Why It’s a Big Deal If the First Covid Vaccine Is ‘Genetic’

Since small companies like BioNTech, Moderna, and Inovio began developing genetic vaccines about 10 years ago, that speed has always been the brightest of its promises. The faster you can make and test vaccines, the faster you can respond to outbreaks of new diseases. But with any novel approach comes risk—risks that the vaccine won’t work well or, worse, that it harms someone, and millions of dollars will be wasted on a technology that turns out to be a flop. Until this year, major vaccine developers had shied away from genetic vaccines. Before 2020, only 12 mRNA vaccines ever made it to human trials. None were approved. Then came the coronavirus.

“Before the pandemic, there weren’t the financial incentives or the opportunities for the big pharmaceutical companies to get involved,” says Peter Hotez, a vaccine researcher and dean of the National School of Tropical Medicine at Baylor College of Medicine. But with governments rushing to fund not just clinical trials but boosts in manufacturing, as in the US’ Operation Warp Speed, it got a lot less risky to try something new. The spoils of that investment, and the potential success of a Pfizer/BioNTech vaccine, will long outlive this pandemic, says Hotez. “It provides a glidepath for using mRNA technology for other vaccines, including cancer, autoimmune disorders, and other infectious diseases, as well as vehicles for genetic therapies. It really does help accelerate the whole biomedical field.”

In addition to Pfizer/BioNTech, Moderna also has an mRNA-based Covid-19 vaccine in Phase III trials and is expecting to receive its first interim findings later this month. Inovio’s DNA-based vaccine has stalled over concerns about the device used to inject the vaccine; company officials announced this week they expect the FDA to make a decision about whether or not the Phase II/III trial can continue later this month. So for now, all eyes remain on Pfizer and BioNTech. And everyone is eager to see more.

“Until the full data set is available, it is hard to interpret the true potential,” says Carlos Guzman, head of the Department of Vaccinology and Applied Microbiology at the Helmholtz Centre for Infection Research in Germany. Important to note, he says, is that Pfizer’s effectiveness claim is based on a relatively small number of trial participants who tested positive for Covid-19, and that so far nobody knows anything about them. How old are the people who are getting sick? How old are the ones who don’t? That’s important information for understanding how well the vaccine will work across different age groups, which could inform who gets it first.

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Another question mark is what’s happening with people’s symptoms and viral loads. According to Pfizer’s trial protocol, one would conclude that the vaccine is preventing people from getting severe cases of Covid-19—but does that mean they’re not getting infected at all? The answer could be the difference between a vaccine that builds up a protective wall of immunity in communities and one that just keeps people out of the hospital (and the morgue). Still another unanswered question is how long any such immunity might last. For that, expect to keep waiting a little while longer, says Guzman: “Data in the coming months will provide a better picture of longer-term vaccine efficacy and whether this vaccine can also protect against severe forms of disease and death.”

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The dissemination of such information will be vital for any vaccine to win public trust—a crucial step in any immunization campaign, but especially one that would roll out amidst rising vaccine skepticism and misinformation. “The scientific community needs to be able to evaluate the study’s results through peer review and transparent data sharing,” says Ariadne Nichol, a medical ethics researcher at Stanford University. So far, Pfizer and BioNTech have published safety data from earlier-stage trials of the vaccine. No serious safety concerns have been observed.

If the Pfizer formula is approved by the FDA, the US will be at the front of the line to receive the first batches of the vaccine. In July, the Trump administration agreed to pay almost $2 billion for 100 million doses of Pfizer and BioNTech’s shot, or enough to immunize about 50 million people. According to The Wall Street Journal, Pfizer will handle the distribution of its products, rather than relying on the federal government. But that also raises questions about how long it could take the vaccine to reach less wealthy nations, especially where the extreme cold chain necessary to keep the formula stable isn’t compatible with local infrastructure. “This is a sprint where Pfizer may end up finishing first,” says Nichol. “But we still have a marathon ahead to tackle issues of production and equitable distribution within our global population.”

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