1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Kennedy’s Comments On Novavax Delay Scientifically, Legally Inaccurate, Experts Say

 
• By Sarah Karlin-Smith

The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.

HHS Secretary Robert F. Kennedy Jr. commented on Novavax's delayed vaccine decision during a 9 April TV interview. (Shutterstock)
Key Takeaways
  • HHS Secretary Robert F. Kennedy Jr. said 9 April that Novavax's COVID-19 vaccine has not been fully approved due to the department's priorities shifting to multiple-antigen vaccines.
  • FDA law experts said Kennedy's remarks do not align with the agency's legal criteria for licensure and the government cannot decline to approve a safe and effective product because of policy priorities.
  • Vaccine experts also emphasized that many effective single-antigen vaccines are available, despite Kennedy's claims otherwise.

Health and Human Services Secretary Robert F. Kennedy Jr. was open about the highly unusual delay of Novavax’s COVID-19 vaccine licensure by political officials during a...

“We’re looking at that vaccine and it is a single-antigen vaccine, and for respiratory illnesses, the single-antigen vaccines have never worked,” Kennedy said. “We are actually shifting our priorities to...

More from US FDA

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on impact availability.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

More from Vaccines

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.