As you read this, the number of omicron variant COVID-19 cases in the United States is rising. Late Thursday, New York officials confirmed five more cases. At least two of those people had traveled recently, one of them from South Africa. Also late Thursday, officials in Hawaii said they had confirmed an omicron infection. That case is worrying partly because the man who was infected there had not recently traveled, indicating the virus is spreading in the community.
All of this happened as the U.S. reported more than 100,000 coronavirus cases for the fourth day in a row and President Joe Biden rolled out plans to keep fighting the virus into a new year.
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 — 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:
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.
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 explains the differences and how to properly perform a home test.
Scientific American points out 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 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.
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 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?
When a fully vaccinated person gets infected with COVID-19, journalists typically call it a “breakthrough” 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.”
The fact is, COVID-19 vaccines have a remarkably good track record 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, the word breakthrough can refer to any presumed infection by SARS-CoV-2 (that is, any positive coronavirus test) 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, 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.
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
