Booster Shots Appear To Offer Protection Against Omicron COVID-19 Variant

“Preliminary laboratory research by Pfizer/BioNTech finds that a third booster shot of its COVID-19 vaccine successfully neutralizes—that is, blocks—the omicron variant of the virus from entering and infecting cells. The researchers tested the new variant against antibodies produced by people one month after they had been inoculated with a third booster dose of the Pfizer/BioNTech vaccine. They report that the boosted level of antibodies “provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron. These antibody levels are associated with high efficacy against both the wild-type virus and these variants.””

“Keep firmly in mind that these are very preliminary laboratory results that need to be confirmed by real-world epidemiological evidence with respect to breakthrough infections and disease severity. Nevertheless, these results corroborate that people who have already gotten two doses of COVID-19 vaccines or have already recovered from a prior COVID-19 infection should go get a booster shot and that people who are not yet fully vaccinated should delay no further.
In case these lab results don’t hold up in the real world, vaccine makers are already working on tweaks to their inoculations that specifically target the omicron variant. The updated vaccines could become available as early as March 2022.”

FDA’s At-Home Testing Screw-Up Is Undermining Promising New COVID Treatments

“On November 4, the United Kingdom’s regulatory authorities approved molnupiravir as a treatment for COVID-19 infections. Meanwhile, the U.S. Food and Drug Administration (FDA) continues to dawdle over approving medications that were so effective that independent Data Monitoring Committees ruled that it would be unethical to continue giving placebos to study participants.

Speaking of dawdling, the FDA has long stymied the development and roll out of another vital component for the effective use of these antiviral medications: namely, at-home COVID-19 testing. Both pills must be taken by people within 3 to 5 days of exposure or symptom onset to be most effective at preventing hospitalization and death. That means that people need to be able to test themselves quickly, easily, and cheaply.

Up until mid-October, the FDA had approved only two over-the-counter at-home COVID-19 diagnostic tests, one of which has now had to be recalled. In the last month and a half, agency regulators have finally gotten around to authorizing nine more.”

Why are rich countries still monopolizing Covid-19 vaccines?

“Vaccines aren’t distributed equally: Rich countries have about twice the population of low-income countries, yet they have received about 50 times as many Covid-19 vaccine doses”

“Hoarding and production constraints are part of the story, but so are less-appreciated obstacles like clogged supply chains and breakdowns in communication between vaccine makers, donors, and recipients. These problems are solvable, however, and countries like the United States are uniquely positioned to contribute.”

“Countries that are counting on Covid-19 vaccine imports, whether through donations or purchases, are often in the dark about when and where rich countries and pharmaceutical companies will ship their doses”

“the United Kingdom donated 9 million Covid-19 vaccine doses to low-income countries this summer, but several of the countries receiving them warned that they would not be able to distribute most of them in time. Many vaccines have a limited shelf life, and donated vaccines are often close to expiration. In May, Malawi was forced to discard 20,000 doses of Covid-19 vaccines because the country’s health system could not administer them before the shots expired.”

The U.S. Is Relying On Other Countries’ Data To Make Its Booster Shot Decisions

“Israeli presenters provided slide after slide showing the power of booster shots. But not all of the FDA advisors were convinced. “What they’re seeing in Israel is not necessarily what we’re seeing here in the U.S.,” said Dr. Archana Chatterjee, dean of Chicago Medical School and member of the advisory committee, during the meeting. In an interview with FiveThirtyEight, she explained that Israel’s data is “interesting and very compelling,” but that Israel differs from the U.S. on key characteristics: Namely, a higher share of the Israeli population is inoculated, and a larger proportion of breakthrough cases in Israel led to hospitalization prior to the booster shot rollout. As a result, she said, Israel had a clear need for additional shots to bump up immunity. In the U.S., meanwhile, the vaccines were still highly protective against severe COVID-19 disease and death.

Chatterjee said that her eventual votes — in favor of booster shots — were not based on data from Israel. Still, the Israeli scientists’ very presence at the meeting demonstrated the shortcomings of the U.S. health system. If the U.S. doesn’t comprehensively track its own data, it has to rely on other countries to tell it how to keep Americans safe. Meanwhile, without clear evidence that they can refer to in making their own COVID-19 decisions, many Americans have been confused about whether they are eligible for — or even need — a booster shot.

Israel has a universal health care system for all citizens and permanent residents. So does the U.K., another country that the U.S. looks to for COVID-19 data. Beyond the health care benefits that such policies provide to residents, universal health care has a clear advantage for data scientists seeking to answer medical questions. When every person in the country is plugged into the same health care system, it’s very easy to standardize your data.”

“In the U.S., vaccine research is far more complicated. Rather than one singular, standardized system housing health care data, 50 different states have their own systems, along with hundreds of local health departments and thousands of hospitals. “In the U.S., everything is incredibly fragmented,” said Zoë McLaren, a health economist at the University of Maryland Baltimore County. “And so you get a very fragmented view of what’s going on in the country.””

“Without a unified dataset allowing U.S. researchers to analyze how well the vaccines are working, policymakers are left with limited information to make crucial decisions, such as determining who should be first in line for a booster shot.”

The Supreme Court finally decides the religious right asked for too much

“under Gorsuch’s approach, the state must exempt religious objectors because it has a single exemption — again, for people who could suffer serious health consequences if they receive the vaccine.

Had Gorsuch’s approach prevailed, it’s likely that religious objectors would be exempted from nearly any law. Speed limits, for example, typically exempt police, ambulances, and other emergency vehicles responding to an emergency. Even laws banning homicide typically contain exemptions for self-defense. (Although, in fairness, Gorsuch concedes that a religious exemption is inappropriate when the “challenged law serves a compelling interest and represents the least restrictive means for doing so.” So Gorsuch probably would not allow religiously motivated murder.)

In any event, Gorsuch’s view did not prevail — though it is far from clear that it will not receive five votes in a future case. Though Justice Barrett joined a majority of the Court in allowing Maine’s vaccine mandate to take effect, her opinion (which is joined by Justice Brett Kavanaugh) clarifies that she did so on exceedingly narrow grounds.

Essentially, Barrett argues that the Supreme Court has discretion to decide which cases it wants to hear. And her opinion suggests that she would exercise her discretion to not hear this particular case.”

“For now, at least, the bottom line is that Maine’s vaccine mandate is in effect. Public-facing health care workers will need to receive the Covid-19 vaccine unless they have a medical excuse.”

“it’s not a huge loss for the religious right. But the decision in Does suggests that there is, at least, some limit to the Court’s willingness to carve out legal exemptions for religious conservatives.”

The Racial Gap Among the Vaccinated Has Essentially Disappeared

“According to a new survey from the Kaiser Family Foundation, as the rate of U.S. adults who report having received at least one dose of the COVID-19 vaccines continues to climb, the rates among racial groups are now basically identical, comprising 71 percent of white adults, 70 percent of black adults, and 73 percent of Hispanic adults.”

Scientists Fight a New Source of Vaccine Misinformation: Aaron Rodgers

““Aaron Rodgers is a smart guy,” said David O’Connor, a virus expert at the University of Wisconsin-Madison and a Packers fan. But, he added, “He’s still vulnerable to the blind side blitz of misinformation.”

In the interview, Rodgers suggested that the fact that people were still getting, and dying from, COVID-19, meant that the vaccines were not highly effective.

Although imperfect, the vaccines provide extremely strong protection against the worst outcomes of infection, including hospitalization and death. Unvaccinated Americans, for instance, are roughly 10 times more likely to be hospitalized and 11 times more likely to die from COVID-19 than vaccinated Americans, according to a study by the Centers for Disease Control and Prevention.

“As far as the people who are in the hospital with COVID, overwhelmingly, those are unvaccinated people,” said Angela Rasmussen, a virus expert at the Vaccine and Infectious Disease Organization at the University of Saskatchewan. “And transmission is being driven overwhelmingly by unvaccinated people to other unvaccinated people.”

Rodgers also expressed concern that the vaccines might cause fertility issues, a common talking point in the anti-vaccine movement. There is no evidence that the vaccines affect fertility in men or women.

“Those allegations have been made since the vaccines first came on the scene, and they clearly have been addressed many, many times over,” said Dr. William Schaffner, a vaccine expert at Vanderbilt University. He added, “The vaccines are safe and stunningly effective.”

There are a few potentially serious adverse events that have been linked to the vaccines, including a clotting disorder and an inflammation of the heart muscle, but they are very rare. Experts agree that the health risks associated with COVID-19 overwhelmingly outweigh those of vaccination.

Rodgers said he ruled out the mRNA vaccines, manufactured by Pfizer and Moderna, because he had an allergy to an unspecified ingredient they contained.

Such allergies are possible — a small number of people are allergic to polyethylene glycol, which is in the Pfizer and Moderna vaccines — but extremely rare. For instance, there were roughly 11 cases of anaphylaxis, a severe allergic reaction, for every 1 million doses of the Pfizer vaccine administered, according to one CDC study.

The public health agency recommends that people with a known allergy to an ingredient in one of the mRNA vaccines not get those vaccines, but some scientists expressed skepticism that Rodgers truly had a known, documented allergy. Even if he did, he may have been eligible for the Johnson & Johnson vaccine, which relies on a different technology.”

Los Angeles Orders Local Businesses To Serve as Vaccination Enforcers

“What the city is actually doing is outsourcing responsibility for getting people vaccinated to private local businesses. Fines for failure to comply with the law fall not on the unvaccinated people attempting to get into restaurants and movie theaters, but on the businesses that fail to catch them. Fines start at $1,000 (beginning with the second violation) and can reach as high as $5,000 per citation.”

Even If Requiring People Who Have Recovered From COVID-19 To Be Vaccinated Is Legal, That Doesn’t Mean It Makes Sense

“when it comes to vaccine mandates, the relevant question is whether an unvaccinated person with natural immunity is substantially more likely to catch and transmit the coronavirus than a vaccinated person without natural immunity. On that point, medical experts disagree.

Peter McCullough, a Dallas internist and cardiologist with a public health degree who testified in support of psychiatrist Aaron Kheriaty’s unsuccessful challenge to the University of California’s vaccine mandate, argued that the coronavirus “causes an infection in humans that results in robust, complete, and durable immunity”—a protective effect that is “superior to vaccination-induced immunity.” McCullough emphasized that antibody tests reflect only part of the immune response to a COVID-19 infection, which includes “antibodies to the nucleocapsid and to the spike protein, as well as T-helper cells, natural killer cells, B-cells, and innate immunity.”

By contrast, the Berkeley epidemiologist Arthur Reingold argued in the same case that the university’s blanket vaccine requirement was justified because the strength and longevity of natural immunity are unclear. “While individuals who have had a documented case of COVID-19 typically have antibodies to the SARS-CoV-2 virus detectable in their blood and are believed to have a reduced risk of getting COVID-19 again in the months that follow,” he said, “neither the completeness nor the durability of protection against a second case of COVID-19 has been established. The extent to which any such immunity resulting from having had COVID-19 provides protection against new variants of SARS-CoV-2 is also unknown.””

“A private employer might conclude that a blanket vaccine requirement is easier to administer than one that makes an exception for previously infected people. The latter approach presumably would require documentation of prior infections. It might also require evidence, similar to the tests cited by Norris, of a robust immune response—although vaccinated people don’t have to produce such evidence, even though their immune responses also vary.

As a matter of public policy, however, that added complication does not seem unreasonably burdensome. The OSHA order described by the Biden administration already includes an exception for employees who agree to be tested at least once a week, which is more expensive and harder to arrange than a one-time requirement that employees document their COVID-19 histories.

Jeffrey Klausner, a clinical professor of population and public health sciences at the University of Southern California, co-authored a systematic review in the journal Evaluation & the Health Professions last month that found “the protective effect of prior SARS-CoV-2 infection on re-infection is high and similar to the protective effect of vaccination,” although “more research is needed to characterize the duration of protection and the impact of different SARS-CoV-2 variants.” While the existing evidence is incomplete, Klausner thinks it is strong enough to justify an exception to vaccine requirements. “From the public health perspective,” he told Kaiser Health News, “denying jobs and access and travel to people who have recovered from infection doesn’t make sense.””

Why people who don’t trust vaccines are embracing unproven drugs

“Some Americans who are reluctant to get vaccinated believe they are living through a very different pandemic — one where the approved Covid-19 vaccines are ineffective and dangerous, and where a long list of “miracle cures,” ivermectin among them, are critical to patients’ health and safety.

From the outside, these positions can seem not just dangerous but incoherent. What would lead a person to say they won’t take a vaccine approved by federal regulators, then take an off-label medication because they read about it online?

Of course, not all Americans who are reluctant to get vaccinated have embraced supposed miracle cures: The reasons that people give for not getting a Covid-19 vaccine are varied and complex. But over the past year, among some refusers, a community of intense vaccine denialism has developed and created a sort of psychological scaffolding to support their views. As a group, the most fervent vaccine deniers construct and perpetuate an alternative narrative of the pandemic. And when inconvenient facts — from a news report to a friend’s or relative’s decision to get vaccinated — challenge that narrative, they give them a place to take refuge.

This phenomenon has its origins in America’s political polarization. One of the best predictors of whether someone is resistant to getting the Covid-19 vaccine is whether they identify as a Republican, and we know those partisan bonds are powerful. But they are not sufficient to explain the intransigence. Most Republicans have gotten the vaccine by now, but about 12 percent of Americans say they will never get vaccinated under any circumstances. (Roughly six in 10 of those people are Republicans, but a small minority of Democrats also say they won’t get the vaccine.)”

““When you really want to believe something — like ‘you can’t trust the vaccines’ — you’ll come up with any number of rationalizations,” Van Bavel said. “It’s like whack-a-mole. You falsify one premise and they just create a new one.”

This is a well-documented social phenomenon. In a new book by Van Bavel and Lehigh psychology professor Dominic Packer, The Power of Us, the authors recount one controversial work of social science in the 1950s. Social psychologists infiltrated a doomsday cult to find out how the members would react when their promised date of salvation — the day that a UFO would come to Earth and take them away — came and went without the prophecy coming true.

The researchers found that when the prophecy failed, most people didn’t quit the cult. They didn’t discard their old beliefs, protest that they had been lied to, and desert the cult’s leader. Instead, the leader offered his followers a brand new narrative, which many of them accepted: Their fervent faith had been so powerful that the apocalypse had been averted.”