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'The Ones With the Most Risk Are the Ones We're Most Ill-Prepared to Reach with the Vaccine' Janine Jackson ([link removed])


Janine Jackson interviewed U Penn’s Ravi Gupta about vaccine infrastructure for the November 20, 2020, episode ([link removed]) of CounterSpin. This is a lightly edited transcript.
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Janine Jackson: Headlines are hailing imminent coronavirus vaccines we’re told are safe, upwards of 90% effective, and ready to be sent for FDA approval “within days.” It's understandable to want to see the discovery of a vaccine as signaling victory over pandemic worries, but one global health official says ([link removed]) it's more like “building a base camp on Mount Everest.”

What happens next has to do with vaccine infrastructure—the systems in place for vaccines’ manufacture and distribution. And our next guest says that infrastructure is due for serious change.

Ravi Gupta is a physician and clinician scholar at the University of Pennsylvania ([link removed]) . His article ([link removed]) , “Our Vaccine Infrastructure Needs a Radical Overhaul,” appeared recently in Boston Review. He joins us now by phone from Philadelphia. Welcome to CounterSpin, Ravi Gupta.

Ravi Gupta: Thank you for having me.
Boston Review: Our Vaccine Infrastructure Needs a Radical Overhaul

Boston Review (11/13/20 ([link removed]) )

JJ: It's called a “novel coronavirus,” and there's much that is lamentably new about this pandemic and its many reverberations. But in your Boston Review piece ([link removed]) , you do anchor what we're seeing now in some lessons from the past, specifically from the H1N1 virus. Maybe that's a place to start: What are some of the persistent problems you see in existing vaccine infrastructure, such that we need to, as you say, “reimagine” it?

RG: I think that's a great place to start. The last pandemic, as you say, was H1N1 in 2009, and it's sometimes easy to forget that a lot of the problems we faced then still exist today. We've made quite a bit of progress in certain areas, but, as I mention in the article, there are plenty of changes that need to happen, one of which is: manufacturing is going to be a huge issue, even if we have approved or authorized vaccines in the next few weeks or months. It depends on a private sector that doesn't take a proactive approach to preparing for surges. And so that's something that really makes it difficult to quickly produce enough vaccines, so that it allows for both domestic and global access.

JJ: And you point, also, to that private sector reliance: There's just been concentration, consolidation in that industry, so that there aren't as many people who are in a position to produce.

RG: Yeah, with H1N1, there were only three manufacturers left, due to consolidation. Now there are a number of agreements and partnerships with new companies, but it still leaves us with not nearly enough doses, and certainly not enough to reach, especially, developing countries. And that's something that we really need to focus in on, especially because we're likely to face—as hard as it is to acknowledge—additional pandemics after this one.

JJ: You're transitioning there to the idea of the global implications of this, and maybe it's worth visiting some of the unfortunate history, frankly, from H1N1, which is kind of what people are seeing and worrying about now: a kind of vaccine nationalism; Peter Maybarduk called ([link removed]) it “vaccine apartheid." The concern is that wealthy countries will buy it up, and there won't be enough to go to places that sorely need it. Now, we have things that are supposed to mitigate against that, but is that global inequity a real concern?

RG: Unfortunately, I think it is. With H1N1 — you know, there's this idea of vaccine nationalism, where wealthy countries, then as well as now, procured doses for themselves, and they bought these doses in advance of the vaccine even being authorized, or before the manufacturing had even started. And they did so at the expense of other countries that can't necessarily pay for it.

With H1N1, the World Health Organization tried to procure commitments from wealthy countries to donate a certain percentage of their vaccine doses. But there were a lot of manufacturing problems with the H1N1 vaccine, and H1N1 turned out to be more serious than countries were anticipating. And so they rescinded these commitments to donate vaccines to developing countries. And by the time that countries like the United States and Australia and Canada did end up donating vaccines to developing countries, it was too late; the H1N1 pandemic had come nearly to an end.

And now we're seeing that with Covid, where a substantial proportion of Covid vaccines have already been purchased by the US and European countries and other wealthy countries. And when you have multilateral organizations and international institutions, like the World Health Organization, that are trying to create a space for globally coordinated strategy, that's undermined when the doses have already been purchased by the wealthier countries.

JJ: Right. You make the point in the piece that not to have a global strategy that encompasses high-risk populations, it's not just morally wrong, but it doesn't make sense, in terms of both biology and economically.

RG: Yeah, there's obviously a moral dimension to this. But then, it also doesn't make any biological or economic sense. And that's what I talk a little bit about a little bit in the article, as you say. Because the pandemic accelerated so quickly because of the fact that we're so interconnected now—more so than we have ever been before—and to only vaccinate a certain segment of the global population means that we can't really get a handle on this virus as a whole. And the international trade that has been devastated because of the pandemic will continue to suffer if certain countries can't vaccinate their populations and allow their citizens to be productive members of the economy. So it overall makes, certainly, no moral sense, but also no economic or biological sense.

JJ: Well, let's bring that to the domestic level. We have federal health officials now saying ([link removed]) that “every state will have vaccines within 24 hours of an FDA greenlight.” But the devil is in the details—too big to be called “details,” really, when it comes to things like race and class disparities, in particular, in the healthcare system in the United States. And so what thoughts do you have, or concerns, about equitable distribution within the US?
Ravi Gupta

Ravi Gupta: "We've had decades-long underfunding of state and local public health departments.... And this hampers coordinated access, and leaves us ill-prepared to reach the very populations that are the most affected by this virus."

RG: I think this is a huge issue. And people are rightly starting to pay more attention to it. So what I focus in on in the piece is this idea that we've had decades-long underfunding of state and local public health departments, and just myopic funding cuts for pandemic preparedness. And this hampers coordinated access, and leaves us ill-prepared to reach the very populations that are the most affected by this virus. And mainly these are Black communities, the Latinx communities and Native American communities in our country. These are the same communities that have suffered the most from Covid, and historically have also been often the communities that have lower vaccination rates. And so what I try to argue for is, this is something that we really need to pay attention to, to help try to reach these communities for vaccination.

And something else that I talk about in the article, and something for us to consider, is that large proportions of these communities are the ones that can't socially distance because they work in the service economy, or they can't socially distance from home and work on their computers or take phone calls. And so they're the ones with the most risk of contracting the virus, and the ones that we’re most ill-prepared to reach with the vaccine.

JJ: Yeah, the piece talks about “social vulnerability as an underlying principle for allocation,” and I think it's a concept people need to understand, that equitable distribution can mean prioritized distribution.

Well, another issue is trust ([link removed]) , and that's a legitimate issue, and it's not just Tuskegee ([link removed]) , but telling someone that you're coming up with medicine at “warp speed ([link removed]) ” is not necessarily a confidence-booster.

I certainly wanted to talk about the Boston Review piece, but I did want to give you an opportunity to briefly explain the concerns that you and Reshma Ramachandran point to in your recent New York Times op-ed ([link removed]) about the 21st Century Cures Act ([link removed]) , if you could just briefly take a moment and talk about how that fits here.
NYT: Does Remdesivir Actually Work Against Covid-19?

New York Times (11/17/20 ([link removed]) )

RG: Absolutely. So we wrote this piece ([link removed]) specifically about remdesivir ([link removed]) , which is a drug that was initially developed for Ebola. This was several years ago, and was shown not to actually work for Ebola. And it's been repurposed for Covid-19, based on some studies that showed it worked for coronaviruses. But we argue that the FDA prematurely gave the drug approval, because it's unclear if it's actually effective. And it's also quite expensive, especially because it's been developed with public dollars.

And we contextualize this with the idea that there has been years of assault on FDA evidentiary standards; there's been an erosion of their ability to really ensure that new therapeutics, new vaccines, are safe and effective. And that stems somewhat from the 21st Century Cures Act ([link removed]) , which was legislation that was passed in 2016, under President Obama, which had a number of positive aspects—it increased NIH funding, and it helped address the opioid epidemic. But part of it was to, exactly what I say, erode FDA standards, based on these unfounded claims that the FDA has an approval process that's too slow. In fact, the FDA is among, if not the, fastest-approval agency in the world.

And so we argue that this idea of remdesivir is just a crystallization of the continued erosion of FDA standards. And so we argue for a stronger FDA that not only ensures that therapeutics and vaccines are safe, but also effective.

JJ: And that idea of using a rubric of “emergency” to say that a particular drug must be produced— there's a particular fillip in the law that you explain in the piece, which is that once one drug has gotten that access as being needed urgently, doesn't it kind of close out others that come behind it, that might conceivably be more effective, because they can't prove that they're necessary anymore?

RG: Yeah, that's a really good point. So there's two different aspects to this: One is this idea of an emergency use authorization ([link removed]) , which is basically the ability of the FDA to authorize a new treatment, or a vaccine, without full evidence as to whether it does truly work. And that makes sense in a crisis, like the one that we're in right now. But with remdesivir, what they did was, they gave a full approval ([link removed]) , and we think that was premature.

And what you're pointing to is this idea that, in the language that the FDA has put for an emergency use authorization, they say that if an alternative treatment has been approved and is available, then additional treatments can't necessarily have an emergency use authorization. So I think that the language is something that precludes additional treatments from being authorized for the same indication. And in this case, it's for patients that are hospitalized with Covid. And so that's something that the FDA will need to address, now that it's given remdesivir full approval.

JJ: I'm going to read a quote now:

But though the players have changed—a novel coronavirus, innovative vaccine technologies, newly formed international organizations—the game is in many other ways the same: constantly playing catchup, rewarding those with influence, unable to collectively share the fruits of human ingenuity. Nothing about this is immutable.

That's from the Boston Review piece ([link removed]) . Let's get to that part, please, about how this situation should be changed and can be changed.

RG: Yeah. I appreciate that. I think that, like we started out with at the beginning of this conversation, there are a number of things that are novel with where we are right now: It's an unprecedented pandemic; it's remarkable that we're even talking about a vaccine that should be distributed. But a lot is still the same, and I talked about this a little bit in the article, near the end, where a number of lawmakers, policymakers and politicians have started to appreciate the difficulty associated with vaccines and treatment, distribution and allocation.

There's a number of pieces of legislation that are stuck in Congress that relate to creating a public system of manufacturing ([link removed]) medicines and vaccines, which is what we were talking about. And then, also, this idea that new therapeutics, new vaccines, have this monopoly protection ([link removed] MMAPPP Act.pdf) that precludes competitors from being able to not only bring the price down, but also to be additional manufacturers for those same treatments and vaccines. And so these are pieces of legislation that are stuck in Congress, but we really need to advance, not only, like I say, for this pandemic, but also for additional crises, additional pandemics, that we're likely to face.

JJ: We've been speaking with Ravi Gupta. You can find his article, “Our Vaccine Infrastructure Needs a Radical Overhaul,” online at BostonReview.net ([link removed]) . Thank you so much, Ravi Gupta, for joining us this week on CounterSpin.

RG: Thank you for having me.
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