• maraaspinall

Vax, treatment, and tests - especially for those who really need it. That’s what we can afford right

Updated: Sep 15

Volume 6, Issue 5 | September 14, 2022 Mara G. Aspinall and Liz Ruark

IN THIS ISSUE:White House COVID plan for the fall and winter Don’t toss those “expired” tests Diagnosing COVID based on the sound of your voice New and NoteworthyWhite House COVID plan, Fall 2022 editionLast week, the Biden administration issued an extensive fact sheet detailing its plans and priorities for managing COVID this fall and winter. The main emphasis continues to be vaccination and treatment, with welcome additional attention to ensuring access for elderly, disabled, and underserved populations. The document also contains a politely biting message from the administration: We’re doing what we can with the money we’ve got, but without additional funding from Congress there’s no way the country can maximize its response to the current situation or be as prepared as it could be for the next surge, variant, epidemic or pandemic. While testing is clearly no longer one of the administration’s top priorities (see funding message above), the fall 2022 plan includes three testing-related initiatives: #1 Rebuilding the national stockpile of COVID tests, with a focus on tests that are made in America. The administration has issued an RFP to purchase 100 million tests, which will - it hopes - enable the feds to allocate tests more strategically if / when the next surge happens. #2 Increasing the number of Test to Treat sites (now at 2800), with a focus on more mobile and telehealth options in order to reduce barriers to access for high-risk people. #3 Funding development of new tests in two categories:

  • Home tests that are easier for folks with disabilities to use, especially people with blindness / low vision, challenges with fine motor skills, and age-related disabilities. Goal: Commercialization in 12 to 24 months.

  • “Next-generation COVID-19 diagnostic technologies with improved performance”: This is code for tests that can detect any variant, and that don’t need to be used serially. Goal: Commercialization in 24 to 36 months.

Commentary: Whether times are good or bad, people tend to believe that they will stay that way - and the COVID situation feels relatively good to most people right now. It’s hard to convince folks that we need to spend more money on dealing with this virus. But honestly - that’s what we need to do. We applaud the administration’s creative use of available funds to be proactive, but we, as a nation, will likely need more. Plus, if there is one thing that virtually everyone agrees with, it’s that we will have other pandemics / epidemics. Smart planning for that will save money and lives when it comes. A final note - All the vaccines, treatments, and tests in the world won’t help people if 1) They don’t know about them, or 2) They refuse to use them. The CDC recently acknowledged that they are more academic than practical in communicating their advice. And the Biden administration now clearly understands that health info needs to come through trusted messengers if it’s going to be effective - the grassroots partnerships mentioned in this fact sheet prove that. Okay, so we know what’s wrong with our communications, and we’re beginning to learn how to improve things. It’s a start. Keep it up. First monkeypox EUA issued, along with priorities for those that followIn early August, HHS Secretary Xavier Becerra declared monkeypox a public health emergency. One month later, on September 7th, he enabled the FDA to issue emergency use authorizations (EUAs) for monkeypox tests - and on that same day, the agency issued the first one: to Quest, for its PCR test. Moving forward, FDA will give priority to reviewing tests that tick the following boxes:

  • They’re high-throughput, allow home specimen collection, or are rapid tests;

  • They’re from an experienced developer with lots of manufacturing capacity;

  • Their developer lets the feds know within 30 days that it’s planning to submit an EUA

Labs, start your engines. Food for ThoughtAre your tests expired? “Don’t be quick to chuck them” We love the headline (from the Sun Journal) and the advice. If the expiration date on your COVID test has passed, don’t throw it away yet! Why not? Manufacturers of test kits continue to monitor their product’s performance after the initial EUA. Once a company has three months of data, they submit it to the FDA in hopes of an extension to the test’s expiration date - and nearly all makers of COVID tests have received such extensions. Right now, all COVID tests under EUA have expiration dates eight months or more from manufacturing (except for Watmid’s, which has the most recent EUA). Fourteen brands expire 12 months or more after manufacturing. But you might not be able to tell that from the label. If the company receives an expiration-date extension while their test kits are still with the manufacturer or distributor, they place a sticker with the new date on the boxes. But when the kits are already on store shelves or on your kitchen counter at home, they can’t do that. If you want to be super-sure that your test hasn’t expired, you can always check the FDA’s website. Separately but related - individual states are using their remaining state or federal funds to distribute tests to those who most need them. As mentioned in the Sun Journal article, Maine is one of five states that participates in Project ACT, which delivers free OTC tests directly to vulnerable and hard-to-reach households. (Project ACT is coordinated by The Rockefeller Foundation and Mara is involved in the administration of the program.) Jeez, you sound like you have COVID.Like, literally. We were quite surprised - and fascinated! - to hear about a voice-based diagnostic for COVID. This isn’t as far-fetched as it . . . um . . . sounds. Speech analysis has been long discussed in neurodegenerative diseases, including Parkinsons. The trial used recordings of coughing, deep breathing, and speaking from more than 4300 individuals - all of them uploaded into the University of Cambridge’s COVID-19 Sounds App. According to the report from Maastricht University in the Netherlands, an AI-based algorithm diagnosed true COVID positives 89% of the time and true COVID negatives 83% of the time. Not clear at what stage the participants were diagnosed. We are intrigued by the possibilities and look forward to listening to more about this creative testing technology. Quick HitsNew York has become the first state to declare a State of Emergency related to polio. The decision enables a wider group of health-care providers to administer polio vaccines. It also requires documentation on immunization rates by community to be submitted to the state, so the state can determine areas where the risk is highest. As the New York Times recently reported, monkeypox tests, vaccines, and treatment are in short supply everywhere in the world - except in the US and Europe. “More than 100 countries are now reporting monkeypox cases, and a vast majority of those have had no vaccine or treatments at all.”

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