World The Danger of a ‘Dudes-Only’ Vaccine
Young Australians' hopes for an overseas holiday could be dashed
Australia had been aiming to open its international borders beyond New Zealand from the end of October when every citizen was expected to receive at least their first vaccine dose. But that timeline is now almost impossible to meet following Thursday's announcement the AstraZeneca Covid-19 vaccine - which Australia had purchased the most doses of - was no longer recommended for under 50s, only the Pfizer jab.
The Johnson & Johnson shot is teetering on the precipice of becoming America’svaccine. On Tuesday, the CDC and FDA advised to investigate six cases of that’s occurred in people within about two weeks of receiving the vaccine—all of them women under the age of 50. In an emergency meeting convened Wednesday by the CDC, experts raised the possibility of , reserving Johnson & Johnson’s vaccine, , for johnsons alone.
That idea, crude though it may be, has something to it. The demographic pattern that’s emerged is striking, and many of the experts I talked with this week told me they suspect that, if the vaccine is ultimately linked to these clots, the relationship will come with a clear-cut sex or gender difference too. (These questions are also beingwith regard to the , which contains comparable ingredients and might very rarely cause a similar or identical type of .)
Here's why the AstraZeneca COVID vaccine is recommended for over 50s but not other Australians
But if you're wondering what Australia's vaccine changes mean for you, or whether it's still safe to take the AstraZeneca vaccine, here's what the expert advice is saying.With the government accepting advice that the small risk of blood clots associated with the AstraZeneca vaccine means it should not be given to people under 50, its plan to vaccinate Australians against the virus is in disarray.
But health officials have strongly cautioned that it’s too early to tell for certain whether a specific subset of the population is at increased risk of this clotting disorder; scientists haven’t even definitively pinpointed the J&J shot as its cause. Prematurely masculinizing the J&J vaccine could not only reinforce, but also run counter to one of the most important goals of the ongoing pause: identifying what factors, if any, do contribute to these unusual clots, and protecting the people they affect.
The post-vaccination clots under investigation belong to a class called cerebral venous sinus thrombosis (CVST), and they seem to manifest when antibodies, perhaps produced in response to the shots, inadvertently rile up platelets in the blood. Platelets exist to keep wounds from bleeding indefinitely: They clump blood cells and proteins together to plug up leaks. But in CVST, they seem to spark a clotting cascade that can clog veins in dangerous places, including the brain, and lead platelet levels to plunge. The disorder is a collision between a powerful immune response and a naturally clot-prone environment; a potentially simple explanation for why they might show up more in women is that the hormone estrogen can amp up both of these factors.
Australia needs to rethink its Covid-19 vaccine rollout, doctor says
Epidemiologist professor Nancy Baxter says the Federal Government won't reach its target to have the entire population vaccinated by the end of the year if they continue on the current trajectory. 'We need to do it faster than we were hoping before, if we're hoping to get everyone vaccinated by the end of the year,' she told Weekend Today. Her doubts come after several setbacks to the vaccine program, which include a delayed rollout and advice, from the country's chief immunisation authority, against the use of the AstraZeneca vaccine.
Estrogen has many jobs in the body, and in a lot of contexts, it’s an instigator: It can boost a person’s propensity to clot, and it can goad immune cells intoto pathogens and vaccines. (There’s also some evidence that can make immune systems .) CVSTs are rare among the general population, but are . Menaka Pai, a hematologist who specializes in blood clots at McMaster University, in Ontario, likens clotting to falling off a cliff; estrogen, among other things, “pushes us closer to the edge.”
Estrogen and chromosomes aren’t the only variables here, though. Physiology undoubtedly influences a person’s responses to diseases, treatments, and vaccines, butand social factors can, too. In recent weeks, have cropped up amid millions of doses of the AstraZeneca shot (which hasn’t yet been green-lit in the United States). As with the J&J effect, most of these cases involved younger women. But in certain countries, women also who were inoculated early on, weakening the clots’ link with gender. Some experts I talked with also noted that women tend to stay in more frequent contact with their health-care providers than do men, and might feel less wary about reporting unusual side effects or symptoms after getting a vaccine.
Karl Stefanovic says he is nervous about getting the AstraZeneca jab
Today host Karl Stefanovic, 46, said on Monday he would preference waiting for an alternative vaccine such as Pfizer over being administered doses of the AstraZeneca jab.Stefanovic, 46, said on Monday he would preference waiting for an alternative vaccine such as Pfizer over being administered doses of the AstraZeneca jab, when speaking to Professor Kristine Macartney.
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If researchers confirm that these two vaccines are operating in similar ways, “being older, being a man—that’s not going to protect you,” Pai told me. In addition to the six cases in women, researchers are now reevaluating a potentially similar CVST case that was. Still, the extreme gender trend in the early J&J reports has been hard to ignore. Prior to the pause, of men and women had received the company’s shot, according to the CDC. I asked Alfred Lee, a hematologist at Yale New Haven Hospital, how often his discussions with colleagues about the clotting disorder had turned to the topic of sex or gender since Tuesday’s news broke. “Literally almost every single one,” he told me. Lee and his team are now being particularly vigilant about monitoring their recently vaccinated female patients, especially those taking estrogen-containing oral contraceptive pills—the group of people they’ve deemed to be “high-risk right now,” he said.
Vaccine Hesitancy Could Create COVID Islands
Public-health leaders in rural America are turning toward the next and more difficult stage of the nationwide vaccination campaign: persuasion.This is the future that keeps some public-health experts awake at night. Right now, America is in the simplest stage of its vaccination campaign: getting shots to people who want them. But many Americans are still reluctant to get a vaccine—especially those living in rural areas, who tend to be politically conservative and are among the most fervently opposed to inoculation. Public-health leaders will soon have to refocus their efforts toward the next and more difficult stage of the campaign: persuasion.
It’s heartening, several people told me, to see the possibility of sex and gender differences in vaccine side effects being openly acknowledged and addressed. For years, gender norms havein ways that haven’t served patients well—by dismissing women’s “hysterical” complaints of pain, for instance, or accusing them of falsifying their symptoms. But grabbing onto a still-tenuous link between sex and certain side effects could create problems, too. The seemingly obvious culprit of estrogen, for example, could end up obscuring some more obtuse cause. Sarah Richardson, the director of the Harvard GenderSci Lab, pointed me to the case of the sleep aid zolpidem, also known by its brand name Ambien. In 2013, the FDA that women should receive a lower dose of the drug than men. The agency claimed that women’s bodies were more sluggish at clearing Ambien, leaving female users more cognitively impaired eight hours after ingesting it. That analysis later turned out to be , in part because the agency hadn’t properly accounted for differences in body weight; the drug wasn’t leaving all women worse off. “There isn’t any scientific evidence supporting sex-based dosage for zolpidem,” Richardson wrote in a for The Washington Post. Ambien, once hailed as a “flagship example of how sex differences can influence health,” she wrote, has morphed into a cautionary tale.
How to develop vaccines faster before the next pandemic
There will be another pandemic. Here are five ways we can fund research now to end it faster.But it was still a full year between the pandemic’s onset and the beginning of mass vaccine distribution, a year in which millions of people have died, global poverty has spiked, and people everywhere have suffered.
To truly home in on what’s at play with the Johnson & Johnson vaccine, Richardson told me, researchers will need to consider factors such as age, sex, gender, race, ethnicity, medical history, evento health-care providers, and figure out how these variables intersect. That work is extraordinarily hard to do with just a handful of people, a likely reason the vaccine’s pause has been prolonged—so more data could be collected and analyzed. “People are really interested in the gender thing,” Lee, of Yale, told me. “But we can’t prove it yet.” That’s in part why a universal halt—one that didn’t segregate by gender, age, or any other demographic—was probably “the right approach” for now, Janna Shapiro, who studies sex differences in immune responses at Johns Hopkins University, told me.
Categorizing these clotting events incorrectly or too early also comes with dangers. The repetitive association of women and clots could stoke vaccine hesitancy in skewed ways. One recent poll showed that public confidence in the safety of the J&J vaccine, and Elaine Hernandez, a medical sociologist at Indiana University, told me she’s concerned that reluctance about vaccines might concentrate among certain subgroups of women. She and her colleagues have found that young women who are Black and Latinx—groups that already have more limited access to vaccines—are more wary of getting immunized than their white peers.
Pushing this association too hard and too quickly could also skew data collection. Health workers could narrow their clinical lens; women might scour themselves for symptoms, while men and other people who don’t identify as women “may not take the symptoms [of CVST] seriously,” Krutika Kuppalli, an infectious-disease physician and vaccine expert at the Medical University of South Carolina, told me. That bell could be especially tough to un-ring in a culture where masculinity is so often considered incompatible with sickness. “People want to appear strong and tough, men in particular,” Hernandez told me. “There are already social pressures to not complain.” Casting the clotting condition as a “female problem” too early means donning blinders. “That’s troubling for the objectivity of the investigation going forward,” Richardson, of Harvard, said. (There’s still a paucity of data on whether transgender, intersex, or nonbinary people, especially those who are on hormonal therapies, might be vulnerable to unique vaccine side effects.)
Is it time for Australia to dump its vaccination strategy and start making its own vaccine?
The vaccine rollout is done for and there's no real plan to get it back on track. Is it time to roll up our sleeves and get the job done ourselves?Today: in the face of new COVID-19 variants and supply shortages, is it time to stop relying on foreign companies and start manufacturing our own vaccines in earnest?
If a clear sex or gender difference does emerge, nuanced messaging will be necessary. As coronavirus cases surge, the risk of taking the vaccine might still be relatively low, especially in parts of the country where the fragile Pfizer and Moderna vaccines are harder to store and administer. Restricting the vaccine to certain age or gender groups could seed equity issues, both in the U.S. and internationally, or trigger repeated rounds of sociopolitical fallout. Shapiro pointed to the HPV vaccine, which was initially targeted to adolescent girls. The shots are now recommended for children of all genders, but misperceptions of the early rollout stigmatized the mostly femalewho signed up for the shots as promiscuous, and the sole bearers of disease.
The goal in the coming days and weeks, Pai told me, is to appropriately titrate expectations of risk—to address concerns, but also avoid sensationalizing them. Our understanding of the clots’ danger could shift quickly as more data are collected. The dangers implied by six cases of a rare clotting disorder out of the roughly 7 million Americans who have received the J&J shot is much lower than the risk implied by six cases within the smaller population of the. But now that physicians know what to look for, the numerator in that ratio will likely change as well. More cases will certainly appear, spanning a wider range of genders, ages, races, and ethnicities. These shifting odds will be easier to communicate if our lens isn’t unnecessarily narrowed: Expanding the definition of an at-risk population is harder than paring it down.
The suspension might already seem frustratingly long to some; plenty of people have called it out as cowardly and unwise, and questioned why federal officials prolonged it. But nearly everyone I’ve spoken with this week has praised the move as prudent, during a time of great uncertainty about who’s most at risk. “Ideally, we find out over time which vaccines are best for which groups, and why,” Leana Wen, an emergency physician affiliated with George Washington University, told me. “That’s the positive way of seeing this—this is in part the kind of information we’re getting here.”
We now have a solution to Covid-19 hotspots. Let’s use it. .
There’s no reason to let cities or states suffer when the US has the vaccines.The idea is straightforward: If a place sees a surge in Covid-19 cases, it should get a surge in Covid-19 vaccinations. That doesn’t mean just more doses of the vaccine, but also more people who can actually administer the shot, resources that bring vaccines closer to workplaces and homes, and education and awareness efforts to convince more of the public to get the shot.