The stalemate over patents is fueling vaccine inequity—and the pandemic

This week, vaccine inequity took a turn for the worse. Moderna said that it would not share the recipe for its COVID-19 shot despite pressure to do so to increase the global vaccine supply. The company, which has sold doses almost exclusively to wealthy countries, also said it would open a new vaccine plant in Africa to boost the supply itself, but it didn’t specify when (or where on the continent) that would happen. 

Inequitable access to vaccines has been an issue since the earliest days of the pandemic. Wealthy countries like the U.S. preordered the doses they needed—and then some—while many nations classified as low-income by the World Bank are still waiting for those orders to be filled before they can get their own. That’s why COVAX (COVID-19 Vaccines Global Access), an international program to ensure that all nations get access to affordable doses, was initiated in the first place. 

But COVAX is falling far behind, and drugmakers are now under mounting pressure to make up the deficit by waiving patents on their vaccines so that poorer countries can make their own doses. Companies have resisted, arguing that patents are critical for incentivizing research and development, and waiving them would hurt the very industry that so quickly produced the vaccines we’re using today. The UN and the World Health Organization have pushed back, arguing that the global population is in crisis, but they appear to lack the power to compel drugmakers. Even the Biden administration, which in May voiced its support for waiving patents on vaccines, has not been able to sway Moderna, which accepted an estimated $2.5 billion in U.S. taxpayer dollars to develop its vaccine. 

Though Moderna is currently in the hot seat, it’s not the only vaccine maker facing pressure to provide equitable vaccine access in recent months. Pfizer announced in July that it would manufacture vaccine doses through an institute in South Africa, but was criticized for doing so in a “fill and finish” capacity, meaning the institute would still rely heavily on shipments of key ingredients from Pfizer. In August, the WHO called out Johnson & Johnson for making fill and finish doses in South Africa but shipping them to Europe. Unlike Pfizer and Moderna, however, J&J and AstraZeneca have sold their doses at cost, making them key to the COVAX initiative. 

Waiving patents is a critical first step toward increasing vaccine access, but it won’t solve the problem overnight. For one thing, says University of Michigan researcher Mario Gaviria, co-author of a Nature Biotechnology paper on the staggering network of patents linked to the mRNA vaccines, there are “dozens and dozens of patents belonging to several different entities,” including many academic institutions, and much of the actual know-how of manufacturing the vaccines is protected by a type of intellectual property known as trade secrets. The only way to get a hold of that information—which he says is essential for other entities to make the vaccines—“is to force the companies to share it” through a process called tech transfer. The WHO set up a tech transfer hub in South Africa in hopes that companies would participate but so far has faced pushback from drugmakers.

Despite these complexities, waiving all IP is feasible, says Gaviria. And likely crucial, if we are to beat the coronavirus. “Something people need to understand is that the longer the virus is circulating and infecting people, the more chances it has to mutate and become more contagious, more prone to evade vaccines, and potentially become deadlier,” he says. “This is why vaccinating the whole world is the only solution to overcoming the pandemic, as opposed to just creating booster shots every time a new variant pops up.” 

The Biden administration, Gaviria adds, has leverage to push Moderna to share its recipe because the company used government funding, or alternatively it “could also share the vaccine recipe itself given that the government does have a stake in the IP surrounding that vaccine.”

The debate over waiving vaccine patents hasn’t budged for several months, unlike the vaccination gap between rich and poor nations. As of October 6, nearly 61% of people in high-income countries have received at least one dose. In low-income countries, the proportion is 3.72%. The gap is getting wider with time, which is why the stalemate over patent waivers is so problematic: Every day that passes without securing shots for the world’s unvaccinated is another day the coronavirus can mutate and spread around the world.

Read more about vaccine makers’ global fight to end the pandemic, and why they were selected to top our Change the World list again this year. 

Thanks for reading, and please reach out if you have any questions or comments—I’d love to hear from you.

Stay safe out there,

Yasmin

@yeahyeahyasmin

DIGITAL HEALTH

Scotland is the first country to offer free digital therapeutics to all citizens. On Wednesday, Scotland’s National Health Service announced that it was giving all citizens access to digital therapeutics for mental health. Daylight, an app based on cognitive behavioral therapy (CBT) techniques, is available for people struggling with anxiety. Sleepio, a six-week digital program and app, applies CBT and sleep hygiene techniques to help people with insomnia. Both are evidence-based products from the U.S.-based company Big Health, which Scotland’s NHS partnered with earlier in the pandemic to provide these services to NHS workers at no cost. 

INDICATIONS

Merck’s molnupiravir forges ahead in the U.S., despite a drawback in India. In last week's Capsule, we discussed molnupiravir, the antiviral pill from Merck that cut the risk of hospitalization and death in people with mild to moderate COVID-19 by 50% in clinical trials. On Monday, the company applied for emergency use authorization from the FDA, which could push through in a matter of weeks. If it does, the drug will be the first oral COVID-19 pill available. Merck has already licensed the drug to at least eight manufacturers of generic drugs in India with the goal of producing enough for lower-income countries. This week, however, two of those drugmakers paused their clinical trials of generic molnupiravir on people with moderate COVID-19, with an Indian health official saying the drug did not show “significant efficacy” against moderate cases. If molnupiravir ultimately becomes available, it should be used in conjunction with other available treatments in order to stave off resistance, said Wellcome Foundation director Jeremy Farrar. (Bloomberg)

 

CRISPR Therapeutics releases promising results on its CAR-T therapy. This week, CRISPR Therapeutics shared results from an early-stage trial showing that 58% of lymphoma patients who received the company’s “off the shelf” CAR-T therapy showed favorable responses without developing grade 3 or higher cytokine release syndrome (CRS), a serious condition. CAR-T therapy, which typically involves modifying a patient’s own T cells to improve their ability to seek out cancer cells and infusing them back into the patient, is promising, but rates of CRS are high and manufacturing the cells can take a long time. Off the shelf CAR-T treatments like that of CRISPR Therapeutics—so named because they’re made using healthy cells from a donor, not the patient—could make such treatments more accessible, if proven safe and effective. (BioPharmaDive)

THE BIG PICTURE

mRNA tackles the flu. The mRNA vaccine technology that underlies the Moderna and Pfizer vaccines was in development for roughly 30 years before the pandemic struck. Now that scientists know how to apply it, they’re setting their sights on creating mRNA vaccines for many other illnesses, including influenza. The annual flu shot is notoriously meh—its effectiveness is between 40% and 60% each year—in part because it takes so long to manufacture that new flu strains can pop up in the meantime, rendering the vaccines moot. (Despite its middling effectiveness, though, the flu shot is still incredibly helpful because so many people catch the flu every year—get yours!) The hope is that, since mRNA vaccines can be made more quickly, it may be easier to develop a flu shot that corresponds with the strain in circulation. (New York Times)

REQUIRED READING

Rich countries’ rush to buy Merck antiviral pill risks leaving poor countries behind in COVID fight—again, by James Paton and Bloomberg

A growing number of chiropractors sow fear and mistrust in COVID-19 vaccines, by Michelle R. Smith, Mike Catalini, Scott Bauere, and the Associated Press

How the COVID pandemic brought an estranged family together, by Tanzina Vega