• maraaspinall

Does it Feel Like the Sunset of the Pandemic to you, too?

Updated: Sep 13

Volume 6, Issue 3 | August 31, 2022 Mara G. Aspinall and Liz Ruark Aug 31

In This Issue: Last chance for free COVID tests COVID public health emergency - how much longer? If asymptomatic Monkeypox patients can transmit, we need to know Schools are open - mostly without anti-COVID protections Wastewater testing needs on-going funding to make an impact New and Noteworthy Free COVID tests from the feds: Act now! Time is running out! If you haven’t ordered your household’s three sets of eight free at-home COVID tests from the federal government, do it now. Like, right now. The program will be “suspended” this Friday, September 2, because Congress hasn’t provided the funding to continue it. The unused inventory, approximately 400,000 tests, is being kept in reserve in case a surge pops up later in the year. Commentary: Understandable but disappointing, for two reasons. #1: C’mon, Congress. People need easy access to tests, and not everybody has health insurance, Medicare, or Medicaid. Testing is the only way to slow a surge. #2: C’mon, people. You had free, super-simple access to tests for eight months. But you only bothered to claim 60% of them. Sigh. COVID State of Emergency likely stays in place - for now An official Public Health Emergency (PHE) can be declared in response to a wide variety of emergencies, from epidemics to natural disasters. Federal PHEs last for three months at a time and can be renewed as necessary. Today, there are actually two PHEs going on - Monkeypox and, of course, COVID-19. Why is the COVID PHE important? LOTS of programs and rules are tied to it, including states’ ability to use federal funds, healthcare professionals’ liability, government employees' ability to change jobs, how and what products can be stockpiled, and more. Ending it is going to have enormous, nontrivial downstream effects. The COVID-19 PHE is set to expire on October 13, 2022. However, since HHS has pledged that it would give states 60 days notice before ending the PHE, we know that it’ll be renewed one more time, at a minimum. Given the broad expectation that we will see another winter COVID surge, it makes sense that the PHE will stay in place until at least January 13, 2022. But after that? Barring the arrival of a new variant that causes a significant spike in hospitalizations and deaths, our guess is that the COVID PHE’s time is running out. Can monkeypox spread asymptomatically? We need testing to find out. Up to this point, it’s been assumed that monkeypox can be transmitted only by people who have the characteristic lesions on their skin. But as STAT Newsreported yesterday, a few small studies have raised concern that it could be spread by people who are asymptomatic. The only way to find out for sure? Test a lot of people who don’t have symptoms. COMMENTARY: Here’s another situation where we need at-home tests with the ability to easily report results to public-health authorities. If this thing transmits without symptoms, we need to know yesterday. Food for Thought COVID prevention waning in K-12 schools The majority of public K-12 schools are back in session by now - most with dramatically reduced COVID-prevention strategies in place that largely ignore even the most recent, relaxed CDC guidelines. Burbio reports that only a very small number of districts are requiring masks, despite the fact that nearly 30% of US counties are still at a high COVID-19 Community Level - the level at which CDC recommends universal masking in schools. Some superintendents are meekly requesting that at that level, maybe people could possibly consider wearing masks and perhaps think about getting vaccinated, if it wouldn’t be too much trouble. Sigh. Screening testing is mostly a nonstarter as well, despite the CDC’s quiet plea that when COVID levels are high, you really should screen kids and adults who are involved in high-risk activities, and screen everyone before big gatherings like prom and after breaks. A few schools have essentially become community distribution sites for COVID at-home tests. Commentary: We get the fact that schools are not health-care centers, and we get that the last thing teachers want to be is the mask police. (Teachers have had enough stress over the past two years to last a lifetime.) We know that COVID rarely causes serious disease in kids. But we also want to see kids in school. If COVID levels are high and few kids are masked, you’re going to have outbreaks. And every kid who gets sick is going to miss at least five days of school - not to mention every teacher. It’s sad to see that as a nation, we’ve decided that that’s more acceptable than wearing a mask or taking a test. Pony up for poop, people! Wastewater continues to be our most cost-effective tool to measure disease activity. It’s also an early indicator, as people shed virus in their stool before symptoms appear. But if it’s not providing data consistently due to lack of funding as Kaiser Health Network reported recently, it becomes hard to rely on. Plus, to have any impact, there has to be follow up - including increased individual testing to identify and isolate infected folks. Commentary: While public money for individual testing is evaporating, we hope that municipalities will continue wastewater testing and analysis - or initiate it where it doesn’t yet exist. A good defense is our best offense for future epidemics. EUA Update Over the last six weeks, the FDA has issued one EUA (molecular - Predicine) and 41 amendments: 11 molecular; 1 genotyping; 16 antigen; 3 collection kits; 7 respiratory panels; 3 serology. In addition, there were four Safety Communications, all revocations: three Amazon and one BD Max. Moving forward, we will summarize the COVID EUA updates on a monthly basis. Monthly Capacity: Current EUAs Update this week shows the continued reduction in COVID test manufacturing and lab capacity. Despite the relatively high COVID infection numbers, testing per capita and per infection is down. As discussed in our review of Q2 financial reports, central lab tests have shown the largest decline. Home antigen tests continue to be the primary testing modality, but demand for them is down from last quarter, as well. Now that it is clear that federal testing purchases in the future will be sparse, two questions remain: Will we see another winter surge, and what role will combination COVID/flu testing play? Will COVID/flu tests authorized for at-home testing be available, or will they remain primarily in physicians’ offices? Quick Hits

  1. Omicron-targeted boosters from Pfizer and Moderna got FDA clearance. CDC’s blessing is expected this week with distribution starting next week. These bivalent vaccines are expected to be more effective at preventing infection from BA.4 and BA.5 subvariants in particular, but they should also boost immunity against non-Omicron variants. They’re likely to be the last shots that come free from the federal government.

  1. K-12 schools in Shanghai will reopen tomorrow, September 1, after almost six months of closure. In keeping with China’s Zero COVID Policy, students and teachers will take a PCR test every day.

Next Week Focus on antibody tests: What are they? Do they work? When and why might they be useful? Who should use them?


Thank you for reading Sensitive & Specific: The Testing Newsletter. Please be in touch with story ideas or topics that you would like us to feature. Email: and

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