Wednesday, November 17, 2021

SARS-COVID 2 is not the same as Inluenza.

Lung autopsies of COVID-19 patients reveal treatment clues

SARS-CoV-2 prevents lung tissue repair, regeneration.


Lung autopsy and plasma samples from people who died of COVID-19 have provided a clearer picture of how the SARS-CoV-2 virus spreads and damages lung tissue. Scientists at the National Institutes of Health and their collaborators say the information, published in Science Translational Medicine, could help predict severe and prolonged COVID-19 cases, particularly among high-risk people, and inform effective treatments.

Although the study was small—lung samples from 18 cases and plasma samples from six of those cases—the scientists say their data revealed trends that could help develop new COVID-19 therapeutics and fine-tune when to use existing therapeutics at different stages of disease progression. The findings include details about how SARS-CoV-2, the virus that causes COVID-19, spreads in the lungs, manipulates the immune system, causes widespread thrombosis that does not resolve, and targets signaling pathways that promote lung failure, fibrosis and impair tissue repair. The researchers say the data are particularly relevant to caring for COVID-19 patients who are elderly, obese, or have diabetes—all considered high-risk populations for severe cases. Study samples were from patients who had at least one high-risk condition.

The study included patients who died between March and July 2020, with time of death ranging from three to 47 days after symptoms began. This varied timeframe allowed the scientists to compare short, intermediate, and long-term cases. Every case showed findings consistent with diffuse alveolar damage, which prevents proper oxygen flow to the blood and eventually makes lungs thickened and stiff.

They also found that SARS-CoV-2 directly infected basal epithelial cells within the lungs, impeding their essential function of repairing damaged airways and lungs and generating healthy tissue. The process is different from the way influenza viruses attack cells in the lungs. This provides scientists with additional information to use when evaluating or developing antiviral therapeutics.

Tuesday, November 9, 2021

Israeli Study Shows How COVID-19 Immunity Wanes over Time – NIH Director's Blog

The winter holidays are approaching, and among the many things to be grateful for this year is that nearly 200 million Americans are fully vaccinated for COVID-19. That will make it safer to spend time with friends and family, though everyone should remain vigilant just to be on the safe side. Though relatively uncommon, breakthrough infections are possible. That’s why the Centers for Disease Control and Prevention (CDC) recommends booster shots for several at-risk groups, including folks 65 years and older, those with underlying medical conditions, and people whose occupations place them at high risk of exposure.

One of the main studies providing the evidence for CDC’s recommendation was recently published in the New England Journal of Medicine [1]. It found that vaccine-induced immunity, while still quite protective against infection and severe illness from COVID-19, can wane after several months.

The study is yet another highly informative report from Israel, where public health officials launched a particularly vigorous national vaccination campaign in December 2020. More than half of adult Israelis received two doses of the Pfizer vaccine within the first three months of the campaign. By May 2021, Israel had extremely small numbers of confirmed COVID-19 cases—just a few dozen per day.

But the numbers crept back up in June 2021. The rise also included a substantial number of breakthrough infections in vaccinated individuals. The vast majority of those cases in June—98 percent—were caused by the emerging Delta variant.

Researchers led by Yair Goldberg, Technion-Israel Institute of Technology, Haifa, wondered whether this resurgence of COVID-19 could be fully explained by the rise of the more infectious Delta variant. Or, they wondered, did the waning of immunity over time also play a role?

To find out, the researchers looked to over 4.7 million fully vaccinated Israeli adults, more than 13,000 of whom had breakthrough infections from July 11 to 31, 2021 with SARS-CoV-2. The researchers looked for an association between the rate of confirmed infections and the time that had passed since vaccination. Without any significant waning of immunity, one shouldn’t see any difference in infection rates among people who were fully vaccinated at the earliest opportunity versus those vaccinated later.

The results were clear: the rate of confirmed COVID-19 infection revealed a slow but steady waning of immunity over time. Among individuals 60 years or older who were fully vaccinated last January, the number of confirmed breakthrough infections was 3.3 per 1,000 people during the three weeks of the study. Those who were vaccinated in February and March had lower infection rates of 2.2 per 1,000 and 1.7 per 1,000, respectively. The data revealed a similar pattern in those aged 40 to 59 and those aged 16 to 39.

An important question is whether these breakthrough infections were serious enough to require hospitalization. While such cases were much less common, more than 400 of those with confirmed COVID-19 breakthroughs went on to develop severe illness. And, again, the data show a similar pattern of waning immunity. The rate of severe COVID-19 among adults 60 years of age or older who were fully vaccinated in January was 0.34 cases per 1,000 persons. The rate of severe illness dropped to 0.26 cases per 1,000 among those vaccinated in February and 0.15 cases per 1,000 for those vaccinated in March. The researchers report that the number of severe COVID-19 cases among the younger fully vaccinated groups were too small to draw any conclusions.

While the Delta variant surely has played a role in the resurgence of COVID-19 in recent months, these findings suggest that waning immunity also is an important factor. Understanding these dynamics is essential for making critical policy decisions. In fact, these data were a key factor in the decision by the Israeli Ministry of Health in July 2021 to approve administration of COVID-19 booster shots for individuals who’d been vaccinated at least 5 months before.

Back in the U.S., if you were among those who got your vaccine on the early side—good for you. If it’s been more than six months since your original shots, and if you are in one of the risk groups, you should consider a COVID-19 booster shot to remain optimally protected in the months ahead. I’ll be getting my Moderna booster this week. While you’re at it, consider getting your annual flu shot taken care of, too. The CDC guidelines state that it’s perfectly OK to get your COVID-19 and flu shots at the same time.

What about it?  WAI

Steve White says:
November 9, 2021 at 11:04 am
I am not against the vaccines or boosters, but I think the numbers the Director is citing from this study indicate the media and CDC have given out very misleading information. Instead of saying “In Israel, 1 in 300 people who got vaccinated in January have gotten infected” – a number which I think CDC knows will not scare people enough – and indeed, their own experts believed was not scary enough (they may not have had all the data available now but they certainly knew breakthroughs were rare when they advised on boosters) – to really push boosters, we are given horror stories about significantly reduced protection.
Stories about breakthroughs, which probably get some people running for their boosters, and others saying :Heck with it, what is the point?” Or other rationalizations.

Maybe they should have said, “breakthrough are so rare, and so unlikely to be severe, that we do not think boosters are really needed for most healthy people” -or something similar to that. Oh, wait …

Or, how about “while there is extra protection from getting a booster, for those who were already infected, the rate of reinfection is very low in either case” ?

I am not even going into the extremely low rate of severe illness among children, and the strong possibility they are better off with natural immunity – remember, the human race, and for that matter, all our ancestor mammalian races, presumably, have dealt with viruses from other species for millions of years. Think about this deeply – maybe we’ve evolved so that children strongly tend to not get severely ill, and tend to get lifelong protection, when exposed to novel viruses. Old folks who are no longer breeding – anything can happen to them – just what we see with this thing so far – and maybe giving kids vaccines, which will protect against one variant (the one they were designed to stop) very well, closely related variants less effectively, and other variants maybe not at all, will set them up to be more vulnerable for the coming variants, than kids who caught the first, apparently least virulent, variant, and now have some immunity to every vulnerable part of it.

Israeli Study Shows How COVID-19 Immunity Wanes over Time – NIH Director's Blog

Tuesday, November 2, 2021

Novavax has been granted its first emergency use authorisation in Indonesia for COVID-19 vaccine NVX-CoV2373, and expects other regulators in India, the Philippines and other countries to follow suit in the coming weeks.

Third world nations have been short changed during the 4 months that the pandemic spread throughout the world.  Many nations have even donated millions of doses of vaccines produced in their own countries. Canada recently agreed to donate several million dollars to the United Nations fund for distributing covid vaccines to those less developed nations.

Indonesia has applied for an emergency authorization for it's vaccine, NVX-COV2373. Nations in their own regional market place, including India. and the Phillipines will also join their effort.  These three nations may pool their resources to produce vacccines for many millions of people.  Local sources for vacccine will eliminate the challenges of distribution,  such a refrigeration, spoilage, and transportation.

Indonesia falls into that category as it has a fragmented healthcare system, despite universal access,  which is amplified by the geographical hurdles associated with being an archipelago with 275 million people spread across 6,000 islands. Initial shipments into the country are expected to begin “imminently,” said Novavax.

The vaccine is the first based on recombinant protein to be approved anywhere in the world, and has the key advantage over many of the currently approved jabs as it can be stored at regular refrigeration temperatures. That makes it well suited to distribution in countries where healthcare delivery is more challenging.

Recombinant protein is produced by recombinant DNA using bacteria (E.Coli) as a manufacturing process. E.coli  is the manufacturing plant for recombinant DNA and in turn. recombinant proteins

Why is E. coli used for transformation?

Other cell types including mammalian cells,  yeast, insect cells, or other eukaryocytic cells could be used. E. coli is a preferred host for protein production due to its rapid growth and the ability to express proteins at very high levels. Bacterial conjugation can be used to transfer large DNA fragments from one bacterium to another.

The following references explain in further the use of recombinant DNA/Protein for the manufacture of other Covid 19 vaccines.

Rather than using messenger RNA (m-RNA) to produce a 'spike protein' from the corona virus, the Indian Covid vaccine is manufactured as an inactive viral particle.

Covax information

1. Center for Systems Science and Engineering, Johns Hopkins University. COVID-19 Dashboard. [Accessed 15 Nov 2020.]
2. World Health Organization. DRAFT landscape of COVID-19 candidate vaccines, 12 November, 2020.
3. World Health Organization. WHO Concept for fair access and equitable allocation of COVID-19 health products. Final working version 9 September 2020. Geneva, Switzerland: World Health Organization, 2020.
4. Emanuel EJ, Persad G, Kern A, et al. An ethical framework for global vaccine allocation. Science 2020;369:1309-12. 10.1126/science.abe2803  [PubMed] [CrossRef] [Google Scholar]
6. Gavi, the Vaccine Alliance. COVAX, the ACT-Accelerator Vaccines Pillar: Insuring Accelerated Vaccine Development and Manufacture, 2020.
7. Gavi COVAX Facility. Over US$ 2 billion raised to support equitable access to COVID vaccines with additional US$ 5 billion needed in 2021. Press release, 13 November 2020.

Novavax gets first authorisation for its COVID-19 jab -

Tuesday, October 12, 2021

Financial speculation surrounding coronavirus drug developed with taxpayer money - The Washington Post

A hedge fund manager profited greatly from the development of a U.S. funded research at Emory University.  Ridgeback Pharma bought a license for it's use and then sold it to Merck.  The husband and wife team,.

Ridgeback Biotherapeutics had no laboratories, no manufacturing facility of its own and a minimal track record when it struck a deal in March with Emory University to license an experimental coronavirus pill invented by university researchers with $16 million in grants from U.S. taxpayers.

But what the tiny Miami company did have was a growing team with experience in pharmaceutical development and research and a willingness from its wealthy owners — chief executive Wendy Holman and her husband, hedge fund manager Wayne Holman — to place a bet on the treatment in the midst of the coronavirus pandemic. That wager paid off with extraordinary speed in May when, just two months after acquiring the antiviral therapy called EIDD-2801 from Emory, Ridgeback sold exclusive worldwide rights to drug giant Merck.

The rapid turnaround of rights to a publicly financed drug highlights the frenzy of financial speculation that has accompanied the spread of the coronavirus around the world. Congress and the Trump administration have authorized more than $7 billion for research and industry subsidies in a desperate hunt for therapies and vaccines.

The perception that companies are profiteering during a global medical crisis — especially in cases where inventions were funded by taxpayers — poses political dangers to the pharmaceutical industry.

Demands are increasing in Congress and around the world that drug companies set affordable prices on coronavirus treatments and vaccines and distribute them equitably. Yet the role of middlemen like Ridgeback puts pressure on companies to increase prices, by adding extra costs. It also raises questions about who is financially benefiting by securing monopoly licensing rights to publicly financed inventions.

Ridgeback, which has one other drug in development for Ebola, was a relatively obscure entity when it snapped up EIDD-2801 from Emory in a deal signed March 19. The university, without disclosing terms, said in a news release that Ridgeback “will be responsible for conducting the necessary trials to bring EIDD-2801 to licensure.”

Within days of securing Emory’s licensing deal, the company mounted a campaign to win hundreds of millions in government funding to develop the drug, according to a whistleblower complaint by Rick Bright, former director of the Biomedical Advanced Research and Development Authority, as well as emails obtained by The Washington Post. After failing to secure the government contracts, Ridgeback launched a human safety trial of the drug in the United Kingdom and transferred rights to Merck in late May.

Stay safe and informed as the United States reopens with our free Coronavirus Updates newsletter

In addition to an upfront payment of undisclosed size from Merck, Ridgeback will receive unspecified “milestone” payments and a share of net proceeds if the drug is approved, the companies said. Merck will conduct future clinical trials, apply for regulatory approvals and manufacture the drug, which has been shown in lab and animal studies to cripple the virus by interfering with viral RNA. Ridgeback said it will remain involved in developing the drug.

Specialists in drug development called Ridgeback’s turnaround unusually rapid.

“I would think that universities … would not normally transfer products to basically a house-flipper,” said Aaron S. Kesselheim, a physician at Brigham and Women’s Hospital in Boston and professor at Harvard Medical School. “I wouldn’t think they would have to engage with speculators, like it appears that Ridgeback Biotherapeutics is.”

Ridgeback tests COVID-19 antiviral for patients in hospital—and at home

Wayne Holman, who holds a medical degree from New York University, is a hedge-fund manager with a long track record of investing in pharmaceutical stocks. He founded his fund Ridgeback Capital Management in 2006. Wendy Holman, chief executive of Ridgeback Biotherapeutics, is a former investment manager who was named to President Trump’s advisory council on HIV/AIDS in 2019.

The Holmans live on Miami’s exclusive Star Island, where they bought two mansions for a combined $47 million in 2014 and tore one of them down. Ridgeback Capital’s headquarters is in a small office building not far away in Coconut Grove, near a private school where Wendy Holman serves on the board of trustees. Ridgeback has one other drug in development that has been supported with $25 million in government contracts, a potential Ebola treatment invented by a division of the National Institutes of Health. 

EIDD-2801 is among hundreds of projects underway around the world to develop treatments and vaccines to combat the coronavirus amid signs that covid-19, the disease the virus causes, will become a stubborn, endemic illness that lingers in human populations for many years. If it works and is found to be safe, it likely would become a strong rival to Gilead’s remdesivir, the first antiviral to treat the coronavirus, which must be given intravenously.

“EIDD-2801 has several attributes including oral availability broad antiviral activity versus multiple coronavirus strains, notably SARS-CoV-2, as shown in preclinical studies, and early clinical results showing that it is well-tolerated from a study conducted by Ridgeback,” Merck said in an email.

But the path to Merck’s portfolio of early-stage drugs has grabbed attention.

Flip this property

“Molecule-flipping is a good characterization of what it is,” said James Love, director of Knowledge Ecology International, a nonprofit watchdog group that tracks public investments and intellectual property.

Hunting through scientific papers and forging alliances with academic laboratories is often done by small firms backed by venture capitalists. Start-ups looking to profit by securing rights to new molecules and nurturing their early-stage development are an ingrained part of the ecosystem of drug development. The goal typically is to push a drug far enough through the approval pipeline — a process that often takes years — until a larger company buys the rights and completes commercialization.

With the coronavirus creating huge demand, that activity is accelerating, say specialists in drug licensing and intellectual property.

“Merck is much better positioned and funded to move the drug through development,” said Joseph A. DiMasi, director of economic analysis and research at the Tufts Center for the Study of Drug Development, which receives drug industry funding. “It is the speed with which this has happened that is extraordinary. That speed in the context of a pandemic is a good thing.”

Stock markets show hunger for a coronavirus treatment. But don’t expect a magic bullet.

The flood of government money is spurring attention to diseases that have been neglected by large drug companies. Vaccines and therapies for viruses do not hold the promise of large, lucrative drug sales because they are not taken as regular treatments for chronic conditions. Many virus outbreaks disappear on their own, making it risky for companies to spend on research. To plug the gap, U.S. government agencies support academic research, or invent and develop drugs directly in government labs.

“When it was limited to things like Ebola and SARS, you didn’t see as much as engagement by the private sectors. These were normally backwater areas in neglected disease,” said Love. “People now are rushing in and scaling up.”

Emory had secured pledges of $30 million in government contracts from science and defense agencies in the past five years to develop EIDD-2801 but tapped just more than half of the available funds, an Emory spokeswoman said. The university did not respond to questions about how it picked Ridgeback.

“Emory is proud that we invented EIDD-2801, and we appreciate the partnerships and government support that makes it possible to provide therapies that will benefit society,” Nancy Seideman, Emory’s vice president for academic communications, said in an email. “Any royalties that we receive — if anything — are channeled directly back to serving our educational and scientific mission.”

In instances where taxpayer-financed drugs make it to market via exclusive licensing deals — which typically have undisclosed terms — debates have sprouted around monopoly pricing.

Liberal members of Congress and consumer advocates have demanded that taxpayers’ investments be factored into government contracts for development of coronavirus treatments and vaccines, and that terms of licensing deals be disclosed to the public. But Democratic proposals to place constraints on prices for covid-19 therapies did not make it into the $3 billion in emergency subsidies for the drug industry that lawmakers approved in March.

Some companies with experimental medicines backed by public investment have been the subject of intense financial speculation. Investors have gambled that Gilead’s drug remdesivir, which has been proven to modestly improve outcomes, will produce a windfall for the company. The company’s stock has been subject to volatile swings in the past three months.

Remdesivir was developed with at least $70 million in public investment, according to advocates, and a debate has begun about costs and access before Gilead has even set a price.

Even finding a covid-19 vaccine won’t be enough to end the pandemic

Moderna is developing a leading vaccine candidate that is co-owned by the NIH. Government interest in the vaccine has not stopped a boost in the company’s stock of nearly 200 percent since the end of February.

EIDD-2801, which was invented as an influenza drug and has demonstrated effectiveness against multiple viruses in lab dishes, works similarly to Gilead’s remdesivir by interfering with viral RNA. But it has the advantage of being a pill, which means it could be taken by people in their homes, soon after symptoms appear. If the drug proves to be safe and effective, it could prevent countless hospitalizations and deaths and reduce the spread of infection.

Drugs in its class have been known to cause genetic mutations that lead to birth defects, but Merck said when it licensed the drug last week that it was “well-tolerated.” Wayne Holman has said the drug can safely be used for a short course of treatment to fight a viral infection.

As for potential pricing, “Merck and Ridgeback are committed to ensuring that any medicines we develop for SARS-CoV-2 will be accessible to patients globally,” Merck said in an email. It would not discuss specifics.

The deal between Emory and Ridgeback was inked by the university’s Drug Innovation Ventures at Emory (DRIVE), a nonprofit tech-transfer corporation led by Emory scientist George Painter, who holds patents related to the drug. Highly accomplished in both laboratories and boardrooms, Painter is the former chief executive of Chimerix, a North Carolina drug company, and a high-ranking official in antiviral research at the former Glaxo Wellcome. Painter did not respond to interview requests.

On March 20, the day after the Ridgeback licensing contract was completed, Painter and other scientists at the University of North Carolina, Vanderbilt University and Emory posted a preliminary scientific paper on the preprint website showing EIDD-2801 thwarted SARS-CoV-2 in human cells and in mice infected with other types of coronaviruses. The peer-reviewed journal Science Translational Medicine published the paper on April 6.

At Vanda Pharmaceuticals, a biotechnology firm headquartered in Washington, D.C., founder and chief executive Mihael Polymeropoulos saw the scientific results in the journal and had his company contact Emory about a potential licensing opportunity. It was too late.

“They came back and they said they had already done a deal with this company, Ridgeback,” Polymeropoulos said. “This deal must have happened in record speed.”

The chief operating officer at Emory’s DRIVE told the Daily Report, an Atlanta trade publication, that the licensing contract, which normally would take four to six months to complete, was negotiated and signed in two weeks after a “mad scramble” by university and Ridgeback lawyers rushing to respond to the coronavirus.

Ridgeback’s involvement burst into the broader public sphere in early May, when Bright, the ousted head of BARDA, filed his explosive whistleblower complaint. Bright alleged that he clashed with Robert Kadlec, the Health and Human Services assistant secretary for preparedness and response, over demands that he award BARDA contracts to well-connected companies. HHS has said it “strongly disagrees” with Bright’s allegations.

In his complaint, Bright cited attempts to secure money for EIDD-2801 — first by Painter in November 2019, and then by Wendy Holman in early April — among episodes of alleged political pressure.

Bright said he rejected requests to fund EIDD-2801 because Emory had already received pledges of $30 million from the National Institute of Allergy and Infectious Diseases and the Department of Defense to cover development of the drug, including human safety testing. Without first seeing safety results, Bright said, it did not make sense to back the drug with new infusions of federal cash.

Wendy Holman’s pleas for government money in early April — less than two weeks after Ridgeback secured rights to the drug from Emory — are contained in emails she wrote to government officials. The full emails, excerpts of which were cited in Bright’s whistleblower complaint, were previously disclosed by the journal Science and were obtained by The Post. Holman said in one email to BARDA that she had been in personal contact with Kadlec, who wanted the project to move forward.

“We need this approval to start the clinical trial for EIDD-2801 as soon as possible,” Wendy Holman wrote to a BARDA contracting official on April 7, just days before Ridgeback planned to launch its first human safety trials. “Lives are literally depending on it, Dr. Kadlec is pushing us to move fast, but we can’t without this authorization.”

“To avoid any delay in executing this clinical trial, Ridgeback must receive approval … as soon as possible” to incur expenses in anticipation of a contract, Holman wrote to a related agency within the Office of the Assistant Secretary for Preparedness and Response on April 3. “We desperately need guidance on this.”

Bright said in his complaint that Ridgeback had been seeking $100 million to further the drug’s development. In an April 13 email, a BARDA official said the proposal from Ridgeback could obligate the government to pay the company more than $300 million. The contract official objected to the outlay because Ridgeback had not followed proper application procedures.

Ridgeback went away empty-handed by the time Bright departed in late April. It started its safety trial on April 10, testing the EIDD-2801 drug against a placebo in 122 healthy volunteers in England, according to its disclosure on It hired a contract research organization called Covance to conduct the study. The NIH said in an email that Ridgeback conducted the study at its own expense.

In an interview with The Post on April 15, before the controversy erupted, Wayne Holman talked up the drug and made it clear that Ridgeback would be seeking partnerships and investment from the private sector.

“Treating orally and early can change the course of this pandemic. Not only would it treat the person that is sick, but it should theoretically reduce the infectiousness of that person, and the time period they are infectious to others,” he said. “We have inbound interest from pharma companies.”

 Covid 19 vaccines and treatments are generating enormous revenue for some pharma companies. It will probably. surpass the gains of Purdue from it's profits from opioid manufacturing.

Imagine if some of these profits were taxed and used to fund health care for low income citizens.

Monday, September 27, 2021

Digital Health ID card for every Indian. 5 key points explained

Are you fed up going through your wallet each time you go to a provider for services to pony up your Medicare card, Private Insurance cared, Medicaid card, social security card and driver's license and more?

It turns out that India is way ahead of the U.S.A. Prime Minister Narendra Modi will launch Ayushman Bharat Digital Mission that looks to provide easier access to integrated healthcare for citizens. 

Digital Health ID card for every Indian. 5 key points explained

Included with the Health ID are the following:

Key Facilities of Ayushman Bharat Digital Mission

Health ID: Every citizen will be allotted a health ID that will be used as their health account. The personal health records of the citizen will be linked to their respective Health ID. These records can be viewed with the help of a mobile application.

Healthcare Professionals Registry (HPR): A repository of registered nurses, doctors, paramedical with their qualifications, experience, and other relevant details.

Healthcare Facilities Registry (HFR): A repository of all public and private healthcare facilities across both traditional and modern systems of medicine. This will ensure ease of doing business for doctors, hospitals, and other healthcare service providers.

Personal Health Record Application: A self-managed health record of an individual linked to the 

Aarogya Setu App.

Thursday, September 16, 2021

FTC says health apps must notify consumers about data breaches — or face fines | TechCrunch

Is your fitness wearable ie, Fitbit, apple watch, or another device (such as a monitored pacemaker, glucometer being hacked ? Many of these devices are monitored by third parties to ensure reliability or report to the provider about the usage of the device. Their intent may. be benevolent to endure you are compliant, however there are many hackers stealing your data to sell to other interested parties.  The concerning issues are pointed out in this bulleting from the Federal Trade Commission.  Check out your monitoring device to see if it is HIPAA compliant. In the near future all monitoring devices should carry a HIPAA compliant badge on it and/or the instruction sheet much like a CE or UL approval rating.

FTC says health apps must notify consumers about data breaches — or face fines | TechCrunch: Facebook today is announcing the launch of new products and features for business owners, following the threat to its ad targeting business driven by Apple’s new privacy features, which now allow mobile users to opt out of being tracked across their iOS apps. The social networking giant has r…

Wednesday, September 15, 2021

Pfizer (PFE) Says Covid-19 Vaccine Efficacy Erodes Over Time - Bloomberg

Should you get a third shot?  Read and listen to the latest, then decide.

Pfizer Inc. said that data from the U.S. and Israel suggest that the efficacy of its Covid-19 vaccine wanes over time and that a booster dose was safe and effective at warding off the virus and new variants.

The company detailed the data in a presentation it will deliver to a meeting of outside advisers to the Food and Drug Administration on Friday. The panel is expected to make recommendations for whether more Americans should receive booster shots.

“Real-world data from Israel and the United States suggest that rates of breakthrough infections are rising faster in individuals who were vaccinated earlier,” Pfizer said in its presentation, which was posted on the FDA website. The drug giant is partnering with Germany’s BioNTech SE to make the shots. 

FDA Staff Report

According to a meeting agenda the FDA posted on its website, the Friday panel meeting will include presentations from the Centers for Disease Control and Prevention, FDA staff, researchers from Israel and the U.K., along with Pfizer. 

Marion Gruber, one of two top vaccine officials who FDA recently said will step down later this year, is also scheduled to speak. Gruber was co-author of an article in The Lancet earlier this week arguing that booster shots weren’t yet necessary for most people. The departure of the two longtime agency staffers is a potential sign of friction over the Biden booster plan. 

Officials from Israel will present data from that country on booster protection against infections and severe disease, according to the agenda, and a professor of medical statistics from the University of Bristol will present data on real-world vaccine effectiveness.

The staff’s 23-page briefing paper noted that the likely benefit of a booster shot would depend on how much the third shot reduces disease relative to the first two. If the first two shots are still highly effective, then the efficacy of the booster shot “is likely to be more limited,” the staff said. Overall data in the U.S. indicate that the first two shots of the vaccine still protect against severe disease and death, the staff said.

The staff also noted that it is not currently clear whether there will be an increased risk of inflammation of the heart and heart lining after a booster shot, and that potential risks of a booster shot also must be considered. It didn’t offer a clear indication of which way the agency was leaning, which it often does before meetings.

Health Train posits it may be worthwhile to have your Covid  antibody levels measured prior to your decision regarding getting a 3rd 'JAB'

The past 18 months have stimulated more knowledge about viruses and vaccines.

Stay tuned and read our reference below

What is the difference between a third shot and a booster?

Pfizer (PFE) Says Covid-19 Vaccine Efficacy Erodes Over Time - Bloomberg

Thursday, September 2, 2021

Telehealth’s Limits: Battle Over State Lines and Licensing Threatens Patients’ Options | California Healthline

Perhaps you live in a city that borders on two-state jurisdictions, such as Minneapolis-St Paul, Washington DC-Maryland-Virginia, 

If you live in one state, does it matter that the doctor treating you online is in another? Surprisingly, the answer is yes, and the ability to conduct certain virtual appointments may be nearing an end.  

This story also ran on Time. It can be republished for free.

Televisits for medical care took off during the worst days of the pandemic, quickly becoming commonplace. Most states and the Centers for Medicare & Medicaid Services temporarily waived rules requiring licensed clinicians to hold a valid license in the state where their patient is located. Those restrictions don’t keep patients from visiting doctors’ offices in other states, but problems could arise if those same patients used telemedicine.  State medical boards don’t want to cede authority, saying their power to license and discipline medical professionals boosts patient safety. Licensing is also a source of state revenue.

Providers have long been split on whether to change cross-state licensing rules. Different state requirements — along with fees — make it cumbersome and expensive for doctors, nurses, and other clinicians to get licenses in multiple states, leading to calls for more flexibility. Even so, those efforts have faced pushback from within the profession, with opposition from other clinicians who fear the added competition that could come from telehealth could lead to losing patients or jobs.
Now states are rolling back many of those pandemic workarounds.  Many states have agreed to interstate medical licensing compacts for physicians, nurses, and some other health care providers

During the past 18 months, the public health emergency for the Covid19 pandemic created a national emergency causing an exponential rise in telehealth visits.  Many states loosened their regulations regarding telehealth visits, including cross-state border visits. CMS (formerly Medicare) loosened it's a restriction only allowing telehealth visits from rural or underserved areas to general usage.  The reasons for this had to do with social distancing and lockdown orders preventing traveling.

Even though the initial spike in telehealth visits has eased, utilization remains 38 times higher than before the pandemic, attracting not only patients but also venture capitalists seeking to join the hot business opportunity, according to a report from consulting firm McKinsey and Co. “As with most things in medicine, it’s a bottom-line issue. The reason telehealth has been blocked across state lines for many years is related fundamentally to physicians wanting to protect their own practices,” said Greenspun.

“The whole challenge is to ensure maximum access to health while assuring quality,” said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.

Patients and their doctors are getting creative, with some consumers simply driving across state lines, then making a Zoom call from their vehicle.

“It’s not ideal, but some patients say they are willing to drive a mile or two and sit in a parking lot in a private space and continue to get my care,” said Dr. Shabana Khan, director of telepsychiatry at NYU Langone Health’s department of child and adolescent psychiatry and a member of the American Psychiatric Association’s Telepsychiatry Committee. She and other practitioners ask their patients about their locations, mainly for safety reasons, but also to check that they are in-state.

Allowing a change that doesn’t put centralized authority in a patient’s home state would raise “serious enforcement issues as states do not have interstate policing authority and cannot investigate incidents that happen in another state,” said then-AMA President-elect Jack Resneck during a congressional hearing in March.

Telehealth’s Limits: Battle Over State Lines and Licensing Threatens Patients’ Options | California Healthline

Saturday, August 21, 2021

Out of control vaccine stockpiling by rich nations can lead to disaster for the world. – Scientific Inquirer

 COVID GLOBAL MAP. click here (will load slowly) source World Health Organization


The allocation of COVID-19 vaccine between countries has thus far tended toward vaccine nationalism, wherein countries stockpile vaccines to prioritize access for their citizenry over equitable vaccine sharing. The extent of vaccine nationalism, however, may strongly impact global trajectories of COVID-19 case numbers and increase the potential emergence of novel variants, according to a Princeton University and McGill University study published Aug. 17 in the journal Science.

“Certain countries such as Peru and South Africa that have had severe COVID-19 outbreaks have received few vaccines, while many doses have gone to countries experiencing comparatively milder pandemic impacts, either in terms of mortality or economic dislocation,” said co-first author Caroline Wagner, an assistant professor of bioengineering at McGill University who previously served as a postdoctoral research associate in Princeton’s High Meadows Environmental Institute (HMEI).

“As expected, we have seen large decreases in case numbers in many regions with high vaccine access, yet infections are resurging in areas with low availability,” said co-first author Chadi Saad-Roy, a Princeton graduate student in ecology and evolutionary biology and the Lewis-Sigler Institute for Integrative Genomics.

“Our goal was to explore the effects of different vaccine-sharing schemes on the global persistence of COVID-19 infections — as well as the possibility for the evolution of novel variants — using mathematical models,” Saad-Roy said.

The researchers projected forward the incidence of COVID-19 cases under a range of vaccine dosing regimes, vaccination rates, and assumptions related to immune responses. They did so in two model regions: One with high access to vaccines — a high-access region (HAR) — and a low-access region (LAR). The models also allowed for the regions to be coupled either through case importation, or the evolution of a novel variant in one of the regions.

“In this way, we could assess the dependence of our epidemiological projections on different immunological parameters, regional characteristics such as population size and local transmission rate, and our assumptions related to vaccine allocation,” Wagner said.

Overall, the study found that increased vaccine-sharing resulted in reduced case numbers in LARs. “Because it appears that vaccines are highly effective at reducing the clinical severity of infections, the public health implications of these reductions are very significant,” said co-author Michael Mina, an assistant professor at the Harvard T. H. Chan School of Public Health.

Senior author C. Jessica E. Metcalf, a Princeton associate professor of ecology and evolutionary biology and public affairs and associated faculty in HMEI, added: “High case numbers in unvaccinated populations will likely be associated with higher numbers of hospitalizations and larger clinical burdens compared to highly vaccinated populations.”

The authors also drew on a framework developed in their prior work to begin trying to quantify the potential for viral evolution under different vaccine sharing schemes. In their model, repeat infections in individuals with partial immunity — either from an earlier infection or a vaccine — may result in the evolution of novel variants.

“Overall, the models predict that sustained elevated case numbers in LARs with limited vaccine availability will result in a high potential for viral evolution,” said senior author Bryan Grenfell, Princeton’s Kathryn Briger and Sarah Fenton Professor of Ecology and Evolutionary Biology and Public Affairs and an associated faculty member in HMEI.

“As with our earlier work, the current study strongly underlines how important rapid, equitable global vaccine distribution is,” Grenfell said. “In a plausible scenario where secondary infections in individuals who have previously been infected strongly contribute to viral evolution, unequal vaccine allocation appears particularly problematic.”

As the pandemic progresses, viral evolution may play an increasingly large role in sustaining transmission, said senior author Simon Levin, Princeton’s James S. McDonnell Distinguished University Professor in Ecology and Evolutionary Biology and an associated faculty member in HMEI. “In particular, antigenically novel variants have the potential to threaten immunization efforts globally through several mechanisms,” he said,” including higher transmissibility, reduced vaccine efficacy, or immune escape.”

Saad-Roy added: “In this way, global vaccine coverage will reduce the clinical burden from novel variants, while also decreasing the likelihood that these variants emerge.”

There are additional considerations for vaccine equity beyond epidemiological and evolutionary ones, said co-author Ezekiel Emanuel, the Diane v.S. Levy and Robert M. Levy University Professor and co-director of the Healthcare Transformation Institute at the University of Pennsylvania.

“​​Ethics also argues against countries stockpiling vaccines or allocating doses for boosters,” Emanuel said. “This study strongly supports that ethical position showing that stockpiling will undermine global health.”


Wednesday, August 18, 2021

Physicians handing out Covid 19 vaccination exemptions for school


California Medical Association (CMA) President Peter N. Bretan, Jr., M.D., issued the following statement in response to rogue physicians selling bogus mask exemptions:

"We are deeply troubled by reports that a few rogue physicians have decided to ignore the science surrounding the spread of COVID-19 and place the lives of children and their families in danger. There are very few medical reasons and situations that would exempt an individual from masking requirements. It strains credulity to think that a single physician would have dozens or hundreds of patients with valid medical claims for such an exemption. Unfortunately, we know there are bad actors who are willing to operate outside the accepted standards of care in order to turn a personal profit. This needs to stop. Physicians have an obligation and a duty to uphold the oath we all take when we assume the awesome responsibility of practicing medicine. Stories like the one coming out of Roseville undermine the credibility of the medical profession and put members of the public at risk. We need strong, immediate action to ensure bad actors are not given carte blanche to interpret the law as they wish."

So, the official word from the CMA exposes this unethical as well as a potentially dangerous practice.  In addition, any physician who does this risks his medical license and can be sanctioned or face termination of his medical license.  Physicians are placed in a dual role, one of having a good relationship with their patients, especially primary care physicians who see their patients frequently.  They must also use good judgment to not allow a patient to harm themself. The term for this is primum non nocere, a consideration used by all physicians to judge whether to prescribe a particular treatment.  In determining this the physician uses the risk/benefit of a particular treatment or non-treatment.  In the risk of non-vaccination, it far outweighs the risk for treatment.  The risks vary according to age, and chronic conditions. Certain other immunologic conditions in children increase the risk of vaccination. Leukemia, Chemotherapy, previous severe allergic reaction (hives anaphylaxis, measles and mononucleosis). Patients can also check the CDC list of questions regarding vaccinations. (note: You must have Adobe Acrobat to open this here It is a free app that you can download from