One of the high points in President Donald Trump’s speech to a joint session of Congress last week was his pledge to unleash a new era of drug development so grand that “our children will grow up in a nation of miracles.” Yet his main strategy for doing so -- slashing Food and Drug Administration regulations -- won’t solve one of the most pressing health challenges facing the country, and the world.
Over a dozen scientific teams have been working for years on a universal flu vaccine, one potentially capable of providing protection from virtually any possible flu strain -- and more importantly, stop the next flu pandemic in its tracks. But the market alone is not motivated to close the deal for one big reason: flu vaccines currently in production are just good enough to be not worth replacing.
This has been a particularly nasty flu season in the U.S. The CDC reported that 4.8 per cent of people seeking medical care near the end of February complained of flu-like symptoms, more than double the usual percentage. It likely hasn’t helped that this year’s flu vaccine was less than 50 per cent effective, which is worse than average -- but not by that much. But the true failures of the current flu vaccine become apparent when an entirely new strain of flu arises and begins spreading among people. Those periodic events are called flu pandemics, and the world experienced one in 2009, when a new strain of H1N1 jumped from hogs to people.
Even though the virus spread across the globe before vaccines could be developed, produced and distributed, it was fortunately mild. We haven’t always been so lucky. The 1918-19 flu pandemic killed as many as 100 million people worldwide, and another pandemic is inevitable. This winter has already seen an unusual spike in human cases of the H7N9 bird flu in China, where a third of the people infected by the virus have died.
While the U.S. has stockpiled millions of doses of vaccine designed to protect against an earlier strain of H7N9, officials now say that vaccine likely wouldn’t be effective against one strain of the H7N9 virus now infecting people in China. The government is ordering a new H7N9 vaccine to replenish the stockpile, but that will take months, and if H7N9 in the meantime were to further mutate and begin spreading easily between people, the world would have little protection.
But we don’t have to leave ourselves so vulnerable. A universal flu vaccine that could last for years or longer and better protect against both seasonal and pandemic strains of influenza is potentially within our reach, said Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases (NIAID) and the nation’s preeminent disease expert. Dr. Barney Graham, deputy director of vaccine research center at NIAID, has a vaccine candidate that has found success in animal trials. Another researcher, Ted Ross at the University of Georgia, is working on an experimental flu vaccine that uses genetic sequences of flu strains that have been in circulation over the past century to provide broadband protection.
Most ambitious of all may be Dr. Peter Palese at Mount Sinai in New York. Palese and his team have created a “chimeric” flu virus never before encountered by humans in their lab, and then used it to reverse engineer a vaccine that would prime the immune system to target the virus. Palese believes that his team’s candidate -- which should begin early clinical trials soon -- can be a truly universal vaccine that would provide lifelong protection, even against future pandemics.
But if a universal flu vaccine would be, as Ross puts it, a “paradigm changing event in the world,” you wouldn’t know it by the way we’re funding the efforts. Michael Osterholm, the director of Center for Infectious Disease Research and Policy at the University of Minnesota and the co-author of the new book Deadliest Enemy: Our War Against Killer Germs, estimates that only between $35 and $40 million is being spent by government and industry each year on universal flu vaccines, compared to the more than $1 billion a year that goes into HIV vaccine research. “I think we have a chance of getting game-changing vaccines,” he says. “But who is investing?”
Bringing a new vaccine to market takes more than a decade, can easily cost in excess of $1 billion -- and vaccines, unlike prescription drugs, are ideally meant to be used once and then never again. That can be a tough business case to make for any CEO, which is why only four major pharmaceutical companies are still in the vaccine business. And in the case of flu, there’s already a reliable, $3 billion annual market for seasonal vaccines. Any drug company that tries to develop and sell a universal flu vaccine would need to charge considerably more per dose, but there’s no guarantee that such a product would beat out the cheap, standard seasonal vaccine -- even if it is only about 50 per cent effective. Obviously that calculation would change in the panic of a pandemic, but by then it would be far too late.
That’s where the government needs to step in. While there has been money for basic research into a universal flu vaccine, that’s the easy part. What is really needed is sustained, multiyear support for the difficult clinical studies that can help carry candidate vaccines across the valley of death from concept and market -- and much of that has to come from government. As Lawrence Summers said last year, speaking at the release of a National Academy of Medicine report on global health security: “This is the quintessential problem for which we cannot rely on the private sector.”
President Trump says he takes the defence of the country very seriously -- and he’s willing to shift tens of billions of the federal budget to the Pentagon to prove it. Yet pandemic influenza represents a threat to American security as great as any from terrorism and armed conflict. We would be foolish not to spend what we need to protect ourselves. - Bloomberg View