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Tag: following month

  • Pfizer Couldn’t Pay for Marketing This Good

    Pfizer Couldn’t Pay for Marketing This Good

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    On June 3, 2021, a roughly 60-year-old man in the riverside city of Magdeburg, Germany, received his first COVID vaccine. He opted for Johnson & Johnson’s shot, popular at that point because unlike Pfizer’s and Moderna’s vaccines, it was one-and-done. But that, evidently, was not what he had in mind. The following month, he got the AstraZeneca vaccine. The month after that, he doubled up on AstraZeneca and added a Pfizer for good measure. Things only accelerated from there: In January 2022, he received at least 49 COVID shots.

    A few months later, employees at a local vaccination center thought to themselves, Huh, wasn’t that guy in here yesterday? and alerted the police. By that point, the German Press Agency reported, the man had been vaccinated as many as 90 times. And still he was not done. As of November, he said he’d received 217 COVID shots—217!

    That’s according to a new paper published in The Lancet. After German researchers learned of the man from newspaper articles, they managed to contact him via the public prosecutor investigating the case. He was “very interested” in participating in a study Kilian Schober, an immunologist at Uniklinikum Erlangen and a co-author on the paper said in a statement. They pieced together his vaccination timeline through interviews and medical records, and collected blood and saliva samples to examine the immunological effects of “hypervaccination.”

    The man’s identity hasn’t been revealed, and in the paper he’s referred to only as “HIM” (seemingly an acronym, though what it stands for is not specified). He is hardly the world’s only hypervaccinated person. A retired postman in India had reportedly received 12 shots by January 2022 and told The New York Times, “I still want more.” A New Zealand man, meanwhile, allegedly racked up 10 in a single day. But pause for a moment and consider the sheer logistics of HIM’s feat. In all, he received his 217 vaccinations over the course of just under two and a half years, which comes out to an average of seven and a half shots a month, although the distribution was far from even. For several weeks in early 2022, he received two shots nearly every day. He seems to have had a strong preference for the Pfizer and Moderna vaccines, but he also got at least one shot of AstraZeneca and Sanofi-GSK and, of course, Johnson & Johnson.

    Why? you might wonder. The paper itself elides this question, saying only that he did so “deliberately and for private reasons.” Perhaps the most obvious explanation would be extreme, probably pathological COVID anxiety. News reports from April 2022 offer another possible explanation: that he did so to sell the vaccination cards. But German prosecutors did not bring charges once HIM’s scheme was uncovered, and he continued getting unnecessary shots.

    Getting 217 COVID shots is very much not the public-health guidance in Germany or anywhere else. Yet the strategy seemingly panned out: HIM has never contracted COVID, researchers concluded based on antigen tests, PCR tests, and bloodwork. “If you ask immunologists, we might have predicted that it would be not beneficial to do this,” Cindy Leifer, an immunologist at Cornell University who wasn’t involved with the Lancet study, told me. They might have expected the constant action to exhaust the immune system, leaving it vulnerable to actual viral threats. But such worries came to nothing.

    Still, immunologists cautioned against inferring any strong causal connection. He avoided the virus; he got vaccinated 217 times. He did not necessarily avoid the virus because he got vaccinated 217 times. In fact, the authors wrote, although hypervaccination seems to have increased the quantity of antibodies and T cells that HIM’s body produced to fend off the virus—even after 216 shots, the 217th still produced a modest increase—it had no real effect on the quality of the immune response. “He would have been just as well protected if he had gotten a normal number of three to four vaccinations,” Schober told me.

    Nor did hypervaccination lead to any adverse effects. By shot 217, one might have expected to see some of the rare side effects associated with the vaccines, such as myocarditis, pericarditis, or Guillain-Barré Syndrome, but as far as researchers could tell, HIM was completely fine. Remarkably, he didn’t even report feeling minor side effects from any of his 217 shots. On some level, this makes total sense: As Schober reasonably pointed out, HIM probably would not have gotten all those shots if each one had knocked him out for a day. Fair, but still: 217 shots and no side effects? How?

    If nothing else, HIM is one hell of an advertisement for the vaccines. Worried about side effects from your third booster? Well, this guy’s gotten more than 200, and he’s a-okay. Travis Kelce has been called Mr. Pfizer, but he’s got nothing on HIM. Scientifically, things are somewhat murkier. The results of the HIM study were largely unsurprising, researchers told me, but the mysteries at the margins—such as the absence of any side effects—are a good reminder that four years after the pandemic began, immunology is still, as my former colleague Ed Yong wrote, “where intuition goes to die.”

    At the end of the paper, the authors are very clear: “We do not endorse hypervaccination as a strategy to enhance adaptive immunity.” The takeaway, Leifer said, should not be the more shots, the better. Schober told me he even tried to personally convey this message to HIM after his 216th shot. “From the bottom of my heart as a medical doctor, I really told him that he shouldn’t get vaccinated again,” Schober said.

    HIM seemed to take this advice seriously. Then he went and got shot No. 217 anyway.

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    Jacob Stern

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  • Flu Shots Need to Stop Fighting ‘Something That Doesn’t Exist’

    Flu Shots Need to Stop Fighting ‘Something That Doesn’t Exist’

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    Produced by ElevenLabs and NOA, News Over Audio, using AI narration.

    In Arnold Monto’s ideal vision of this fall, the United States’ flu vaccines would be slated for some serious change—booting a major ingredient that they’ve consistently included since 2013. The component isn’t dangerous. And it made sense to use before. But to include it again now, Monto, an epidemiologist and a flu expert at the University of Michigan, told me, would mean vaccinating people “against something that doesn’t exist.”

    That probably nonexistent something is Yamagata, a lineage of influenza B viruses that hasn’t been spotted by global surveyors since March of 2020, shortly after COVID mitigations plummeted flu transmission to record lows. “And it isn’t for lack of looking,” Kanta Subbarao, the director of the WHO’s Collaborating Centre for Reference and Research on Influenza, told me. In a last-ditch attempt to find the missing pathogen, a worldwide network of monitoring centers tested nearly 16,000 influenza B virus samples collected from February to August of last year. Not a single one of them came up Yamagata. “The consensus is that it’s gone,” Cheryl Cohen, the head of South Africa’s Centre for Respiratory Diseases and Meningitis, told me. Officially removing an ingredient from flu vaccines will codify that sentiment, effectively publishing Yamagata’s obituary.

    Read: The flu may never be the same

    Last year around this time, Subbarao told me, the WHO was already gently suggesting that the world might want to drop Yamagata from vaccines; by September, the agency had grown insistent, describing the ingredient as “no longer warranted” and urging that “every effort should be made to exclude it as soon as possible.” The following month, an advisory committee to the FDA unanimously voted to speedily adopt that same change.

    But the switch from a four-flu vaccine to a trivalent one, guarding against only three, isn’t as simple as ordering the usual, please, just hold the Yams. Trivalent vaccines require their own licensure, which some manufacturers may have allowed to lapse—or never had at all; manufacturers must also adhere to the regulatory pipelines specific to each country. “People think, ‘They change the strains every season; this should be no big deal,’” Paula Barbosa, the associate director of vaccine policy at the International Federation of Pharmaceutical Manufacturers and Associations, which represents vaccine manufacturers, told me. This situation is not so simple: “They need to change their whole manufacturing process.” At the FDA advisory-committee meeting in October, an industry representative cautioned that companies might need until the 2025–26 season to fully transition to trivalents in the Northern Hemisphere, a timeline that Barbosa, too, considers realistic. The South could take until 2026.

    In the U.S., though, where experts such as Monto have been pushing for expedient change, a Yamagata-less flu vaccine could be coming this fall. When I reached out to CSL Seqirus and GSK, two of the world’s major flu-vaccine producers, a spokesperson from each company told me that their firm was on track to deliver trivalent vaccines to the U.S. in time for the 2024–25 flu season, should the relevant agencies recommend and request it. (The WHO’s annual meeting to recommend the composition of the Northern Hemisphere’s flu vaccine isn’t scheduled until the end of February; an FDA advisory meeting on the same topic will follow shortly after.) Sanofi, another vaccine producer, was less definitive, but told me that, with sufficient notice from health authorities, its plans would allow for trivalent vaccines this year, “if there is a definitive switch.” AstraZeneca, which makes the FluMist nasal-spray vaccine, told me that it was “engaging with the appropriate regulatory bodies” to coordinate the shift to a trivalent vaccine “as soon as possible.”

    Quadrivalent flu vaccines are relatively new. Just over a decade ago, the world relied on immunizations that included two flu A strains (H1N1 and H3N2), plus one B: either Victoria or Yamagata, whichever scientists predicted might be the bigger scourge in the coming flu season. “Sometimes the world got it wrong,” Mark Jit, an epidemiologist at the London School of Hygiene & Tropical Medicine, told me. To hedge their bets, experts eventually began to recommend simply sticking in both. But quadrivalent vaccines typically cost more to manufacture, experts told me. And although several countries, including the U.S., quickly transitioned to the heftier shots, many nations—especially those with fewer resources—never did.

    Now “the extra component is a waste,” Vijay Dhanasekaran, a virologist at the University of Hong Kong, told me. It’s pointless to ask people’s bodies to mount a defense against an enemy that will never attack. Trimming Yamagata out of flu-vaccine recipes should also make them cheaper, Dhanasekaran said, which could improve global access. Plus, continuing to manufacture Yamagata-focused vaccines raises the small but serious risk that the lineage could be inadvertently reintroduced to the world, Subbarao told me, as companies grow gobs of the virus for their production pipeline. (Some vaccines, such as FluMist, also immunize people with live-but-weakened versions of flu viruses.)

    Some of the researchers I spoke with for this article weren’t ready to rule out the possibility—however slim—that Yamagata is still biding its time somewhere. (Victoria, a close cousin of Yamagata, and the other B lineage that pesters people, once went mostly quiet for about a decade, before roaring back in the early aughts.) But most experts, at this point, are quite convinced. The past couple of flu seasons have been heavy enough to offer even a rather rare lineage the chance to reappear. “If it had been circulating in any community, I’m pretty sure that global influenza surveillance would have detected it by now,” Dhanasekaran said. Plus, even before the pandemic began, Yamagata had been the wimpiest of the flu bunch, Jit told me: slow to evolve, crummy at transmitting, and already dipping in prevalence. When responses to the pandemic starved all flu viruses of hosts, he said, this lineage was the likeliest to be lost.

    Read: The pandemic broke the flu

    Eventually, companies may return to including four types of flu in their products, swapping in, say, another strain of H3N2, the most severe and fastest-evolving of the bunch—a change that Subbarao and Monto both told me might actually be preferable. But incorporating a second H3N2 is even more of a headache than returning to a trivalent vaccine: Researchers would likely first need to run clinical trials, experts told me, to ensure that the new components played nicely with each other and conferred additional benefits.

    For the moment, a slimmed-down vaccine is the quickest way to keep up with the flu’s current antics. And in doing so, those vaccines will also reflect the strange reality of this new, COVID-modified world. “A whole lineage of flu has probably been eliminated through changes in human behavior,” Jit told me. Humanity may not have intended it. But our actions against one virus may have forever altered the course of another.

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    Katherine J. Wu

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