ALSO IN THIS ISSUE
National PHE Renewal #11
First Saliva-Based OTC Home Test
Subvariant Soup
Yankee Candle Index Lives On
New and Noteworthy
National Public Health Emergency Remains in Place
HHS announced that the current Public Health Emergency (PHE) has been extended for another 90 days, until January 11, 2023 - the 11th renewal. No surprise here, as the Biden administration has promised that they would give a 60-day heads-up before ending it.
We liked this article in Becker’s Healthcare, which outlined both sides of the argument about whether the PHE is still necessary. The issue is more complex than it might seem - it’s not just a question of whether 400 people dying per day is “enough” to still constitute an “emergency,” but the fact that a lot of current health care is predicated on the PHE remaining in place, including Medicare eligibility and access to telehealth.
One note - we take issue with Becker’s and many other publications using reported COVID cases as if they are the accurate count of all cases. They are not - with the broad use of home testing (virtually none of which is being reported), actual cases are at least seven to eight times higher than reported cases.
First Saliva-Based At-Home Test with no Prescription Needed
Aptitude Medical just received the first EUA for an at-home COVID test that can use either saliva or a nasal swab as a sample. The test, called Metrix COVID-19, uses molecular technology - LAMP - to give a read-out in 30 minutes. Saliva has been used as a sample for laboratory-based COVID tests for much of the pandemic, with the first EUAs going to clinical reference labs and Yale’s SalivaDirect during the summer of 2020. For those who don’t want to have to have the Snoot not Snot discussion again, this one’s for you!
Food for Thought
Omicron Sub-Variants Converge on Immune Escape
Omicron’s continued dominance and sprawling evolution has left the WHO naming system in the dust - as of this writing, the Pango Network has assigned “letter.number” labels to about 350 sub-Omicron lineages.
So, do we in the US need to worry about any of the flavors making up this “subvariant soup”?
Last week we said no - none were growing fast enough here to concern us. This week, however, the CDC announced, belatedly, that they had broken BQ.1 and BQ.1.1 out of BA.5 for the first time. That change revealed that what had looked like a stable BA.5 presence was, in fact, anything but: Together, the two sub-variants, which have even stronger immune evasion than the original BA.5, had reached 11.4% of US sequences. We now know that they reached this level over a month ago - the Twitter-verse was incensed!
So, now we’ve got a problem on our hands. The remaining two currently authorized mAb therapies (AstraZeneca’s Evusheld and Lilly’s bebtelovimab) can be obsoleted by just a handful of single amino-acid mutations in the spike receptor binding domain (AA locations 346, 444, 452, 460, and 486). All the different sub-variants, including BQ.1 (aka Typhon) and BQ.1.1 (aka Cerberus) seem to be converging on this handful, as shown in virologist Daniele Focosi’s detailed Omicron family tree (sub-variants shown within the colored circles are those that escape the two mAb treatments).
Is there anyone else on the tree we need to watch? We’d say XBB (aka Gryphon), which now accounts for half of all cases in Singapore and Bangladesh. If you’re interested in how Gryphon, Typhon, and Cerberus got to where they are today, evolutionarily speaking, take a look at our highlighting of Dr. Focosi’s image below.
Older Adults Love Direct-to-Consumer Tests; Results Reporting Remains a Challenge.
Home tests for multiple conditions are popular and becoming more so. According to the University of Michigan’s 2022 National Poll on Healthy Aging, 48% of people ages 50 to 80 have bought at least one kind of at-home health test, including 32% who had bought COVID tests and 17% who had bought a DNA test (think 23andMe and Ancestry). Right now, use of such direct-to-consumer medical tests varies greatly by age, race/ethnicity, marital status, income, and years of education. However, those differences may decrease over time, as 82% of older adults say that in the future, they would be somewhat or very interested in taking a medical test at home.
While that potential increase in access to tests is exciting, results reporting remains a big concern. It’s important to note that the problem isn’t intentional resistance: The vast majority (92%) of older adults agree that home test results should be shared with one’s health care provider. The problem, instead, is follow-through, at least for certain types of tests: Among those who have used a home test for a non-COVID infection such as HIV or a urinary tract infection, just 55% shared their result with their primary care provider. On the other hand, 90% of those who bought and used a cancer-related home test said they shared the result. COMMENTARY: As home test availability burgeons, we sorely need an easy, convenient, and standardized way for home tests to be reported.
Once Again, Nobody Knows What the Winter will be Like
Lots of informed but inconclusive speculation about the winter ahead (including this CNBC interview with Scott Gottlieb). Our hope is that if we do have a new Omicron surge, it is likely to be mild for most. Why? One reason is Omicron’s cell-entry mechanism, which allows it to infect us more easily than prior variants but also causes less impact in the lower respiratory tract - a more deadly locale than the upper. Another reason is the US immunity landscape, which includes a tremendous number of folks who’ve already been infected with Omicron at least once - though the longer ago that infection was, the less protection it’s likely to provide.
Quick Hits
Displeased Yankee Candle Reviews Once Followed COVID Surges - now they precede waves, according to Northeastern associate professor of political science Nick Beauchamp. Beauchamp, who has published a paper on the link between COVID surges and increases in the number of Yankee Candle reviews which complain that the candles have no smell, notes that the switch happened as the quality and quantity of COVID data from traditional sources was decreasing.
COVID Test Companies are Preparing for the End of the EUA Era. The FDA has been clear that test developers and manufacturers need to focus on preparing for 510K approval. Companies are responding by updating their fact sheets, with cautions that their tests do not have clinical data on currently circulating variants.