Pfizer’s decision to add a third shot to the primary vaccination series for children under five means it didn’t hit FDA’s goal of a median follow-up of two months post-vaccination – at least with blinded data – and the sponsor could only do a preliminary descriptive efficacy analysis since the study had not hit the protocol-specified number of COVID cases.
Pfizer Inc. andBioNTech SE’s COVID-19 vaccine package for the youngest Americans appears to have more data gaps than Moderna, Inc.’s heading into a 15 June advisory committee meeting.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will weigh whether FDA should authorize Pfizer/BioNTech’s three-dose, 3μg shot for...
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.
The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.
The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
