There’s not been much about the federal government’s handling of the COVID-19 pandemic to inspire confidence, so I was not surprised to learn that the experts who gathered last month to help the FDA figure out how to deliver an effective vaccine at “warp speed” seemed unable to even reach a consensus on what the drug should be designed to do.
Some members of the advisory committee, pointing to the pandemic’s recent surge of hospitalizations and its mounting death toll, argued that approval of any vaccine that didn’t demonstrate an ability to save lives was a waste of time and resources — and wouldn’t be accepted by an already skeptical public. “Simply preventing mild cases is not enough and may not justify the risks associated with vaccination,” Peter Doshi, PhD, an associate professor at the University of Maryland School of Pharmacy, tells Kaiser Health News.
But developing a vaccine with proven ability to prevent severe illnesses isn’t something that can be done at a politically palatable speed. Only a handful of new vaccines have been introduced in the past 25 years; a vaccine for HIV, for instance, has eluded Big Pharma since the 1980s. So other members of the panel argued that we will probably have to be content with a dose of something that will prove only marginally effective.
“We’re probably not going to have the perfect vaccine,” concedes Corey Casper, MD, MPH, of Seattle’s Infectious Disease Research Institute. “But I do think we’re likely to have vaccines that, if we can show they’re safe, can put an inflection point on this pandemic.”
Supporters of fast-tracking the vaccine trials point to the measles vaccine as an example of a drug that was initially thought to prevent only mild cases of the disease and later proved to reduce mortality. And while no one is suggesting current efforts would produce something that effective, Casper says the group was “trying to lower that bar and determine how much lower is acceptable.”
But, as Merck CEO Ken Frazier has pointed out, the government’s sprint to a much-hyped vaccine solution to the pandemic does “a grave disservice” to the public. “What worries me the most is that the public is so hungry, is so desperate to go back to normalcy, that they are pushing us to move things faster and faster,” he said in a recent Harvard Business School interview. “Ultimately, if you are going to use a vaccine in billions of people, you’d better know what that vaccine does.”
Amid the controversy over the vaccine’s development, there may be a flawed assumption at work here: As William Haseltine, PhD, president of Access Health International, puts it, “Everyone thinks COVID-19 will go away with a vaccine.”
And that’s not very likely to occur — especially among my compatriots here in Geezerville, who account for 80 percent of pandemic deaths in the United States. Older adults are notoriously prone to infectious diseases and generally not well protected by vaccines. Even in those years when the seasonal flu shot happens to hit on the right viral strain, for example, it only reduces our risk of infection by about half. And just because a vaccine is available doesn’t mean everyone will roll up their sleeves.
Distribution among the Medicare set also presents a challenge. As Thomas Lally, MD, and Marc Rothman, MD, explain in STAT News, some 2 million seniors are permanently homebound and untold millions more suffer from conditions that make even a trip to the doctor a sketchy endeavor. Getting whatever vaccine is eventually approved to them will require a level of strategic competence we’ve not recently observed from federal agencies.
“These challenges must be addressed before a vaccine arrives by putting into place strategies to gain the trust of the public and reach essential adherence rates, which is needed to bring good health to all, including vulnerable and underserved populations,” they write. “To that end, the home setting should be included in vaccine distribution planning.”
Both Lally and Rothman work in the home healthcare industry, so their interest in persuading government to utilize their expertise in fighting the pandemic shouldn’t be surprising. Indeed, they’d like to see public-health officials use the current flu season to test-drive an in-home vaccine program in preparation for the eventual roll-out of the COVID-19 vaccine.
If the current state of affairs at the FDA is any indication, though, they may be expecting way too much way too soon. While Big Pharma struggles and the government dithers, we might be better advised to simply mask up and maintain our social distance — tools that require nobody’s approval but our own.
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