Lunchtime pandemic reading.
Standard disclaimer: this is a roundup of informative pieces I've read that interest me on the severity of the crisis and how to manage it. I am not a qualified medical expert in ANY sense; at best I am reasonably well-read laity. ALWAYS prioritize advice from qualified healthcare experts over some person on Facebook.
This is also available as an email newsletter at https://lunchtimepandemic.substack.com if you prefer the update in your inbox.
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On vaccine safety in the US. "The physician leadership of the US Food and Drug Administration (FDA) (including the authors of this Viewpoint) unequivocally state that candidate COVID-19 vaccines will be reviewed according to the established legal and regulatory standards for medical products. While Operation Warp Speed is an important initiative and FDA has lent technical expertise around end point selection and safety considerations to this public-private partnership for vaccine development, there is a line separating the government’s efforts to focus resources and funding to scale vaccine development from FDA’s review processes, which are rooted in federal statute and established FDA regulations.4 To offer clarity to the public, FDA issued a guidance document on June 30, 2020, which outlines key considerations for the development and licensure of vaccines to prevent COVID-19.5
First and foremost, FDA is committed to ensuring that any vaccine is manufactured in accordance with all of FDA’s quality standards and that its safety and effectiveness are verified before being authorized or licensed. To ensure that a widely deployed vaccine is effective, FDA has specifically recommended in its guidance to vaccine developers that “the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%, and the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval (CI) around the primary efficacy endpoint point estimate is >30%.”5 In other words, the lower limit of a 95% CI would have to be greater than 30%.
While historically the agency has not prospectively recommended numerical end point estimates for license approval, FDA believes recommending a baseline for performance is necessary to provide confidence that broad distribution of a potential vaccine could offer immunity to the majority of the population. To properly verify efficacy, trials should also follow best practices for methodology (eg, randomized double-blind designs with placebo control). In terms of safety, adequately powered trials are necessary to detect adverse events and to evaluate safety considerations with regard to dosing. FDA generally advises the minimum population size for a prelicensure safety database for preventive vaccines to exceed 3000 patients, and to date, the anticipated enrollment for COVID-19 vaccine trials (15 000 to 20 000 patients receiving active vaccination) well exceeds FDA’s recommendation. FDA recognizes that there could be rare adverse events not detected in a trial of 15 000 to 20 000 patients, so postmarketing surveillance will be critical."
Source: https://jamanetwork.com/journals/jama/fullarticle/2769421
Commentary: I appreciate the transparency that the FDA is publishing with regard to vaccine trials. All data around COVID-19 is and should be treated as a public good, including vaccine efficacy, and I'm encouraged by these statements in reputable medical journals that despite outside influences, they will not cut corners.
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Thanks, llamas. "Inspired by a unique kind of infection-fighting antibody found in llamas, alpacas, and other camelids, a research team at the University of California, San Francisco, has synthesized a molecule that they say is among the most potent anti-coronavirus compounds tested in a lab to date.
Called nanobodies because they are about a quarter of the size of antibodies found in people and most other animals, these molecules can nestle into the nooks and crannies of proteins to block viruses from attaching to and infecting cells.
The lab-made one created by the UCSF team is so stable it can be converted into a dry powder and aerosolized, meaning it would be much easier to administer than Covid-19 treatments being developed using human monoclonal antibodies. While the work is still very preliminary, the goal is to deliver the synthetic nanobody via simple inhaled sprays to the nose or lungs, allowing it to potentially be self-administered and used prophylactically against Covid-19 — if it’s shown safe and effective in both animal tests and clinical trials."
Source: https://www.statnews.com/2020/08/11/scientists-create-potent-anti-coronavirus-nanobody-inspired-by-llamas/
Commentary: As with so many discoveries during our sprint towards a vaccine and other therapeutic interventions, the use of llama nano-antibodies may or may not have an impact for COVID-19, but will almost certainly have use in treating other diseases at some point. This is a source for great optimism; while we may not be able to shut down the COVID-19 pandemic as quickly as we would like, the discoveries we're making now could pay dividends for decades to come.
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Winter is coming. "The good news: The United States has a window of opportunity to beat back Covid-19 before things get much, much worse.
The bad news: That window is rapidly closing. And the country seems unwilling or unable to seize the moment.
Winter is coming. Winter means cold and flu season, which is all but sure to complicate the task of figuring out who is sick with Covid-19 and who is suffering from a less threatening respiratory tract infection. It also means that cherished outdoor freedoms that link us to pre-Covid life — pop-up restaurant patios, picnics in parks, trips to the beach — will soon be out of reach, at least in northern parts of the country.
Unless Americans use the dwindling weeks between now and the onset of “indoor weather” to tamp down transmission in the country, this winter could be Dickensianly bleak, public health experts warn.
“I think November, December, January, February are going to be tough months in this country without a vaccine,” said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.
It is possible, of course, that some vaccines could be approved by then, thanks to historically rapid scientific work. But there is little prospect that vast numbers of Americans will be vaccinated in time to forestall the grim winter Osterholm and others foresee.
Human coronaviruses, the distant cold-causing cousins of the virus that causes Covid-19, circulate year-round. Now is typically the low season for transmission. But in this summer of America’s failed Covid-19 response, the SARS-CoV-2 virus is widespread across the country, and pandemic-weary Americans seem more interested in resuming pre-Covid lifestyles than in suppressing the virus to the point where schools can be reopened, and stay open, and restaurants, movie theaters, and gyms can function with some restrictions.
Osterholm said with the K-12 school year resuming in some parts of the country or set to start — along with universities — in a few weeks, transmission will take off and cases will start to climb again. He predicted the next peaks will “exceed by far the peak we have just experienced. Winter is only going to reinforce that. Indoor air,” he said."
Source: https://www.statnews.com/2020/08/10/winter-is-coming-as-flu-season-nears-americas-window-of-opportunity-to-beat-back-covid-19-is-narrowing/
Commentary: Prepare for a long, difficult winter in America. It's anecdotal, but I'm certainly seeing lower compliance and lax protective measure being taken in the place I live - and that's with comparatively good weather.
What should you prepare for? With more lockdowns and/or more restrictions almost a certainty, reflect back on the early months of the pandemic and what ran short, what you lacked. Stock up on that now while people are out behaving irresponsibly.
It reminds me of the children's fairy tale about the ant and the grasshopper - be on the side of the ant.
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Black counties received disproportionately smaller federal pandemic assistance on the basis of need. "Tying relief funding to revenue resulted in allocations largely unrelated to health or financial needs. It also meant disproportionately Black communities received the same level of relief funding as counties with less health and financial need. Although race may co-vary with socioeconomic status or education, it is unique in having special protections under the law. The findings suggest the relief funding allocation may have a “disparate impact” on Black populations, a legal concept referring to policies that negatively affect a protected group, even if they do not explicitly use information about that group."
Source: https://jamanetwork.com/journals/jama/fullarticle/2769419
Commentary: When we discuss systemic racism, this is what we're talking about. It's open to interpretation whether the architects of the CARES Act intended for it to be used to openly discriminate against a population. What is not interpretable is the negative outcome against Black communities, based on using a metric that did not reflect the reality of the need. Dismantling systemic racism means evaluating the measures by which we make decisions, from vaccine allocation to healthcare funding, with an aim towards equal outcomes, especially around public health.
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A reminder of the simple daily habits we should all be taking.
1. Wash/sanitize your hands every time you are in or out of your home for any reason. Consider also spraying the bottoms of your shoes with a general disinfectant (alcohol/bleach/peroxide) when you return home. Remember that cleaners are never to be ingested or injected.
2. Wear a mask when out of your home and if going to a high risk area, wear goggles. Respirators are back in stock at online retailers, too.
3. Stay home as much as possible. Minimize your contact with others and maintain physical distance of at LEAST 6 feet / 2 meters. Avoid indoor places as much as you can; indoor spaces spread the disease through aerosols and distance is less effective at mitigating your risks.
4. Get your personal finances in order now. Cut all unnecessary costs.
5. Replenish your supplies as you use them. Avoid reducing your stores to pre-pandemic levels in case an outbreak causes unexpected supply chain disruptions.
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Common misinformation debunked!
There is no genomic evidence at all that COVID-19 arrived before 2020 in the United States and therefore no hidden herd immunity:
Source:
There is no evidence SARS-CoV-2 was engineered, nor that it escaped a lab somewhere.
Source: https://www.washingtonpost.com/world/2020/01/29/experts-debunk-fringe-theory-linking-chinas-coronavirus-weapons-research/
Source: https://www.nature.com/articles/s41591-020-0820-9
Source: https://www.nationalgeographic.com/science/2020/05/anthony-fauci-no-scientific-evidence-the-coronavirus-was-made-in-a-chinese-lab-cvd/
There is no evidence a flu shot increases your COVID-19 risk.
Source: https://www.factcheck.org/2020/04/no-evidence-that-flu-shot-increases-risk-of-covid-19/
Source: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa626/5842161
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A common request I'm asked is who I follow. Here's a public Twitter list of many of the sources I read.
https://twitter.com/i/lists/1260956929205112834
This list is biased by design. It is limited to authors who predominantly post in the English language. It is heavily biased towards individual researchers and away from institutions. It is biased towards those who publish or share research, data, papers, etc. I have made an attempt to follow researchers from different countries, and also to make the list reasonably gender-balanced, because multiple, diverse perspectives on research data are essential.