Yves here. $500 million, for somewhat disfavored vaccine approach (because seizures, among other reasons), for a flu vaccine safety tested on only 45 people? This sounds like the medical industry version of vaporware. But why should HHS be any more pure than the rest of the Trump Administration by forswearing grifting?
Having said that, there is reason to think inactivated virus vaccines can provide broader immunity; that’s claimed to be true for the oft-maligned Sinovac (China) Covid vaccines.
And even though the flu, particularly in bad years, does kill people, it does not seem all that high on the list of public health risks, if nothing else by not being primed to turn into a full bore crisis, unlike, say, drug-resistant TB. In other words, even if this old vaccine approach does have merit, does it merit this level of priority?
By Arthur Allen, senior KFF Health News correspondent, who previously worked for Politico and the Associated Press, as well as writing freelance for publications such as The New York Times, The Washington Post, Smithsonian Magazine, and Slate. He is the author of the books “Vaccine: The Controversial Story of Medicine’s Greatest Lifesaver,” “Ripe: The Search for the Perfect Tomato,” and “The Fantastic Laboratory of Dr. Weigl.” Originally published at KFF Health News
The Trump administration’s unprecedented $500 million grant for a broadly protective flu shot has confounded vaccine and pandemic preparedness experts, who said the project was in early stages, relied on old technology, and was just one of more than 200 such efforts.
Health and Human Services Secretary Robert F. Kennedy Jr. shifted the money from a pandemic preparedness fund to a vaccine development program led by two scientists whom the administration recently named to senior positions at the National Institutes of Health.
While some experts were pleased that Kennedy had supported any vaccine project, they said the May 1 announcement contravened sound scientific policy, appeared arbitrary, and raised the kinds of questions about conflicts of interest that have dogged many of President Donald Trump’s actions.
Focusing vast resources on a single vaccine candidate “is a little like going to the Kentucky Derby and putting all your money on one horse,” said William Schaffner, a Vanderbilt University professor and past president of the National Foundation for Infectious Diseases. “In science we normally put money on a number of different horses because we can’t be entirely sure who’s going to win.”
Others were mystified by the decision, since the candidate vaccine uses technology that was largely abandoned in the 1970s and eschews techniques developed in recent decades through funding from the Department of Health and Human Services and the Defense Department.
“This is not a next-generation vaccine,” said Rick Bright, who led HHS’ Biomedical Advanced Research and Development Authority, or BARDA, in the first Trump administration. “It’s so last-generation, or first-generation, it’s mind-blowing.”
The vaccine is being developed at the National Institute for Allergy and Infectious Diseases by Jeffery Taubenberger, whom Trump named as acting chief of the institute in late April, and his colleague Matthew Memoli, a critic of U.S. covid-19 policy whom Trump picked to lead the NIH until April 1, when Jay Bhattacharya took office. Bhattacharya named Memoli his principal deputy.
Taubenberger gained fame as an Armed Forces Institute of Pathology scientist in 1997 when his lab sequenced the genome of the 1918 pandemic influenza virus, using tissue samples from U.S. troops who died in that plague. He joined the NIH in 2006.
In a May 1 news release, HHS called the Taubenberger-Memoli vaccine initiative “Generation Gold Standard,” saying it represented “a decisive shift toward transparency, effectiveness, and comprehensive preparedness.” Bhattacharya said it represented a “paradigm shift.”
But the NIH vaccine-makers’ goal of creating a shot that protects against multiple or all strains of influenza — currently vaccines must be given each year to account for shifts in the virus — is not new.
Then-NIAID Director Anthony Fauci launched a network of academic researchers in pursuit of a broadly protective flu vaccine in 2019. In addition to that NIH-led consortium, more than 200 flu vaccines are under development in the U.S. and other countries.
Many use newer technologies, and some are at more advanced stages of human testing than the Taubenberger vaccine, whose approach appears basically the same as the one used in flu vaccines starting in 1944, Bright said.
In the news release, HHS described the vaccine as “in advanced trials” and said it would induce “robust” responses and “long-lasting protection.” But Taubenberger and his colleagues haven’t published a complete human study of the vaccine yet. A study showing the vaccine protected mice from the flu appeared in 2022.
For Operation Warp Speed, which led to the creation of the covid vaccine during Trump’s first term, government scientists reviewed detailed plans and data from academic and commercial laboratories vying for federal money, said Greg Poland, a flu expert and president of the Atria Health Academy of Science and Medicine. “If that’s happening here, it’s opaque to me,” he said.
When asked what data beyond its press release supported the decision, HHS spokesperson Andrew Nixon pointed to the agency’s one-page statement. Asked whether the decision would curtail funding for the Fauci-created consortium or other universal vaccine approaches, Nixon did not specifically respond. “Generation Gold Standard is the most promising,” he said in an email.
Taubenberger did not respond to a request for comment. Nixon and NIH spokesperson Amanda Fine did not respond to requests for an interview with Taubenberger or Memoli.
The HHS statement stressed that by developing the vaccine in-house, the government “ensures radical transparency, public accountability, and freedom from commercial conflicts of interest.” While any vaccine would eventually have to be made commercially, NIH involvement through more stages of development could give the government greater influence on any vaccine’s eventual price, Schaffner said.
If the mRNA-based covid shots produced by Moderna and Pfizer-BioNTech represented the cutting edge of vaccine technology, applying ultra-sophisticated approaches never before seen in an inoculation, the approach by Taubenberger and Memoli represents a blast from the past.
Their vaccine is made by inactivating influenza viruses with a carcinogenic chemical called beta-propiolactone. Scientists have used the chemical to neutralize viruses since at least the 1950s. This whole-virus inactivation method, mostly using other chemicals, was the standard way to make flu vaccines into the 1970s, when it was modified, partly because whole-virus vaccines caused high fevers or even seizures in children.
The limited published data from the Taubenberger vaccine, from an initial safety trial involving 45 patients, showed no major side effects. The scientists are testing the vaccine as a regular shot and as an intranasal spray with the idea of stopping the virus in the respiratory tract before it causes a broad infection.
“The notion of a universal influenza A pandemic vaccine is a good one,” said Poland, who called Taubenberger an excellent scientist. But he added: “I’m not so sure about the platform, and the dollar amount is a puzzler. This vaccine’s in very early development.”
Paul Friedrichs, a retired Air Force general who led the Office of Pandemic Preparedness and Response Policy in President Joe Biden’s White House, said that “giving $500 million upfront with very little data to support it is unlike anything I’ve ever seen.”
“The technology for developing vaccines has tremendously evolved over many decades,” Friedrichs said. “Why would we go back to an approach historically associated with greater or more frequent adverse events?”
The government appeared to be transferring the money for the Taubenberger vaccine development from an existing $1.3 billion vaccine fund at Project NextGen, a mostly covid-focused program at BARDA, Friedrichs said. Most of that money was earmarked to support advanced research on covid and other viral vaccines, including those protecting against emerging diseases.
It is “very concerning that we’re de-emphasizing covid, which we may live to regret,” Poland said. “It assumes we won’t have a covid variant that escapes the current moderately high levels of covid immunity.”
Nixon said Project NextGen, for which some funds were earmarked for mRNA research, is under review. Kennedy is critical of mRNA vaccines, once claiming, falsely, that they are the deadliest vaccines in history.
Ted Ross, director of global vaccine development at the Cleveland Clinic, said he was “happy to see them investing in respiratory vaccines, including a universal flu vaccine, with all the programs they’ve been cutting.”
“But I don’t think this is the only approach,” Ross said. “Other universal flu vaccines are in progress, and their success and failure are not known yet.”
His team, part of the NIAID-funded flu vaccine consortium, is using artificial intelligence and computer modeling to design vaccines that produce the broadest immunity to influenza, including seasonal and pandemic strains.
As interim director, Memoli oversaw the start of the administration’s massive cuts at the NIH, with the elimination of some 800 agency grants worth over $2 billion. More than 1,200 NIH employees have been fired, and many researchers, including Ross, are in limbo.
His lab is close to testing a candidate vaccine on people, Ross said, while waiting to find out about its NIH funding. “I’m not sure whether my contract is on the chopping block,” he said.
The inactivated virus vaccine is (i) likely to work (ii) represents a risk/benefit that has prior societal acceptance (iii) does not depend on mRNA vaccine technology which has had one rodeo (COVID) and got trampled on efficacy and, as the data come out, safety and (iv) as a polyvalent vaccine, may be useful if H5N1 becomes a lethal pandemic in man.
NB: the efficacy problem is a result of coronaviruses themselves mutuating so freely that they are poor targets for vaccination but the safety problem is intrinsic to the mRNA strategy, of expressing a viral spike protein scattergun in vivo and encapsulating mRNA in PEG micelles.
Unless you had to, why would you base an important public health measure on the equivalent of a new Windows release rather than a stable platform…?
This is a straw man of the post and extant US policy. mRNA was NEVER mentioned and I have not once seen it treated as a candidate for vaccinations for flu or any other pathogen with extant vaccines.
Even IM Doc, who has seen many Covid vaccine injuries, is enthusiastic about mRNA vaccines for cancer.:
https://www.nakedcapitalism.com/2025/05/the-attack-on-science-contiunes-interrupted-by-a-very-good-result-on-a-vaccine-that-prevents-cancer.html#comment-4209856
And inactivated virus vaccines are relatively safe:
https://www.sciencedirect.com/topics/immunology-and-microbiology/inactivated-virus-vaccine
Similarly from Wikipedia:
https://en.wikipedia.org/wiki/Inactivated_vaccine
So there is a likely compliance issue, that some patients won’t get all the initial shots and boosters.
Apologies but I wasn’t deliberately straw-manning the article. Not only does it hold up mRNA vaccines as the latest technology, the way it is written leads naturally to a discussion of them in opposition to “old-fashioned” inactivated vaccines because there just aren’t many “modern technologies” in vaccines.
Whole inactivated vaccines were the gold standard for the second half of the 20th century as, as you point out, were “relatively” safe. The first mass polio vaccine (the Salk vaccine) had issues with inadequate inactivation leading to frank infection in some recipients but the Sabin vaccine that followed had much better safety and usability.
Any modern technology either involved expression of a bacterial or viral protein in some kind of tissue culture system, from which a vaccine is prepared, or, like the mRNA technology, uses the patient to do this by hijacking protein transcription. The “more modern technologies” slant of the article points at these technologies. The issue of potentially narrow immune response is common to any vaccine based on a single protein, whether expressed endogenously or in a bioreactor whereas the issue of the PEG micelle (and some other issues around stabilising the mRNA by tweaking the infectious agent’s sequence) are specific to mRNA vaccines.
As for cancer, this is precisely where the mRNA technology started. Moderna pivoted away from cancer indications because the dosing required (amount per dose, repeated dosing) was badly tolerated in early trials because patients developed sensitivity to the PEG encapsulation. Vaccines were their get out of gaol card, based on the theory that only one small shot was ever required (oddly, nobody seems to have thought about the cumulative consequence of delivering many of the gamut of childhood vaccines this way).
Apologies if I have derailed the discussion.
Also, I do not see anything in the article asserting the problem below, that this proposed approach is that it will require multiple administrations to induce immunity. Is that critique of this approach from some background or deep-linked reading?
This IS a straw man.
This NIH paper describes vaccine technologies versus viruses as well as bacteria.
It contains a graphic showing the options v. each type.
Against virus, it shows two older approaches, live attenuated and whole inactivated.
The other four are newer. Only one of the four is mRNA.
This paper also refers to mRNA as “next generation” as opposed to “modern,” underscoring its status as not yet ready for prime time.
https://pmc.ncbi.nlm.nih.gov/articles/PMC8708925/
If you mean Figure 3, it does show all the technologies but only DNA/RNA and recombinant viral vectors and subunits are next-generation technologies within the body of the paper. The other technologies are all categorised as Classical technologies.
I think our disagreement may arise from the formatting of the paper and the figure.
The diagram doesn’t categorise them according to the text and in the text the distinction in categories is only made by way of a single subheading between 4.1.6 and 4.1.7, 4.1.1-6 being classical and the rest 4.1.7-4.1.10 being next-generation. (A computer scientist would have numbered the latter 4.2.1-4!). So the set of classical techniques is much wider than perhaps appears from the diagram and section headings, particularly reading on a mobile.
But it still came across as a strawman attack so I apologise again. I should have stuck to a direct criticism of the original article’s unfair aspersions on an established technique and ignored the ancillary mRNA vaccine (forgive the pun…) boosterism.
I am very bothered by the consistent display of cognitive bias in the comments to this post.
No one contested the validity of its big claims:
1. That the technology that HHS was backing was one of 200 tried, much less far along in being tested, and HHS was funding ONLY it in a big was as opposed to spreading the risks and picking the best of a small group from the 200.
2. The elevation of that one looked odd both by virtue of not being at all far along in testing and using a technology that has been surpassed: “uses technology that was largely abandoned in the 1970s” That is WAY WAY WAY before mRNA.
Acting as if the piece was all or significantly about mRNA, or that the post was “boosterist” is a gross distortion.
It’s as if someone uses the term “mRNA” and reader brains become fixated with that, to the exclusion of all else, the way men’s allegedly do when shown pictures of attractive naked women (or men if that suits their tastes).
.
What Does mRNA Mean for the Flu Vaccine?
“Throughout the COVID-19 pandemic, messenger RNA, or mRNA, has been in the spotlight for the critical role it’s playing in the first-ever approved mRNA vaccine.1 But in fact, Pfizer and BioNTech had entered into a worldwide collaboration agreement in 2018 to work on an mRNA vaccine for a different virus.
“Pfizer’s first partnership with BioNTech was to look at ways to develop a more effective flu vaccine,” says John McLaughlin, who is Vice President, COVID-19/Flu Vaccines & Antivirals Lead with Pfizer.
This work has continued, and in September 2022, Pfizer began recruiting volunteers to participate in its Phase 3 clinical trial for that mRNA flu vaccine candidate. . .”
http://www.pfizer.com
Thanks but the fact that you had to go to the Pfizer site to find this, and the trials were being started in 3Q 2022 (my impression is that means on a normal timetable, with 4-8 weeks for the trial proper) that they’d be done and dusted by mid 2023. No news = trial showed too low efficacy or too many problems.
So again, the apparent bust Pfizer effort does not establish that mRNA vaccines are going anywhere ex cancer.
And let us not ALSO forget that Moderna has long been working on mRNA cancer vaccines, since IIRC before 2015.
Well even when it’s a step in the right direction”right direction”, at least we can agree that RFK’s brainwork has struck again. I do appreciate that Yves, a noted economist, is never short of expressing her medical and scientific opinions. How about Ivermectin, old girl?
Actually, ivermectin is quite effective in vitro against Covid, and some other viruses. Problem is, you can’t safely get an effective blood level with ivermectin, so it didn’t pan out for Covid infections.
For-what-it-is-worth:
Realizing that Covid viruses first bind to receptors in the nasal passages, then after a few days move on to other parts of the body, my wife and I decided to try swabbing out our noses deeply with 1% ivermectin cream [Rosivir™, mainly prescribed to control rosacea] twice a day, every day. We’ve been doing that since ~2021. Nasal ivermectin, in combination with faithful use of N-95 masks, and numerous [~12 doses each] Covid immunizations, has keep us free of Covid and in fine health. We haven’t had any colds either, during that time.
Is half a billion now really such small change that administrations can just direct spends in that amount without any prior Congressional authorization? I guess my impression was since Congress passes 1,000 page budget bills, even if they don’t read them, that the money authorized in those must be very detailed as to what it can and can’t be spent on. But judging by how the current regime is behaving, maybe not?
When you state “But judging by how the current regime is behaving, maybe not?” you forgot to mention the previous (handful of) regimes. Money “authorized” for (Ukraine Iraq, Libya, Taiwan, Syria ….) many wasted efforts over the past 10+ years for example.
My reading is that the funds are already appropriated by Congress, just not for this specific purpose. So the money is “there”, not yet spent on what it was appropriated for. I agree that, IMO, Congressional approval ought to be sought to permit repurposing of previously-appropriated funds.
As lawlessness goes, this might be lower on the scale than other things that have been done in recent months.
It’s a little unclear here, but it sounds like the “cutting edge” technology that is being rejected for a more old school approach is the mRNA vaccine:
“If the mRNA-based covid shots produced by Moderna and Pfizer-BioNTech represented the cutting edge of vaccine technology, applying ultra-sophisticated approaches never before seen in an inoculation, the approach by Taubenberger and Memoli represents a blast from the past.”
If that is the case, then the author seems to be simply *assuming* that it has proven its superiority and that there have been no legitimate questions about its efficacy or safety. I do not believe that is the case. His other criticisms may be valid – cronyism, placing all our money on one horse, etc. But to me the apparent unreflective mRNA boosterism makes me uncomfortable, especially in a KFF publication.
No, no, no, this is a COMPLETE misreading. NO ONE SAID ANYTHING ABOUT MRNA!
The more modern vaccine = an attenuated vaccine, which produces a stronger immune response and so does not require multiple initial shots.
I may well have misread this. If so, I am relieved. But I read it carefully to figure out what the “more modern technologies” were to which he referred, looking for a sentence like the one you give here. I could not find it, but I did read the passage I quote above, and later in discussing Project NextGen he notes specifically that it was funding mRNA research and Kennedy had made “false” claims about that technology. My apologies if I did not infer the reference.
I just posted this in reply to Revenant. Your additional find of “next generation” which was used in the paper below too to apply to mRNA, further supports the idea that mRNA should not be conflated with “modern”. To repeat what I said below, “next generation” suggests “not yet ready for prime time”.
_____
This NIH paper describes vaccine technologies versus viruses as well as bacteria.
It contains a graphic showing the options v. each type.
Against virus, it shows two older approaches, live attenuated and whole inactivated.
The other four are newer. Only one of the four is mRNA.
This paper also refers to mRNA as “next generation” as opposed to “modern,” underscoring its status as not yet ready for prime time.
https://pmc.ncbi.nlm.nih.gov/articles/PMC8708925/
Seems to me the big problem is the change in approach – I’d much rather see many different trials than putting all the resources into just one. I think this was a big weakness in the SARS-2 effort, mRNA was pushed so hard and other approaches deprecated. I haven’t been able to find a pharmacy that carries the Novavax (protein subunit) vaccine now that I’m due for a booster. It would also be great if the US could evaluate vaccines developed in other countries instead of just assuming we are “the best”.
I’m not a biomedical person, but from what I’ve read vaccine effects are not particularly predictable and must be studied carefully.
The academic paper https://doi.org/10.1093/infdis/jiy103 outlining the NIH-Consortium plans proposes bypassing regulatory safeguards, abbreviating clinical trials, and rushing experimental interventions including mRNA vaccines to human use.