First, there is now a Resources Page here for the most commonly asked questions I’m getting.
Happy to continue to answer your questions/concerns as best I can, so don’t be shy about that.
My latest post on Forbes:
The People’s Vaccine—Moderna’s Coronavirus Vaccine Was Largely Funded By Taxpayer Dollars
Good overview: How key decisions slowed FDA’s review of a Covid-19 vaccine — but also gave it important data
…“It takes a few months usually to review these kinds of data, and now this has been shortened to a few weeks,” …
ways it could have been further sped up. The first, and biggest, revolves around an FDA decision to require two months of safety data for half the patients in a study before a company asked for authorization.
Why is the review of the data taking so long? The FDA takes the raw data that companies provide and reanalyzes them, often picking apart statistical calculations made by manufacturers.
This type of analysis, routine for new drug approvals at the FDA, is not legally necessary for emergency use authorizations during a pandemic. But given that Covid-19 vaccines could be given to hundreds of millions of people, the agency decided a thorough review was needed.
…FDA’s decision, announced quietly on Oct. 6 in the prelude to an earlier FDA advisory committee, to tell vaccine makers not to ask for an EUA until half the patients in their studies had been followed for two months. Setting the threshold slightly lower would have saved time, but meant less safety data.
In May, Scott Gottlieb, who was the FDA commissioner early in the Trump administration, and Luciana Borio… co-authored a Wall Street Journal op-ed saying that immune response data alone should not be used as the basis of an approval. (Almost all experts agree, and it wasn’t.) In August, 400 vaccine experts signed a letter cautioning the FDA to make sure sufficient data were collected.
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The overall rate of any serious sleep difficulties, including initiating sleep, maintaining sleep, or waking too early, rose from 36% before the pandemic to 51%
“We also observed that 8% of our sample reported an increase in the frequency of sleeping medication used during the outbreak,” she said.
2 new drugs for insomnia:
Lemborexant (Dayvigo), a dual orexin receptor antagonist (DORA), became available after winning FDA approval in late December 2019 to treat insomnia with sleep onset or sleep maintenance difficulties.
The drug inhibits orexin signaling by binding to orexin receptor 1 (OX1R) and 2 (OX2R). When activated, OX1R is thought to suppress REM sleep; OX2R is thought to suppress non-REM and REM sleep.
Research about investigational daridorexant, another DORA, also showed efficacy in treating insomnia this year. Compared with placebo, daridorexant at 25 mg and 50 mg significantly improved sleep onset and sleep maintenance from baseline
Behavioral therapy emerged as a front-runner for first-line insomnia treatment in other trial data published this year: a similar proportion of insomnia patients responded to behavioral therapy and zolpidem (Ambien) as first-line therapy, but the proportion of responders diverged with second-line treatments.
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Delirium common in Covid-19
Study: 55% of the 2,000 people they tracked who were treated for COVID-19 in intensive-care units (ICUs) around the world had developed delirium. Usually, about one-third of people who are critically ill develop delirium, according to a 2015 meta-analysis.
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Covid Unknowns Leave Survivors Fearing Life Insurance Rejection
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What vengeful fresh hell is Trump plotting?
The White House removed nine members of the Pentagon's Defense Business Board on Friday and installed people loyal to President Donald Trump in their place, including presidential allies Corey Lewandowski and David Bossie.https://t.co/lUjUnz0X8l— Natasha Bertrand (@NatashaBertrand) December 4, 2020
still an incredible, negligent lack of testing.
Maryland’s acting health secretary finally admitted publicly that none of the 500,000 South Korea tests were used. Last week, @GovLarryHogan said there were no problems with a single test—and that they were being used all over the state. Hmm 🤔 https://t.co/wO0Xonnhdx— Eric Cortellessa (@EricCortellessa) December 3, 2020
Hogan also would not provide a testing site to Allegany County–now we have the highest rate in the state.
Moderna plans to begin testing COVID-19 vaccine in children ages 12-17
Cambridge-based Moderna will soon begin looking for 3,000 children to take part in a trial of its COVID-19 vaccine.
Participants between the ages of 12 and 17 will be split into two groups, with half receiving two shots of the vaccine 28 days apart and half receiving shots of saline. Details about the study, which is not yet recruiting participants, were posted Wednesday on ClinicalTrials.gov.
“A child’s immune system is very different than adults and it’s constantly evolving over time – and this is why it’s so important to do clinical trials specifically on kids,” Boston Children’s Hospital’s Dr. John Brownstein recently told NewsCenter 5.
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MIT study: Moderna, Pfizer, AstraZeneca and other vaccines may not do as well covering people of Black or Asian genetic ancestry as they do for white people https://t.co/n1shnNga88— Tim Mak (@timkmak) December 4, 2020
“[The] weakness [of the vacines], the MIT report contends, which is that they do not use a sufficiently diverse set of viral particles to stimulate the same level of immune response in all people in the population, depending on genetic makeup.”
MIT release has finer point: Asians least likely to respond to covid vaccines. “people whose cellular immune system is not predicted to robustly respond to the vaccine ranged from [<.5%] of white participants to nearly 10 percent of Asian participants.” https://csail.mit.edu/news/mit-study-covid-19-vaccines-may-be-less-effective-asian-americans
Professor Akiko Iwasaki says not to panic about this:
Within just the receptor binding domain (RBD) of the spike protein (221 amino acid), 0.8% of White, and 37.3% of Asian had no predicted peptides that bind to their MHC class II proteins. However Moderna, Pfizer, AstraZeneca vaccines all use the full length S (1273 aa). (9/n)
Good news is that authors found that >99% of White, Black and Asian populations’ MHC class I can present at least 5 peptides from the Spike protein. On MHC class II, >98% of all people have at least 3 peptides predicted to be presented. (10/n)
What does this mean? That current leading vaccine candidates have the capacity to generate good T cell responses in diverse populations. T helper cells will also stimulate good antibody responses from B cells. (11/n)
The ultimate proof of vaccine-induced protection will become available when millions of people get vaccinated. Until then, there is little need to worry about Blacks and Asians not being protected by vaccines.
Full thread to explain the findings of this study, that used computational tools to predict…: https://threadreaderapp.com/thread/1335278168584884227.html…
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Aviptadil, a vasodilator originally developed to treat erectile dysfunction, led to a 72% survival in critically ill COVID-19 patients.
Initial data from an US expanded access (EA) use of RLF-100™ (aviptadil) in 90 ICU patients with critical COVID-19 and severe comorbidities point to a 72% survival 28 days after initial treatment. According to NeuroRx Inc and the virtual biotech company Relief Therapeutics Holding AG , data from a clinical Phase IIb/III trail along with scientic publications suggest that only 27% patients, who received placebo and the best standard of care survived until day 28, while the survival rate seen was similar. If the results are confirmed in a large patient population this would mean a significant progress.
According to the developers of aviptadil as a treatment for COVID-19, in the EAP, no drug-related Serious Adverse Events have been reported to date.
Vasoactive Intestinal Polypeptide (VIP), the active ingredient in aviptadil been shown in more than 100 peer-reviewed studies to have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, 70% of the VIP in the body is bound to a rare cell in the lung, the alveolar type 2 cell, that is critical to transmission of oxygen to the body. VIP has a 20-year history of safe use in humans in multiple human trials for sarcoidosis, pulmonary fibrosis, asthma/allergy, and pulmonary hypertension.
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Vaccines and Related Biological Products Advisory Committee (VRBPAC) December 10, 2020 Meeting Announcement – Pfizer
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible.
The online web conference meeting will be available at the following:
https://twitter.com/US_FDA (Supported in Chrome browser)
Vaccines and Related Biological Products Advisory Committee (VRBPAC) December 17, 2020 Meeting Announcement – Moderna
9:00 AM – 6:00 PM ET The online web conference meeting will be available at:
The VRBPAC will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer vax on 12/10 and Moderna on 12/17 Inc., COVID-19 Vaccine for the prevention of COVID-19 in individuals >18 years Meeting Materials
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, any background material will be made publicly available at the time of the advisory committee meeting, and additional materials will be posted on FDA’s website after the meeting.
Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.
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Study finds metformin reduced COVID-19 death risks in women
Conducted by the University of Minnesota Medical School and UnitedHealth Group, it is one of the world’s largest observational studies of COVID-19 patients
UNIVERSITY OF MINNESOTA MEDICAL SCHOOL
MINNEAPOLIS- December 3, 2020 – University of Minnesota Medical School and UnitedHealth Group (NYSE: UNH) researchers found that metformin was associated with significantly reduced COVID-19 death risks in women in one of the world’s largest observational studies of COVID-19 patients.
Metformin is an established, generic medication for managing blood sugar levels in patients with type 2 diabetes. It also reduces inflammation proteins like TNF-alpha that appear to make COVID-19 worse.
The study, published in The Lancet Healthy Longevity, is a retrospective cohort analysis based on de-identified patient data from UnitedHealth Group. The team analyzed about 6,000 individuals with type 2 diabetes or obesity who were hospitalized with COVID-19 and assessed whether or not metformin use was associated with decreased mortality.
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NIH Guidelines Shrink Scope of Remdesivir Use in COVID-19
— Only dexamethasone now listed for sickest patients
In a revision to its therapeutic management guidelines released on Thursday, the NIH no longer recommends remdesivir with dexamethasone as an option for hospitalized COVID-19 patients who require mechanical ventilation or ECMO, recommending only dexamethasone instead.
For patients who are hospitalized and require supplemental oxygen, remdesivir is recommended for patients who require “minimal supplemental oxygen,” with dexamethasone and remdesivir recommended for patients who require “increasing amounts” of supplemental oxygen. The rating of recommendations for remdesivir also dropped from A (strong) to B (moderate).
Updates to NIH guidelines come on the heels of interim results for the World Health Organization’s Solidarity trial being published Wednesday in the New England Journal of Medicine. WHO researchers found no mortality benefit for remdesivir overall or in any subgroup of hospitalized patients.
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AstraZeneca and Oxford’s stories clash on COVID-19 vaccine dosing
Why did some volunteers only get half the originally intended dose?
New research in from Germany on face masks— Dr Alexandra Phelan (@alexandraphelan) December 4, 2020
– reduced incidence 15% and 75% over a period of 20 days after mandatory introduction
– reduced daily growth rate of reported infections by ~ 47%
Critically (often ignored point): v. low cost measurehttps://t.co/WARCVPKk9J
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I love Bill Nye. Here’s how masks work!— Titus (@TitusNation) December 4, 2020
18% positivity rate; 190 cases/100,000 population. — 3x downstate rate
What is the “percent positive” and why does it matter?
The percent positive will be high if the number of positive tests is too high, or if the number of total tests is too low. A higher percent positive suggests higher transmission and that there are likely more people with coronavirus in the community who haven’t been tested yet.
The percent positive is a critical measure because it gives us an indication how widespread infection is in the area where the testing is occurring—and whether levels of testing are keeping up with levels of disease transmission.
What does a high percent positive mean?
A high percent positive means that more testing should probably be done—and it suggests that it is not a good time to relax restrictions aimed at reducing coronavirus transmission. Because a high percentage of positive tests suggests high coronavirus infection rates (due to high transmission in the community), a high percent positive can indicate it may be a good time to add restrictions to slow the spread of disease.
How high is too high?
The higher the percent positive is, the more concerning it is. As a rule of thumb, however, one threshold for the percent positive being “too high” is 5%. For example, the World Health Organization recommended in May that the percent positive remain below 5% for at least two weeks before governments consider reopening
Allegany County, Maryland Commissioner Creade Brodie Jr. had no interest in doing his job & wants you to stay home rather than address the virus killing your neighbors. This is how our small town politicians are talking about public health, @GovLarryHogan pic.twitter.com/nLBUGPo78S— Cassie Conklin (@conklin_cassie) December 6, 2020
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A New England Journal of Medicine study yesterday of cancer patients with COVID-19 demonstrated viral RNA shedding for up to 78 days and live virus for up to 61 days, suggesting extended infectiousness in patients whose immune system is suppressed.
Dec 1 N Engl J Med study
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Nice Data Viz: Aerosol transmission of Covid-19:
A room, a bar and a classroom: how the coronavirus is spread through the air
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So, first note how few such studies we have here. Jealous. This kind of intense shoe-leather epidemiology can give us better answers about potential transmission paths than large=N but less precise tracing which are useful, too but in a different manner. https://t.co/nKoxiOsfaZ pic.twitter.com/vXP5rv2SWb— zeynep tufekci (@zeynep) December 3, 2020
Cancer patients may shed viable COVID-19 virus for 2 months
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Dr. Mackay writes great explainers at VirologyDownUnder
Tips, general reading for public:
Wash your hands.
Rinse and repeat.
Alcohol-free hand sanitizer just as effective against COVID as alcohol-based versions
A new study from researchers at Brigham Young University finds that alcohol-free hand sanitizer is just as effective at disinfecting surfaces from the COVID-19 virus as alcohol-based products.
…they treated samples of the novel coronavirus with benzalkonium chloride, which is commonly used in alcohol-free hand sanitizers, and several other quaternary ammonium compounds regularly found in disinfectants. In most of the test cases, the compounds wiped out at least 99.9% of the virus within 15 seconds.
I feel like the presidents recently pardoned former national security advisor calling for a military coup and martial law to overturn an election should be bigger news.— Tim Miller (@Timodc) December 2, 2020
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2/ A pretty kickass reporter, Nicole Carr, recorded the video before the guy took it down. When she confronted him he insisted it was all a joke and of course he didn’t register in Georgia. But she checked and he had.— Josh Marshall (@joshtpm) December 3, 2020
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‘There absolutely will be a black market’: How the rich and privileged can skip the line for Covid-19 vaccines
(Particularly egregious to me is how essential workers might be defined to include financial sectors)
Several bioethicists warned that the number of high-profile politicians, including President Trump, Chris Christie, and Ben Carson, who received early access to experimental Covid-19 treatments set a dangerous precedent. When that occurred, the general consensus, Caplan said, was a wink and a blink and a, “Well, that’s the way it is.”
With publication in Morbidity and Mortality Weekly Report, CDC formalized recommendations for allocating initial vaccine supplies–health care workers and residents of Long Term Care Facilities to be in first wave.
But CDC Director Robert Redfield, MD, suggested he wasn’t happy that folks over 70 in multigenerational households aren’t included.
And all the plans are now in jeopardy: Pfizer slashed its December vaccine shipment target in half due to supply chain issues. (Wall Street Journal)
Natural herd immunity is not the way to go — unless you’re okay with losing 1 in 3 people over the age of 84. (Slate)
Cyberattack derails hospital’s operations Handling the surge in attacks has been hamstrung by President Trump’s firing of Christopher Krebs, director of the Department of Homeland Security’s cybersecurity division, after Krebs said there was no voter fraud in the Nov. 3 election. https://www.medpagetoday.com/
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Fired Nurse Faces Board Review for Wearing Hospital Scrubs
— Cliff Willmeng was dismissed after raising safety concerns; now his license hangs in the balance
When I did Infection Control for the hospital here, I rec to the CEO that the hospital provide scrubs to all the staff (or launder theirs if there was a major contamination of the clothes), especially for ICU nurses, to prevent them from taking nasty bugs home. They refused. $$$
Feel good du jour:
A family got a racist note after putting up a Black Santa. Soon, neighbors began displaying their own Black Santas. https://t.co/BiT98gsCxN— Judy Stone (@DrJudyStone) December 4, 2020
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“Where do you see yourself in 10 years?” https://t.co/cXQtnUe07G— ᴘᴀᴠʟᴏᴠ ᴛʜᴇ ᴄᴏʀɢɪ (@PAVGOD) December 1, 2020
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The best place on the internet is the reviews of hats for cats because every review is like “5 stars, amazing hat” and then a picture of the cat looking absolutely furious pic.twitter.com/ZKkpxDqh0g— little piss pants, PhD (@DoctorPissPants) December 3, 2020
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Please enjoy these ducks changing their minds. pic.twitter.com/v1jvCTNMmK— Dick King-Smith HQ (@DickKingSmith) December 5, 2020
Being good at things is not the point of doing them. pic.twitter.com/82L0tzcuEm— Jodi (@jodotcom) December 1, 2020
Bits of beauty: