ReportWire

Tag: annual COVID shot

  • FDA Panel Backs Shift Toward One-Dose COVID Shot

    FDA Panel Backs Shift Toward One-Dose COVID Shot

    [ad_1]

    Jan. 26, 2023 – A panel of advisers to the FDA unanimously supported an effort today to simplify COVID-19 vaccinations, with the aim of developing a one-dose approach — perhaps annually — for the general population.

    The FDA is looking to give clearer direction to vaccine makers about future development of COVID-19 vaccines. The plan is to narrow down the current complex landscape of options for vaccinations, and thus help increase use of these shots. 

    COVID remains a threat, causing about 4,000 deaths a week recently, according to the CDC. 

    The 21 Members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously “yes” on a single question posed by the FDA: 

    “Does the committee recommend harmonizing the vaccine strain composition of primary series and booster doses in the U.S. to a single composition, e.g., the composition for all vaccines administered currently would be a bivalent vaccine (Original plus Omicron BA.4/BA.5)?”

    In other words, would it be better to have one vaccine potentially combining multiple strains of the virus, instead of multiple vaccines – such as a two-shot primary series then a booster containing different combinations of viral strains.

    The FDA will consider the panel’s advice as it outlines new strategies for keeping ahead of the evolving virus.

    In explaining their support for the FDA plan, panel members said they hoped that a simpler regime would aid in persuading more people to get COVID vaccines.

    Pamela McInnes, DDS, MSc, noted that it’s difficult to explain to many people that the vaccine worked to protect them from more severe illness if they contract COVID after getting vaccinated. 

    “That is a real challenge,” said McInness, a retired deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health.

    “The message that you would have gotten more sick and landed in the hospital resonates with me, but I’m not sure if it resonates with” many people who become infected, she said.

    The Plan

    In the briefing document for the meeting, the FDA outlined a plan for transitioning from the current complex landscape of COVID-19 vaccines to a single vaccine- composition for the primary series and booster vaccination. 

    This would require:

    • Harmonizing the strain composition of all COVID-19 vaccines;

    • Simplifying the immunization schedule for future vaccination campaigns to administer a two-dose series in certain young children and in older adults and persons with compromised immunity, and only one dose in all other individuals;

    • Establishing a process for vaccine strain selection recommendations, similar in many ways to that used for seasonal influenza vaccines, based on prevailing and predicted variants that would take place by June to allow for vaccine production by September.

    During the discussion, though, questions arose about the June target date. Given the production schedule for some vaccines, that date might need to shift, said Jerry Weir, PhD, director of the division of viral products at FDA’s Center for Biologics Evaluation and Research. 

    “We’re all just going to have to maintain flexibility,” Weir said, adding that there is not yet a “good pattern” established for updating these vaccines. 

    [ad_2]

    Source link

  • Are We Really Getting COVID Boosters Every Year Forever?

    Are We Really Getting COVID Boosters Every Year Forever?

    [ad_1]

    School is in session, pumpkin spice is in season, and Americans are heading to pharmacies for what may soon become another autumn standby: your annual COVID shot. On Tuesday, the White House announced the start of a “new phase” of the pandemic response, one in which “most Americans” will receive a COVID-19 vaccine just “once a year, each fall.” In other words, your pandemic booster is about to become as routine as your physical exam or—more to the point—your flu shot. One more health-related task has been added to your calendar, and it’s likely to remain there for the rest of your life.

    From a certain standpoint, this regimen makes a lot of sense. The pandemic’s biggest surges so far have come in the winter, and a fall booster could go a long way toward mitigating the next of those surges. What’s more, the new plan greatly simplifies COVID-vaccination regimens, both for the public and for providers. “It has been bewildering in many cases to understand who is eligible for a booster, how many boosters, when, which boosters, how far apart,” Jason Schwartz, a vaccine-policy expert at Yale, told me. “I think that has held down booster uptake in some really discouraging ways.” In a sense, White House COVID-19 Response Coordinator Ashish Jha told me, the new plan just codifies the way things already worked: The last time low-risk Americans became eligible for another shot was last fall. (The elderly and immunocompromised have operated on a different schedule and will likely continue to do so, Jha said.)

    Still, some public-health experts worry that the White House is jumping the gun. Back in April, a number of them told Stat News’s Helen Branswell they were concerned that the U.S. would adopt such a policy without the data needed to support it. When the White House made its announcement on Tuesday, many felt their concerns had been vindicated. “We’ve had twists and turns and surprises every single step of the way with COVID, and the idea that we’re going to have one shot and then we’re done is not really consistent with how things have worked in the past,” Walid Gellad, a professor at the University of Pittsburgh School of Medicine, told me. The plan, in his view, glosses over considerable uncertainties.

    For one thing, it assumes that the virus will follow an annual schedule with peaks in the fall and winter—not unlikely, but also not a given. For another, we still don’t have a firm grasp on the magnitude or duration of the benefits offered by the new Omicron-specific vaccine. For all we know, Gellad told me, the added protection afforded to someone who gets the shot tomorrow may have largely dissipated by New Year’s Eve.

    And that’s not to mention the massive uncertainty presented by the specter of future variants. In a briefing Tuesday, Jha acknowledged that “new variant curveballs” could change the government’s plans. But the announcement itself includes no such caveats, which some public-health experts worry could cause problems if course corrections are needed down the line. For all we know, new variants could necessitate more frequent updates, or, if viral mutation slows, we might not even need annual shots, Paul Thomas, an immunologist at St. Jude Children’s Research Hospital, in Tennessee, told me.

    If the routine the White House describes sounds a lot like flu shots, that’s no accident. The announcement explicitly recommends that COVID vaccines be taken between Labor Day and Halloween—“just like your annual flu shot.” That comparison, though, is part of what concerns critics, who worry that the shift into a more flu-like framework will entail the adoption of a vaccines-only approach to COVID prevention. Many of the interventions that have proved so effective over the past two and a half years—masking, distancing, widespread testing—have not traditionally been a major part of our flu-season protocols. If we treat COVID like flu, the thinking goes, such interventions risk falling even further by the wayside. The announcement, which makes no mention of any other prevention tactics, doesn’t offer much reassurance to the contrary.

    But that reading, Jha told me, is “just clearly wrong.” Although vaccines are “the central pillar of our strategy,” he said, testing, masking, and improving indoor air quality are all important as well. But as my colleague Katherine Wu has written, the country has been relying more and more on vaccines—and less and less on the other interventions at our disposal—for some time. Even if you do read the new policy as an abnegation of masking, ventilation, and the like, it may not functionally be much of a departure from the status quo.

    For now, Thomas said, the White House’s plan makes sense—as long as it stays sensitive to changing circumstances. “We keep learning new things about this virus,” he told me. “The rate of mutation is changing. The spread through the population is changing.” And as such, he said, our response must be flexible.

    The White House announcement seems like a good-faith attempt to balance competing priorities: on the one hand, the need to communicate uncertainty and acknowledge complexity; on the other, the need to keep the message from getting so complex that it confuses people to the point that they tune it out entirely. In this case, the administration seems to have come down on the side of simplicity. That could be a mistake, Gellad says—one that public-health authorities have made over and over throughout the pandemic. “When you try and make things simple and understandable and present them without sufficient uncertainty,” he told me, “you get into trouble when things change.”

    [ad_2]

    Jacob Stern

    Source link