Plus, what qualifies as a 'breakthrough' case, a third of hospital workers are still unvaccinated as the federal mandate approaches, and more. Email not displaying correctly?
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** The winter 2021 rules for fighting COVID-19
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Boxes of BinaxNow home COVID-19 tests made by Abbott and QuickVue home tests made by Quidel are shown for sale near Lysol cleaning and sanitizing products and a holiday decoration, Monday, Nov. 15, 2021, at a CVS store in Lakewood, Wash., south of Seattle. (AP Photo/Ted S. Warren)

We are heading into a second winter of wearing masks, jamming swabs up our noses and listening to health officials plead with people to get vaccinated, get boosted and don masks on planes and buses and trains. And it will once again be onerous to travel to the United States from other countries.

This isn’t all just because a couple hundred people worldwide have been infected by a new COVID-19 variant that so far has caused only mild to moderate illness. The current variant is also spreading quickly again as people gather unmasked indoors. New York, for example, reported 11,300 new positive cases of COVID-19 ([link removed]) — the highest number of new cases reported in a single day there since late January.

Under President Joe Biden’s winter 2021 plan, the Federal Emergency Management Agency will open Family Mobile Vaccination Clinics, starting in Washington and New Mexico but expanding nationwide. Biden will also push employers to give people time off from work to get booster shots.

The president also outlined a plan that would require insurance companies to cover the cost of home COVID tests, probably starting around Jan. 15, although some details of that are not clear. For example, how many tests will be covered? Biden said 15 million tests will be sent to community health centers and rural clinics for people who have no insurance or are covered by Medicaid.

FierceBioTech told readers ([link removed]) :

The guidance is expected to take effect early next year, with the federal labor, treasury and health and human services departments slated to finalize the rule by Jan. 15. Reimbursement will begin only after the rule has taken effect — rather than retroactively covering previous at-home test purchases — and the government has not yet specified whether there will be a cap on the reimbursement amount available to each covered individual.

Before the new strain had even been detected on U.S. soil, companies like Thermo Fisher Scientific, Abbott, Qiagen, Cue Health and more began rushing to release data showing that their diagnostic offerings were still viable amid the rapidly evolving virus.

As Mark Stevenson, Thermo Fisher’s chief operating officer, explained earlier this week: “Like all viruses, we have always known that SARS-CoV-2 would continue to mutate and that effective testing strategies are a key to curbing the pandemic.

Home tests can run around $12 each in the U.S. But in other countries, like Germany and Britain, home rapid tests are free or just a dollar.

A battle will unfold again today over Biden’s federal mandate that companies with 100 or more employees require workers to be vaccinated or submit ([link removed]) to regular COVID-19 testing. At midnight tonight ([link removed]) , the federal government will shut down without a new budget or continuing resolution that appeared to be in the works Thursday, but then, again, fell apart. Senate Republicans say they will stall a continuing resolution as long as federal dollars are used to enforce Occupational Safety and Health Administration rules requiring vaccinations or frequent testing.

How useful will all of that home testing be?

This might be a good time to explain the difference between quick antigen tests and laboratory-screened PCR tests. This article by UMass Chan Medical School ([link removed]) explains the differences and how to properly perform a home test.

Scientific American points out ([link removed]) that home quick tests are not a substitute for vaccinations, and they do not detect all infections:

The accuracy of antigen tests varies. These assays correctly identify a SARS-CoV-2 infection in 72 percent of people with symptoms and 58 percent of people without them, according to a review study ([link removed]) published in March. And timing matters. The tests detect an average of 78 percent of cases in the first week of symptoms but only 51 percent during the second week, the researchers found.

Antigen tests arguably are more likely than (more expensive) PCR tests to only return a positive result when a person’s case reaches the threshold of infectious — not when they are just infected. For instance, the accuracy of Abbott’s BinaxNOW clinical antigen test increases from about 85 percent to 95 percent among symptomatic people with higher amounts of virus in their nose, the company states ([link removed]) .

There is a reason that the federal mandate requires frequent testing. In fact, for quick tests to make much of a difference in protecting you, you need to test yourself around three times a week. Why so much testing? Because any test can only give you the result for that moment. If you are not infected and take a test, and are infected 10 minutes later, the test will not tell you that. Scientific American said:

Repeated antigen testing at frequent intervals is ideal to increase the chances of spotting an infection if more accurate polymerase chain reaction (PCR) tests are not available. One small study ([link removed]) found that antigen testing every three days is 98 percent accurate at detecting SARS-CoV-2 infections, but there is no magic number for how often concerned individuals should take these tests, experts say. People who test positive (or “detected”) should take the result seriously and seek health care. A negative test can ease anxieties, at least for the time being — but people with symptoms should still follow up with a more accurate test.

For example, if you test positive on one of these quick tests, you should not attend multiple political rallies and a presidential debate.


** What qualifies as a breakthrough case?
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When a fully vaccinated person gets infected with COVID-19, journalists typically call it a “breakthrough ([link removed]) ” case. I have seen such references to the second known omicron variant infection in the U.S., which involved a person who had gotten two doses of the vaccine and a booster shot. Dr. Anthony Fauci used the word “breakthrough” to describe the first omicron case that showed up in California. That person also had gotten two doses of the vaccine.

But The Atlantic’s Katherine Wu makes the case that we are misusing the phrase “breakthrough” because we mistakenly expect vaccines to prevent all infections. Wu points out, “They’re flame retardants, not impenetrable firewalls, when it comes to the coronavirus. Some vaccinated people are still getting infected, and a small subset of these individuals is still getting sick — and this is completely expected ([link removed]) .”

The fact is, COVID-19 vaccines have a remarkably good track record ([link removed]) of preventing serious illness and death. But Wu argues that the public does not clearly understand that when a vaccinated person gets infected, it is not a sign that vaccines have failed. In part, that is because we misuse words like “breakthrough,” versus, say, “post-vaccination infections.” Wu writes:

As the CDC defines it ([link removed]) , the word breakthrough can refer to any presumed infection by SARS-CoV-2 (that is, any positive coronavirus test ([link removed]) ) if it’s detected more than two weeks after someone receives the final dose of a COVID-19 vaccine. But infections can come with or without symptoms, making the term imprecise.

That means breakthroughs writ large aren’t the most relevant metric to use when we’re evaluating vaccines meant primarily to curb symptoms, serious illness, hospitalizations, and death. “Breakthrough disease is what the average person needs to be paying attention to,” Céline Gounder, an infectious-disease physician at Bellevue Hospital Center in New York, told me. Silent, asymptomatic breakthroughs — those that are effectively invisible in the absence of a virus-hunting diagnostic — are simply not in the same league.

To put this in perspective, consider the original criteria laid out by the FDA about this time last year ([link removed]) , back when the United States was still solidly in its second infectious surge. An effective inoculation, the agency said, should be able to “prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.” It’s an easy benchmark to forget. By the close of 2020, two vaccines absolutely obliterated those expectations; two months later, a third followed, and now there’s buzz of a fourth ([link removed]) .

I imagine that people who doubt the value of vaccines would say using any phrase other than “breakthrough” would be changing the expectations for the vaccines’ usefulness.


** As the Jan. 10 federal mandate deadline approaches, a third of hospital workers are still unvaccinated
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Medical professionals pronate a 39-year-old unvaccinated COVID-19 patient in the intensive care unit at St. Luke's Boise Medical Center in Boise, Idaho, on Aug. 31, 2021. (AP Photo/Kyle Green, File)

The Wall Street Journal says ([link removed]) some hospitals and nursing homes expect to lose around a third of their workforce if President Biden’s federal vaccine mandate survives court challenges and goes into effect Jan. 10. To make that deadline, workers would have to get their first dose of a two-dose vaccine by Dec. 6.

A federal judge in Missouri ruled this week ([link removed]) that the federal mandate will not take effect in Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming until a lawsuit to block the order is heard. The lawsuit says sweeping orders — like the one issued by the Department of Health and Human Services that requires all health care workers to get vaccinated or their employer would lose federal Medicare and Medicaid payments — should have to be approved by Congress.


** Fully vaccinated people who get infected are less likely to infect others
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New research just published in the New England Journal of Medicine says ([link removed]) people who are vaccinated but get infected with COVID-19 are less likely to pass the virus along to others. The reason, according to the study, is that vaccinated people shed the virus for a shorter period of time than unvaccinated people. Shedding exposes other people to the virus.

The study, which involved 173 NBA players, found that vaccinated people who got infected cleared the virus out of their bodies in 5.5 days while it took unvaccinated people 7.7 days on average.


** Moderna says vaccine targeting omicron variant could be ready in March
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Even just two years ago, the notion that a pharmaceutical company could formulate and test a new version of a vaccine in three months would be unthinkable. But Moderna officials say ([link removed]) they think the company could have a vaccine ready to present for Food and Drug Administration approval in March. Moderna executives are thinking of the potential new dose as a booster for fully vaccinated people.


** New research shows Moderna’s vaccine is slightly more effective than Pfizer’s
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[link removed] practical nurse Yokasta Castro, of Warwick, R.I., draws a Moderna COVID-19 vaccine into a syringe at a mass vaccination clinic, Wednesday, May 19, 2021, at Gillette Stadium, in Foxborough, Mass. (AP Photo/Steven Senne)
Licensed practical nurse Yokasta Castro, of Warwick, R.I., draws a Moderna COVID-19 vaccine into a syringe at a mass vaccination clinic, Wednesday, May 19, 2021, at Gillette Stadium, in Foxborough, Mass. (AP Photo/Steven Senne)

Read this with one thing in mind ([link removed]) : Both the Moderna and Pfizer vaccines are effective in preventing deaths and severe illness from COVID-19. But until now, researchers had not been able to compare which one of those vaccines was more effective in “real world” use.

Harvard researchers worked with the Department of Veterans Affairs and looked at health records for almost a half-million patients. The study concluded:

This large-scale study allowed us to detect subtle differences between these two highly effective vaccines. While the identified differences in estimated risk were small on the absolute scale, they may be meaningful for larger decision-making bodies, such as health care systems ([link removed]) and higher-level organizations, when considering the large population scale at which these vaccines are deployed.”


** Want to die by assisted suicide? Get vaccinated first.
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Unvaccinated people cannot get help ending their life in some European countries. The Jerusalem Post says ([link removed]) , “The Zurich-based Association for Assisted Dying (Verein Sterbehilfe) announced that, in the future, only vaccinated and recovered members will be admitted to assisted suicide.”

The Swiss group says it is too risky for staffers to work with unvaccinated people who do the preparatory examination.


** A wearable COVID monitor could be in your future
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What if you could have a smartwatch that works like a fitness tracker and also monitors for COVID-19? Nature Medicine has a story about Stanford researchers ([link removed]) who built such a thing. It detected the coronavirus in 80% of infected individuals in the study. Importantly, the device detected the virus a few days before symptoms developed.


** No, you can’t undo a vaccine with a bath, although bathing is good
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It is hard to know how much of this is just curiosity ([link removed]) or how many people might actually take it seriously, but a TikTok video with hundreds of thousands of views is promoting a ridiculous “detox the vax” notion that has circulated among other anti-vax movements over the years.

The premise is that when workplaces make you get vaccinated, you should do something to suck the vaccine out of your body. First, that is not possible. Second, the stuff they want you to bathe in can be harmful. I have also seen “detox sprays” on Amazon. The one below, available for $14.99, carries this on its label:
(Amazon)

The label says you are supposed to put 15 drops of this stuff in your mouth three times a day. It contains arnica (an unproven treatment for pain), merc corros (which was used for everything from syphilis and measles to paralysis in the old days; homeopathic practitioners swear by it for sore or dry throats), sulfur iodatum (homeopathic followers use it for acne treatment) and Thuja occidentalis (which comes from a tree and was thought to be useful to treat scurvy back in the 1500s; traditional use also included treatment of breathing problems, but there is no modern clinical evidence ([link removed]) it works).

All the same, if you get COVID-19, taking a bath might make you feel a little better.

We’ll be back Monday with a new edition of Covering COVID-19. Are you subscribed? Sign up here ([link removed]) to get it delivered right to your inbox.
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