“You can’t fight scarcity with scarcity. The only way out of the vaccine problem is by making a lot more of it.” -James Krellenstein
India is the world’s largest supplier of vaccines but the government there suspended the export of all COVID-19 vaccines after a devastating outbreak this spring. This is just the latest reason why global health leaders are calling for a new, decentralized approach to vaccine manufacturing around the world. In this week’s episode we’ll look at the challenge facing developing nations when it comes to vaccines; how life-saving technology like mRNA vaccines could be rolled out around the world; and why it’ll take a generational investment to make sure the developing world is prepared for the next pandemic.
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Peter Hotez: The whole global roadmap for vaccinating the world depended heavily on vaccines being produced in India for the world. So not only is India in a difficult situation, but we even have less of a game plan for Africa and Latin America.
Chelsea Clinton: I just think we need to have a different mindset than we’ve had so far. We need to have a global mindset to help tackle our global pandemic.
Céline Gounder: You’re listening to EPIDEMIC, the podcast about the science, public health, and social impacts of the coronavirus pandemic. I’m your host Dr. Céline Gounder.
India is the world’s largest exporter of vaccines. The country exports 60% of the vaccines used around the world every year. And the largest manufacturer of vaccines in India is the Serum Institute.
So it was no surprise that a global initiative aimed at equitable access to COVID vaccines, COVAX, decided to work with Serum. The deal was to make hundreds of millions of doses of the Oxford-AstraZeneca vaccine for many middle and lower income countries around the world. In February, the first AstraZeneca vaccines manufactured by the Serum Institute for COVAX arrived in Africa.
Ghana, NBC News: Today we are in Ghana, and this is really a historic moment.
Global News: 600,000 doses of AZ vaccine arrived in the African Nation.
Global News, Canada: Precious cargo for the Ivory Coast: For this flight, more than 500,000 doses of the AstraZeneca vaccine, produced at the Serum Institute in India.
Céline Gounder: But just a month later… those much needed shipments… suddenly ended.
France 24: We just heard, hours ago, that India had placed a temporary hold on its Oxford AstraZeneca vaccine.
Al Jazeera English: India recorded its highest number of Coronavirus cases in five months this week. The government said it must now prioritize local supply.
Céline Gounder: India became the epicenter of the COVID pandemic this spring. A record-breaking 4500 people died in a single day in May. Prime Minister Narendra Modi banned the export of all locally produced COVID vaccines. Last week, news broke that the Serum Institute would not export any more COVID vaccines for the remainder of 2021.
John Nkengasong: And that really frightens me when I see what is going on in India. And I imagine that it can happen in Africa anytime, I get very, very worried.
Céline Gounder: This is John Nkengasong.
John Nkengasong: I currently serve as the Director of the Africa Centers for Disease Control and Prevention, which is a specialized technical institution of the African Union based in Addis Ababa, Ethiopia.
Céline Gounder: The Indian government’s decision to halt vaccine exports has hit countries like Ethiopia hard. John says that Ethiopia administered the more than 2 million AstraZeneca doses it received from COVAX before the ban.
John Nkengasong: But the challenge now is that we don’t know when the next doses will come. So it’s very possible that people would take their first shots and would not be able to determine when the second shots will come. So that is the challenge that a country like Ethiopia, the country of 100 million people, will find itself in many other African countries are in the same situation.
Céline Gounder: The continent of Africa imports 99% of all the vaccines its people need. There are a handful of countries in Africa that manufacture vaccines — nations like South Africa, Egypt, and Senegal. But outside of some partnerships in South Africa, none are manufacturing COVID vaccines.
John Nkengasong: The COVID-19 pandemic has exposed the continent in an unprecedented manner in a way that says that our entire health security is dependent on the ability of the external factors to support us or not support us in the areas of vaccination and I think we need to change that dynamic.
Céline Gounder: Africa is not the only region struggling with the vaccine shortage. Latin America and parts of Asia were also depending on vaccines from the Serum Institute. The suspension of vaccine exports from India is just the latest reason why leaders like John are calling for a new, decentralized approach to vaccine manufacturing around the world. In this week’s episode we’ll look at the challenge facing developing nations when it comes to vaccines…
John Nkengasong: Africa is struggling and doesn’t truly know when they will meet their vaccination targets.
Céline Gounder: How life-saving technology like mRNA vaccines could be rolled out around the world…
James Krellenstein: I really think we could be talking about a massive increase in the mRNA vaccine production capacity in under six months.
Céline Gounder: And why it’ll take a generational investment to make sure the developing world is prepared for the next pandemic…
Peter Hotez: Most global leaders, they just shake their head and walk away because they feel it’s like building the pyramids. It’s just going to be too high an investment, too high risk. And the time horizons are horrendous.
Céline Gounder: This week on EPIDEMIC… vaccines for the world.
Chelsea Clinton is the Vice Chair of the Clinton Foundation and an Adjunct Associate Professor of Health Policy and Management at Columbia University. She also hosts the podcast In Fact with Chelsea Clinton.
Chelsea Clinton: And I think for the purposes of our conversation today, what’s most important is, I’m a public health advocate.
Céline Gounder: Chelsea’s father, former President Bill Clinton, formed the Clinton Foundation and its Health Access Initiative after leaving office. One of its first priorities was tackling inequalities in access to HIV medications around the world.
Chelsea Clinton: He didn’t feel like he had done enough on HIV and AIDS, domestically or globally, while he’d been in office. And so, he set up the foundation kind of with this hope that he could convene the right people at the right time with a real sense of urgency, to coalesce around a commitment that kind of really would then be activated to shift the medicine for HIV and AIDS from being a kind of high price, low volume dynamic, to really a high volume, low price one.
Céline Gounder: Chelsea hopes this will soon be the case for COVID vaccines too. She recently co-authored an article in The Atlantic calling for the United States to do more to improve access to vaccines around the world. Since her article came out, President Joe Biden’s administration announced its support to temporarily suspend intellectual property protections on vaccines — something called a TRIPS waiver — but Chelsea is calling for more:
Chelsea Clinton: It’s not just enough to commit toward a TRIPS waiver, kind of by the end of the year. It’s a necessary step, it’s certainly in and of itself is not sufficient to really scale up vaccine manufacturing globally in the way that we desperately need to be doing.
Céline Gounder: So far, most vaccine production has focused on supplying wealthy nations in Europe and the United States. Despite the global demand for vaccines… only a limited number of facilities around the world are making them. Vaccine makers say concerns about safety and quality control, and a lack of skilled workers are part of the reason why they’re not licensing their vaccine to manufacturers abroad.
Chelsea Clinton: I am unsympathetic to the, the posture of, “well, no one could do this,” because I just don’t think that that’s true .
Céline Gounder: Drug manufacturers in many countries that weren’t making vaccines are updating their facilities to help meet the need. But many pharmaceutical companies are still not licensing their vaccine technology. In her article, Chelsea mentioned the case of the vaccine manufacturer Biolyse, based in Canada. It’s been petitioning Johnson & Johnson for a license to make 15 million doses bound for Bolivia.
Céline Gounder: What does this tell us, that even Canadian manufacturers can’t make this happen?
Chelsea Clinton: I think that it signals a continued privileging of profit over patient and public health.
Céline Gounder: It’s not enough just to license the technology to other manufacturers. Companies like Pfizer, Moderna, J&J, and AstraZeneca need to share their manufacturing know-how — the blueprints to make the vaccines.The companies can only support technology transfer to so many partners at once, so that’s creating a bottleneck. But there are other reasons they may be resistant to sharing their blueprints for making mRNA vaccines. Many worry that doing so could risk handing mRNA technology to China and Russia… technology that could be used to make other vaccines… as well as treatments for cancer, heart disease, and other medical conditions. And that worry is a major barrier to sharing the technology.
Chelsea Clinton: So I don’t have a lot of sympathy to that. I’m not naive, that could undermine our kind of, relative posture of being advanced in those areas. But I just think that the moral imperative is far greater than the concerns for what the kind of eventual effect may be.
Céline Gounder: And Chelsea thinks that, just like HIV generics, expanding access to these technologies will be a net positive for the world.
Chelsea Clinton: I also candidly, think that if kind of sharing these technologies were to unlock kind of more people working on possible applications for other infectious diseases, for other vaccines or for cancer therapeutics, I’m, I’m okay with that. Like, I don’t think that’s a bad thing.
Céline Gounder: Johnson & Johnson, whose COVID vaccine relies on a different technology, does have partnerships with manufacturers in other countries, like Aspen Pharmacare in South Africa. Aspen became the first company to manufacture a COVID vaccine on the African continent. Johnson & Johnson is also working with another South African company, Biovac.
Chelsea Clinton: But we know that like tens of millions aren’t enough Céline, right. We need to be manufacturing billions, but we know that we get there by having multiple arrangements.
Céline Gounder: Chelsea says that if the pandemic is going to end, vaccine production has to ramp up all over the world, not just in a small number of countries. That will only repeat the mistake of centralizing production of the world’s vaccine supply in one country.
Chelsea Clinton: We get out of this by vaccinating the world, and we vaccinate the world by democratizing access to the underlying vaccine recipe know-how and knowledge and providing support to helping that happen as quickly as possible.
Céline Gounder: And making a lot more vaccines.
James Krellenstein: You can’t fight scarcity with scarcity.
Céline Gounder: This is James Krellenstein.
James Krellenstein: That the only way out of the vaccine problem is by making a lot more of it. And the only way that we’re going to be able to rapidly make a lot more of it is if we get public money to scale up that production capacity.
Céline Gounder: James is the co-founder of a group called PrEP4All. It’s an advocacy organization dedicated to improving access to HIV treatment and prevention.
James Krellenstein: But in January of 2020, we sort of got pulled into the COVID response, and we’ve been working on COVID ever since.
Céline Gounder: It’s important to remember that the manufacturing processes needed for vaccines are very different from those to make generic HIV drugs.
James Krellenstein: We have to make these in very, very complicated, large bioreactors that are actually literally propagating human cells.
Céline Gounder: COVID vaccines like those from AstraZeneca and Johnson&Johnson are called adenovirus vector vaccines.
James Krellenstein: They are modified cold viruses.
Céline Gounder: Think of adenovirus vector vaccines as harmless, gutted viruses that deliver the recipe for Spike protein to our cells.
James Krellenstein: And this process is very, very complicated and very expensive. And it’s something that even extremely experienced biological manufacturers like Johnson&Johnson, like AstraZeneca really have trouble actually scaling up.
Céline Gounder: The biggest problem is time. The time it takes to get a vaccine factory up and running is time many nations don’t have.
James Krellenstein: But the difference is, is that mRNA vaccines are made in a process that really doesn’t require human cells. It’s made chemically. So this is much more of a classical industrial process than it is like any of the other biologics, as we call them, a manufacturing processes for the other vaccines.
Céline Gounder: mRNA is also attractive because it can be adapted quickly if booster shots are needed for variants of concern. And building out capacity in places like Africa would mean those regions could better react to future threats. James sees another benefit when it comes to rolling out mRNA vaccine facilities around the world.
James Krellenstein: We have to understand that unlike any of the other vaccine technologies before February of 2020, the world had no industrial capacity to manufacture mRNA vaccines. And by December, basically a couple of companies with a lot of government funding built enough capacity in just a couple months to make 3.5 billion doses per year.
Céline Gounder: James acknowledges that vaccine manufacturers don’t have incentives to build new mRNA facilities around the world.
James Krellenstein: It’s probably going to cost billions of dollars to to build the mRNA production capacity that we need. That’s small compared to the economic cost of allowing COVID to continue to spread. I mean, it’s chump change. It’s very big for a single company to, or even multiple companies to take on themselves. And furthermore, that once this pandemic is over, there’s not going to actually really be that large of a demand to make 8 or 16 billion doses as a year right. So we’re asking companies to basically build infrastructure that will inherently be unprofitable.
Céline Gounder: So he’s calling for governments to step up to help pay for it.
James Krellenstein: And I think that if we actually mobilized our economy and it wouldn’t cost that much money—
Céline Gounder: About $4 billion, he estimates —
James Krellenstein: I really think we could be talking about a massive increase in the mRNA and a vaccine production capacity in under six months.
Céline Gounder: John Nkengasong with the Africa CDC thinks it’s possible to make mRNA vaccines in Africa.
John Nkengasong: That kind of technology can lend itself to appropriate partnerships that can actually help all of us to leapfrog a vaccine manufacturer in Africa, starting with COVID.
Céline Gounder: We’ll hear how John would like to see mRNA technology reach Ethiopia and other African nations. That’s after the break.
Céline Gounder: John Nkengasong says it’s urgent to get vaccines to the continent as soon as possible. That’s especially true because of where COVID cases are concentrated for the moment.
John Nkengasong: The greater number of our cases are still in major cities. But that will not be the case in the next coming month. The virus who seep up into remote areas, and it will become very, very difficult to do a mop-up operation in those areas.
Céline Gounder: One of the common criticisms of rolling out mRNA vaccines in places like Africa is cold chain storage—or the need for refrigerators and freezers. But John says if the vaccines can reach people while the majority of cases are still in urban areas, this won’t be a problem.
John Nkengasong: In a country like Ethiopia where I’m based, 60 to 70% of the caseloads for COVID-19 are in Addis Ababa. So then the question becomes, can I put minus twenties and minus seventies in a city like Addis Ababa. The answer is yes, I mean, without thinking.
Céline Gounder: The Africa CDC has set a goal to produce 60% of the vaccines the continent needs by 2040. And that is going to be a generational investment.
Peter Hotez: Most global leaders just shake their head and walk away because they feel it’s like building the pyramids.
Céline Gounder: This is Peter Hotez. Peter wears a lot of hats but for this podcast, he’s the Dean for the National School of Tropical Medicine at Baylor College of Medicine, and the co-director of the Texas Children’s Hospital Center for Vaccine Development.
Peter Hotez: So it really does take visionary leadership to want to build vaccine production and in a country that hasn’t done it before.
Céline Gounder: And it means investing in all kinds of vaccine technology… not just mRNA.
Peter Hotez: At the start of this COVID-19 pandemic. If you had asked me what was going to be the most successful vaccine, would have said the VSV Ebola vaccine developed by Merck. That was an extraordinary vaccine. But it didn’t work for COVID-19. So you never know which technologies are going to apply best for a new pathogen. So what you need are these hubs for training and centers of excellence for about five or six different vaccine technologies. So you could that’ll increase your shots on goal for having one that seems to work well.
Céline Gounder: So Peter’s team is developing their own COVID vaccine that relies on vaccine technology that’s been around for a long time. Yeast.
Peter Hotez: Ours is a recombinant protein vaccine produced through my microbial fermentation and yeast. And the reason that’s useful information. It’s the same technology used for the hepatitis B vaccine. That’s been around for three, four decades. So it’s a great safety track record. It’s cheap. We think our vaccine might be able to be produced for a $1.50, a dose, simple refrigeration. So it checks a lot of boxes for resource poor settings and there’s really no upper limits to the amount that you can make.
Céline Gounder: Making a vaccine like this is kind of like brewing beer.
Peter Hotez: So the way beer is made is you have big fermentors and the yeast are, releasing alcohol as a product of fermentation and some other goodies to make beer.
Céline Gounder: They don’t use the same yeast as in beer making. Instead, they used genetically engineered yeast that produces the Spike protein that is then used in the vaccine.
Peter Hotez: It looks really good in terms of inducing virus, neutralizing antibodies, which is how all of these vaccines work.
Céline Gounder: Because the facilities making hepatitis B vaccines have been around so long, there are a lot of factories around the world that could quickly shift to produce Peter’s COVID vaccine.
Peter Hotez: So Merck makes hepatitis B vaccines. GSK does, Instituto Butantan in Brazil, which is one of the big, one of the largest vaccine producers in, in Latin America. So there’s a lot of heft in terms of ability to scale up and produce that for the world, if they’re interested.
Céline Gounder: At this recording, Peter’s vaccine is about to start Phase III clinical trials in India. If the trials this summer are successful… and they’re able to get approval from the WHO… he thinks the vaccine could be ready for production as early as the fall.
Peter Hotez: Again, a lot of stars have to align, but that would be the most optimistic time scenario. And then, you know, hopefully we can start really vaccinating the world before the end of 2021. And we have not filed any patents on it.
Céline Gounder: No patents. No trade secrets. Texas Children’s Hospital Center for Vaccine Development decided to sidestep the whole debate around intellectual property and make a vaccine free to the public.
Peter Hotez: So if somebody in Indonesia or Paraguay or Panama wants to copy what we’ve done and try to produce it. You know, our attitude is, you know, God bless them. How can we help you? Because this is what our goal is: Global health, not financial return.
Céline Gounder: Deciding not to patent their vaccine is one less hurdle that countries will have to face if they want to make it. But Peter says intellectual property rights aren’t the biggest problem facing countries that want to manufacture their own vaccines.
Peter Hotez: It’s more about training scientists in how to produce the vaccine at scale and under that quality umbrella. So it’s training the human capital. It’s not even the bricks and mortar and, and that’s the piece that I think a lot of people outside the vaccine field often fail to understand.
Céline Gounder: Building out the capacity of the Global South to make its own vaccines is going to be a generational project. It’s going to take the commitment of leaders in developing countries… and it’s going to involve resources and training from countries like the United States. These are important investments in global health and the world’s economy…
Peter Hotez: In the near term, we need somebody to produce 6 billion doses of vaccines now. We can’t wait until 2024, 2023.
Céline Gounder: John Nkengasong agrees.
John Nkengasong: Even if you did intellectual property now, it doesn’t give us vaccines immediately. What can enable us to vaccinate our population now is available vaccines, and we have plenty of available vaccines in storage in certain parts of the world.
Céline Gounder: European countries and the United States have more than enough vaccine to cover their respective populations. To head off a future surge like the one happening in India, countries with surplus vaccine need to help scale up global manufacturing and donate more of their excess supply.
John Nkengasong: Those who sitting on excess vaccines should redistribute them now and not later, so that we can get over this quickly as possible.
Céline Gounder: John says a survey conducted in Ethiopia found that 95% of respondents said they would take a COVID vaccine. And Ethiopia has the infrastructure to get these vaccines out.
John Nkengasong: In the middle of this crisis, Ethiopia was able to vaccinate 12 million children with measles vaccines. It speaks to the fact that if vaccines are available, many countries in Africa will be able to roll up their sleeves and do the vaccination.
Céline Gounder: At this recording, 50% of adults in the U.S. have been fully vaccinated. But the vast majority of other countries are struggling to get their hands on any vaccine supply.
John Nkengasong: We are not going to win the war against COVID-19 if only some parts of the world are vaccinated. From that perspective, it is now at a collective responsibility to see that those who are sitting on excess vaccines should redistribute them now and not later. Then the second thing that must be done is that they need to build the right partnerships, not just in Africa, but regionally, so that each region of the world can produce its own vaccines and enable us to be better prepared for the future, but also enable us to end the current pandemic.
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I’m Dr. Celine Gounder. Thanks for listening to EPIDEMIC.