COVID-19 - Facts and Information Only Topic

[BillsFan4]

 

[Hapless Bills Fan]

Good summary article on vaccine development progress, organized a bit by phase of clinical trial

https://www.nationalgeographic.com/science/health-and-human-body/human-diseases/coronavirus-vaccine-tracker-how-they-work-latest-developments-cvd/

 

Slightly saltier blog from Derek Lowe, starting with readable but technical explanation of the different approaches being taken to vaccine development:

https://blogs.sciencemag.org/pipeline/archives/2020/09/03/coronavirus-vaccine-roundup-early-september

 

 

[shoshin]

From StatNews, just a good single location for all the vaccine progress to supplement Hapless's post above and IMO a little easier to digest quickly. The below is through 9/9.

 

Coronavirus Vaccines Tracker : Sheet1

	Company	Stage	Description	Notes & Updates	Related Coverage
	University of Oxford and AstraZeneca	Phase 3	University of Oxford researchers have developed a potential vaccine that uses a harmless virus engineered to contain the genetic sequence that encodes for a protein on the surface of the novel coronavirus. The researchers, from the University’s Jenner Institute and Oxford Vaccine Group, are working at uncommon speed, starting a placebo-controlled clinical trial while finalizing the manufacturing of their potential vaccine. British drug maker AstraZeneca has partnered on the project.	March 27: Oxford begins recruiting patients for a placebo-controlled trial that will enroll up to 510 healthy volunteers. The vaccine will not be ready for "some weeks," according to the university. April 30: AstraZeneca announces it will partner with Oxford to develop the vaccine. July 20: Oxford publishes Phase 1/2 data demonstrating an immune response with mild to moderate side effects. Aug. 31: AstraZeneca begins enrollment in a U.S. Phase 3 trial that will involved 30,000 volunteers. Sept. 8: AstraZeneca says a hold has been put on the trial following a suspected adverse reaction in a participant.	Read more
	Moderna Therapeutics	Phase 3	Moderna’s vaccine, mRNA-1273, is a synthetic messenger RNA that encodes for a protein found on the surface of the novel coronavirus. By compelling cells to produce that protein, the vaccine would spur an immune response, causing the body to generate antibodies that would protect against infection. The company set a drug industry record with mRNA-1273, identifying a vaccine candidate just 42 days after the novel coronavirus was sequenced.	March 16: First patient dosed in a Phase 1 trial April 16: Moderna plans to begin a Phase 2 study by July May 1: Moderna announces it will partner with Swiss firm Lonza on development May 7: FDA clears Moderna to start a 600-patient Phase 2 study, which will begin "shortly" May 18: Moderna discloses interim Phase 1 data, in which eight volunteers developed antibodies to the coronavirus May 29: Moderna doses the first volunteers in a Phase 2 study, planning to enroll about 600 people July 14: Moderna publishes Phase 1 data showing a consistent antibody response and mild to moderate side effects. July 27: Moderna begins enrollment in a 30,000-subject Phase 3 trial	Read More
	BioNTech and Pfizer	Phase 3	Germany’s BioNTech is working on a multitude of mRNA vaccines for the novel coronavirus, planning to develop them in parallel. Like its competitors, the company uses strands of mRNA to generate protective antibodies. Earlier this month, Shanghai’s Fosun Pharma signed a deal to market BioNTech’s vaccine in China if it’s eventually approved. Pfizer has agreed to co-develop the vaccine in the rest of the world.	April 9: BioNTech says it will begin its first human trials "as early as the end of April" April 29: BioNTech and Pfizer dose the first patients in a Phase 1 trial in Germany, planning to enroll about 200 patients May 5: BioNTech and Pfizer begin Phase 1 study in the U.S., recruiting up to 360 patients total May 12: BioNTech says it expects preliminary data in June or July July 1: In a Phase 1 trial, BioNTech's vaccine led to an increase coronavirus antibodies at three doses, according to a preprint paper July 27: Pfizer and BioNTech begin enrollment on a 30,000-volunteer study, expecting data as early as October	Read more
	Sinovac	Phase 2	Sinovac, headquartered in Beijing, is developing a vaccine using an inactivated version of the novel coronavirus. The company used the same technology to craft approved vaccines for hepatitis A and B; swine flu; avian flu; and the virus that causes hand, foot, and mouth disease.	April 17: Sinovac begins a placebo-controlled Phase 1/2 trial, planning to enroll 144 healthy volunteers in China May 6: Sinovac publishes results from a preclinical study in which its vaccine successfully protected monkeys from contracting the novel coronavirus. The company plans to start a second, larger human trial by mid-May June 14: Sinovac released preliminary results from its Phase 2 trial, saying its vaccine induced neutralizing antibodies in “above 90%” of participants	Read more
	CanSino Biologics	Phase 2	CanSino Biologics, headquartered in Tianjin, is developing a coronavirus vaccine using the technology that led to a China-approved Ebola virus vaccine. CanSino’s approach involves taking a snippet of coronavirus’ genetic code and entwining it with a harmless virus, thereby exposing healthy volunteers to the novel infection and spurring the production of antibodies.	March 17: CanSino begins Phase 1 trial in China April 10: Based on preliminary data, CanSino says it will move into Phase 2 "soon" May 22: CanSino published data from a 108-subject trial, in which its vaccine generated a immune response in volunteers June 29: Chinese regulators provisionally approved CanSino's vaccine for military use July 20: CanSino publishes interim Phase 2 data showing a consistent antibody response but one that seemed to wane in older subjects	Read more
	Inovio Pharmaceuticals	Phase 1	Inovio has spent the last four decades working to turn DNA into medicine, and the company believes its technology could quickly generate a vaccine for the novel coronavirus. Inovio has come up with a DNA vaccine it believes can generate protective antibodies and keep patients from infection. The company has partnered with a Chinese manufacturer, Beijing Advaccine Biotechnology, to produce the vaccine.	April 6: Inovio doses first patient in Phase 1 trial June 30: Inovio says its vaccine led to an immune response in 94% of patients but does not provide data	Read more
	Novavax	Phase 1	Novavax is at work on a coronavirus vaccine that begins in the ovaries of an insect. The company’s vaccine platform involves genetically engineering a harmless virus and exposing it to cells isolated from worms. Those cells then churn out the proteins needed to stimulate antibodies, and those proteins become vaccines. For Covid-19, Novavax has isolated the spike protein found on the surface of the novel coronavirus.	April 8: Novavax selects a vaccine candidate, planning to begin human trials in May with preliminary data in July May 26: Novavax begins Phase 1 trial, planning to enroll about 130 volunteers with data expected in July Aug. 4: Novavax presents detailed data from its Phase 1 trial, demonstrating an immune response with mostly mild side effects	Read more
	Sanofi and GlaxoSmithKline	Phase 1	Sanofi is employing the same technology it employs for flu vaccines, which uses a genetically modified version of a virus to create proteins that train the immune system to react. The company is combining its approach with GlaxoSmithKline's proprietary adjuvant, an additive that makes vaccines more potent.	Feb. 18: Sanofi begins work on a coronavirus vaccine April 14: Sanofi partners with GlaxoSmithKline and plans to begin human trials in the second half of 2020 and generate pivotal data in 2021 Sept. 3. Sanofi and GlaxoSmithKline begin a 400-volunteer, Phase 1/2 trial, expect data in December	Read More
	Johnson & Johnson	Preclinical	Johnson & Johnson, which has in the past responded to outbreaks of the Ebola and Zika viruses, is using the same technology to develop a vaccine for the novel coronavirus. J&J’s vaccine is made by grafting the coronavirus genes that confer immunity onto a harmless virus, injecting it triggering an immune response without causing infection.	March 30: J&J expects to begin Phase 1 by September, with a vaccine available for emergency use as soon as early 2021
	Arcturus Therapeutics	Preclinical	Arcturus Therapeutics is pressing forward with a vaccine that relies on engineering RNA. The company plans to take an RNA virus that has been edited to encode for proteins that will protect against infection and load it into a liquid nanoparticle. The resulting vaccine, being developed in partnership with Duke University, promises a better immune response at a lower dose than competing mRNA approaches, according to the company.	April 9: Arcturus plans to begin a Phase 1 trial in Singapore over the summer
	Clover Biopharmaceuticals and GlaxoSmithKline	Preclinical	Clover Biopharmaceuticals, headquartered in Chengdu, is developing a vaccine that would inject patients with a protein found on the surface of the novel coronavirus. GlaxoSmithKline is providing its proprietary adjuvant, an additive that makes vaccines more potent.	Feb. 10: Clover identifies its vaccine candidate Feb. 24: GlaxoSmithKline provides its adjuvant
	CureVac	Preclinical	CureVac uses man-made mRNA to spur the production of proteins and protective antibodies. Like Moderna, the company got a grant from the nonprofit Coalition for Epidemic Preparedness Innovations to apply its technology to coronavirus.	March 17: CureVac said it expects to have a candidate ready for animal testing by April, aiming to start a clinical study in the summer
	Imperial College London	Preclinical	Led by the immunologist Robin Shattock, Imperial College London is developing an RNA-based vaccine for the novel coronavirus. The scientists have engineered a virus-derived RNA strand that will get into cells, spur the production of the coronavirus’s signature protein, and then replicate itself. In animal studies, the vaccine has resulted in the generation of protective antibodies.	April 17: With funding from the U.K. government, Imperial plans to complete preclinical work and begin human trials in June
	University of Queensland and GlaxoSmithKline	Preclinical	Australia’s University of Queensland, with funding from the Coalition for Epidemic Preparedness Innovations, has been developing a coronavirus vaccine since January. Queensland has a proprietary technology meant to make protein vaccines more effective at triggering an immune response. Called a molecular clamp, the university’s approach keeps the coronavirus’s key protein in its natural shape before grafting it onto the vaccine.	April 9: Queensland plans to begin human trials in the third quarter
	Merck	Preclinical	Merck purchased a Vienna-based company called Themis, which is developing an experimental Covid-19 vaccine based on a measles vaccine. It also partnering with the nonprofit IAVI on the development of a coronavirus vaccine related to the company's existing Ebola vaccine.	May 26: Merck says the Themis vaccine will enter human trials in a matter of weeks while the second candidate could reach the clinic by the end of the year	Read more
	Sanofi and Translate Bio	Preclinical	Sanofi partnered with Translate Bio to develop potential vaccines using synthetic messenger RNA, which would compel the body to produce antibodies against the novel coronavirus. The two companies have worked together in the past on vaccines for infectuous disease.	March 27: Sanofi and Translate Bio announce their collaboration but do not specify a development timeline

Edited September 9, 2020 by shoshin

[DefenseWins]

https://www.yahoo.com/news/severe-covid-19-riskier-heart-190554603.html

[Hapless Bills Fan]

AstraZeneca/Oxford vaccine trial paused while adverse event is investigated:

https://abcnews.go.com/Health/astrazeneca-pausing-covid-19-vaccine-trial-good-news/story?id=72903384

This is how it's supposed to work. 

 

AstraZeneca chief says vaccine by the end of the year still possible

https://www.msn.com/en-gb/money/news/oxford-covid-19-vaccine-is-still-possible-this-year-says-astrazeneca-chief/ar-BB18TuZr

 

Transverse Myelitis is no joke.  Most people afflicted with it recover, but can suffer serious long-term effects:

https://www.mayoclinic.org/diseases-conditions/transverse-myelitis/symptoms-causes/syc-20354726

It is associated with viral infection, including infection with herpes viruses, CMV, Epstein-Barr, HepB, enteroviruses, influenza

 

The Oxford vaccine uses a chimpanzee Adenovirus particle to deliver the genetic material for the Sars-Cov2 coat protein that raises the desired anti-covid-19 immune response.

 

The Phase III trial aimed to enroll 50,000 people.  A serious vaccine-related adverse event at the 1 in 30,000 rate would affect about 10,000 people if administered to the majority of the 329 million population of US or 447 million population of EU

 

 

[Hapless Bills Fan]

Updated Covid-19 Vaccine Tracker at the NYT.

Can filter search results by the phase of clinical trial a vaccine is in.

 

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

 

Astrazeneca has lifted their pause to Phase 3

 

[Hapless Bills Fan]

From NYTimes, via Shoshin:

 

Positive results from Eli Lilly's monoclonal antibody drug trial.  This is a double-blind, placebo-controlled study of 450 patients and the trial is ongoing, meaning the result was significant enough to break the blind:

https://www.nytimes.com/2020/09/16/health/coronavirus-drug-eli-lilly.html?surface=home-discovery-vi-prg&fellback=false&req_id=841659783&algo=identity&imp_id=690733981&action=click&module=Science Technology&pgtype=Homepage

 

Key points:

-monoclonal antibody, meaning a single human anti-covid-19 antibody cloned and produced at large scale in mammalian cells

-administered to newly diagnosed patients, including those with mild or moderate disease

-1.7% of those who received the drug hospitalized, 6% of those who received placebo

 

An early clinical trial usually features healthy people, but this could be a true boon if, for example, it could be administered to exposed people who are at risk - nursing home patients exposed to an infected caregiver, say, or exposed people with known risk factors such as heart disease or diabetes.

 

Thanks @shoshin

 

Bit less excited article from Stat pointing out the watch-outs:

https://www.statnews.com/2020/09/16/lilly-covid-19-antibody-helps-patients-rid-their-systems-of-virus-sooner/

“This is a good start,” said Eric Topol, the director and founder of the Scripps Research Translational Institute. “A lot is pinned not only on Lilly but on the whole family of these [monoclonal antibodies], because even though they’re expensive and they’re not going to make a gajillion doses, they could make a big difference in the whole landscape of the pandemic.”

 

Lilly, which is developing the drug with the biotechnology firm AbCellera, tested three doses of its antibody against placebo in a trial enrolling about 450 patients recently diagnosed with mild to moderate Covid-19. The middle dose, 2,800 milligrams, met the trial’s primary goal of significantly reducing patients’ levels of SARS-CoV-2 after 11 days.

 

But other doses of the drug did not meet that goal, including a higher dose of 7,000 milligrams and a lower one of 700 milligrams. That could raise the risk that the benefit was due to chance, because normally one expects a medicine to become more effective as the dose increases, known as a dose response.

 

I can't think of an effective, approved drug that showed that pattern.  Normally what one sees is stronger therapeutic effect on the one hand vs increased side effects and adverse events on the other hand, and one chooses the dose to balance between the two.  Sars-Cov2 is a tricky virus, and "the human immune system is where intuition goes to die" so it's always possible.  The smart money says that ain't the result Eli Lilly expected, and it's worrisome.

 

But Lilly is targeting the right population next:

Lilly is conducting larger tests of the antibody, including one study in using the antibodies to prevent infection in nursing homes that is using recreational vehicles to provide on-site hubs for running the clinical trial. That study is being run with the National Institute of Allergy and Infectious Disease.

 

Commentary from my boi Derek Lowe on why seeking an EUA for this would be bad, but I imagine Lilly will face a lot of pressure to that end:

https://blogs.sciencemag.org/pipeline/archives/2020/09/16/monoclonal-antibody-data

 

[Hapless Bills Fan]

https://apnews.com/article/pfizer-vaccine-effective-early-data-4f4ae2e3bad122d17742be22a2240ae8
https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html?smtyp=cur&smid=tw-nytimes
 

Standard clinical trial design protocol is that an independent data review board to "break the blind" when a milestone is reached that will likely result in a statistically significant finding.  In this case, it was 94 total covid-19 infections in 44,000 trial participants. 

 

The number (which is set during the trial design phase) is chosen to allow a read out of statistical significance if the vaccine met a lower milestone for effectiveness - the FDA has said it will accept license applications for vaccines as little as 50% effective, but that was probably not Pfizer's target.  My guess would be they were going for 75%.

 

There have been challenges, such as individual behavior - for example if the placebo injection produces no vaccine-site reaction or symptoms, people who get the placebo may guess they likely got the placebo and may continue taking precautions that make them less likely to be infected. 

 

Pfizer had hoped to break the blind in September or October, but they simply weren't getting enough infections to allow that:

Pfizer Chairman and CEO Albert Bourla said on CNBC that the election was always an artificial deadline and that the data was going to be ready when it was ready. The independent data monitors met on Sunday, analyzing the COVID-19 test results so far and notifying Pfizer.

Pfizer's vaccine has been manufactured "at risk" but there are still hurdles to overcome such as assembling the safety data in trial participants, and stability data on the vaccine itself:

Pfizer plans to ask the Food and Drug Administration for emergency authorization of the two-dose vaccine later this month, after it has collected the recommended two months of safety data. By the end of the year it will have manufactured enough doses to immunize 15 to 20 million people, company executives have said.

 

This is the vaccine that raised eyebrows by requiring a -70C cold storage chain.

 

 

[Greg S]

https://www.nytimes.com/2020/11/18/nyregion/nyc-schools-covid.html

[Hapless Bills Fan]

Moderna's vaccine also 95% effective.  Very similar principles, but requires less stringent cold storage

 

https://www.cnn.com/2020/11/16/health/moderna-vaccine-results-coronavirus/index.html

[Hapless Bills Fan]

 

Pfizer and BioNTech announce they will file for EUA (emergency use approval) for their vaccine

 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization

 

 

[Hapless Bills Fan]

Astrazeneca vaccine.  Participants with 2 full doses, 64% effective.  Participants with 1/2 dose followed by full dose, 90% effective.  Overall, 70% effective.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-idINKBN2830HC

 

To recap difference between Moderna, Pfizer, and Astra-Zeneca vaccines:

-all 3 work by handing over the genetic blueprint for making part of the Sars-Cov2 exterior protein coat to the part of your immune system that stimulates adaptive immunity (antibodies and t-cells)

-this means that absolutely no Sars-Cov2 virus is involved anywhere in the manufacturing process and the vaccine absolutely can not give you covid-19 disease.  No way.

-the difference is in the "delivery truck" used to deliver the blueprint to the correct part of your immune system.  Other parts of the human immune system are primed to seek-and-destroy foreign genetic material seen wandering randomly about your body's premises unescorted

 

-The Pfizer and Moderna vaccines use proprietary lipid (fat) particles to protect the genetic material long enough for proper delivery.  Lipids don't evoke much immune response.

-The disadvantage is that's not a particularly robust vehicle, so it needs careful (frozen) storage.  It's sort of like floating downriver in a birchbark canoe - it works, if you're careful.

 

-The AstraZeneca vaccine uses the empty shell of another virus as the "delivery truck".  This means the "delivery truck" itself is going to evoke an immune response which can interfere with the delivery of its payload to develop the desired Sars-Cov2 immune response

-The reason they do this, is because the viral shell is tougher and more stable than a little lipid particle.  Engineered by nature, so to speak.

-In AstraZeneca's case, the shell is a Chimpanzee Adenovirus.  The good news is most people probably don't have a strong pre-existing immune response to a chimp virus.  The bad news is that because human Adenoviruses are all over the place, some people likely do have a preexisting immune response, at least partially. 

 

[Hapless Bills Fan]

Some more good stuff about the Astra-Zeneca/Oxford vaccine and the Pfizer/BioNTech and Moderna vaccines from Pharma Blogger Derek Lowe

 

Lowe shares my speculation that the 1/2 dose/ full dose improved efficacy might be related to the possibility of raising an immune response to the chimp Adenovirus “delivery truck”.  We’re all waiting to see more data.

 

 

 

 

 

[Hapless Bills Fan]

Vaccine Side Effects: bear in mind that when you look at ~70-80,000 people for a period of several months, you expect some deaths in the natural way of things.

 

Fact check of rumor piece:

https://www.reuters.com/article/uk-factcheck-pfizer-health-concerns-idUSKBN28K2R6

 

Good general commentary from a knowledgeable Pharma R&D guy:

https://blogs.sciencemag.org/pipeline/archives/2020/12/04/get-ready-for-false-side-effects

[Hapless Bills Fan]

State of the pharmaceutical treatment:

 

https://yourlocalepidemiologist.substack.com/p/covid19-drugs?fbclid=IwAR0VfGv7xjFTjxQItgI0onn4kd5hFfQGGy5iUkkrEbfZAi8mHUAjkatUNT0

Quote

On Feb 11, 2021, the National Institutes of Health published a 280 page report summarizing COVID19 treatment options. Treatment options were based on severity of disease (see Table for summary). And, really, there’re only two options that work so far:

Corticosteroids: This has been consistently effective against death from severe and critical COVID19 disease. Corticosteroids also help prevent mechanical ventilation and decrease ICU length of stay. There has been one study on mild COVID19 disease and corticosteroids did NOT help.

Remdesivir: This is the only FDA-approved antiviral drug found effective for COVID-19. And, specifically, only for people hospitalized needing supplemental oxygen (NOT ventilation).

 

The NIH report it references:

https://www.covid19treatmentguidelines.nih.gov/therapeutic-management/

 

She starts out with a clear explanation of the difference between population health and patient health, which is important to understand.

Quote

Preface: There is a difference between population health (another word for public health and epidemiology) and patient health (another word for clinical care or patient-care). The distinction is important and we shouldn’t use them interchangeably, especially when we talk about drugs. Population health fixes problems for populations at a time. It takes into account everything that impacts health: culture, environment, government, and even genetics. Patient health fixes problems for one person at a time. So, for example, Ivermectin might have worked for your uncle or neighbors mother. It may have even worked for 100 patients for one doctor. But this does NOT mean it works for the rest of the population. This is important to distinguish because population health (not patient health) drives policy. And… this is a blog about population health.

 

[Hapless Bills Fan]

Evidence that vaccines block transmission of Covid-19. 

https://www.vox.com/future-perfect/22291959/covid-vaccines-transmission-protect-spread-virus-moderna-pfizer?fbclid=IwAR1EF-UFnsKzL7Qixd_iGIY1kjFGMXqBiuRLFBRkqSd4LOYbMapf8tV0j5A

 

Public health figures are by nature cautious in their statements

Quote

“In their own lives, medical experts — and, again, journalists — tend to be cleareyed about the vaccines. Many are getting shots as soon as they’re offered one. They are urging their family and friends to do the same,” David Leonhardt argues in a New York Times piece. “But when they speak to a national audience, they deliver a message that comes off very differently. It is dominated by talk of risks, uncertainties, caveats and possible problems. It feeds pre-existing anti-vaccine misinformation and anxiety.”

 

Vaccination dramatically decreases infection overall, not just symptomatic infection:

Quote

A new working paper published with The Lancet’s preprint publication program on Monday looked at health care workers in the United Kingdom who were vaccinated with the Pfizer/BioNTech vaccine. It finds that the vaccine doesn’t just make people less likely to get symptomatic infections (which we already knew from Pfizer/BioNTech’s initial trials) — it also makes them much much less likely to get infected at all. “Vaccine effectiveness was 72% ... 21 days after first dose and 86% ... 7 days after the second dose,” the study concludes.

That’s lower than the 95 percent headline number you might have seen, but that 95 percent measures symptomatic infections; this measures all infections, even “invisible” asymptomatic ones, through routine testing of healthy people.

 

Quote

Another new paper, this time out of Israel, looked at the Pfizer/BioNTech vaccine as well. (A big caveat: The findings were announced in a press release, but the study itself hasn’t been released yet.) It found a drop of 89.4 percent in infections among people who got two doses of the vaccine, compared to unvaccinated people. We don’t have as much information from this research as we’d like yet, as the paper has yet to be made public, and given the methodological challenges of estimating transmission, the details of the paper matter a lot. But that number is similar to the one from the UK study.

 

Also this:

https://time.com/5942076/proof-covid-19-vaccines-work/

 

 

Quote

In their initial clinical trials, Moderna and Pfizer didn’t study whether vaccinated people got asymptomatic cases of Covid-19 — that is, people who tested positive for the coronavirus but did not suffer any symptoms. However, when people went in for their second shot, Moderna did give them a nasal swab test for Covid-19.....

Using Moderna’s nasal swab test data, infectious disease biologist Marm Kilpatrick at UCSC estimated that the vaccine, after a single shot, reduces a person’s odds of infection with Covid-19 by up to 90 percent. (When I emailed him, we determined that with some more pessimistic assumptions, the reduction might be more like 78 to 88 percent.) Of course, the overall efficacy of the vaccine after both doses will almost certainly be higher.

 

Quote

“Our discussion about vaccines has been poor, really poor,” Dr. Muge Cevik, a virologist, told the New York Times. It has overwhelmingly emphasized the fact that post-vaccine transmission is still possible, rather than frankly discussing the probability of such transmission and leaving it up to people to make their own risk calculation.
 

That’s because a lot of public health officials worry about encouraging people who’ve been vaccinated to “party like it’s 1999,” potentially spreading the virus to other people who haven’t had their chance to get vaccinated yet.
 

It’s important to note that for a vaccinated person’s behavior to be more dangerous than an unvaccinated person’s, they’d have to go really wild. If vaccines reduce infection by 90 percent, then unless your behavior gets 10 times more dangerous after you’re vaccinated, you are still safer to be around than you were before the vaccine. (...)
 

Vaccinated people should, of course, respect businesses’ rules about masks — the essential workers asked to enforce those rules have no way to know if you’ve been vaccinated. And while most people are still unvaccinated, the vaccinated should be thoughtful about protecting those who haven’t had a chance at the vaccines yet. But those reminders shouldn’t drown out an accurate understanding of the fact that the vaccines are really effective.

 

Another report on the Israel study of 1.2 million people (600,000 vaccinated:

https://www.cbsnews.com/news/pfizer-covid-19-vaccine-effective-real-world-study-israel/

 

Quote

The study, involving about 1.2 million people total, showed just one shot of the vaccine is 57% effective in protecting against symptomatic infections after two weeks. The vaccine also proved to be 62% effective at preventing severe disease after one shot, and 92% effective after two. ....In terms of preventing hospitalization, the shot was 74% effective after one dose and 87% effective after two. 

 

 

[Hapless Bills Fan]

New US study confirms earlier Israel, UK studies: in real life use, vaccines dramatically lower the number of infections, and if you're not infected, you can't spread disease:
 

Quote

The workers came from eight locations in six states — Arizona, Florida, Minnesota, Oregon, Texas and Utah. They received vaccinations between mid-December, when the doses first became available, to mid-March, a 13-week period that included the deadly winter surge that was killing more than 3,000 people a day by January. The study is also one of the first to estimate vaccine effectiveness among participants against infection — rather than just monitoring for symptomatic cases — including infections that did not result in symptoms, according to the CDC.

Quote

Among 2,479 fully vaccinated people, just three had confirmed infections. Among 477 people who received one dose, eight infections were reported.

By comparison, among 994 people who were not vaccinated, 161 developed infections.

No deaths were reported.

 

https://www.washingtonpost.com/health/2021/03/29/vaccine-effective-essential-workers-study/?fbclid=IwAR3HIvEXE_BS37MBwOV3fXNuVc6cwRd0hT9R8eWO4CM_mZNKQgdIWdCPHM8

PSA: Love One Another; Get the Jab

[Hapless Bills Fan]

Just found this site which gives the exact ingredients in all 3 currently authorized covid-19 vaccines

 

https://www.hackensackmeridianhealth.org/HealthU/2021/01/11/a-simple-breakdown-of-the-ingredients-in-the-covid-vaccines/

[Hapless Bills Fan]

Lancet study suggesting link between spike in area covid-19 cases and >5000 fans attendance at Football Games.

 

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3805754

[Hapless Bills Fan]

This is the vaccine assessment of a long term Pharma R&D scientist I respect a lot, "In the Pipeline" author Derek Lowe

 

https://blogs.sciencemag.org/pipeline/archives/2021/04/07/getting-vaccinated

 

Quote

I’ve now had my first coronavirus vaccine dose (Pfizer/BioNTech). Since I’ve been writing about the mRNA vaccines for months here and cheering on the vaccine efforts in general, I can tell you that I’m very, very happy to be able to follow through and actually take one. So far, the only signs are a sore upper arm.

 

Quote

I wondered if I should even mention this, to be honest, because with the vaccine supplies continuing to ramp up, it’s (fortunately) no longer such a rare event to get vaccinated. States all over the country are opening their programs up, in many cases to anyone who wants to come in, which is excellent news. But I decided to make the public statement, in light of the continued emails and comments I get about the vaccinations in general. There are a lot of people out there still worrying about a lot of things: antibody-dependent enhancement, short-term immune reactions, possible long-term side effects, CNS penetration, and more. And those are just the worries that are founded in actual medical science – beyond those, you have the Bill-Gates-George Soros-microchip crowd, the 5G activists, the mark-of-the-beast fringe, and who knows what else. Fortunately, we don’t get too many of those folks around this site, but I know that they’re out there.

 

Quote

For people who are honestly wondering about real immunological issues, though, I wanted to say that as someone who’s been doing drug discovery work for over 30 years now, and who has been covering the vaccine developments in detail with great interest during the entire pandemic, that I had no hesitation about rolling up my sleeve. I weighed the risks and benefits as thoroughly as I could, with all the medical knowledge that I could bring to bear on the decision, and my decision was clear: get the vaccine. My wife has been vaccinated, my college-aged children are getting vaccinated (my son a few days ago in another state, my daughter tomorrow), and my wife’s mother is way out ahead of us with both her shots done some time ago. In short, I am very, very willing to take this step and have my closest family members do likewise – and I take their health and safety very seriously indeed (not to mention my own). If this can be of any use in helping to persuade someone who’s worried and on the fence about this decision, I’m happy to offer it.

 

 

[Hapless Bills Fan]

There is a really cool video here explaining part of the Pfizer mRNA vaccine manufacturing process

 

https://www.cnn.com/2021/04/01/health/pfizer-covid-vaccine-efficacy-six-months-bn/index.html

 

 

[Hapless Bills Fan]

https://www.usnews.com/news/health-news/articles/2021-04-13/cdc-fda-recommend-pause-of-johnson-johnson-coronavirus-vaccine-over-blood-clot-concerns

 

The number of events in the above link is 6 per 6.8 million doses, or 0.88 per million. 

 

There appears to be debate on what the background rate is for this disorder, called vaccine-induced immune thrombotic thrombocytopenia (VITT).  One source in the EU said the background rate was 0.6 per million, which would put this somewhat over background.

 

There is confusion about number of events because some are publishing total blood clot side effects while some are publishing numbers only for VITT.   Normal people get blood clots in the normal course of life and a number of widely-used medications have blood clots as a side effect including birth control pills.  Covid itself also has a high rate of causing blood clot disorders. 

This is a specific blood-clotting syndrome involving low platelets.  The anti-coagulant Heparin has a similar rare side-effect.

 

[Edit: the Astra-Zeneca vaccine appears to have 4-10 in 1 million of the same disorder or ~10x the incidence]

 

 

 

 

[Hapless Bills Fan]

BeastMode interviews Dr Fauci.  This is totally classic

 

 

 

I 💓 Marshawn

[Hapless Bills Fan]

1) FDA approves Pfizer vaccine for 12-15 yr olds

https://www.npr.org/sections/coronavirus-live-updates/2021/05/10/993591902/hold-fda-oks-pfizer-covid-19-vaccine-for-12-15-age-group

 

There are 3 essential steps:

1. FDA EUA

2. ACIP meeting / review & recommendations

3. CDC Director approval & publishing of guidance in the MMWR.

 

2) CDC met and reviewed data yesterday, recommended it

https://www.khou.com/article/news/health/coronavirus/vaccine/cdc-advisory-committee-may-12-to-discuss-pfizer-vaccine-ages-12-to-15/507-7d3fa638-5dc3-435e-a94b-ad1cda43dc2f

 

3) 12-15 yr olds can now be vaccinated with Pfizer vaccine

 

Find appointments at Walgreens, CVS, Walmart, Sams, and health department clinics using the Pfizer vaccine near you:

https://www.vaccines.gov/search/
https://www.vaccinespotter.org/
 

https://www.wsj.com/articles/how-to-get-a-covid-19-vaccine-a-state-by-state-guide-11611703769

Or call your physician and ask for help finding an appointment.

 

 

[Hapless Bills Fan]

The new variant popularly called "Delta" (officially B.1.617.2, first noted in India) is now >90% of the cases tested in UK.

Here's gouge on vaccine effectiveness from Public Health Scotland and Public Health England.

 

Conclusion:  After 2 doses of either vaccine there were only modest differences in vaccine effectiveness with the B.1.617.2 variant. Absolute differences in vaccine effectiveness were more marked with dose 1. This would support maximising vaccine uptake with two doses among vulnerable groups.

 

(click to enlarge)

References:

Preprint (Public Health England)

Lancet (Public Health Scotland)

Popular Article based on these data

 

Note on vaccination programs in UK: vaccines used are Astrazeneca/Oxford (most common) or Pfizer.  In order to vaccinate more people quickly, it has been public health policy to administer only one dose to as many people as possible, then circle back to get most vulnerable first.

 

Based upon their similarity in many other studies, it would be predicted that 2 doses of Moderna vaccine would provide similar protection to 2 doses of Pfizer vaccine; it would likewise be predicted that 1 dose of J&J vaccine would provide similar protection to 1 dose of Astrazeneca vaccine.

 

No hard data I could find yet with regard to protection against Delta compared to infection with original virus.

There are data showing a previous infection with Covid-19 provided protection against the variants circulating in US through February, 2021

 

 

 

 

 

 

[HappyDays]

38 minutes ago, JaCrispy said:

Well, to be fair, covid did not specifically kill that many people...if you noticed on the data charts, all other causes of death went significantly down over the passed year

 

I mean this is simply not true. One measure researchers use is "excess mortality," which tracks how many people died in a given year compared to how many people should have died based on mortality rates over the last 5 years. If covid was not actually as deadly as scientists claim, we would expect mortality rates to stay the same. Instead researchers find that mortality rates increased significantly during the pandemic.

 

https://www.medpagetoday.com/infectiousdisease/covid19/91910

 

Quote

No harder measure of the coronavirus pandemic's toll exists: death from any cause rose 23% nationwide in 2020.

That meant 522,368 excess deaths from March through the end of 2020 compared with a projection from the prior 5 years, Steven Woolf, MD, MPH, of Virginia Commonwealth University School of Medicine in Richmond, and colleagues reported in JAMA.

It's well above the unofficial tally of COVID-19 deaths, which reached about 339,000 deaths by the end of 2020. COVID directly accounted for about 72% of the excess mortality, Woolf's group found.

 

https://www.cebm.net/covid-19/excess-mortality-across-countries-in-2020/

 

According to that link, mortality in the US was 12.9% higher than expected in 2020. Keep in mind the pandemic didn't really begin until March so in just 10 months we saw that level of difference.

 

https://ourworldindata.org/grapher/excess-mortality-p-scores?country=~USA

 

This chart shows excess mortality in the USA on a weekly basis. You can use the slider at the bottom to change the end date. Notice that excess morality rises sharply right when the pandemic first began in 2020, starts declining at the time most states instituted social restrictions, rises again as certain states removed those restrictions before peaking in January of this year at 51% excess mortality, then drops sharply at the same time the vaccine rollout began earlier this year.

 

You can believe whatever you want but you can't hide from the data.

Edited June 26, 2021 by HappyDays

[Hapless Bills Fan]

1 hour ago, Weatherman said:

False positives are a thing I can attest.  Also wondering if the vaccine can cause a false positive soon after you’ve been vaccinated.  So many questions not many verified answers.  

 

No.  It is impossible for any of the current vaccines to cause a false positive on a diagnostic test for covid-19 disease. 

 

https://www.gavi.org/vaccineswork/can-you-test-positive-covid-19-test-after-getting-vaccine

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html

https://www.goodrx.com/blog/testing-positive-for-covid-after-getting-vaccinated/
https://www.nebraskamed.com/COVID/you-asked-we-answered-will-the-vaccine-make-you-test-positive

https://www.forbes.com/sites/coronavirusfrontlines/2021/02/26/could-vaccination-cause-me-to-test-positive-for-covid-19/

 

There Is No "not many verified answers" on this point.  It's not possible and any reputable medical source will tell you so.

 

The only way you would test positive is if you actually got infected with covid between being vaccinated and developing full immunity, or if there was a lab SNAFU causing a false positive PCR test.

 

 

[Doc Brown]

2 hours ago, JaCrispy said:

Well, to be fair, covid did not specifically kill that many people...if you noticed on the data charts, all other causes of death went significantly down over the passed year- not because they were suddenly cured, but because any one who died with covid was listed as dying from covid- a “slight of hand” that the establishment used to, likely, make it seem worse than it was...Also, we know that hospitals were monetarily incentivized to list covid as cause of death...the more covid casualties, the more money received from the gove\ment...Fear is a hell of a drug...👍

 

There was a 15.9% increase in the death rate in the US in 2020 compared to 2019 after three straight years of decline. 

[Hapless Bills Fan]

3 hours ago, El Guapo said:

I wonder how many that tested positive were vaccinated. We’ve seen it happen at our office already. She wasn’t having any symptoms, but they tested her before a medical procedure and she was positive. 

 

Studies suggest that with regard to the original Covid-19 strain and Alpha ("UK" strain, the mRNA vaccines are 90% effective at preventing any infection, including asymptomatic infection.

https://www.cdc.gov/media/releases/2021/p0607-mrna-reduce-risks.html

This means that if 100 unvaccinated people are infected with Covid, you would predict 10 equally-exposed vaccinated people would be infected with Covid (a tenfold reduction in relative risk of any infection, including asymptomatic infection).

 

On the other hand, against the more contagious Delta ("Indian") variant (see post above), recent data from UK Health suggest that the mRNA vaccines are 80% effective at preventing infection.   This means that if 100 unvaccinated people are infected with Covid, you would predict 20 equally-exposed vaccinated people would be infected with Covid (a 5-fold reduction in relative risk of any infection, including asymptomatic infection).

 

Applied to the 13 infected members of the NC State "Cinderella" team, these data suggest 1 or 2 of the infected players could have been vaccinated.

[Hapless Bills Fan]

https://www.vdh.virginia.gov/coronavirus/covid-19-data-insights/covid-19-cases-by-vaccination-status/

 

 

 

[Hapless Bills Fan]

Clearest graphic I've found showing the real impact of vaccination on Covid in the UK;

Infection rates rise, but deaths do not

 

The vertical axis is days since the "wave" started

1 = 9/8/20 for 2nd wave on L

1 = 5/14/21 for 3rd wave on R

 

Data are from the UK Public Health service, are linked in the original graph, and I spot verified.

Source is Newstatesman, High factual, Left-biased.  Citing only because data are sourced, and verifiable.

 

UK is one of the most highly vaccinated countries in the world, but much of the population has had only ONE DOSE, which turns out not to be very effective against asymptomatic or mild infection vs. Delta. (see above post for sources)

 

Data data from Public Health UK suggest younger people are more likely to be "S-gene positive" (infected with Delta), so this may change as more elders are infected.  Same data suggest a fully-vaccinated >80 yr old has ~= risk to unvaccinated 50 yr old, which is why there is still a substantial death rate among vaccinated elders.

 

 

 

Source: BBC

[Coach Tuesday]

1 hour ago, 4merper4mer said:

Is that a documented mathematical truth or simply a belief?  Not a shot at you, just wondering if it is documented somewhere with numbers or if it is simply anecdotal.  
 

What about people who had the virus in the past?  Do their natural immunities count them as vaccinated even if they’ve had no shot?  Do they spread it more easily than someone vaxxed?

 

If these answers are unknown, it seems very odd to have unequal rules for different groups of people.  
 

Rules should be made based on logic, not feelings or panic.  If there are logical reasons, these reasons should be explained.

 

https://www.cidrap.umn.edu/news-perspective/2021/08/study-ties-covid-vaccines-lower-transmission-rates

 

(Mods, pls. remove if not appropriate to link to a study/article.)

 

Edit: Please note that this study, while excellent, took place between February and May in Netherlands where "Alpha" or "UK Strain" was dominant

[PTS]

On 8/24/2021 at 9:38 AM, Hapless Bills Fan said:

 

No such studies are coming out.  See above.  Possible, yes.  "Just as possible" no.  This is ranging into general Covid discussion and should not be continued.

 

What the NFL is probably going to do, is resume testing of vaccinated individuals at a more frequent interval than 1x in 14 days, and resume universal masking indoors except when distanced for eating.  This will probably not occur until at least one team has an outbreak, however.

 

"No such studies are coming out?" You serious? Let's throw out some blatant misinformation and then say this discussion should not be continued? Every day there are more and more studies, data, stories that state everyone is spreading COVID variants, vaxxed or not. Simple Google search will show that form leading medical institutions.

 

https://publichealth.jhu.edu/2021/new-data-on-covid-19-transmission-by-vaccinated-individuals

 

Quote

THE NEW DATA SAYS THAT A FULLY VACCINATED PERSON WHO EXPERIENCES A BREAKTHROUGH INFECTION CAN SPREAD THE VIRUS JUST AS MUCH AS AN UNVACCINATED PERSON.

----------------------------------------------------------------------------------------------------------------------------------------------------

Hapless sez:

OK let's Do This Thing and break this down.

 

The original statement was that vaccinated people are just as likely to transmit Covid as unvaccinated people. 

As far as I know, that is still considered to be incorrect, and the study referenced in the link is being misinterpreted.

 

There are two parts to considering how likely a person is to transmit Covid:

1) how likely they are to get an infection in the first place - makes sense, right, if you're not infected you can't transmit it?

2) whether any infection they get is as likely to be transmitted - this is believed to be related to the viral titer carried by an infected person

 

Let's get this out of the way right up front: No responsible scientist or public health official anywhere, EVER, claimed that vaccines would completely prevent covid (as some have said was claimed).  The best effectiveness claimed was 94-95% against symptomatic disease, ~92% against any infection.  The other claim is higher protection against severe infection/hospitalization, which is still true.

 

With the UK variant "Alpha",

1) Public Health UK published peer-reviewed studies showing the Pfizer vaccine (for example) was 92% effective at preventing infection, meaning a vaccinated person was 12x less likely to be infected at all. 

2) In addition, a CDC study of healthcare workers showed that vaccinated people carried substantially lower viral titer, and the study quoted by the UMN article @Coach Tuesday linked showed that the "attack rate" (secondary infections) of a vaccinated, infected person was ~3x lower (11%). 

 

So the OVERALL chance of a vaccinated person transmitting covid "Alpha" was infection rate * attack rate:(1-.92)* (.11) or 0.0088,  less than 1% - relative to an unvaccinated person (1)*(.31) or 31%.  These data were the basis for the current NFL rules, estimating a vaccinated person is about 35x less likely to be infected then transmit Covid after a close contact.

 

That was Then, This is now.

 

With the "Delta" variant which is now responsible for estimated >90% of new cases in the US, the basic reproduction rate (number of people infected by an infected person in the absence of vaccines or other mitigation like masks) is higher - Ro of 5-6 for Delta vs 2-3 for Alpha.  The best published data I've seen on vaccine effectiveness against Delta, is again, from Public Health UK.  (Israel claims have been quoted in the press, but I can't find published studies with details of data set, data collection etc).

1) Public Health UK published peer-reviewed studies showing the Pfizer vaccine (for example) was 78% effective at preventing infection, meaning a vaccinated person was 4.5x less likely to be infected at all. 

2) I have not yet seen data on attack rates for Delta yet, but data have shown that a vaccinated, infected person and an unvaccinated, infected person are carrying the same titer.  So let's make a reasonable assumption here and say that they're equally likely to infect someone else.  The attack rate for "Alpha" for an unvaccinated person was given in the UMN article as 31%.  If we combine this with an Ro ~2x higher, that means potentially an attack rate of ~60%.

 

So the overall chance of a vaccinated person transmitting covid "Delta" may be (1-.78)*(.6) or 13% relative to an unvaccinated person (1)*(.6) or 60%.  The same NFL rules may not work when a vaccinated person is only about 5x less likely to be infected then transmit Covid.  And it may, in an NFL facility, be higher chance of transmission, because many players chose to be vaccinated with J&J, for which we lack good data on effectiveness vs. any infection for Delta as yet.

 

Two take-home points:

 1) the NFL rules about vaccinated people being tested 1x every 14 days, not masking, and not being quarantined upon exposure seem relatively reasonable if a vaccinated person has less than 1% chance to transmit covid

2) but now, if a vaccinated person has about ~13% chance to transmit covid, things look different epidemiologically. 

 

The rules probably need to change, and soon, to maintain a reasonable level of protection for unvaccinated players.

 

Hope this clarifies a bunch of stuff and if questions/corrections/better data Hit Me in PM - I'm not an epidemiologist and sometimes I slip up.  Thanks!

 

 

 

 

 

 

 

[Hapless Bills Fan]

Update of the best US study on vaccine effectiveness in the "real world" (vs clinical trial), initially published by the CDC in April.

Summary: https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm

Full paper: https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7034e4-H.pdf

 

They studied vaccinated and unvaccinated health care workers - first responders, healthcare workers, and other patient-facing essential workers.

Every study participant was tested every week, in order to identify all infections, not just symptomatic infections.

 

Previously, from December through April, they had found the vaccines were 90% effective in preventing any infection (symptomatic or asymptomatic)

 

They now extended the study to August 2021 and determined "Delta variant predominant weeks"  They found the vaccines were 66% effective in preventing any infection (symptomatic or asymptomatic) during "Delta variant predominant weeks", which were also weeks in which a longer time had elapsed since vaccination

 

They found a decreasing effect of vaccination by binning the participants into <120 or >150 days since vaccination, but the effect was not "statistically significant" given the small numbers of Covid cases in each group.

 

Click to embiggen this table:

 

I think a point that jumps out to anyone, is that there were 5x as many vaccinated as unvaccinated study participants - 2,352 vs 488 (a lot of the initial unvaccinated group apparently dropped out, possibly to get vaxxed).

 

But, the number of covid infections were comparable (24 vs 19), in 5x as many vaccinated study participants.  That right there says the vaccine is still reduces the chance of getting any infection of Delta variant Covid (including an asymptomatic infection) by ~5x, before any numbers gagiggery was performed.  KISS, baby, KISS.

 

The adjusted VE of 66% is a 3x reduction, lower because they adjusted for "local virus circulation, study location, and occupation" - the point is they aren't jiggering the raw data to make their results look better, in fact they're making them look worse.  [The reason to do jiggering is because the vaccinated and unvaccinated study participants may not be evenly distributed over each study site or within each occupation, and obviously if more unvaccinated participants live in a community with high community infection while more vaccinated participants live in a community with lower community infection, it would bias the resultsl  Same for occupation.  It's a sign of a carefully done study.]

 

Another finding was that during the Delta-variant predominant weeks, 94.7% of the infections in unvaccinated people were symptomatic (remember, they are testing every week so as to catch all infections).  75% of the infections in vaccinated people were symptomatic, meaning 25% of them were asymptomatic.  I don't think you need to be a "genius in France" (or maths) to figure out that if asymptomatic infections can be transmitted and if it takes as little as 4-5 days from exposure to become infectious, testing every 2 weeks is gonna miss some asymptomatic, infectious people.

 

OK, that's all I got.  Questions -> PM me.  (Be nice)

 

 

 

 

 

 

 

 

 

 

[Hapless Bills Fan]

Published, peer-reviewed study of Pfizer/BioNTech vaccine safety from Israel.  Hot off the press (August 25, 2021)

https://www.nejm.org/doi/full/10.1056/NEJMoa2110475

This is the first country-wide, same population same time study of vaccination side effects vs. Covid-19 disease side effects.

 

The study matched 880,000 unvaccinated patients infected with Sars-CoV2 and 880,000 patients vaccinated with the Pfizer vaccine, which is the only vaccine used in Israel.

 

Everyone in the vaccine arm of the study was vaccinated before May 24, 2021.

 

Quote

We used data from the largest health care organization in Israel to evaluate the safety of the BNT162b2 mRNA vaccine. For each potential adverse event, in a population of persons with no previous diagnosis of that event, we individually matched vaccinated persons to unvaccinated persons according to sociodemographic and clinical variables.

 

This graph is pretty compelling:

 

Seems clear and compelling that the rates of kidney injury, cardiac arrhythmias, blood clots (deep vein thrombosis and pulmonary embolism), myocarditis, and pericardits are much higher in the unvaccinated group.

 

The two principle higher risks of the vaccinated group were lympadenopathy, which means temporary swollen lymph glands (a common side effect of many vaccinations; for example, women in US have been advised to delay their mammograms for a month after receiving a covid-19 vaccine to avoid false positive results, but after a month, it's fine and in the meantime, they go about their normal lives) and...... herpes zoster infection  - I did NOT see that one coming.  The risk was 16 per 100,000 (0.016%). For some context, the risk of injury from skydiving is estimated at 0.3% to 0.7%, so you're about 18x more likely to get hurt skydiving (mostly ankles) than to get

 

The risk of pericarditis and myocarditis is 5.5x higher from a natural covid-19 vaccination than from the Pfizer covid-19 vaccine - despite the fact that the latter has been getting all the press.  The risk from vaccination was an excess 3 per 100,000 or 0.003%

 

[Hapless Bills Fan]

With all the talk about boosters, people who got the J&J shot are wondering "what about me?"

 

https://www.facebook.com/permalink.php?story_fbid=372783124503333&id=100053149454347

 

"Your Local Epidemiologist" does a great job collating the data to date, what we do and don't know.

[Hapless Bills Fan]

Thought our Canadian friends would like this information from YLE.  Click to Embiggen.

 

The most cogent information is that Any Combination of Two Doses of an FDA approved/authorized or WHO-listed vaccine will be recognized as "Fully Vaccinated", along with 1 dose of J&J.

 

 

CDC Info on Air Travel to the US

https://www.cdc.gov/coronavirus/2019-ncov/travelers/proof-of-vaccination.html

 

CDC information on International Travel

https://www.cdc.gov/coronavirus/2019-ncov/travelers/international-travel/index.html

 

Hope this helps any of our Canadian brethren planning to attend a game at Highmark.

[Hapless Bills Fan]

PSA: How to Obtain Monoclonal Antibody Therapy

 

https://combatcovid.hhs.gov/i-have-covid-19-now/monoclonal-antibodies-high-risk-covid-19-positive-patients

 

Quote

If you’ve tested positive for COVID-19, one of the first questions you may have is, What can I do to reduce the risk of getting sicker? The good news is, there are treatments that may reduce that risk. Depending on your age, health history, and how long you’ve had symptoms of COVID-19, you may qualify for a promising form of treatment for the disease. It’s called monoclonal antibody (mAb) treatment.

 

Some early evidence suggests that mAb treatment can reduce the amount of the SARS-CoV-2 virus (the virus that causes COVID-19) in a person's system. This amount is known as viral load. Having a lower viral load means you may have milder symptoms thereby decreasing the likelihood of you needing to stay in the hospital.

 

mAb treatment may help people who:

Have a positive COVID-19 test, and had symptoms for 10 days or less

Are at high risk of getting more serious symptoms

 

 

How to know if you qualify?  You need not be "very high risk", just be over 65 or have one or more known risk factors:

https://combatcovid.hhs.gov/i-have-covid-19/how-do-i-know-if-im-high-risk

 

Have symptoms, but no healthcare provider? Call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585.

 

This tool may or may not be useful to find locations which offer this treatment near you:

 

https://protect-public.hhs.gov/pages/therapeutics-distribution

 

Fundamentally, your primary care physician should help you obtain this treatment, but if you don't have one, there's a toll-free number to call and a website showing locations that have received shipments.

 

Note that the monoclonal therapies are believed to be most helpful if they are started EARLY (within 10 days) and before one becomes seriously ill.

 

Some people in this area (Missouri) have obtained referrals to outpatient infusion centers through an Urgent Care visit.

 

[Hapless Bills Fan]

Omicron.  This is one of the best summaries I've seen to date:

 

https://yourlocalepidemiologist.substack.com/p/omicron-update-nov-27

 

Omicron has been declared a "Variant of Concern" by WHO because it has a large number of mutations to the Spike protein and appears to be more transmissible

-The Spike protein is the protein that studs the outside of the virus and binds to the cellular receptor that allows the protein entry into our cells

-The Spike protein is (not coincidentally) the target of vaccines (vaccines target what the body sees, and that's the protein studding the outside of the intact virus)

 

However, there is a whole lot of surmise and not a lot of hard data yet

-We don't yet know if or to what degree vaccines will still be protective

-Or whether/to what degree it's more transmissible

-Or whether it will be more or less virulant

 

Quote

4. We still have no scientific updates on Omicron’s impact on immunity escape or transmissibility. If you’re hearing anything right now (even if it’s the British PM) it’s purely speculation. Hypotheses are important to discuss, but not the solid evidence we need. Getting answers takes time because good science takes time. I give it a week or two until the evidence starts rolling in.

 

Quote

5. We’re seeing a lot of cases but not a lot of severe disease. Yesterday, Dr. Rudo Mathivha, head of the ICU at an Omicron epicenter hospital said that among their patients:

“About 65% are not vaccinated and most of the rest are only half-vaccinated”.

This is incredibly encouraging news. This may be a sign that our vaccines continue to protect against severe disease and death. I cannot stress enough, though, that this is preliminary evidence. We need to know a few more things:

Is this because of a small sample size? Maybe Omicron just hasn’t spread enough in South Africa to see hospitalizations rise.

Is this because of lag time? Population-level hospitalization trends lag cases trends by 3-4 weeks.

Is this because of the population? Populations will respond differently to infections. What may be happening in South Africa may not be representative of what will happen elsewhere.

 

NY Times coverage:

https://www.nytimes.com/2021/11/26/health/omicron-variant-vaccines.html

Quote

Independent scientists agreed that Omicron warranted urgent attention, but also pointed out that it would take more research to determine the extent of the threat. Although some variants of concern, like Delta, have lived up to initial worries, others have had a limited impact.

 

“Epidemiologists are trying to say, ‘Easy, tiger,’” said William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health. “This could be bad. This could be very bad. But we don’t know enough to roll that tape forward.”

 

Quote

Dr. Hanage and other researchers said that vaccines will most likely protect against Omicron, but further studies are needed to determine how much of the shots’ effectiveness may be reduced.

 

Quote

The researchers found more than 30 mutations on a protein, called spike, on the surface of the coronavirus. The spike protein is the chief target of antibodies that the immune system produces to fight a Covid-19 infection. So many mutations raised concerns that Omicron’s spike might be able to evade antibodies produced by either a previous infection or a vaccine.

 

Quote

Some earlier variants, such as Beta and Mu, had evolved a strong ability to evade immune defenses. But they never became a serious threat to the world because they proved to be poor at transmitting.

 

Some mutations in Omicron suggest that it may indeed transmit well. Three mutations alter a region of the spike protein called the furin cleavage site, which is already known to help the spike protein attach more effectively to cells.

 

I have some questions about the data from South Africa that I'm not going to comment on; things will sort out in a week or two.

 

 

[Hapless Bills Fan]

OK, we have our first data on Omicron.  First of all, lab study from South Africa.  This is a peer-reviewed, accepted publication from a lab that has been in the forefront

 

https://secureservercdn.net/50.62.198.70/1mx.c5c.myftpupload.com/wp-content/uploads/2021/12/MEDRXIV-2021-267417v2-Sigal.pdf

 

Quote

The emergence of the SARS-CoV-2 Omicron variant, first identified in South Africa, may compromise
the ability of vaccine and previous infection (1) elicited immunity to protect against new infection.
Here we investigated whether Omicron escapes antibody neutralization elicited by the Pfizer
BNT162b2 mRNA vaccine in people who were vaccinated only or vaccinated and previously infected.
We also investigated whether the virus still requires binding to the ACE2 receptor to infect cells. We
isolated and sequence confirmed live Omicron virus from an infected person in South Africa. We
then compared neutralization of this virus relative to an ancestral SARS-CoV-2 strain with the D614G
mutation. Neutralization was by blood plasma from South African BNT162b2 vaccinated individuals.
We observed that Omicron still required the ACE2 receptor to infect but had extensive escape of
Pfizer elicited neutralization. However, 5 out of 6 of the previously infected, Pfizer vaccinated
individuals, all of them with high neutralization of D614G virus, showed residual neutralization at
levels expected to confer protection from infection and severe disease (2). While vaccine
effectiveness against Omicron is still to be determined, these data support the notion that high
neutralization capacity elicited by a combination of infection and vaccination, and possibly by
boosting, could maintain reasonable effectiveness against Omicron. If neutralization capacity is
lower or wanes with time, protection against infection is likely to be low. However, protection
against severe disease, requiring lower neutralization levels and involving T cell immunity, would
likely be maintained

 

Bottom line: both immunity from previous infection and immunity from vaccination have decreased effectiveness against Omicron, as shown by testing for neutralizing antibodies.  Vaccination PLUS previous infection maintains higher protection.

 

Bear in mind: antibodies are only one arm of the adaptive immune system, and may not be the most important aspect of immune response to prevent severe disease.  As the authors note "protection against severe disease, requiring lower neutralizaton levels and involving T cell immunity, would likely be maintained"

 

This is from Pfizer/BioNTech about vaccination and Omicron (the overall facts are likely to be true, but the numbers may be more favorable than an independent study):

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-omicron-variant

 

-two doses of Pfizer vaccine are 25x less protective against Omicron (note that above, real life SA study said 40x)

-"According to the companies’ preliminary data, a third dose provides a similar level of neutralizing antibodies to Omicron as is observed after two doses against wild-type and other variants that emerged before Omicron. These antibody levels are associated with high efficacy against both the wild-type virus and these variants. A third dose also strongly increases CD8+ T cell levels against multiple spike protein epitopes which are considered to correlate with the protection against severe disease. Compared to the wild-type virus, the vast majority of these epitopes remain unchanged in the Omicron spike variant."

 

This would be consistent with the South African data that 2 doses of vaccine PLUS a prior infection provided good protection, saying 2 doses plus a booster provide good infection.

 

It is not unknown for vaccines to require 3 or 4 doses to provide consistent protection - for example, many childhood vaccines have a 3 or 4 dose series and a booster is recommended in the teenage years.  Years ago, when I was vaccinated against Hepatitis B with the original vaccine as a condition of my employment and they took blood and checked for antibodies 3 weeks after each shot, it took me five (5) doses to seroconvert.