White House COVID-19 Response Coordinator Ashish K. Jha made bold claims about the forthcoming updates to Pfizer Inc./BioNTech SE and Moderna, Inc.’s mRNA COVID vaccines 16 August – statements that contrast to the dearth of clinical data the US Food and Drug Administration is expected to have ahead of a potential fall 2022 authorization and booster campaign.
Overhyped? White House COVID Coordinator's Claims About New Boosters Go Beyond Data
Ashish Jha made promises about the upcoming bivalent COVID-19 boosters that neither he nor the companies are likely going to be able to keep when the rollout begins.
More from Vaccines
• By
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
• By
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
• By
The disruption of CDC’s Advisory Committee on Immunization Practices meeting schedule adds fuel to concerns about potential alterations of the vaccine schedule raised by former FDA Commissioner Scott Gottlieb.
• By
Only government staff participated in the meeting defining the next season’s influenza vaccine composition after the annual public FDA vaccines advisory committee meeting was cancelled.
More from Pink Sheet
• By
Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.