“Universal Flu Vaccine” Unveiled by DHHS

On May 1, 2025, the U.S. Department of Health and Human Services (DHHS) announced plans to develop a universal influenza vaccine that would eliminate the need for annual flu shots and offer protection against other pandemic influenza threats, including bird flu and respiratory disease caused by coronaviruses. The initiative, called “Generation Gold Standard,” will cost $500 million and reportedly combine “traditional vaccine technology” with modern tools. The “traditional” vaccine technology, called a beta-propiolactone (BPL)-inactivated, whole-virus platform, involves injecting people with a chemically altered version of the whole virus designed to make it harmless but still capable of stimulating the immune system.^{1 2 3}

The announcement follows a recent study out of the Cleveland Clinic that found this year’s flu shot for the 2024-2025 flu season to be -26.9 percent effective and linked to an increased risk of influenza compared to unvaccinated individuals

“Generation Gold Standard is a paradigm shift,” said U.S. National Institutes of Health (NIH) director Jay Bhattacharya, MD, PhD. “It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats—not just today’s, but tomorrow’s as well—using traditional vaccine technology brought into the 21st century.”¹

The Generation Gold Standard initiative was made public the day after the DHHS announced that all newly developed vaccines will be required to undergo placebo-controlled clinical trials before receiving licensure. “Our commitment is clear: every innovation in vaccine development must be grounded in gold standard science and transparency, and subjected to the highest standards of safety and efficacy testing,” said DHHS Secretary Robert F. Kennedy, Jr.⁴

Some researchers questioned the decision to rely on what they consider an outdated and potentially inadequate approach. “This is a head-scratcher to me. This is puzzling,” Gregory Poland, MD, a vaccine expert from the Atria Academy of Science and Medicine in New York, told NPR. “We’re going back to technology that was used 40, 50 years ago or more. So this is a little surprising to me why you would go backwards to this technology? It’s a very old technology,” Poland says. “This is what influenza vaccines in the 40s, 50s and 60s looked like.”²

Dr. Poland suggested that newer technologies, such as the mRNA-based COVID shots, are safer and produce fewer side effects compared to whole inactivated virus vaccines, which he says typically produce high fevers and seizures and potentially scare patients away from getting vaccinated. “We have live attenuated nasal spray influenza vaccines. We have recombinant influenza vaccines. We have an mRNA-based influenza vaccine,” he says. “So why would you put all your eggs in one basket?”²

Researchers Warn of Underreported Injuries, Push for mRNA Vaccine Pause

While some experts criticize this approach as outdated, whole-virus vaccines, compared to mRNA (messenger ribonucleic acid) biologics technology, have been in use for decades and have well-documented safety profiles.⁵ Meanwhile, mRNA biologics have been at the center of ongoing controversy and public concern since mRNA COVID shots were approved for distribution by the FDA in December 2020.⁶

A 2024 study published in The Journal of American Physicians and Surgeons suggests that COVID-19 shots should never have been classified as vaccines in the first place. “COVID-19 modRNA vaccines were misclassified as traditional vaccines rather than gene therapy products, bypassing stricter regulatory requirements; and WHO guidelines from 2005 were used for nonclinical assessments, despite being outdated and inapplicable to modRNA vaccines,” epidemiologist Nicolas Hulscher, MPH said in a Substack post discussing the study findings.^{7 8}

While some researchers criticize the DHHS for relying on what they view as outdated vaccine platforms under the Generation Gold Standard initiative, others point out that adverse events related to COVID shots may be significantly underreported and inadequately addressed by public health agencies. A wide range of suspected COVID vaccine injuries have been reported, from myocarditis and neurological issues to fertility and autoimmune complications. There has been criticism of inadequate regulatory oversight that suggests a litany of potential safety signals have not been thoroughly acknowledged or investigated, and questions about whether the risk-to-benefit profile of mRNA COVID vaccines has been misrepresented.⁷

The universal influenza vaccine, according to the statement, “offers the unprecedented capability to protect against avian influenza without inducing antigenic drift—a major step forward in proactive pandemic prevention.” Because the BPL platform is fully government-owned and NIH-developed, the statement says the initiative ensures “radical transparency, public accountability, and freedom from commercial conflicts of interest.”¹

According to the U.S. Centers for Disease Control and Prevention (CDC), vaccines typically require 10-15 years of research. The universal influenza vaccine could enter clinical trials as early as next year and be available to the public by 2029.¹

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