HHS and the National Institutes of Health are developing a project that involves producing vaccines from chemically inactivated whole viruses with the goal of making “universal” vaccines that protect against multiple strains of a virus at once.
Here’s what to know:
1. The project, called Generation Gold Standard, is a “decisive shift toward transparency, effectiveness and comprehensive preparedness,” according to a May 1 HHS news release. Vaccines are in development for universal influenza, coronavirus and multiple strains of pandemic-prone viruses like H5N1, SARS-CoV-2, SARS-CoV-1 and MERS-CoV.
2. Scientists have been trying to develop universal vaccines for decades, but have been unsuccessful so far, The Wall Street Journal reported. However, HHS said the platform is adaptable for future use against respiratory syncytial virus, metapneumovirus and parainfluenza.
3. The Trump administration has invested $500 million in the project, an unusually large sum, especially during a time when health agencies are cutting budgets and staff. The research is co-led by Matthew Memoli, MD, who serves as its principal deputy director, and Jeffery Taubenberger, MD, who is acting director of NIH’s infectious diseases institute.
4. Clinical trials for universal influenza vaccines are scheduled to begin in 2026, and intranasal BPL-1357 flu vaccines are already in advanced trials. Both are targeted to receive FDA approval in 2029, according to the HHS release.
5. HHS also said that all new vaccines will be required to undergo placebo-controlled trials prior to licensure, The Washington Post reported. The agency has not clarified how the change will be implemented, for which vaccines testing would apply or how a “new vaccine” will be defined. The government has indicated the requirement would not apply to the flu vaccine.
6. Moreover, the new placebo requirement has raised concerns among health experts who worry the changes could cast doubt on vaccines that are safe and effective. Vaccines for new pathogens have often been tested with placebos, but doing this on well-researched disease like measles and polio would be unethical because the placebo group would not receive a known effective intervention, according to the Post. In cases of diseases that cause serious illness or fatality, the use of placebos is often not considered ethical and is not necessary because scientists can look for evidence that vaccines induce a biological response, or a correlate of protection.
