The US Department of Health and Human Services (HHS) is striving to develop a universal flu vaccine by 2029, a challenge that has been unmet for 45 years, aiming to protect against multiple strains with pandemic potential like H5N1 avian influenza. The initiative, called 'Generation Gold Standard', seeks to extend protection beyond current strain-specific vaccines using inactivated whole-virus technology, despite skepticism from some experts who question the use of this older approach. HHS also plans to create universal coronavirus vaccines targeting SARS-CoV-2, SARS-CoV-1, and MERS-CoV, but the requirement for placebo-controlled trials for updated Covid-19 vaccines could delay their availability. This new approach has raised concerns among experts about the feasibility and safety of whole virus vaccines, given past issues with adverse reactions. Additionally, the HHS's decision to require more rigorous testing for new vaccines marks a significant shift in policy, which may impact the approval timeline for updated Covid-19 vaccines from companies like Moderna and Pfizer.

HHS aims to achieve FDA approval for a universal flu vaccine by 2029, targeting strains with pandemic potential, using a traditional vaccine technology updated for modern application.

The initiative involves using inactivated whole-virus vaccines, which are chemically altered to prevent infection, but this approach has raised concerns due to historical cases of adverse reactions.

Experts like Dr. Paul Offit and Dr. Greg Poland express skepticism about the feasibility of developing a universal vaccine, despite significant funding and efforts, citing the complexity of flu virus mutations.

HHS's plan also includes the development of universal coronavirus vaccines to protect against SARS-CoV-2 and its related viruses, potentially impacting seasonal Covid-19 vaccination strategies.

The shift to requiring placebo-controlled trials for new vaccines could delay the availability of updated Covid-19 vaccines, potentially leaving vulnerable populations at risk.

Vaccine experts are questioning the HHS's decision to invest heavily in whole-virus vaccine technology, which the scientific community had largely moved away from due to safety concerns.

The FDA's new requirements for vaccine testing represent a departure from past practices, possibly affecting the timeline for vaccines currently in development and challenging existing safety monitoring systems.