“OSHA’s ETS, which it published on November 5, demands that companies with 100 or more employees require them to be vaccinated against COVID-19 or wear face masks and undergo weekly virus testing. The U.S. Court of Appeals for the 5th Circuit stayed the ETS on November 6, citing “grave statutory and constitutional issues.” The 5th Circuit extended that stay a week later, when it said the mandate is “fatally flawed” because it “grossly exceeds OSHA’s statutory authority.”
After that ruling, the many lawsuits challenging the mandate were consolidated and assigned by lottery to the 6th Circuit, which the Biden administration asked to lift the 5th Circuit’s stay. In doing so, the 6th Circuit majority criticized the other appeals court for reaching hasty conclusions unsupported by precedent and for failing to properly consider the evidence that OSHA presented in favor of its mandate.
An emergency standard allows OSHA to circumvent the usual rule making process by publishing regulations that take effect immediately. But to avoid the public notice, comment, and hearing requirements that ordinarily apply to OSHA rules, the agency has to identify a “grave danger” to employees “from exposure to substances or agents determined to be toxic or physically harmful or from new hazards.” It also has to show the emergency standard is “necessary to protect employees from such danger.”
In her 6th Circuit majority opinion, Stranch has little trouble concluding that COVID-19 qualifies as an “agent” that is “physically harmful.” Citing the Merriam-Webster Collegiate Dictionary, she says “an ‘agent’ is ‘a chemically, physically, or biologically active principle,'” while “a virus is defined, in part, as ‘any [of a] large group of submicroscopic infectious agents.'””
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“Larsen opens her dissent by chiding Stranch for misrepresenting reality. “The majority opinion describes the emergency rule at issue here as permitting employers ‘to determine for themselves how best to minimize the risk of contracting COVID-19 in their workplaces,'” she writes. “With respect, that was the state of federal law before the rule, not after.”
Larsen also suggests that Stranch has pulled a bait and switch. “The majority opinion initially agrees…that an emergency standard must be more than ‘reasonably necessary’; it must be ‘essential,'” she writes. “But then that word, and the concept, disappear from the analysis. What starts as a demand for an ‘essential’ solution quickly turns into acceptance of any ‘effective’ or ‘meaningful’ remedy; and later, acquiescence to a solution with a mere ‘reasonable’ ‘relationship’ to the problem. The majority opinion never explains why ‘necessary’ undergoes such a metamorphosis.”
As Larsen sees it, OSHA “has not made the appropriate finding of necessity.” She notes that “OSHA’s mandate applies, in undifferentiated fashion, to a vast swath of Americans: 84 million workers, 26 million unvaccinated, with varying levels of exposure and risk.” OSHA has the burden of explaining “why the rule should apply to a large and diverse class,” she says, but the agency “does not do so.””
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“In some respects, Larsen thinks, OSHA’s judgments are inconsistent with the numbers it cites. “OSHA has determined that no vaccinated worker is in ‘grave danger,’ whereas all unvaccinated workers are,” Larsen writes. “But the government’s own data reveal that the death rate for unvaccinated people between the ages of 18 and 29 is roughly equivalent to that of vaccinated persons between 50 and 64. So an unvaccinated 18-year-old bears the same risk as a vaccinated 50-year-old. And yet, the 18-year-old is in grave danger, while the 50-year-old is not. One of these conclusions must be wrong; either way is a problem for OSHA’s rule.””
“There appear to be millions of Americans walking around who have received a single dose of a Covid-19 vaccine, who may think they are protected against whatever the virus can throw at them — and who could be sorely wrong.
“I’m not sure we should regard them as equivalent to unvaccinated people,” Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization, told me. “But they are at higher risk than fully vaccinated and boosted people.”
That was the early consensus among the experts I consulted, and the preliminary data shows, as expected, low effectiveness against omicron after one dose of the Pfizer/BioNTech vaccine. The effectiveness against omicron also declines over time after two doses but is restored to high levels (76 percent efficacy against infection) after a third dose. This was a fairly small study out of the UK, and more data will be forthcoming, but it gives an initial picture of how the vaccines are holding up against the new variant.
People who have received only one dose of a vaccine could conceivably be almost as vulnerable to infection from omicron as the unvaccinated. They may still have some level of protection against severe illness because of the multiple layers of immunity induced by the vaccines. But it’s an open question at this point — and may soon become an urgent one for the Americans who fall into this camp.”
“Governments make choices that shape millions of lives. Workers and businesses are taxed to provide health care to the elderly and to the least fortunate. Men and women are incarcerated or even killed for crimes defined by the state. Wars are fought. Refugees are given a place of safety or turned away at the border.
If you believe in democracy, such power is justified only because it flows from the will of the people. “Governments,” the United States declared in its formational document, “are instituted among Men, deriving their just powers from the consent of the governed.” The premise of any democratic republic is that there are some decisions that must be made collectively, and that these decisions are legitimate because they are made by elected officials.
On Friday, the Supreme Court will hear two sets of cases that test the justices’ commitment to the idea that the right to govern flows from the will of the people, and both involve challenges to President Joe Biden’s efforts to encourage vaccination against Covid-19.
The first bloc of cases, which is likely to be consolidated under the case name Biden v. Missouri, challenges a federal rule requiring nearly all health care workers to become vaccinated. The second bloc, which is likely to be consolidated under the name NFIB v. Department of Labor, challenges a rule requiring workers at companies with 100 or more employees to either get vaccinated or be regularly tested for Covid-19.
Even on their faces, the stakes in Missouri and NFIB are enormous. These cases ask what steps the United States can realistically take to quell the spread of a disease that has already killed more than 820,000 Americans. But the full stakes in these cases are even higher.
Someone has to decide how the United States will respond to a global pandemic, and the Biden administration’s argument essentially boils down to a case for democracy. An elected Congress authorized the executive branch to take certain steps to encourage vaccination, and Joe Biden was elected to lead that branch. So that means that President Biden and his duly appointed subordinates get to make difficult decisions, even if some Americans don’t like those decisions.
The parties challenging Biden’s policies, meanwhile, effectively argue that the Supreme Court should decide America’s vaccination policy. They couch their arguments in arcane legal doctrines, with weighty-sounding names like the “Major Questions Doctrine” or “nondelegation,” But these doctrines are vague — so vague that they are easily manipulated by justices who disagree with the Biden administration’s policies and wish to conceal their desire to halt those policies behind a patina of legal reasoning.
I don’t want to minimize the significance of the policies at issue in Missouri and NFIB. In creating these policies, the Biden administration determined that its fundamental duty to preserve human life overrides many individuals’ interest in refusing medical treatment. This is a weighty decision, placing the collective health of the nation before the individual liberties of many of its citizens.
But the Biden administration estimates that its two vaccine regulations will save hundreds or even thousands of lives every month. And it decided that saving those lives is worth requiring some Americans to do something they don’t want to do. This decision is no more significant than many of the decisions governments make — to send troops to a distant conflict, to tax and to spend that money in service of a nation’s people, to save lives, or to take them. This is what governments do.
Again, someone needs to decide what America’s vaccination policy will be. It will either be made by the man chosen by the American people, or the Supreme Court will wrest that decision away from him and give it to themselves.”
“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.””
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“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.”
“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.”
“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”
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“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.”
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“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”
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“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.”
“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.”
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“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.””
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“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.”
“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.”
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“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.”
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“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.”
“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.”