The Trump administration has announced two key vaccine maneuvers in an effort to increase safety and reduce the number of injections given to Americans.
The Department of Health and Human Services (HHS) will now require all new vaccines to be tested in placebo-controlled trials before they’re approved for use.
This means some people in the study will receive the vaccine while others receive a benign substance such as saline before the results are compared.
HHS boss Robert F Kennedy said the move will increase trust in vaccines and boost transparency — but some experts fear it could lead to unethical practices.
While vaccines for new diseases are often tested with placebos, they are not used for shots for existing, treatable pathogens like the measles and polio viruses. Experts say it’s unethical to knowingly expose unprotected people to a preventable illness.
Meanwhile, HHS also announced the creation of a new $500 million project developing vaccines that protect against multiple strains of viruses in a single dose.
The ‘universal’ vaccines, slated to be FDA-approved by 2029 at the earliest, is aimed at reducing the need for boosters every year for diseases like Covid.
The latest initiative aligns with Kennedy’s past arguments that ‘No other country gives as many vaccines in the first year of life as the United States’ and ‘We’re injecting kids with dozens of vaccines, many of which they don’t need.’
The latest initiative reflects Kennedy’s longstanding position that American children receive significantly more vaccines in early childhood than those in other nations, with many being medically unnecessary
The platform will be supported by the US government’s Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH), with no involvement from the private sector.
RFK Jr has frequently charged government health agencies with colluding with Big Pharma to produce lucrative medicines that people do not need, and pledged, when he entered office, to curtail the industry’s involvement in government health and science initiatives, such as vaccine development.
The project will initially focus on universal flu and Covid vaccines, targeting two specific candidates: the BPL-1357 flu shot, currently awaiting Phase 2 trials, and the universal BPL-24910 Covid vaccine, which is about to enter Phase 1 trials.
The universal vaccine project is being pioneered by two recently appointed senior scientists at the NIH, Drs Matthew Memoli and Jeffery Taubenberger.
A universal Covid or flu vaccine could significantly reduce the number of needed compared to current vaccination strategies.
While people generally get a flu shot every year, the appeal of a universal vaccine is long-lasting protection against several strains that erases that need.
Additionally, people generally need two doses of a Covid vaccine and regularly boosters every year.
A universal Covid vaccine would replace those boosters with one shot roughly every five years – saving people from being jabbed around 15 additional times over a decade.
The technology underpinning the universal vaccines is the BPL platform, which chemically inactivates whole viruses, preserving multiple viral proteins (not just one, like the spike protein on Covid).
These vaccines are likely safer for immunocompromised individuals than live-attenuated vaccines because they cannot replicate or cause infection.
By preserving multiple viral proteins, they may also stimulate stronger T-cell responses compared to subunit or mRNA vaccines, offering broader and more durable protection.
According to HHS, the vaccine technology ‘is fully government-owned and NIH-developed.
‘This approach ensures radical transparency, public accountability, and freedom from commercial conflicts of interest.’
A universal Covid or flu vaccine would dramatically decrease the number of required doses compared to current approaches. Unlike annual flu shots, a universal vaccine could provide durable, broad-spectrum protection, eliminating the need for frequent updates
Touting its goal of providing the public with full transparency, an HHS spokesperson said that requiring that all new vaccines undergo placebo-controlled trials – in which one study population receives a shot not containing the vaccine, calling it, ‘a radical departure from past practices.’
Most vaccines are already tested this way, but experts argue it doesn’t work well—and may even be unethical—for established vaccines like measles and polio.
Withholding proven protection from the placebo group would put those people at unnecessary risk of a deadly infection.
Stanley Plotkin, a pioneer in the field of vaccinology who developed the rubella vaccine told the Washington Post: ‘Ethics must be taken into account when you set up a study.
‘Can I ethically agree to having people acquire the disease because they receive a placebo?’
RFK Jr is far from the first health official to call for the development of a universal flu vaccine. The NIH has been funding projects to develop one for about 15 years, including one by Dr Taubenberger that laid the groundwork for the technology; however, the reality remains elusive.
The HHS announcement of the new program notes that clinical trials for universal flu vaccines will not begin for at least another year, with the earliest possible approval for both universal flu and Covid vaccines expected by 2029.
The timeline far exceeds that of the highly effective vaccines for Covid, which were developed by pharmaceutical giants Pfizer, Moderna, and J&J. Development began in 2020, and they were deemed safe and effective by the FDA in December of the same year.
RFK Jr has made the misleading claim in the past that this hyper-accelerated timeline meant sacrificing rigorous safety testing.
Steps during safety trials were not skipped; instead, they were done in parallel. Phases of trials ran simultaneously while scientists continuously analyzed data.
Development was completed faster thanks to unlimited funding, global recruitment of tens of thousands of subjects, and real-time data analysis without bureaucratic red tape.
Trump administration officials called Generation Gold Standard a vaccination breakthrough—modernizing traditional methods to protect broadly against current and future flu strains, overcoming strain-specific limits
The latest Gold Standard platform will align more closely with the traditional schedule for developing vaccines.
Preclinical and Phase 1 trials can take about two years, while later phases two to four can take up to four years.
But when universal vaccines do hit the market, tens of thousands of deaths could be avoided. American researchers from top universities estimated in 2019 that a universal flu vaccine would prevent 5.3 million infections, 81,000 hospitalizations, and 6,300 flu-related deaths in the US every year.
This could save the U.S. healthcare system $1.1 billion annually compared to pre-Covid flu seasons.
NIH Director Dr Jay Bhattacharya said: ‘Generation Gold Standard is a paradigm shift.
‘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.’
The massive investment is set against the backdrop of a massive government-wide push to slash spending. Over 800 NIH research grants have been canceled. An estimated 20,000 HHS employees have been fired including around 1,200 NIH scientists.
