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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Pfizer data on 5-11 year olds is in. " Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”"
Source: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results
Commentary: The next step is for Pfizer to submit its data to the FDA for an Emergency Use Authorization. Hopefully that means within weeks, school age children will be able to receive the vaccine. That will allow schools to fully reopen, along with reducing spread by stopping infections from spreading in the household.
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No on universal boosters - coverage from Dr. Jeremy Faust. "Friday, an advisory committee on vaccines for the US Food and Drug Administration voted down Pfizer’s proposal for Covid-19 vaccine boosters for everyone 16 years or older who are more than 6 months out from completing their initial vaccination series. Boosters for those ages 65 and older passed. Frontline workers and other people at high risk for severe disease were also supported. Based on these votes, the FDA will make a final decision soon.
I was actually being interviewed by ABC Nightly News when the news broke that the panel had voted against boosting everyone over 16. It wasn’t a live interview but the reporter read me the result and asked me for my immediate, honest, gut reaction. Naturally, I did what anyone being filmed on national television would do in the face of such new information without adequate time to process it: I absolutely did not supply him with my immediate, honest, gut reaction! I said something vanilla. (They ended up using one decent quotation from me, which is always appreciated).
The truth is that my immediate, honest, gut reaction—my personal Inside Medicine if you will—was somewhere on the surprise-satisfaction-joy spectrum. I genuinely had not realized until right then that even though I felt the data only supported boosting people over 60 years old (and the evidence even for that remains a little thin for my taste), I half expected the panel to bow to pressure and support boosters for everyone, as Pfizer requested. (My on-the-record prediction had been that they would only approve boosters for older people, but I guess I was more pessimistic that they’d get it wrong than I realized).
Why did I think that the committee would green light boosters for all? Because I had read the briefing document that Pfizer had submitted to the FDA ahead of Friday’s meeting. The document was a muddled mess. One sentence referred to infections, the next to symptomatic disease. It was a lot of bobbing and weaving on whether Delta or waning immunity was to blame for breakthrough infections, all the while boasting about how successful vaccines have been. The prevailing sense I had reading the file was intellectual whiplash. I was worried that the panel, would basically buy into it because the document was, in effect, an information firehose (Pfizerhose?) approach. I think Pfizer hoped that if they drenched the committee with droves of data, nobody would be able to process and reconcile it all and they’d just rubber stamp it."
Source: https://insidemedicine.bulletin.com/149709367281976/
Commentary: If you were in an earlier vaccination group due to one or more higher risk factors, contact your physician or qualified healthcare professional and ask about whether a booster is applicable to you.
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COVID-19 created a negative birth rate in Alabama. "For the first time in Alabama’s known history, the state had more deaths than births in 2020 — a grim milestone that underscores the pandemic’s calamitous toll.
“Our state literally shrunk in 2020,” Dr. Scott Harris, Alabama’s state health officer, said at a news conference on Friday. There were 64,714 total deaths in the state last year, compared to 57,641 births, Dr. Harris said.
Such a gap had never been recorded, not even during World War I, World War II and the flu pandemic of 1918, Dr. Harris said. Going back to the earliest available records, in 1900, “We’ve never had a time when deaths exceeded births,” he said.
Nationally, the birthrate declined for the sixth straight year in 2020, and some experts say the pandemic may be accelerating that trend. A study from the University of New Hampshire found that half of the 50 U.S. states had more deaths than births in 2020, compared with only five states with more deaths than births in 2019.
In Alabama last year, 7,182 deaths were officially attributed to Covid, according to data from the Alabama Department of Public Health.
On Wednesday, in a town hall discussion with Al.com, Alabama’s largest digital news site, Dr. Harris dismissed arguments that Covid deaths were being misrepresented.
“We get skeptical people who go, ‘Oh well, those were just older people who were going to die anyway, and you’re just attributing their deaths to Covid,’” he said. “That is not the case.”"
Source: https://www.nytimes.com/2021/09/18/world/covid-alabama-deaths-birthrate.html
Commentary: Many COVID-19 deaths are preventable through vaccination and masking. Do both. Continue to do both.
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A reminder of the simple daily habits we should all be taking.
1. Wear the best mask available to you when you'll be around people you don't live with, even after you've been vaccinated. Respirators are back in stock at online retailers, too. Wear an N95/FFP2/KN95 that's NIOSH-approved or better mask if you can obtain it. If you can't get an N95 mask, wear a surgical mask with a cloth mask over it.
2. Verify your mask's NIOSH certification here: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html
3. Get vaccinated as soon as you're able to, and fulfill the full vaccine regimen. Remember that you are not vaccinated until everyone you live with is vaccinated. If you received an adenovirus vaccine (J&J/AstraZeneca), consider getting an mRNA single shot booster (Pfizer/Moderna) if permitted.
4. Wash/sanitize your hands every time you are in or out of your home.
5. Stay out of indoor spaces that aren't your home and away from people you don't live with as much as practical. Minimize your contact with others and avoid indoor places as much as you can; indoor spaces spread the disease through aerosols and distance is less effective at mitigating your risks.
6. Aim to have 3-6 months of living expenses on hand in case the pandemic gives another crazy plot twist to the economy.
7. Replenish your supplies as you use them. Avoid reducing your stores to pre-pandemic levels in case an outbreak causes unexpected supply chain disruptions.
8. Ventilate your home as frequently as weather and circumstances permit, except when you share close airspaces with other residences (like a window less than a meter away from a neighboring window).
9. Masks must fit properly to work. Here's how to properly fit a mask:
10. If you think you may have been exposed to COVID-19, purchase a rapid antigen test. This will detect COVID-19 only when you're contagious, so follow the directions clearly. https://amzn.to/3fLAoor
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Common misinformation debunked!
There is no basis in fact that COVID-19 vaccines can shed or otherwise harm people around you.
Source: https://www.reuters.com/article/factcheck-covid19vaccine-reproductivepro-idUSL1N2MG256
There is no mercury or other heavy metals in the Pfizer mRNA vaccine.
Source: https://www.technologyreview.com/2020/12/09/1013538/what-are-the-ingredients-of-pfizers-covid-19-vaccine/
There is no basis in fact that COVID-19 vaccines pose additional risks to pregnant women.
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2104983
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/
Source: https://www.smh.com.au/national/are-we-ignoring-the-hard-truths-about-the-most-likely-cause-of-covid-19-20210601-p57x4r.html
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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Disclosures and Disclaimers
I declare no competing interests on anything I share related to COVID-19. I am employed by and am a co-owner in TrustInsights.ai, an analytics and management consulting firm. I have no clients and no business interests in anything related to COVID-19, nor do I financially benefit in any way from sharing information about COVID-19.
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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.
This is also available as an email newsletter at https://lunchtimepandemic.substack.com if you prefer the update in your inbox.