For all the steps public health professionals have taken over the past few years crush comparison while COVID-19 and influenza, indeed there seems to be a lot of effort these days to equate the two.At an advisory meeting convened today, the FDA will showed its intent To Start handing out COVID vaccines, just like flu shots: Once a year, in the fall, for almost everyone, indefinitely. Regardless of brand, primary series shots and boosters (which may no longer be called “boosters”) protect against the same variants and make them interchangeable. Doses are no longer counted numerically. “This will be a radical shift,” said Jason Schwartz, a vaccine policy expert at Yale University.
A hint of the yearly approach, though less subtle, has been declining over the years.but Spring 2021, the CEO of Pfizer had an idea for the annual shot. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: teased That’s through 2022.this he september, joe biden officially approved It’s “a new phase in our COVID-19 response,” Ashish Jha, the White House COVID officer, said. comfortable On combining flu and COVID vaccinations in one appointment, it said:
Still, at today’s meeting, FDA officials said more forceful than ever In advocating for influenza vaccine influenza. Jerry Weir, director of the FDA’s Office of Viral Products, said, “We believe the simplification of vaccination regimens will help ease vaccine deployment, improve communication, and increase vaccination rates. Timing is key: After renewing the US pandemic emergency declaration earlier this month, the Biden administration appears set to allow it to expire in April of this year. It is very useful to repackage the crisis-scale vaccination paradigm that we have developed as regular, seasonal, and normal-looking. , suggesting it’s “no longer in emergency mode,” said Maria Sundaram, a vaccine researcher at the Marshfield Clinic Institute. Or at least, that’s the message the public is likely to hear.
But federal regulators may be trying to fit the COVID-type peg into the flu-type hole. The experts I spoke to largely agreed: Ultimately, sometimesGregory Poland, a vaccine specialist at the Mayo Clinic, says the annual fall shot for COVID “probably will be enough.” “Are we ready for that yet? I’m not sure at all.”
Even in the short term, COVID-vaccination tactics need to be reviewed. “First and foremost, it’s clear that the current approach isn’t working,” Schwartz told me. Despite plentiful supply, demand for his COVID boosters in the US is very low, and interest seems to dwindle with each additional dose.Last autumn’s bivalent shot just reached my arm 15% of Americanseven among adults over age 65 who sign up for influenza vaccination each fall, vaccination coverage is not yet reached 40%.
For most of the time COVID-19 vaccination has become available, it has been cumbersome to determine when to vaccinate, with guidelines and requirements varying according to age, gender, risk factors, vaccination history, etc. Pharmacies had to stock a bewildering number of vials and syringes to accommodate the various combinations of brands and doses. Keeping records on flimsy paper cards was a complete joke. “I do this for a living, and it’s almost untraceable,” says Schwartz. Recommendations regarding proper timing and number of doses have also changed so many times that many Americans have checked them out. poll found A surprising percentage of people didn’t even know shots were available.
Streamlining COVID vaccine recommendations would eliminate much of that headache, Sundaram said. Most people only have to keep her one mantra in mind, that he takes one dose each fall, and can satisfy the flu and her COVID immunity at the same time. It reduces the burden on pharmacies and clinics and makes communication much easier. This change could make a particularly big difference for those whose children have the lowest COVID vaccine coverage. Charlotte Hobbs, a pediatric infectious disease specialist at the University of Mississippi Medical Center, says, “It will be more planned and systematic.” A COVID-19 shot, she told me, can easily be provided by her at one pediatric visit a year. “We already know that it works.”
Convenience is not the only benefit of vaccination against influenza virus. If a COVID vaccine needs to be pushed into the existing paradigm, Sundaram told me, influenza is the best candidate. I am good at it. Spreads easily in winter. And immunity to infection tends to decline rapidly. All of this leads to the need for regularly updated shots. Such systems have been implemented for decades against influenza. At the end of each winter, a panel of experts convenes to select strains for the next formulation.Manufacturers will spend the next few months building large batches in time for rollouts like the fall. Dependent About the global surveillance system for influenza viruses and regular surveys of antibody levels in the community to determine which strains people are still protected from. This premise has been well-tested by now, as it allowed researchers to skip the chore of running large clinical trials to determine the efficacy and safety of each newly updated recipe. rice field.
But seasonal strategies are most effective against seasonal viruses, and SARS-CoV-2 does not yet exist, said Hana El-Salih, an infectious disease specialist at Baylor College of Medicine. increase. Influenza viruses tend to shuttle between the Earth’s hemispheres, afflicting the North and South alternately during each cold season, but the new coronavirus has yet to confine its spread to any part of the calendar. (FDA’s Marks attempted to address this concern at today’s meeting, arguing that “we’re starting to see seasonality,” making that fall very sensible for an annual rollout.) SARS-CoV- 2 are also spitting out. Out on variants and subvariants at a faster rate than the flu (and flu vaccinations are already struggling to keep up with evolution). New FDA Proposal suggest Select a SARS-CoV-2 variant in June to have a vaccine ready by September, a shorter timeline than influenza. It may not be fast enough yet.”By the time we detect the subspecies, it will have ripped through the world’s population and will be gone in a few more weeks. This overlapped with the subvariant dominance of the target for only two months.Avnika Amin, a vaccine epidemiologist at Emory University, says that “if we have stable and predictable dynamics,” COVID ‘s influenza model would make more sense. “I don’t think we are at that point.”
Ambiguity about vaccine efficacy also complicates this transition. Determining how effective a coronavirus vaccine is and for how long is becoming increasingly difficult, experts say. refueling discussion About how often they should be given and how often their composition should be changed. Many people are now infected with the virus multiple times, which could obscure the calculations of vaccine efficacy. Better treatments also change the risk profile. And many researchers told me they were concerned that the data shortcut we use for flu—measurement of antibodies as a surrogate for immune protection—won’t work for COVID vaccination. “We need better clinical data,” El Sahly told me. In their absence, hasty adoption of an influenza framework may result in too frequent or insufficient COVID vaccination updates and distributions.
Even a flu-like approach won’t solve all the problems of COVID vaccines. Today’s discussion suggests that even with the new COVID shot strategy changes, the authorities still need to recommend several different dose sizes for several different age groups. At the same time, COVID immunizations continue to be more targeted by misinformation campaigns than many other vaccines, and are more likely to cause nasty side effects, at least for mRNA-based injections. Angela Shen, a vaccine policy expert at the Children’s Hospital of Philadelphia, says these and other issues are declining attention, and that simply reorienting to the flu paradigm “doesn’t solve the uptake problem.” said.
Perhaps the biggest risk of making the COVID vaccine more like a flu shot is that it can lead to more complacency. modelwe also have it sealingFlu vaccinations are essential public health tools that save lives, but they are by no means the best performing vaccines on our roster. Their timelines are slow and inefficient. As a result, formulations do not always match circulating strains. Already, with COVID, the world is struggling to keep track of variants with vaccines that simply can’t keep up. Experts say moving too quickly to a good but flawed framework for influenza could discourage research into his COVID vaccine, which is more durable, variant-resistant and has fewer side effects. There is a nature. The diffusion rate of influenza vaccine is also not high. half of americans Sign up for an annual shot. Despite years of valiant efforts, “I have yet to find a way to improve it consistently,” Amin told me.
Vaccinations will almost certainly have to change whenever the COVID emergency declaration expires. Access to injections could be jeopardized for tens of millions of uninsured Americans. Local public health departments may have even fewer resources to disseminate vaccines. Influenza models may improve the status quo.But if the negatives outweigh the positives, Poland told me it could help erode public confidence. At multiple points during today’s meeting, FDA officials said COVID no influenza. They are right that COVID is not the flu and never will be. But vaccines can be a lens through which we see the dangers they fight. By equating the frontline response to these viruses, the United States risks sending the wrong message.
