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New Booster Approvals, Data on Kids’ Shots, and More News

New Booster Approvals, Data on Kids’ Shots, and More News

More boosters are approved, kids’ shots prove effective, and more countries open up. Here’s what you should know:

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The FDA and CDC approve Moderna and J&J boosters

Yesterday, the US Centers for Disease Control and Prevention endorsed boosters for eligible people who received initial doses of the Moderna or Johnson & Johnson vaccines, which means that tens of millions more Americans can get an additional shot as soon as today. The agency’s approval followed similar authorization from the FDA the day prior. The FDA, and later the CDC, also said that people who are eligible for boosters can get them from a different drugmaker than their first shots. There’s some evidence to show that any extra dose increases immunity, and in particular that people who got a first shot from Johnson & Johnson had a much better immune response if they got a second dose of an mRNA vaccine. The FDA said anyone who got a Johnson & Johnson shot is eligible for a booster two months after their initial vaccination.

Already, there are more boosters than first doses being administered in the US. But some medical ethicists and international organizations continue to voice their dismay with the way the US has prioritized eradicating any infection within its own borders over helping other countries secure initial doses, thereby reducing severe illness and death worldwide.

Pfizer and BioNTech submit data to the FDA demonstrating their vaccine’s efficacy in kids

Pfizer and BioNTech submitted data to the FDA today showing that their Covid-19 vaccine proved 90.7 percent effective at preventing symptomatic disease in children ages 5 to 11 during clinical trials. Participants received one-third of the adult dosage and saw only mild side effects. There were no cases of severe illness or myocarditis or pericarditis, heart conditions that have been seen in some other age groups of vaccine recipients, notably young men. Earlier this week the White House outlined its plan for distributing shots to kids once they’re approved, which could happen within weeks. The administration will partner with pediatricians’ offices and community clinics, among other health care providers, and will focus on educating parents about the shots.

Pfizer and BioNTech also filed with Health Canada for approval of their vaccine in younger kids this week. When it comes to vaccinating adolescents, Canada has been an exemplar. It was the first country to approve shots for kids ages 12 to 15 last spring, and more than 80 percent of Canadians 12 and older are fully inoculated.

Countries around the world ease restrictions for vaccinated residents and tourists

On Friday, Melbourne, Australia’s second-largest city, reopened after being locked down for 262 days, the longest cumulative lockdown for any city in the world during the pandemic. It follows in the footsteps of Sydney, where restrictions began easing two weeks ago. Starting next month, fully vaccinated international travelers will no longer need to quarantine when entering the two cities. In neighboring New Zealand, Prime Minister Jacinda Ardern said that country’s lockdown will end when 90 percent of eligible residents are vaccinated; so far, 86 percent of the population has received at least one dose. Kuwait also announced it will lift restrictions for people who’ve been vaccinated. And Thailand has said it will open up to visitors who’ve received their shots.

Covid Misinformation Protests, Pediatric Cases, and More News

Covid Misinformation Protests, Pediatric Cases, and More News

Reddit users protest misinformation, pediatric cases trend upward, and countries change travel advisories. Here’s what you should know:

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Reddit moderators protest the rise of Covid misinformation online

In the past week, dozens of Reddit moderators coordinated a blackout to protest the company’s lax policies on Covid disinformation, making their subreddits private and posting messages critical of the platform. Reddit initially responded with statements about the importance of free speech, but on Wednesday reversed course and quarantined 54 Covid-denial subreddits, adding more hoops people need to jump through to join and limiting the spread of content. It also banned /r/NoNewNormal, a large subreddit that has been quarantined since mid-August for spamming other communities with falsehoods about the virus.

One instance of misinformation that has propagated on Reddit and elsewhere is the trend of vaccine-hesitant people taking ivermectin, an antiparasitic commonly used in livestock, to treat or prevent the disease. While the Food and Drug Administration and Centers for Disease Control and Prevention have warned against using the drug, which has not proven to be a remedy and can cause severe illness, just this week podcast host Joe Rogan said he took it after testing positive for Covid-19.

Pediatric cases continue to rise, to the concern of parents and officials

Last week, children accounted for 22.4 percent of weekly reported Covid-19 cases in the US, and the rate of cases among kids is rising. Coupled with the start of the school year and a surge of respiratory syncytial virus (RSV) cases, there’s mounting concern about the urgency of protecting children, especially as pediatric hospitals experience an “unprecedented strain.” The CDC has recommended universal indoor masking for all students, teachers, staff, and visitors at schools, regardless of vaccination status. And the US Department of Education is investigating five states over concerns that their mask mandate bans could be discriminatory against students with disabilities and health conditions that make them more vulnerable to Covid-19.

As pediatric cases rise, some parents, physicians, and scientists have been debating the ethics of vaccinating kids by prescribing shots “off-label,” or offering a drug for a reason or to a group not studied during the approval process. Now that Pfizer-BioNTech’s vaccine has full FDA approval, this may be possible—but most experts and officials strongly discourage it.

Changing restrictions and a holiday weekend impact travel

Earlier this week, the European Union voted to change its travel restrictions, notably removing the US from its list of safe countries for nonessential travel. These are recommendations, and it’s up to individual member nations to decide whether and how to enforce them. The change will most likely affect unvaccinated Americans. The US has yet to reopen its doors to tourists from the EU, and the CDC added seven new places to its list of highest-risk destinations this week, including Switzerland and Puerto Rico. The agency has also urged Americans to be cautious this holiday weekend, particularly those who are unvaccinated.

All of the changing protocols and uncertainty surrounding pandemic travel have been a boon for one industry: travel advisers. A recent survey of American tourists found that roughly 17 percent were likely to get professional help booking a trip for the first time when the pandemic is over.

Daily Distraction

Video game tutorials can be overly complicated, unhelpful, or just plain annoying. But even so, they’re more necessary now than ever.

Something to Read

Decades ago, evolutionary biologist Richard Lewontin made waves studying the genetic overlap between different racial groups, and concluded that many of the differences that define us in society aren’t reflected in our DNA. Lewontin may have passed away this summer, but his work is enduringly relevant.

Sanity Check

If you have a child heading back to school this fall, chances are you need to refresh your mask stash. Here are a few of our favorite face coverings for kids.

One Question

Why did Florida’s Covid surge screw with its water supply?

The pandemic is worse than it’s ever been in Florida. And last week the Tampa Bay water utility announced that, with so much liquid oxygen going to hospitals’ Covid wards, it wasn’t able to properly treat its water; the plant’s supply had been reduced by about half. Liquid oxygen is used in two ways: to disinfect water and to keep it from smelling terrible. Officials insist that the quality of drinking water remains safe. But they may substitute something else for oxygen to improve the water’s smell, and have encouraged people to limit water use as the pandemic rages. The one other thing Floridians can do to improve the situation, if they haven’t already? Go get vaccinated.

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Would It Be Fair to Treat Vaccinated Covid Patients First?

Would It Be Fair to Treat Vaccinated Covid Patients First?

Around the world, hospitals and clinicians have broadly agreed that both Covid and non-Covid patients should have the same triage principles applied, that care shouldn’t be first-come, first-served (because of differences in accessibility), and that the primary metric should be getting the greatest number of people to leave the hospital alive. Cultural values sometimes come into play about whether to consider a more subtle prognosis: quality of life, or years lived, or, like, which person is somehow more valuable, if that was even calculable. (And triage isn’t the only way to divide vaccinated and unvaccinated people; the fact that private insurers are pulling back on paying for Covid care seems like a pretty good repudiation of the idea of forgoing one’s shots.)

One thing ethicists and clinicians have come back to again and again is avoiding “categorical exclusion criteria,” attributes that knock someone out of the triage running. For example, before the widespread availability of vaccines, elderly Covid patients died at a much higher rate than younger ones. But nobody wanted to exclude old people from treatment, right? That’d be monstrous. Or, as a team of Swiss ethicists argued last spring, you might distinguish between “first-order criteria,” like demographics, and “second-order criteria,” more subtle stuff that’d only come into play in a tiebreaker—two patients, alike in every possible way, similar prognoses, similar diagnoses. But deciding what differences to take into account is very tricky. If it’s health status, how do you assess that? How might socioeconomic status influence prognosis, and can you account for that equitably? What ethicists and the Texas task force were floating is, essentially, whether vaccination status might be a second-order exclusion criterion—even though, to be clear, one of the task force’s main points is that vaccination status could not, by itself, be a categorical exclusion criterion.

In part, that’s because the whole idea comes with a caveat the size of, well, Texas. Yes, far fewer vaccinated people get severely ill. But no one knows if severely ill vaccinated people have better outcomes—more survivability—than severely ill unvaccinated people. It seems likely that once you’re sick enough to be in the hospital, you’re sick enough to be in the hospital. But as far as I can tell, no such published data exists. “I personally have that sense from the data I’ve seen, but that is very preliminary data. There is no peer-reviewed study showing that,” Fine says. “So one has to be careful.”

Careful indeed. A big part of the rationale for triage guidelines is consistency, so individual doctors don’t have to rely on their intuitions. “Covid has taught us lots of things, but certainly that there’s a lot of implicit bias within the health care system, and certainly with Covid outcomes,” Lo says. “And we want not to make that worse.”

Plus, as much as we all might understand and empathize with the rage and frustration of health care workers—emotionally drained, epidemiologically at risk—whatever blame we might place could well be misdirected. “We know people are frustrated and angry, but that’s not a basis for decisionmaking,” Fine says.

Vaccination status, as Fine notes, is more complicated than that anger might allow. “I think we have to be really careful about saying someone chose not to be vaccinated. Some people do,” Lo says. “But there are still people who have difficulty making an appointment, who aren’t internet-savvy, who don’t speak English as a first language. A lot of people work in jobs where they don’t have time off, or if they get even a day of adverse effects from the vaccine and can’t work, their pay gets docked.” And how would a clinician trying to triage based on vaccination status distinguish among those groups, even if they were allowed to?

For that matter, even the people who resist vaccination because think they’ll never get sick, or that if they do then a horse deworming drug will save them, or that vaccines contain magnetizing 5G antennas through which Bill Gates can turn them into werewolves (They don’t! None of those things are things!)—those people have been lied to by leaders they trusted. Bad information is cheap; better information is expensive. And as ugly as the Covid numbers might be getting across the South, rage might be better directed at political leaders who are resisting basic public health measures instead of the people suffering as a result.

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The FDA OKs an Extra Vaccine Dose for Immunosuppressed People

The FDA OKs an Extra Vaccine Dose for Immunosuppressed People

Today, the committee voted to approve the third dose for people in “moderate to severe immune compromise.” That includes anyone who received an organ transplant and is taking anti-rejection drugs; is undergoing treatment for cancers in various organs, or varieties of leukemia; has received stem-cell transplants or CAR-T cells as part of cancer treatment; has advanced (or untreated) HIV or a primary immune-deficiency syndrome; or takes high doses of steroids, TNF blockers, or other immune system-suppressing drugs.

During the Friday meeting, officials estimated that the change might cover 7 million people, the 2.7 percent of US adults affected by a serious immune deficit. But the committee did not stretch the authorization to a potentially larger group who experience impaired immunity as a result of chronic illnesses.

“The intent is to limit this to individuals which are considered under the EUA to be in moderate or severe” immunosuppression, Amanda Cohn of the CDC said during the meeting. “That would not include long-term care facility residents or persons with diabetes, persons with heart disease—those types of chronic medical conditions are not the intent here.”

That did not sit well with some members of the public who spoke during the meeting’s public comment period. “I want to stress the importance of recommending third doses for people in all categories of immune compromise,” said a woman connecting to the video session from Tennessee. “Please give all of us who are immune-compromised a fighting chance to protect ourselves.”

Evidence has been building for several months that the Covid vaccines, which create robust protection in healthy people, have not been doing the job for immune-compromised ones. Right after the FDA authorized the mRNA vaccines in December, a team from the Johns Hopkins University School of Medicine put out an invitation on social media for immune-suppressed people to enroll in a registry so their immune responses to vaccination could be documented. In the spring, the team published their first analyses: After their first dose, only 17 percent of participants made antibodies to a section of the virus’s spike protein; only 54 percent showed an antibody response after the second dose. (In the manufacturers’ clinical trials, 100 percent of vaccine recipients developed antibody responses after their first dose.)

Another study, from Weill Cornell Medical Center, found that only 25 percent of kidney transplant recipients developed detectable antibodies. A team at the University of Pittsburgh warned of “virtually non-existent” responses to the vaccine in leukemia patients. A project shared by the Washington University School of Medicine and UC San Francisco showed that antibody levels can vary in patients with chronic inflammatory diseases—such as rheumatoid arthritis, lupus, and multiple sclerosis—depending on which immune-suppressing drugs they take.

To some patients and their physicians, it was already obvious that the vaccines were not protecting them. Despite being fully vaccinated, they came down with Covid—not the mild breakthrough cases experienced by fully immune people, but serious illness requiring hospitalization. Data cited by the CDC on Friday shows that immune-impaired people shed the virus for longer and are more likely to infect their household contacts than healthy people; they comprise up to 44 percent of vaccinated people hospitalized with breakthrough infections. And a study published online last month in the journal Transplantation estimates that organ transplant patients who have received two vaccine doses are 82 times more likely to develop breakthrough infections than healthy fully vaccinated people, and 485 times more likely than healthy vaccinated people to be hospitalized with Covid or die.

Online communities of patients began sharing information about their increased risk, and some of those who hadn’t fallen ill began hacking a remedy: seeking out third doses by finding sympathetic health care workers, pretending to lose their vaccine cards, or crossing state lines so the third shot wouldn’t be recorded in their home state’s registry. (According to CDC data presented at the Friday meeting, more than 1 million Americans may have received unauthorized boosters.)

The Dam Is Breaking on Vaccine Mandates

The Dam Is Breaking on Vaccine Mandates

It didn’t need to be this way. This spring, as people lined up for newly available, miraculously effective Covid-19 vaccines, it was easy to imagine a direct and speedy path to a protected society. The curve of administered doses appeared limited only by the supply, and the curve was looking good—perfectly calibrated for things to be normal (at least by some definition of the word) by the end of summer, just in time for schools and workplaces to reopen. So long as the vaccination rate kept pace. Which, of course, it didn’t. Much too soon, the curve reached its inflection point, shifted from the upswing, and flattened itself out. Add to that a euphoric, masks-off reopening in much of the country. Then add the more transmissible Delta variant. Result: a pandemic of the unvaccinated that, because of its immense scale, now threatens even people with two shots thanks to the possibility of breakthrough infections.

All of this has added up to a tipping point: The week when the carrot met the stick, when dozens of influential organizations all decided it’s time for vaccine mandates.

That was the message this afternoon when President Joe Biden announced vaccine rules for 4 million federal workers. “Right now, too many people are dying, or watching someone they love die,” he said. Those workers will now face a choice: attest to their completed vaccination status, or test one or two times a week, wear masks, and face travel restrictions. “We have the tools to prevent the next wave of Covid shutting down our businesses, our schools, our society,” he said, adding that the government would reimburse small businesses that allow workers to take paid time off to vaccinate themselves or their families, and that his administration encourages state and local governments to offer residents $100 incentives. Biden also instructed the Department of Defense to look into how and when they will require Covid-19 vaccinations for members of the armed forces.

Biden’s announcement followed similar statements from a flurry of major tech firms, including Google and Facebook, which have told their tens of thousands of employees around the country that vaccinations will be required for workers returning to the office, and an earlier raft of mandates from universities, state governments and medical centers. The moves received more legal clarity last month, after a federal judge threw out a lawsuit from a group of employees at Houston Methodist Hospital who had argued the rules were illegal because the vaccines are only authorized by the FDA for emergency use. And it’s not just employers. In San Francisco, for example, most of the city’s bars and clubs said they will require proof from patrons starting this week.

Is it ideal to force people into doing the right thing for public health? Not really, says Kirsten Bibbins-Domingo, an epidemiologist who studies health equity at the University of California, San Francisco. That’s why you first try messaging to overcome skeptics and incentives for those who need a nudge—as public health officials have done for months and will continue to do, she adds. But at this critical stage of the pandemic, the tipping point on mandates is welcome news to her. “We need to use every tool at our disposal,” she says. “It’s clearly the right thing to do at this point and something that will hopefully build into more places taking action.”

There’s already a clear herding effect at play. A vanguard of leaders from hospitals, universities, and state governments made the initial argument—that the benefits of protecting their patients and residents from unvaccinated workers outweighs the worries of individual employees—and clarified that the mandates are legal. Then the big tech corporations got on board, theorizing that a fully vaxxed workforce would be good for business; they’ve been a sort of Covid cultural bellwether, leading the shutdown of offices early in March, 2020, with many shifting to remote work for the long term.