Universal Vaccines Have Eluded Scientists for Years. RFK, Jr., Is Betting This Approach Will Succeed
Trump’s HHS and NIH are planning to invest $500 million in a killed-whole-virus approach to universal vaccines, including such vaccines for flu and COVID. Here’s why that’s challenging
A worker wearing personal protective equipment (PPE) holds a tray containing unlabeled vaccine vials.
Andrey Rudakov/Bloomberg via Getty Images
Scientists have spent decades in hot pursuit of a universal influenza vaccine—a single shot to protect people from past and possible future strains of a frequently mutating virus. This would lessen the need of annual flu shots to boost the immune system before seasonal cases surge.
Now the Trump administration is reportedly brewing plans to invest $500 million in a universal vaccine research project, according to the Wall Street Journal. The potential federal funding appears to be part of a U.S. Department of Health and Human Services and National Institutes of Health initiative, called Generation Gold Standard, to develop a universal vaccine platform based on a so-called beta-propiolactone-inactivated (BPL-inactivated) whole-virus approach, in which whole viruses are killed and used in a vaccine.
In an announcement released on Thursday, the agencies said the initiative will focus on universal influenza and coronavirus vaccines for broad protection against potentially pandemic-causing viruses, such as the highly pathogenic H5N1 bird flu virus and the coronaviruses responsible for severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS) and COVID. The WSJ reports that Generation Gold Standard marks a switch from the Biden era’s $5-billion Project NextGen, which supported the development of new COVID vaccines.
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“On the face of it, this is very encouraging because trying to stimulate scientific research that would get us improved COVID and influenza vaccines down the road would be of enormous benefit to the global community,” says William Schaffner, an infectious disease physician and a professor at Vanderbilt University Medical Center. But, he adds, “the devil is in the details.”
Scientific American spoke with Schaffner about how universal vaccines work and what challenges and considerations researchers face in developing them.
[An edited transcript of the interview follows.]
What is a universal vaccine?
We know that influenza and COVID viruses mutate, and that’s why we have to update the vaccines on an annual basis. That’s very troublesome; it takes a lot of work, a lot of effort and a lot of revaccination for everyone. Wouldn’t it be better if we had an influenza vaccine and a COVID vaccine that would protect against all of these strains—or most of the ones in the past but also potential new ones?
Scientists have been trying to develop such universal influenza and COVID vaccines, looking to get parts of the virus that are the same from strain to strain. There are external parts of the virus that mutate and change, and we make our current vaccines to adapt to those external changes. But there are more internal structures that are, as we say, conserved. That is, they’re the same no matter what the strain is. If we could get the immune system to respond to those stable parts of the virus, we would have a universal vaccine so that no matter how much the virus had changed, we would still be protected.
What is the current state of the research?
This has been a gleam in scientists’ eyes for quite some time. We have had candidate universal vaccines being tried out for influenza, but we don’t have any viable one yet for COVID. So the investment, determination and monies may well accelerate the scientific progress to get to those highly desirable goals. This would not only benefit the population of the U.S. but would have global benefits.
The NIH and HHS’s new initiative is focusing on a whole-virus platform for universal vaccines. How would this work?
There are different ways to try to create a vaccine, and one of the oldest ways is to do it very simply: you get the whole virus, and you just kill it, and then you use it—or all of its broken-up parts, depending on how you kill it—as the vaccine. Often when you kill the virus, you bang it and break it up. So you hope that the immune system not only will respond to those external pieces but will get greater access to those internal structures that are more stable and constant from mutation to mutation. That’s had some success in the past.
It’s an interesting theory. It may or may not work. There may be more than one road that leads to Rome, as they say. We may have to try them all. So you don’t want to strain yourself in the beginning—because if that one mechanism doesn’t work, then you have to try others, and it’s better to have different teams working on different approaches simultaneously. So I say: Let the scientists loose. Take off their leashes, support them, but let them choose a number of different possibilities because it’s very difficult to predict the winner.
What other challenges of a universal vaccine need to be considered?
We’ve talked about creating the vaccine. The other part of the equation you always have to look at with any vaccine is its safety. What are its side effects? One of the other challenges will be how to design clinical trials to determine how effective the vaccine is. Now we get to the hard part—because, in the past 48 hours, I’ve seen news reports that say, “Well, there’s a desirability to test all new vaccines against a salt solution, a placebo.”
There’s no doubt that that’s the most rigorous way to proceed. Here’s the difficulty: If you already have a vaccine of that type, and it’s already recommended for everybody, is it ethical to give people a placebo? The design of these studies must pass ethical review boards, and it has been standard practice of these review boards to say that if you already have a recommended vaccine, you can’t withhold that and those potential benefits from people and give them a salt solution. You have to devise another way to try to determine the effectiveness of your new vaccine, and that presents different kinds of challenges. You can’t do a placebo-controlled trial, but you might be able to do a comparative trial—the standard vaccine versus the new [universal] vaccine. That might be one way around that.
As mentioned, clinical trials for universal influenza vaccines are already in the works. What’s the thought behind a universal coronavirus vaccine?
The coronaviruses are a family of viruses of which COVID is one [member]. There are four coronaviruses that cause a lot of respiratory illness of a minor kind in humans, and then there were two others that notoriously caused a lot of disease: The SARS virus and the MERS virus. A universal coronavirus vaccine would protect against COVID, MERS, SARS, and a lot of minor respiratory infections that humans get, also that are troublesome, and that have an economic impact. These are viral diseases that cause people to stay home. They can interrupt schooling. So that would be a terrific benefit, going beyond COVID to all of these other viruses in the coronavirus family, and might well protect against some future new coronavirus that would create another pandemic.