US

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

The “chronic disease paradigm” presents a real challenge for companies marketing advanced therapies.

Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.

Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.

Surprising move to have VRBPAC debate offering mRNA boosters to everyone 18 and up, less than one month after the panel shot that down for Pfizer’s vaccine, thus stalling the White House’s plan for a broad booster rollout, was driven internally by the FDA, a senior health official said.

Pilot program offers Part D beneficiaries an alternative to manufacturer assistance in the form of copay coupons, which are prohibited in government-sponsored health plans. New program also available to commercial insurance and cash-paying patients.

Congress is considering legislation that would reverse some of the Trump administration's friendly corporate tax policies, presenting another challenge to the biopharmaceutical industry.

Agency assessors couldn’t independently verify several Janssen analyses of booster shot data and raised concerns about small samples sizes and an unvalidated immunogenicity assay.

Though not designed to facilitate inter-group comparisons, a preprint study of heterologous and homologous boosting with the three US available COVID-19 vaccines indicate Johnson and Johnson primary vaccines may get greater protection from an mRNA booster.

Johnson and Johnson’s one-shot Covid vaccine gets a solid efficacy boost with second shot administered two months after primary vaccination, but the company will argue based on much more limited data that a longer window between shots may be preferable for some populations.  

Immune responses to a single booster dose of mRNA-1273 would be considered successfully bridged to the two-dose primary series if each of two immunobridging criteria were met, but the mRNA vaccine missed the prespecified success criteria for seroresponse rate, the FDA said.

Peter Marks says Acting Commissioner Janet Woodcock’s tenure running the FDA has been no different than if a permanent commissioner were in place.