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The acute phase of the pandemic is probably over

Health and Benefits|Wellbeing
COVID 19 Coronavirus

By Jeff Levin-Scherz, MD | May 4, 2022

Whether the pandemic has formally ended or not, people’s behavior has changed. Also, an update on potentially misleading prenatal tests.
 

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About the series

Dr. Jeff Levin-Scherz provides regular updates on the latest COVID-19 developments with a focus on the implications for employers and guidance on how they can tackle pandemic-related challenges to keep their workplaces safe. Explore the series.

Last week, Dr. Anthony Fauci said that the United States is exiting the pandemic phase of COVID-19. Then he walked back the statement and said, “How close are we to the end of this pandemic?” is really an “unanswerable question.” Despite this mixed message, we certainly are in a better place than a year ago, with more immunity, widespread availability of home testing and increasing availability of potent antiviral medications.

In regard to Dr. Fauci’s “misstatement,” the truth is most people are behaving as if the “acute phase” of the pandemic is over. Fewer people are wearing masks, although those who are masked are more likely wearing N95 and KN95 masks. The airlines were back to pre-pandemic passenger capacity in March. Meanwhile, restaurants, movies and museums are sometimes crowded. Nonetheless, I’m still learning of friends and colleagues who are newly infected, but they are generally not getting exceptionally ill.

Despite these trends, this is not the first time that some have suggested that the pandemic is becoming less deadly, so we will need to see how the pandemic evolves over the coming months as the immunity from the December-January Omicron wave starts to wane.

A roundup of recent COVID-19 news:

The Centers for Disease Control and Prevention (CDC) reported that in February, 58% of Americans had antibodies showing that they had had COVID-19, up from just 34% in December. About three-quarters of children 17 and under had antibodies showing they previously had COVID-19. 

During September–December 2021, overall antibody rates increased by 0.9–1.9 percentage points per 4-week period.

During December 2021–February 2022, overall U.S. antibody rates increased from 33.5% to 57.7%. Over the same period, antibody rates increased from 44.2% to 75.2% among children aged 0–11 years and from 45.6% to 74.2% among persons aged 12–17 years. Antibody rates increased from 36.5% to 63.7% among adults aged 18–49 years, 28.8% to 49.8% among those aged 50–64 years, and from 19.1% to 33.2% among those aged ≥65 years.

Infection-induced antibody rates

Source: CDC April 26, 2022

  • An Israeli study published in Nature Medicine showed that those over age 60 who received a second booster shot were 64% less likely to be hospitalized and 78% less likely to die. This isn’t a perfect comparison. It’s possible that those who voluntarily got a second booster were more cautious or lower risk. But the difference is large, and I’m pretty happy to have gotten my second shot. For skeptics who believe we should never recommend an intervention without a randomized double-blind trial, I refer you to this classic 2003 BMJ article: Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials.
  • The U.S. is transitioning from Omicron variant BA.2 to BA.212.1, which is more contagious but not more dangerous. It appears that both vaccination and previous Omicron infection provide protection, so we are not seeing a huge increase in new cases. Across the country, though, cases are going up modestly, and hospitalizations are trending a bit higher.
  • A Scandinavian study showed that those who worked from home were 7% less likely to accomplish 150 minutes of moderate to vigorous physical activity each week and about 50% more likely to sit more than eight hours a day. Pandemic weight gain and physical inactivity could promote cardiovascular disease and diabetes.
  • The antiviral Paxlovid, which decreases risk of hospitalization and death by 89%, is now widely available. The drug also decreases viral load, so it likely would prevent some transmission. Still, many adults at risk are having a hard time getting a prescription when they need it because it’s not easy to get a same-day physician appointment. Over half of the public would qualify for this medicine if they have a positive COVID-19 test. The drug should be started within five days of infection, so delays in getting a prescription could lead to preventable hospitalizations or even deaths. The Biden administration’s proposal to have Paxlovid dispensed directly by pharmacists without a physician prescription would improve access to this medication but is currently stalled as physician advocacy groups oppose direct pharmacist prescriptions.
  • A new study from Lancet Respiratory Medicine suggests that the protection against hospitalization and emergency room visits from a J&J booster diminishes substantially three months after being received. The CDC recommends that a second booster (Pfizer or Moderna) be given four months after the first booster for those initially immunized with the J&J COVID-19 vaccine.

Implications for employers:

  • Employers can feel comfortable that the risk of vaccinated employees becoming seriously ill from a workplace COVID-19 exposure is much lower now, although the chance of infection remains high especially in some geographies.
  • There’s good reason to continue to encourage vaccination and boosters (and second boosters).
  • Employers can continue to provide an environment where workers feel comfortable wearing masks for medical or personal reasons.
  • Employers should encourage regular exercise for workers regardless of whether or not they are onsite.
  • Employers should encourage employees who feel ill to take COVID-19 tests and to seek care quickly if they are positive so they can be treated with antiviral medications if they are eligible. Antigen tests give the quickest answer, although people with symptoms should retest for a few days or get a PCR test before they stop using masks, since there are many reports of delayed antigen test positives with Omicron.

FDA issues warning on noninvasive prenatal screening tests

The Food and Drug Administration (FDA) last week advised pregnant women and their physicians caution when interpreting noninvasive prenatal screening tests. These tests are also called “cell free DNA tests,” and they evaluate a sample of the pregnant woman’s blood to find fragments of fetal (baby) DNA to find evidence of genetic defects.

These tests are not FDA approved. They are laboratory developed tests that do not require FDA authorization because they are developed and used within a single laboratory. Such tests allow rapid advances (most of the early PCR tests for COVID-19 were laboratory developed tests), but laboratories sometimes overstate the value of the tests that they have devised.

These prenatal tests are often marketed to pregnant women directly or through their obstetricians. These tests require just a blood draw and don’t carry the risks of invasive tests like amniocentesis or chorionic villus sampling, where medical providers insert a needle to collect cells from the fetus. Some laboratories include genetic counseling with the test, although many don’t.

Laboratories offering these tests often declare that they are highly accurate, but the FDA points out that: “Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test. The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

Here’s the problem. Many pregnancies have a genetic abnormality that would often lead to miscarriage. But the chances that any given pregnancy has each specific genetic abnormality are very low. Even when a test has high “specificity” (very low false positives), the false positives will still often be far more common than true positives when the diagnosis is rare in the tested population. Positive tests should be confirmed with a test using fetal cells, but many ordering physicians likely misunderstand the likelihood of false positives. Therefore, women who have a positive test may choose to have an abortion of a fetus that is in fact genetically healthy.

New York Times reporter Sarah Kliff reported on these tests in January, and included a literature review showing that over 80% of the positives are wrong for such terrible birth defects as DiGeorge syndrome (heart defects), ap36 deletion (seizures and intellectual disability), Cri-du-chat syndrome (delayed walking and talking), Prader-Willi (seizures and uncontrollable appetite) and Wolf-Hirschhorn syndrome (seizures, growth delay and intellectual disability).

These tests are generally not covered by employer-sponsored health insurance, although some might be marketed directly to employers. In some instances, the ordering obstetrician could bill the patient for such tests and pay the laboratory only a portion of the fee collected, allowing prenatal testing to be a physician profit center.

Employers should resist urges to pay for screening tests that have not received FDA approval and have not been approved by their insurance carriers. We should all be mindful that even highly “accurate” tests will have many false positives when used to screen a population for a rare disease.

Author

Population Health Leader, Health and Benefits, North America

Jeff is a practicing physician and has led WTW’s clinical response to COVID-19. He has served in leadership roles in provider organizations and a health plan, and is an Assistant Professor at Harvard Chan School of Public Health.


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