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

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

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

WHO GLOBAL MAP AND STATISTICS

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.”

 

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 link...click here It is a free app that you can download from adobe.com 

 

THE REVOLUTION IS IN CYBERSPACE AND MACHINE LEARNING

Today’s typical medical check-up is based largely on a physical exam developed in the 1820s using tools that haven’t been upgraded in over a hundred years. And what passes as “a comprehensive health check” happens only once a year, giving us a mere snapshot of our actual health. A lot can happen within a year’s time. For an exponentially accelerating world in which our phones, computers, and cars update their software every few weeks, the idea of checking in on your health on an annual cadence is abysmal.  The problem is that our bodies are accelerating at such a rapid rate that even a microscopic change like a gene deletion in a single cell can lead to cancer––sometimes in a matter of weeks or months. I’ve seen a patient deteriorate from a triathlete champion to a stage IV pancreatic cancer patient nearing the end of her life within 6 months. It’s terrifying.  Now let’s imagine a different world. What if you could monitor your health constantly and in real-time? Use machines to detect subtle changes in your body and your blood chemistry so we can catch diseases before it’s too late? Before serious disease has the opportunity to manifest inside of you.   In this blog, I’ll explore advancements in diagnostics for two areas: (1) Telehealth (2) Continuous health monitoring  Together, these advancements will ultimately allow us to become the “CEOs of our own health.” They will extend our healthspan and lower our overall medical costs by an order of magnitude. (Note: According to a report from the Medicare, about a quarter of the total Medicare budget is spent on services for beneficiaries in their last year of life, 40% of it on the last 30 days.)  Let’s dive in... (This blog is written by Peter Diamandis, MD and Felicia Hsu, MD) MAKING THE DOCTOR’S VISIT VIRTUAL According to a McKinsey report on healthcare in 2020, COVID-19 caused a massive spike in telehealth services, from a mere 11% of US consumers to 46% by the end of 2020. The biggest concern across patients and providers was how to conduct a physical exam without touching a patient. How can you hear someone’s lungs over a video call? Feel how much swelling someone has in their legs? Hear a heart murmur?  But as we soon learned, there are several companies giving providers all the information they need virtually.  Before patients have the chance to see the doctor, they have their vitals taken. HD Medical has taken this virtual with their newest creation, HealthyU, a credit card-sized device that can instantly measure their heart rate, temperature, oxygen saturation, and heart sounds with the touch of their finger and make it all accessible to the provider in real-time. Within this small device, they’ve managed to pack in a remote EKG, which is a physician’s roadmap to a patient’s heart health and can help catch serious diseases like arrhythmias and heart attacks.  Now what about the physical exam? Tyto has created a palm-sized handheld exam kit and app that lets you perform your own guided medical exam that the physician can see remotely. Have a sore throat? Tyto’s camera can look clearly into the back of your throat. Having shortness of breath or chest pain? Tyto turns into a stethoscope you can just place on your chest and back so the physician can virtually listen to your heart and lungs.  These technologies will play a monumental role in making telehealth more of a norm in healthcare moving forward. But now that we’ve addressed the doctor’s visit virtually, what about the other 364 days you’re not seeing a doctor? CONTINUOUS HEALTH MONITORING In hospitals, patients are hooked to so many machines that will sound an alarm as soon as their heart rate goes even one beat out of range.  These days, data is our best friend. The more we have, the better we’re able to predict outcomes and be better informed. And what’s better than getting rid of the unknown, especially when it comes to our own health? A Grandview market analysis report valued the global wearable technology market size at $32.6B in 2019, and projected for it to expand at a rate of 15.9% from 2020 to 2027. There’s no disputing that consumer brands like Apple Watch, Fitbit, and Garmin have taken over the wearable health market. Their products give us an impressive amount of data––heart rate, sleep quality, calories burned. Athletes wear textiles flooded with sensors to give performance feedback.   But I want to turn your attention to five other equally impressive ways of watching your health at a granular level of detail. (1) Can we predict when we’re getting sick with the flu or even Parkinson’s? The Oura Ring is one of most promising wellness rings, covering an impressively wide range of parameters using infrared LEDs, accelerometers, gyroscopes, and body temperature sensors. Initially designed to monitor quality of sleep, it quickly expanded to measure body temperature, heart rate, and respiratory rate. After the NBA resumed its season during COVID-19, NBA players were offered the Oura Ring to monitor their health. Through a joint study with UCSF, it was able to detect common COVID-19 symptoms such as fever, cough, fatigue, and difficulty breathing three days earlier with 90% accuracy. It’s even able to use someone’s sleep movements to predict early onset of neurodegenerative disorders such as Parkinson’s. (2) Can we address the adult obesity crisis? Adult obesity has reached a record high with a prevalence of 42.4% in the US. Its partner in crime, diabetes, stands at 10.5% of the US population. Nutrition and dietary habits play a large role in both diseases. DexCom boasts an impressive continuous glucose monitoring wearable sensor that takes finger pricks and guessing glucose levels completely out of the equation. It allows patients to see their glucose trends throughout the day, link it with their dietary habits and help them achieve tight glucose control. (3) Can we prevent falls, the leading cause of injury deaths in adults over 65? These falls can lead to brain injuries, fractures, and immobilization that often lead to a spiral of other conditions. To address this, Nobi, acts as an extra pair of eyes at home. While it is not a wearable, it is a ceiling mounted smart lamp that detects falls and sends out alerts for help. It also prevents falls with activity monitoring and helpful reminders if it realizes the user is unsteady. (4) Can we infer contextual information to predict someone’s mental health? Over 20% of adults and 10% of youth experience depression. And these numbers are on the rise. Researchers have applied machine learning methods to continuous sensor data from wearables, smartphone applications, social media, and physical activity to better predict the onset of mental health conditions such as depression and anxiety. (5) Can we measure our blood pressure at all times? A lab based out of UT Austin made a proof of concept electronic tattoo that can measure continuous blood pressure. It uses an ultra-thin clear plastic film with embedded sensors that can monitor electrical heart signals. This would shift the use of continuous heart monitors from the bulky Holter monitor to a stick-on tattoo. Sensors and continuous monitoring systems have been developed to non-invasively detect what’s happening in the body in real-time. The field has used creative methods of elucidating human health data––through skin, vibrations, temperature, and interactions with an app. Technology advancements have occurred in essentially every organ system in our bodies. This list is by no means exhaustive—it is scratching the surface of what the field has already come up with.  CONCLUSION Technology is increasingly integrated into our lives—Alexa giving us music suggestions, autonomous cars reducing human error accidents, dating algorithms matching us with our other halves. It’s happening in almost unimaginable ways. Why not tap into that potential for our health? We envision a world in which devices that monitor our daily behaviors will be able to detect micro-changes and be able to alert us when we’re starting to develop pneumonia, stressing our heart too much, or starting to develop early-onset Alzheimer’s. Medicine is moving away from the annual physical exam and blood work. It’s going to rely on constant monitoring to detect changes that are happening in our bodies every second.  We are in the midst of a data-driven healthcare revolution: an era of abundance during which we’ll obtain a massive amount of health data. In the next few years, we’re going to see data analytics platforms that will help physicians use this mine of data. This shift will make medicine personalized, predictive, and preventive.   Let’s put the power of exponential technologies into patients’ hands and revolutionize patient care Ref: Peter Diamandis

Inbox (11,123) - gmlevinmd@gmail.com - Gmail

Laughing gas shows promise for treatment-resistant depression, small trial finds

Perhaps a trip to your dentist will help your mood.  Contrary to what you feel about going to see your dentist for that toothache, it may have a beneficial effect on your mood due to a finding from a limited study. In this study, it turns out laughing gas (Nitrous oxide) may be a treatment for depression that does not respond to other treatments for chronic depression.

Laughing gas has been used to dull pain in dental offices and maternity units for more than a century, and researchers now think the gas, called nitrous oxide, may effectively treat depression when other therapies have failed.

That's according to the results of a small phase 2 clinical trial, published Wednesday in the journal Science Translational Medicine.

About one-third of individuals suffering from depression are at risk for treatment resistance. Whereas inhaled 50% nitrous oxide has early antidepressant effects on individuals with treatment-resistant major depression (TRMD), adverse effects can occur at this concentration. In this phase 2 clinical trial, Nagele et al. studied the effects of a single 1-hour treatment with 25% nitrous oxide on depression symptoms in those with TRMD, finding that this lower concentration had comparable efficacy to 50% nitrous oxide over several weeks but was associated with significantly fewer adverse effects. These results highlight that lower concentrations of nitrous oxide may be a useful treatment for TRMD.

Up to 30 percent of people diagnosed with major depressive disorder don't respond to typical treatments, leaving a significant proportion of patients in need of new treatment options.

"Magic" mushrooms containing the psychedelic compound, Psilocybin

A Phase 2 clinical trial, conducted by researchers in London, was the first randomized trial to compare therapeutic doses of psilocybin — the psychedelic compound found in so-called magic mushrooms — with daily medication. The results were released in The New England Journal of Medicine.

"This is huge because it's showing that psilocybin is at least as good — and probably better than the gold standard treatment for depression," said Roland Griffiths, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins University, who was not involved in the study.

Research on how psychedelics can be used to treat mental health conditions is still in its early stages, and much more will be needed to determine whether psychedelics, including psilocybin, are an effective long-term treatment. It's also still unclear how treatment involving psychedelics would be used in the real world, as patients must be monitored for hours when they are given the drug.

In addition to psychedelic drugs, ketamine an anesthetic drug used for many years for minor procedures is now approved by the FDA for use as a nasal spray.

Spravata, an FDA approved nasal spray containing esketamine

Just what can the drugs do? A single treatment with psilocybin has been shown to relieve crippling anxiety in people with terminal cancer. The drug has also been shown to be an effective therapy for substance use disorders. MDMA can provide valuable help to people suffering from post-traumatic stress disorder (PTSD).

And there’s more. Preliminary evidence suggests that psychedelic drugs can be effective for eating disorders, obsessive-compulsive disorder, and major depression — including cases that don't respond to conventional antidepressants.

The drugs may also be good for helping smokers kick the habit, a process that's often notoriously difficult via conventional means.

 

Stay tuned.

 

Laughing gas shows promise for treatment-resistant depression, small trial finds

Digital Health Passes in the Age of COVID-19: Are “Vaccine Passports” Lawful and Ethical? | Law and Medicine | JAMA | JAMA Network

As the rate of Covid 19 decreases behold thresholds social distancing will be discontinued as well as masking.  Some venues may require masking and vaccination to enter.  Some are planning to use a vaccine passport to screen entrants to large venues.  Questions arise as to the legality of this being required.

With the use of smartphone apps or even a printed vaccination. card, much like the yellow one we used as children, it will be easy to carry your vaccine passport where ever you go.

Smartphone app developers are already in the process of having these available on the Google Play Store 

Once you activate your passport, a quick flash of your phone (QR code) will be your entry ticket to large sporting events or other large gatherings.

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment).1 The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings.2 This Viewpoint examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Benefits of DHPs

Digital health passes offer health and economic benefits until herd immunity is achieved. By allowing a safe return to a more normal life, DHPs encourage people to be vaccinated. Digital health passes also allow a gradual reopening of the economy in key sectors such as food, retail, entertainment, and travel. Consumers are likely to rejoin recreational and commercial activities if they are confident doing so is safe. Digital health passes offer a less restrictive means to relax COVID-19 preventive measures such as quarantines, business closures, and stay-at-home orders.

Are DHPs Lawful?

Public-Sector DHPs

Governments have the power to validate and monitor vaccination status while requiring proof of vaccination for access to certain privileges. International law poses few restrictions on DHPs. The International Health Regulations, signed by 196 countries, grant wide discretion to exercise evidence-based public health powers. Article 31 of these regulations specifically allows governments to require “proof of vaccination or other prophylaxis,” while Annex 7 authorizes yellow fever vaccination certificates for international travel.

In the US, individual states hold primary public health powers. States already condition school entry on proof of vaccination. During the COVID-19 pandemic, states and localities have also required masks and social distancing in certain venues. They similarly could authorize or require DHPs, authenticating vaccination status either through public or private digital platforms.

The president has broad power to require vaccination for entry to airports and federal buildings and land, just as President Biden did for masks. However, a federal DHP system would likely require congressional action, and a clear necessity to prevent the interstate spread of infectious diseases. Congress could also allocate funding for state DHPs, even conditioning further COVID-19 relief spending on state adoption of DHPs.

Government DHPs must navigate constitutional and civil rights constraints. While the Supreme Court grants public health agencies wide discretion, it is more protective of First Amendment freedoms, including religion, speech, and assembly. The Court has struck down COVID-19 public gathering restrictions as applied to houses of worship. The Court would likely subject government-run DHPs to high-level scrutiny if they prevented unvaccinated individuals from attending religious services or infringed other constitutionally protected rights.

Private-Sector DHPs

The private sector has a particular interest in ensuring that employees and customers are vaccinated because it facilitates a return to social and commercial activities. Businesses could rely on government-run or proprietary DHPs. The Equal Employment Opportunity Commission (EEOC) issued guidance on SARS-CoV-2 vaccinations, which applies to any vaccine “approved or authorized by the Food and Drug Administration,” suggesting that employers could require vaccinations even under an Emergency Use Authorization.

The EEOC allows employers to require SARS-CoV-2 vaccination to return to the workplace, thus ensuring employees do “not pose a direct threat to health or safety.”5 Employers also can use DHPs for proof of vaccination. Businesses can require employees to “provide proof they have received a COVID-19 vaccination.” Requiring a proof of vaccination, moreover, does not violate the Americans With Disabilities Act or the Genetic Information Nondiscrimination Act. However, employers should caution employees “not to provide any medical information as part of the proof.”

Digital health passes also would be unlikely to violate privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). Employers typically are not “covered entities” under HIPAA. Digital health passes could actually be advantageous because they provide proof of vaccination without sharing any other medical information.

Although employers may require proof of vaccination, they must abide by civil rights law. Thus, employers, whenever possible, should afford persons with disabilities “reasonable accommodations,” such as through telework. Similarly, employers should provide reasonable accommodations to individuals who hold a “sincere religious belief, practice, or observance.” Some states are considering prohibiting private-sector use of DHPs, but courts may decide whether they have the legal authority to do so.

Ethics and Equity

As long as there is supply scarcity, DHPs would unfairly exclude individuals who cannot access vaccines. Yet once everyone can gain access to vaccines, there is a strong ethical justification for DHPs designed to create safer environments to work, shop, recreate, and travel, as they represent a less restrictive alternative to current public health measures.6 Unvaccinated individuals have no right to impose risks on others, thus impeding a return to normal activities. Digital health passes therefore must be fully and equally available to all members of society, including the most disadvantaged people. Individuals who cannot be vaccinated for medical reasons also should not be excluded from DHP privileges. Consideration should also be given to granting exemptions for genuine religious or conscientious objections.

Health disparities based on race have been a persistent challenge. Black and Hispanic individuals in the US have had a significantly lower uptake of SARS-CoV-2 vaccines compared with the overall population.7 Racial minorities’ historic distrust of the health system should not disqualify them from economic and social opportunities. Governments should amply fund community-based outreach to encourage vaccine uptake.

Governments or airlines could soon introduce “vaccine passports” to facilitate international travel. Yet requiring proof of vaccination as a condition of travel would unfairly burden most low- and middle-income countries, which may lack adequate doses to fully vaccinate their populations for several years. Approximately 70 countries have not even begun vaccination campaigns, including most sub-Saharan African nations. COVAX, the global vaccine facility, aims to vaccinate only 20% of lower-income populations by 2022. Compounding the unfairness, high-income countries have contributed to supply scarcity by signing advance purchase agreements with vaccine companies. High-income countries could help ameliorate inequities through funding and donating vaccine doses to COVAX while building manufacturing capacities in low- and middle-income countries, including technology transfer.8

Digital health passes could become an important vehicle for a rapid return to commerce, recreation, and travel. To ensure their success, they must be scientifically well-grounded and the least restrictive alternative. Above all, DHPs must be administered equitably, ensuring that everyone has a fair chance to return to a normal life.

Scientific and Technical Challenges

Digital health passes involve considerable scientific and technical challenges, including variable effectiveness by vaccine type, effectiveness in preventing transmission, the durability of immunity, and the emergence of variant strains. Currently, the overall efficacy of 6 SARS-CoV-2 vaccines, mRNA-1273 (Moderna/NIAID), BNT162b2 (Pfizer-BioNTech), Ad26.COV2.S (Janssen/Johnson & Johnson), ChAdOx1 nCoV-19 (University of Oxford/AstraZeneca), Gam-COVID-Vac/Sputnik V (Gamaleya Research Institute of Epidemiology and Microbiology), and BBIBP-CorV (Sinopharm/Beijing Institute of Biological Products), authorized for use in select countries, ranges from 65.5% to 94.6% in preventing symptomatic COVID-19 based on published clinical trial data. Each vaccine could have variable effectiveness against currently circulating and future SARS-CoV-2 variants. Considerable variability in vaccine effectiveness in preventing symptomatic disease could affect the usefulness of DHPs. If DHPs were limited to only certain vaccine products, it would also exacerbate inequities based on access to particular vaccines.

The duration of protection afforded by SARS-CoV-2 vaccines is uncertain. Coronavirus infections, such as from the 2002-2004 SARS-CoV-1 outbreak, generally afford limited protection for 1 to 2 years.3 Reinfection with SARS-CoV-2 has occurred, albeit rarely. Yet there is limited evidence of vaccine-induced immunity beyond limited follow-up of clinical trial participants. Waning vaccine immunity will be better understood with follow-up of clinical trial participants, along with observational studies. Digital health passes should include dates of series completion to determine expiration once longevity of vaccine protection is better defined.

Digital Health Passes in the Age of COVID-19: Are “Vaccine Passports” Lawful and Ethical? | Law and Medicine | JAMA | JAMA Network

Study: 99.75% of hospitalized COVID-19 patients weren't vaccinated - Axios

Vaccination has made a tremendous difference decreasing serioius illness and hospitalization.

The Good News

The Cleveland Clinic on Tuesday released a study showing that 99.75% of patients hospitalized with COVID-19 between Jan. 1 and April 13 were not fully vaccinated, according to data provided to Axios.

Why it matters: Real-world evidence continues to show coronavirus vaccines are effective at keeping people from dying and out of hospitals. The Pfizer-BioNTech and Moderna vaccines have been found to be 95% and 94% effective, respectively, at preventing symptomatic infections.

Details: The study also looked at 47,000 Cleveland Clinic employees who had received one shot, both shots or no shots at all.

The Cleveland Clinic found that 99.7% of its employees who were infected with the coronavirus were not vaccinated, and 0.3% of infections occurred in those who were fully vaccinated.

The study found that in this group, mRNA vaccines were more than 96% effective in protecting against coronavirus infections.

What you should know about Vaccines

Vaccines are complicated. Here’s what you need to know about how they work to prevent deadly diseases; the different kinds of vaccines; and why herd immunity matters.

1. Key information about the effective COVID-19 vaccines

2. Demand for coronavirus vaccines is outstripping supply

3. Fauci: U.S. could achieve herd immunity by fall if vaccine rollout goes to plan

4. Tech's hidden hand in the vaccine rollout

5. Vaccine distribution information mess

6. Fighting the coronavirus infodemic

7. America’s vaccine trust crisis

The Bad News

Despite the paradigm shift in vaccine manufacturing which involved an entirely new process using messenger RNA, several things diminished the rollout of the covid19 vaccine.

A coincidental major national election intensified disagreements between political parties who are already deeply divided on most things.  An "infodemic" of misinformation and disinformation has helped cripple the response to the novel coronavirus.

Why it matters: High-powered social media accelerates the spread of lies and political polarization that motivates people to believe them. Unless the public health sphere can effectively counter misinformation, not even an effective vaccine may be enough to end the pandemic.

How to protect yourself in the infodemic?

Driving the news: This month the WHO is running the first "infodemiology" conference, to study the infodemic of misinformation and disinformation around the coronavirus.

What they're saying: While fake news is anything but new, the difference is the infodemic "can kill people if they don't understand what precautions to take," says Phil Howard, director of the Oxford Internet Institute and author of the new book "Lie Machines."

Beyond its effect on individuals, the infodemic erodes trust in government and science at the moment when that trust is most needed.

A study by the Reuters Institute found 39% of English-language misinformation assessed between January and March included false claims about the actions or policies of authorities.

The infodemic has spread nearly as widely as the pandemic itself in the U.S.

As early as March, about half of surveyed Americans reported they had encountered at least some completely made-up news about the pandemic.

38% of Americans surveyed by Pew in June said that compared to the first couple of weeks of the pandemic, they found it harder to identify what was true and what was false about the virus.

In that same survey, roughly a third of Americans exposed to a conspiracy theory that the COVID-19 outbreak was intentionally unleashed by people in power said that they saw some truth in it.

How it works: Misinformation and disinformation have always been a destabilizing feature of infectious disease outbreaks. But several factors have made the situation worse with COVID-19.

An evolving outbreak: COVID-19 is new, and as scientists have learned more about the virus, they've had to change recommendations. That's how science works, but "if you're distrustful of authorities, an expert taking a position different than it was three days ago just confirms your bias," says Joe Smyser, CEO of the Public Good Projects.

Social media: While experts give some credit to companies like Facebook and Twitter for their efforts to stem the spread of coronavirus misinformation, the reality is that platforms built on engagement will often end up as conduits of conspiracy content, which Howard notes tends to be unusually "sticky." A review by the Reuters Institute of 225 pieces of misinformation spread by political figures and celebrities made up only 20% of the sample but accounted for 69% of engagement.

Disinformation warfare: In June, the European Commission issued a joint communication blaming Russia and China for "targeted influence operations and disinformation campaigns around COVID-19 in the EU." And those campaigns are effective — in a recent study, Howard found disinformation from Russian and Chinese state sources often reached a bigger audience on social media in Europe than reporting by major domestic outlets.

Political and media polarization: "In our hyper-polarized and politicized climate, many folks just inherently mistrust advice or evidence that comes from an opposing political party," notes Alison Buttenheim of the University of Pennsylvania School of Nursing. Conservatives are particularly vulnerable — an April study found Americans who relied on conservative media were more likely to believe conspiracy theories and rumors about the coronavirus.

Public health experts must take an active role in combating the infodemic, says Timothy Caulfield, research director of the University of Alberta's Health Law Institute.

One example is the "Nerdy Girls," an all-female team of experts who spread accurate information about the pandemic on social media in a way that aims to "engender trust," says Buttenheim, one of the group's members. 

(Who are the Nerdy Girls ?)   Those Nerdy Girls, a volunteer team of female PhDs, MDs, and DOs curating COVID-19 content for the greater good. We love facts. For educational purposes; nothing here substitutes for advice from your healthcare provider. Stay safe, stay sane.

Individuals can do their part by practicing information distancing as well as social distancing. "If you can just nudge people to pause before they share on social media, you can actually decrease the spread of misinformation," says Caulfield.

Study: 99.75% of hospitalized COVID-19 patients weren't vaccinated - Axios: The study found that 0.3% of infections occurred in people who were fully vaccinated.

To Vaccinate Younger Teens, States and Cities Look to Schools, Camps, Even Beaches -

At the beach, Pacific Beach, San Diego

As usual, especially along either the left or right coast or the river or lake, young people head to the beach to picnic swim, surf, sunbathe, or just plain relax this summer vaccination will be offered to young people. Now that the FDA has approved Covid 19 vaccination for 12-15 year olds. 

The F.D.A.’s authorization of Pfizer’s Covid shot for 12- to 15-year-olds is a milestone in battling the coronavirus, but actually getting them vaccinated involves new challenges.

Even more incentives could include a free joint (with parental permission). Let's face it almost all kids have tried marijuana or want to try it. Marijuan is no. longer consiered a 'gateway drug"The scientific risk of a joint is far less than contracting covid, or at least equal. (my own personal opinion) and not to be taken as medical advice.  Public health concerns should outweigh other issues.

Any parent knows this age group is particularly independent, contrary and unlikely to go to a public health vaccination site.  In addition this group does not drive, in the no mans land of pubescence and adulthood. Peer pressure and conformance with their peers is an overriding feature of this age group.  Wanting to belong is almost the only personal objective of teenagers.

Other possible venues for vaccination are music festivals, pop concerts, sporting events.  Go to where they are decreases the likelihood young people will avoid the 'shot'.

Colorado River, a favorite place on the California Arizona Border

To Vaccinate Younger Teens, States and Cities Look to Schools, Camps, Even Beaches - The New York Times