COVID-19 Vaccines In Five And Younger Could Get Earlier FDA Advisory Committee Review

Peter Marks says agency will proceed to meeting once Pfizer and/or Moderna complete their submissions and that the two may be considered at the same VRBPAC panel. FDA's effectiveness standard has not changed, CBER director says, but acknowledges that vaccines might be a little less effective than 50% in subpopulations.

pediatric vaccine
FDA may complete review of mRNA vaccines for children five years and younger by June • Source: Shutterstock

Amidst cries from Congress and the public to act more quickly to authorize COVID-19 vaccines in children under the age of five, the US Food and Drug Administration is ready to move up tentatively scheduled dates for its Vaccines and Related Biological Products Advisory Committee to consider authorization of Pfizer Inc./BioNTech SE and Moderna, Inc.’s vaccines in the youngest populations as soon as it receives their complete submissions.

“I fully expect that we’ll have the data in June or by June ready for review” and whichever of these...

More from Vaccines

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

Valneva Expects UK And France to Lift Ixchiq Age Restriction Following EMA Decision

 

Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By 

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

More from Pink Sheet

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.