The Flu-ification of COVID Policy Is Almost Complete

Despite all the work public health experts have done over the past few years to quash comparisons between COVID-19 and the flu, there seems to be a lot of effort nowadays to equate the two. At an advisory meeting earlier today, the Food and Drug Administration indicated its intention to begin distributing COVID vaccines just like flu vaccines: once a year in the fall, to nearly everyone, ad infinitum. Whatever the brand, the initial series stills and boosters (no longer called “boosters”) will protect against the same variants, making them interchangeable. Doses will no longer be numerically calculated. “This will be a fundamental shift,” says Jason Schwartz, a vaccine policy expert at Yale University, the biggest change to the coronavirus vaccination system since it first emerged.

Hints about the annual approach have been dropping, not subtly, for years. Even in the spring of 2021, the CEO of Pfizer was broaching the idea of ​​annual shots; Peter Marks, director of the FDA’s Center for Biologicals Evaluation and Research, has teased this topic throughout 2022. Last September, Joe Biden officially endorsed it as “a new phase in our response to COVID-19,” and Ashish Jha, the White House COVID Kaiser, memorably highlighted the convenience of combining a flu vaccine and a COVID vaccine in one appointment: “I really think that’s why God gave us two arms.”

However, in today’s meeting, FDA officials were more insistent than ever in their call for influenza vaccines for COVID. “We believe that simplifying the vaccination system will contribute to easier vaccine deployment, better communication, and better vaccine coverage,” Jerry Ware, director of the FDA’s Division of Viral Products, said at the meeting. Timing matters: After renewing the US pandemic emergency declaration earlier this month, the Biden administration appears ready to let it expire next April. This makes the present moment all the more opportune to repackage the chaotic, crisis-level vaccination model as a seemingly mundane, seasonal, scheduled model. A once-a-year strategy, similar to a routine recommendation, says Maria Sundaram, a vaccine researcher at the Marshfield Clinic Research Institute, suggests we are “no longer in an emergency.” Or at least, that’s the message the public is most likely to hear.

But federal regulators may be trying to put a COVID-shaped peg into a flu-shaped hole. The experts I spoke with largely agreed: SomedayAnnual fall COVID shots “will likely be sufficient,” says Gregory Poland, a vaccinologist at the Mayo Clinic. “Are we ready for that yet? I’m not sure that’s the case at all.”

Even in the short term, coronavirus vaccination tactics need a revamp. “It’s clear above all else that the current approach isn’t working,” Schwartz told me. Despite plentiful supply, demand for COVID boosters in the United States has been bad — and interest seems to wane with each additional dose. Last fall’s bivalent shot reached the arms of just 15 percent of Americans. Even among adults over 65 — most of whom sign up for flu shots every fall — the vaccination rate has not yet reached 40 percent.

Most of the time COVID shots have been around, figuring out when to get them was tedious, with different guidelines and requirements based on age, gender, risk factors, vaccination history, and more. Pharmacies had to stock an unreasonable number of vials and syringes to accommodate the various brand formulations and dose sizes; The record keeping on flimsy paper cards was a complete joke. “I do this for a living,” Schwartz said, “and I can barely keep track of it.” Recommendations for proper timing and number of doses have also changed so many times that many Americans simply checked them out. After the bivalent prescription first came to light, surveys found that an alarming percentage of people didn’t even know a shot was available to them.

Simplifying COVID vaccine recommendations would take away a lot of that headache, Sundaram told me. Most people will only need to keep one mantra in mind — one dose, every fall — and they can get their immunity to flu and COVID at the same time. Burdens on pharmacies and clinics would be lower, and communication much easier — a change that could make an especially big difference for those with children, among whom the uptake of the COVID vaccine has been the lowest. “It’s going to be more scheduled, more systematic,” says Charlotte Hobbs, MD, a pediatric infectious disease specialist at the University of Mississippi Medical Center. She told me that COVID shots can simply be offered at annual childcare visits. “It’s something we already know works well.”

The advantages of the COVID flu shot aren’t just about convenience. Sundaram told me that if we have to put COVID vaccines into a stand-alone model, influenza is the best candidate. SARS-CoV-2, like the flu, is excellent at altering itself to evade our defenses; It spreads easily in winter. Our immunity to infections tends to wane quickly. All of this adds to the need for regularly updated snapshots. Such a system has existed for decades for influenza: At the end of each winter, a panel of experts meets to choose which strains the next formula should target; Manufacturers spend the next several months collecting large batches in time for the fall season to begin. The pipeline relies on a global surveillance system for influenza viruses, as well as regular surveys of antibody levels in the community to see which strains people are still protected from. The hypothesis has been so well vetted so far that researchers can skip the chore of conducting large-scale clinical trials to determine the efficacy and safety of each new and updated prescription.

But the seasonal strategy works best for a seasonal virus—and SARS-CoV-2 wasn’t there yet, says Hana Al-Sahli, MD, an infectious disease physician at Baylor College of Medicine. Although influenza viruses tend to travel between hemispheres, alternating north and south during their respective cold months, this new coronavirus did not limit its spread to one part of the calendar. (Marx, of the Food and Drug Administration, tried to address that concern at today’s meeting, asserting that “we’re starting to see some seasonality” and that this fall has already made a lot of sense for annual circulation.) SARS-CoV-2 has also been spitting in terms of variants and sub-variants at a rate Faster than the flu (and flu vaccines are already having a hard time keeping up). The new proposal from the FDA suggests selecting SARS-CoV-2 variants in June to have a vaccine ready by September, which is a shorter timeline than what’s used for influenza. That may not be fast enough: “By the time we discover a variant, it will have ripped through the world’s population, and in a few more weeks,” Al-Sahli told me. The world got a preview of this problem with a bivalent shot last year, which overlapped the dominance of target subvariants by just two months. An influenza model for COVID would make more sense “if we had stable and predictable dynamics,” says Avnika Amin, a vaccine epidemiologist at Emory University. “I don’t think we’re at that point.”

Uncertainty about the vaccine’s efficacy also makes this transmission complicated. It’s becoming much harder to know how well our COVID vaccines work, and for how long, experts told me, fueling discussions about how often they should be given and how often their formulation should be changed. Many people have now contracted the virus multiple times, which could muddy calculations of a vaccine’s efficacy; Better treatments also change risk profiles. And several researchers told me they worried that the data shortcuts we use for influenza — measures of antibodies as a surrogate for immune protection — wouldn’t fly to get COVID shots. “We need better clinical data,” Al-Sahli told me. In their absence, hasty adoption of the influenza framework may cause COVID shots to be updated and distributed more often, or less often.

Nor will the flu approach fix all of the problems with COVID vaccines. Today’s discussion suggested that even if a new COVID-shot strategy were changed, officials would still need to recommend several different dose sizes for many different age groups—a more complex regimen than influenza—and may recommend additional shots for those at high risk. . At the same time, COVID shots will continue to be more of a target for disinformation campaigns than many other vaccines, and at least in the case of mRNA-based injections, they are more likely to cause troublesome side effects. These and other issues have led to diminished interest — and simply focusing on the influenza model “isn’t going to solve the uptake problem,” says Angela Shin, a vaccine policy expert at Children’s Hospital of Philadelphia.

Perhaps the biggest danger in making COVID vaccines more like flu vaccines is that it could lead to more complacency. In model making of influenza A modeland also threaten to make it a roof. Although flu vaccines are an essential, life-saving public health tool, they are by no means the best-performing vaccine on our list. Their schedule is slow and inefficient. As a result, the combinations do not always match the prevalent strains. Already, with COVID, the world has struggled to chase variants with vaccines that simply can’t keep up. Experts tell me that if we move too quickly to the rigorous but flawed influenza framework, it could dampen research into COVID shots that are more durable, more resistant to variety, and have fewer side effects. Access to flu shots has never been stellar: Only half of Americans sign up to get vaccinated each year—and despite years of valiant efforts, “we still haven’t figured out how to continually improve it,” Amin tells me.

When the COVID-Emergency Proclamation expires, vaccination will almost certainly change. The shots could put tens of millions of uninsured Americans at risk; Local public health departments may end up with fewer resources for vaccine education. The influenza model may offer some improvements to the status quo. Poland told me that if the negative aspects outweigh the positives, it could erode public confidence. Either way, it could distort attitudes toward the coronavirus in irreversible ways. At multiple points during today’s meeting, FDA officials emphasized that COVID is no flu. They’re right: COVID is not the flu, and it never will be. But vaccines can sometimes become a lens through which we see the risks they face. By equating our frontline responses to these viruses, the United States risks sending the wrong message that they carry the same threat.


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