The Cost of Living

Why aren’t Covid-19 vaccine makers allowing other manufacturers to produce more doses? James Love on the hype and reality of the new drug technology, messenger RNA. “It’s a weird thing: Oh, here’s a billion dollars—but it’s your vaccine, and you get to do the trial however you want, even though we’re paying for it.” Trade Secrets Why aren’t Covid-19 vaccine makers allowing other manufacturers to produce more doses? James Love on the hype and reality of the new drug technology, messenger RNA. In a groundbreaking deal for a promising Covid-19 treatment, the pharma firm Merck signed a [licensing agreement]( on Oct. 27 to allow drugmakers in 105 developing countries to produce Merck’s Covid-19 pill, molnupiravir. In clinical trials, the new drug cut hospitalizations and deaths in half among patients with early Covid-19, Merck said. Unlike most licensing arrangements, Merck will not receive any royalties. As wealthy countries [rush]( to buy up molnupiravir, drugmakers can now produce identical, generic versions for 105 countries with about half the world’s population. More than 50 companies have already [inquired]( about obtaining a license to make generic molnupiravir for the developing world. But even as the pill and the licensing deal raise hopes of controlling the pandemic, less than half of the world’s population has received a single dose of a coronavirus vaccine. So why haven’t Pfizer, Moderna, and Johnson & Johnson made licensing deals like Merck’s? James Love is the director of Knowledge Ecology International, a nonprofit research foundation that supports intellectual-property transfers in biotechnology. In Love’s view, the primary reason is that pharma corporations don’t want to share the new technology that underlies their vaccines, confident it will lead to the further innovation of blockbuster drugs and major profits. The Pfizer and Moderna vaccines are biologic drugs based on a new platform called messenger RNA, or mRNA, which only a few other pharmaceutical companies know how to use—and none of them are large-scale generic-drug manufacturers. For Love, even if national governments require vaccine makers to license their patents—which all countries’ laws allow their governments to do—only a handful of manufacturers worldwide could produce the vaccines without extensive training in mRNA technology. Potential generic versions of the branded drugs would require regulatory approval, which would be time-consuming, expensive, and difficult, because of the novel technology. Despite these challenges, Love says, governments could do more to promote or compel greater vaccine production, but around the world, they all tend to tread lightly with Big Pharma. ——— Michael Bluhm: Why is Merck giving away its breakthrough drug for free to developing countries? James Love: Merck has a fair amount of experience in infectious disease and working with the public-health community. They’re comfortable with the idea that sometimes, it’s better to make a voluntary agreement for areas that you’re not likely to serve very well than to be involved in endless disputes about why you’re not doing a better job of serving their populations. I was surprised that it was royalty-free. Merck will want to focus its attention on selling the product in higher-income markets. The voluntary license covers little more than half the world’s population, with a per-capita income of just under $2,600 per year. The area that Merck is retaining an exclusivity for has a per-capita income of over $20,000 per year. Merck would rather sell in the higher-income market and avoid being subject to criticism for focusing on it and not the lower-income market. Merck’s in a position to say, If people don’t have access to our drug in the lower end of the market, don’t blame us, because we’ve licensed and even offered technology transfer to the best generic companies in the world, regardless of where they’re located. It’s no longer our responsibility to address access in those countries. There have been three voluntary agreements involving Covid-19 therapeutics. Who has not issued voluntary licenses? None of the biologic therapeutics—such as [the broad-spectrum antiviral medication] remdesivir—and none of the U.S.-approved vaccines have been licensed. More from James Love at The Signal: “For biologics like the messenger-RNA vaccines, the know-how is considered a much more valuable asset than the know-how for small-molecule drugs such as molnupiravir. We had a discussion with Moderna early in 2020, when they announced they were not going to enforce their patents on their vaccine technology. We asked them, What will do you do about sharing know-how? They said, We won’t do it. If other companies can make our vaccine, they can make our next product.” “Right now, countries are interested in messenger RNA as industrial policy. They think messenger RNA is some important new technology that’s going to be important not just for this pandemic. They want to have some manufacturing capacity in their national backyard. That’s why Canada didn’t put Covid on its schedule for compulsory licenses, because they were negotiating with Moderna to build manufacturing facilities in Canada. A lot of countries want to develop positive relationships with companies making mRNA vaccines.” “Regulators aren’t quite sure what in the manufacturing process to pay attention to. They should be somewhat conservative in who they green-light. The regulatory pathway for messenger RNA will be difficult, but not too difficult. Messenger-RNA technology will be shared, and you’ll see generic versions. It will become increasingly important for manufacturing vaccines and other products.” ——— Meanwhile: Are cultural conflicts over education coming to dominate U.S. elections? Concerns about “critical race theory” and school-related issues, along with frustration about how the education system handled the pandemic, played a prominent role in the recent campaign for governor in the U.S. state of Virginia—in which the Republican businessman Glenn Youngkin ended up defeating the former Democratic governor Terry McAuliffe. I spoke with Rick Hess, the director of Education Policy Studies at the American Enterprise Institute, [back in May]( about how Republicans saw an opening to attack Democrats over cultural issues in the education system, so I asked him what he thinks the outcome of the election in Virginia signifies about where these conflicts are going in America. —Graham Vyse Hess: In Virginia, parent frustration had been boiling up over the past 18 months, with schools slow to reopen and seemingly haphazard in the way they handled remote learning, addressed kids with special needs, or communicated with parents. There were also questions around race and gender, which led to McAuliffe making what ended up being a controversial statement: “I don’t think parents should be telling schools what they should teach.” Many in education, many in media, and certainly many in the Democratic Party have sometimes framed parents’ frustration with how schools handled the pandemic as these parents being unreasonable, loud, and demanding. That’s a fundamentally problematic way to think about people trying to make sure their kids are cared for. In many ways, it’s the same dynamic that’s played out with debate about “critical race theory”—an issue proponents have consistently framed a question of whether schools should teach about slavery. But more than 80 percent of Republicans say schools should teach about slavery. This debate isn’t about that. This debate is about, for example, professional developers telling teachers that independent thought is a hallmark of “white supremacy culture.” It’s about how a student was sexually assaulted at a school in Loudoun County, and the country superintendent lied in denying knowledge about this—and when the student’s father was arrested at a meeting, trying to get questions answered, the National School Boards Association cast him as an example of threatening and violent parents. If you keep cheapening important issues like racism and white supremacy—if you just label everybody who disagrees with you as racist or a white supremacist—there’s a sugar high and a short-term benefit, in terms of freezing the debate and winning some elections, but the long-term costs have been extraordinary. Democrats are getting pulled by influential elites to a place which isn’t only out of touch with lots of independents and Republicans but frankly, as [the progressive data scientist and political consultant] David Shor has noted, out of touch with lots of Black and Latino Democratic voters as well. These issues are very state-centric. While I’m sure they’ll affect the 2022 U.S. midterm elections, I imagine they’ll play more significantly in gubernatorial races. People who want to be governor will be asked where they stand on “critical race theory,” parental engagement, and the freedom to opt students out of instruction with sexually explicit materials. It’s harder to make these things directly relevant to a member of Congress, but because they’re so much about values and a nationally resonant set of cultural issues, I’m sure they’ll loom large. For more from Rick Hess on America’s education culture wars … ——— ——— [The Signal]( is a new digital publication exploring urgent questions in democratic life and the human world—sustained entirely by readers like you. To support The Signal and for full access: © 2021 The Signal The Signal | 717 N St. NW, Ste. One, Washington, DC 20011 [Unsubscribe {EMAIL}]( [Constant Contact Data Notice]( Sent by newsletters@thesgnl.email