Enlarge / California Gov. Gavin Newsom talks with 7th grade students at James Denman Middle School on October 01, 2021 in San Francisco, California. (credit: Getty | Justin Sullivan )

California Governor Gavin Newsom on Friday announced that the state will add COVID-19 vaccines to the list of immunizations students are required to get to attend in-person public and private schools.

California is the first state to announce such plans. COVID-19 vaccines will join the ranks of vaccine for measles, mumps, polio, hepatitis B, pertussis, tetanus, and chicken pox, which are already required for school attendance.

The mandate isn't immediate. The requirement will not kick in until the vaccine is fully approved by the Food and Drug Administration for school aged children. As such, the requirement will be phased in by grade groups—grades 7 through 12 and K-6—and begin at the start of the school term following full FDA approval.

Enlarge / The US Food and Drug Administration in Silver Spring, Maryland. (credit: Getty | Xinhua News Agency )

Two top vaccine regulators have resigned from the Food and Drug Administration, revealing anger, frustration, and turmoil at the federal agency as it faces intensifying pressure to authorize COVID-19 vaccine booster shots and doses for children under the age of 12.

The two regulators leaving are Marion Gruber, director of the FDA’s Office of Vaccines Research and Review (OVRR), and OVRR Deputy Director Phil Krause. Gruber has been with the FDA for more than 30 years, and Krause has been at the agency for more than a decade.

Their resignations, first reported by pharmaceutical trade publication BioCentury , were apparently sparked by frustration that the Biden administration had overstepped the FDA in announcing plans to offer COVID-19 booster shots beginning on September 20. The pair also clashed with higher-up Peter Marks, who reportedly went along with the administration's plans. Marks is the director of the FDA's Center for Biologics Evaluation and Research (CBER), which includes the OVRR.

Enlarge / A phlebotomist draws blood meant for antibody testing. (credit: Frederic J. Brown / Getty Images )

We've tended to treat the RNA-based vaccines from Moderna and Pfizer/BioNTech as functionally equivalent. They take an identical approach to producing immunity and have a very similar set of ingredients. Clinical trial data suggested they had very similar efficacy—both in the area of 95 percent.

So it was a bit of a surprise to have a paper released yesterday indicating that the two produce an antibody response that's easy to distinguish, with Moderna inducing antibody levels that were more than double that seen among people who received the Pfizer/BioNTech shot. While it's important not to infer too much from a single study, this one was large enough that the results are likely to be reliable. If so, the results serve as a caution that we might not want to base too many of our expectations on relatively crude measures of antibody levels.

The new study

The work itself was remarkably simple. A Belgian medical center was vaccinating its staff and asked for volunteers willing to give blood samples. Samples were taken both prior to vaccination and six to 10 weeks after, with the levels of antibody specific to the SARS-CoV-2 spike protein tested at both points. About 700 participants received the Moderna vaccine, while roughly 950 took the one from Pfizer/BioNTech.

Enlarge (credit: Aurich Lawson | Getty Images)

A county judge in Ohio has ordered a hospital in Cincinnati to administer ivermectin to an intensive care patient, a move raises questions about the role of the courts in the medical system.

“It is absurd that this order was issued,” Arthur Caplan , professor of bioethics at New York University’s Langone Medical Center, told Ars. “If I were these doctors, I simply wouldn’t do it.”

The order was spurred by a lawsuit filed by Julie Smith, whose 51-year-old husband, Jeffrey, is being treated in West Chester Hospital for COVID-19. The lawsuit was first reported by the Ohio Capital Journal . Jeffrey has been in the hospital since July 15, and as his condition declined, his wife Julie began investigating alternative treatments.

Enlarge / Two classrooms had to be shut down due to a series of problems with maintaining policies meant to limit the spread of the pandemic. (credit: Andrew Lichtenstein / Getty Images )

On Friday, the CDC released a report that traced the spread of the Delta variant through a California elementary school. It's tempting to make this into a story of gross irresponsibility—a teacher was unvaccinated and read to the class while unmasked. But beyond that, it provides a number of warnings about how our public health system remains under stress as we close in on two years since the start of the pandemic. It also reemphasizes how the Delta variant ensures that small errors can easily explode into big problems.

One bad apple

The school in question was a small one, with only a bit over 200 students and 24 staff. It is an elementary school, meaning that its student population is also younger than the cutoff for approved vaccine use. The school did a number of things right, though. Class sizes were kept small, and individual classes were kept in separate rooms, with doors and windows kept open and air filtration equipment installed. There was also a standing policy requiring mask use in place.

But not everything was ideal. The CDC notes that two of the 24 staff members were unvaccinated. While the vaccinated can clearly transmit the Delta variant, they are likely to be less infectious, and in a worst case they'd be infectious for a shorter period of time.

Enlarge (credit: Getty Images | naruecha jenthaisong)

A judge in Illinois has stripped visitation rights from an 11-year-old boy’s mother because she has not been vaccinated against COVID-19.

Earlier this month, at a child support hearing held over Zoom, Cook County Circuit Court Judge James Shapiro asked if Rebecca Firlit, the boy’s mother, had received the vaccine. She replied that she had not.

The judge said that until Firlit receives the vaccine, she cannot see her son in person, according to a report in the Chicago Sun-Times . Since the hearing, her interactions with him have been limited to phone calls and care packages. It’s unclear what prompted Shapiro to ask the question, and the Cook County clerk’s website was down for maintenance at the time of publication.

Enlarge (credit: Mario Tama | Getty Images)

On Monday, the US Food and Drug Administration gave formal, full approval to the Covid-19 vaccine made by the drug companies Pfizer and BioNTech. You might’ve already gotten a dose of it, of course; millions of Americans have, thanks to an “ emergency use authorization ” awarded in December 2020. But the new designation was more than just a formality. “If you’re one of the millions of Americans who said they will not get the shot until it has full and final approval from the FDA, it has now happened,” President Joe Biden said when he announced the approval. And, in the same speech: “If you’re a business leader, a non-profit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that—require it.”

Pretty much right away, a lot of places did. Vaccines are safe, effective, and free, but somewhere around 30 percent of Americans haven’t got their shots. Carrots didn’t work; here come the sticks. And they might be able to crush the fourth wave of the Covid pandemic in the US—if they’re done right.

Like the other vaccines still available under EUA, the Pfizer drug is extraordinarily good at keeping people from getting really sick or dying from Covid. But with more than 100,000 people in the hospital with Covid in the US—the most since January—and with the vast majority of them unvaccinated, it’s clear that alone isn’t enough. States, localities, and businesses have tried inducements like prizes, cash, or lotteries , little tricks designed to corral people into doing what’s good for them. In the language of behavioral economics, that’s called a nudge. But in states with low vaccine uptake, those nudges didn’t change the momentum. So now, it’s time for mandates . If you’re one of the 30 percent or so of Americans who haven’t gotten vaccinated yet, get ready for a good hard shove.

Enlarge / tablets of Ivermectin drugs in Tehatta, West Benga, India on 19 May on 2021. (credit: Getty | Nurphoto )

Amid the current delta-fueled wave of COVID-19, officials have noted a dangerous surge in the misuse of a deworming drug routinely used in livestock. The result is an uptick in calls to poison control centers, empty shelves in farming supply stores, and pleas from regulators.

In an attention-grabbing tweet over the weekend, the Food and Drug Administration wrote bluntly: "You are not a horse. You are not a cow. Seriously, y'all. Stop it."

The agency stressed that the drug, ivermectin, is not FDA-approved to treat or prevent COVID-19 and, so far, there is no evidence that it does either of those things. However, it can cause serious side effects and overdoses, which can be life-threatening, the agency warned. Overdoses can result in nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma, and even death.