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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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Headlines

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.

FDA Backs Boosters, Travel Restrictions Lift, and More News

FDA Backs Boosters, Travel Restrictions Lift, and More News

The FDA backs additional doses, international travel restrictions end, and vaccine mandate rules progress. Here’s what you should know:

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Headlines

FDA panel signs off on additional Moderna and Johnson & Johnson doses

Today, an FDA advisory committee recommended a second dose of the Johnson & Johnson shot. Many fewer Americans received this vaccine than either of the mRNA shots, so there’s less data overall, but the group has recommended that a second dose be available to recipients 18 and older two months after their initial vaccine. On Thursday, the same committee unanimously recommended booster shots for recipients of Moderna’s vaccine who are 65 and older or are part of several other vulnerable populations. The next step will be for a Centers for Disease Control advisory panel to discuss additional doses in meetings scheduled for next week. If they approve, distribution could start shortly thereafter.

The first boosters, third doses of Pfizer’s vaccine, were approved in the US in August, and in the time since, President Biden has touted additional shots as an effective way for vulnerable Americans to protect themselves. But boosters have not been without controversy, especially because so many countries around the world are still struggling to procure initial doses.

Pandemic travel constraints lift around the world

The Biden administration announced today that, starting November 8, it will lift travel restrictions for fully vaccinated visitors from 33 countries, including a number of European nations, China, and Iran. There will be stricter requirements for travelers coming from places other than these approved countries. Next month, the US will also lift restrictions for fully vaccinated travelers entering the country from Canada or Mexico by land. A different border policy will still apply to migrants.

Outside the US, many other countries are also lifting stringent travel requirements that have been in place for much of the pandemic. Australian officials have said that vaccinated travelers coming to Sydney will no longer need to quarantine starting next month. After 19 months, India is about to start allowing foreign tourists. And Bali and Malaysia will also be opening to vaccinated visitors soon.

Government vaccine mandate rules are in final review despite pushback

Last month, President Biden directed the Occupational Safety and Health Administration to write rules regarding company vaccine mandates, and earlier this week the agency showed its proposal to the Office of Management and Budget for final review. A number of state attorneys general have said they’ll oppose the measures, but many businesses have already implemented their own protocols in accordance with the president’s executive order. Southwest Airlines and American Airlines, for instance, recently upheld their employee mandates even though both are based in Texas, where the governor has banned such policies. And another aerospace company, Boeing, recently joined the ranks of organizations requiring workers to get their shots.

Sweeping Mandates, New Vaccines Underway, and More News

Sweeping Mandates, New Vaccines Underway, and More News

Biden announces additional mandates, researchers probe new shots and treatments, and global vaccine distribution falters. Here’s what you should know:

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The White House announces a sweeping new plan for combating the next phase of the pandemic

Yesterday, President Biden announced a slew of new Covid-19 policies. The six prongs of his plan are increasing vaccinations, boosting protections for the unvaccinated, keeping schools safe and open, increasing testing and masking, bolstering economic recovery, and revamping care for people who get sick. Vaccine mandates are a centerpiece. All employers with over 100 employees will have to require either vaccinations or weekly testing, give workers paid time off to get their shots and recover from side effects, and risk facing fines of up to $14,000 per violation if they don’t. And all federal workers in the executive branch and government contractors will also need to be vaccinated.

Biden has also called on governors to require vaccinations for school employees. This week, Los Angeles, the country’s second-largest school district, took things one step further and announced that it will require all students over the age of 12 to be vaccinated as well in order to attend classes in person.

Drugmakers and researchers work to develop more vaccine and treatment options

BioNTech’s top executives recently announced that the drugmaker is readying to request approval around the world to use its Covid-19 vaccine in children as young as 5. FDA officials added today that the agency is “working around the clock” to approve vaccines for kids. Meanwhile, other drugmakers have said that plans are underway for a new kind of vaccine, one that could combat both Covid-19 and the flu. Novavax said this week that it has started early-stage trials to test its combined shot, and it expects results in the first half of 2022. Moderna is also developing a two-in-one booster.

Researchers have also been working to find existing drugs that could treat mild cases of Covid and keep more people out of the hospital. Early data suggests that one drug, an antidepressant called fluvoxamine, could prove useful, but further research is necessary to say for sure. And though ivermectin had some promising early results, there’s no evidence to suggest it helps prevent or treat Covid.

International vaccine distribution efforts continue to fall short

The Biden administration is expected to suggest an international summit to discuss the pandemic, and vaccine manufacturing and distribution in particular, around the time of the United Nations General Assembly meetings later this month. Equitable vaccine dispensation continues to be fraught: This week COVAX announced that it’s on track to fall almost 30 percent short of its distribution goal for 2021. Drugmakers have said there should be enough vaccines for every adult in the world in 2022, but rich nations who have bought most of the world’s supply will need to make sure those shots are distributed fairly.

This week, the head of the WHO spoke out again about booster shots, calling on wealthy countries to pause them until the end of the year to make those doses available to people elsewhere who haven’t yet received their initial doses.

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Why are hospital-related infections on the rise during the pandemic?

Health-care-associated infections, which often befall people while they’re in the hospital, are caused by a few factors. Patients in the ICU are vulnerable to infections, but they are being treated in close proximity to other sick people, and health care staff can unwittingly be carriers, as can lifesaving equipment. Overcrowding and added demands on hospital staff don’t help either. During the pandemic, the pressure of caring for people sick with Covid has undermined years of progress in preventing these kinds of infections. The good news is, the solution to this problem may well be the same as the solution to the pandemic: vaccination. The fewer people are seriously ill, the better hospitals will be equipped to protect everyone who comes through their doors.


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Covid Misinformation Protests, Pediatric Cases, and More News

Covid Misinformation Protests, Pediatric Cases, and More News

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

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Headlines

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.

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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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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.)