Latest from Sarah Karlin-Smith
The FDA wants to update 2017 requirements for the data needed before initiating RSV vaccine trials in infants and toddlers after vaccine-associated enhanced respiratory disease triggered an indication-wide research hold.
Efforts to de-risk the pharma supply chain’s reliance on China likely will not completely disappear if the BIOSECURE proposal dies.
Former Sen. Richard Burr suggested to the Pink Sheet that Trump’s HHS leadership picks will have less ability to enact their agendas than people expect.
Pink Sheet Podcast: COVID-19 Vaccine EUAs In Danger, DOGE And US FDA, New 340B Rebate Pricing Models
Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccines under the Trump Administration, the DOGE commission’s search for spending cuts and its impact on the FDA, as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program’s costs.
Martin Makary prides himself on following the data, but some health policy experts said his positions sometimes stray from or distort the evidence, which could create trust issues.
Pulling a product that was granted an emergency use authorization is easier than pulling a fully licensed vaccine, which could place Pfizer and Moderna’s COVID-19 vaccine pediatric indications at risk, along with Novavax’s vaccine in all age groups.