
Operation Warp Speed’s Difficult Holiday Season
The US missed even its revised year-end target for COVID vaccines, but the news isn’t all bad; there’s steady progress on clinical research even as federal officials seem out of ideas for how to speed actual vaccinations.
COVID-19 Vaccine Should Demonstrate At Least 50% Effectiveness, US FDA Says
Guidance on COVID-19 vaccine development and licensure appears to set a precedent in specifying the clinical efficacy rate for a product approval; agency also takes accelerated approval off the table for now and says emergency use authorization may be granted only after safety and efficacy have been demonstrated.
Medicare Payment Cuts For Vaccines: MedPac Suggests Moving To New WAC-Reimbursement Formula
Proposal, which could be formally endorsed by MedPac this spring, would lower the payment rates for vaccines while simultaneously moving all preventative vaccine coverage to Medicare Part B. Commission signals further cuts to payment rate, through an average sales priced-based methodology that might eventually be recommended.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: