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A COVID-19 vaccine exemption letter

BY ANISH KOKA

I recently saw a young man who came to see me because his place of future employment, a large health system was requiring him to complete the 1º series of his COVID-19 vaccination. He was concerned because he had chest pain after his first mRNA vaccine and was uncomfortable with the risks of a second mRNA dose. He attempted to get a Johnson and Johnson vaccine and was told by pharmacists he was not allowed to mix and match this particular vaccine as he had already received an mRNA dose. With no other option, he came to ask me whether I thought a vaccine exemption was reasonable in his case. He already had a family medicine physician sign an exemption that had been denied by his future employer’s vaccine exemption committee. The young man works on the “back end” of the health system remotely from home and he has no patient contact. The entire process has caused him to lose his health insurance from his former employer, and he was now paying out of pocket for an expensive COBRA health insurance plan. What follows is my letter to the vaccine exemption review committee regarding his case. (Published with permission, only the relevant names have been changed/redacted)


Dear Vaccine Exemption Review Committee,

I am writing this letter on behalf of John Smith DOB: xx/xx/xx in regard to a mandate from xxxx Health that Mr. Smith receive a second dose of an mRNA vaccine to complete his primary COVID-19 vaccine series.

Mr. Smith has asked me to render an opinion specifically related to his cardiac risk of receiving a second dose of an mRNA vaccine. I am a board-certified cardiologist in Philadelphia, Pennsylvania, and have been in active clinical practice for 13 years.

After reviewing the details of his case, I have grave concerns about compelling him to receive a second dose of an mRNA vaccine and would like to outline the reasons for my conclusion in this letter. I am going to specifically discuss his risk of an important, now well-recognized, adverse event: vaccine myocarditis.

What follows is some important background information about vaccine myocarditis that has been gleaned over the last 2 years before I discuss the particulars of Mr. Smith’s case.

It is relevant to note here that as a physician active clinically in both the inpatient and outpatient arenas, I am an eyewitness to the severe toll COVID-19 took on my patients in the Spring or 2020. I was impressed enough with the initial mRNA vaccine data to acquire the vaccine available from the Philadelphia Department of Health (Moderna) and ran multiple vaccine clinics in order to vaccinate my mostly high-risk patients.

What follows is data produced since the vaccine rollout that is relevant to Mr. Smith’s case.

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Matthew’s health care tidbits: The Stupidity Vaccine

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

For my health care tidbits this week, I think we need a new vaccine. We need one that prevents stupidity.

Look I get that some people don’t think the flu vaccine is effective and don’t think the effects are too bad, so they don’t get one every year. Many people don’t get a vaccine for shingles. But as someone who had shingles long before the recommended age for the vaccine, let me tell you, you’ll wish you had the vaccine should you get it. And even sensible liberal Maggie Mahar a long while back was pretty suspicious of Merck’s Gardasil vaccine for cervical cancer–although since then it’s been replaced both by a more effective updated version and by Cervarix and the long term results are really good.

But since COVID-19 appeared the cultural and ideological identification among most Republicans has been that only wussy liberals take the COVID vaccine. This is stupid and indefensible. Even Donald Trump thinks so! But when he told his cult members that, they booed him! And so the US is stuck on not enough people vaccinated to repel variants or stop ICUs filling up. There are now hundreds of thousands of unnecessary deaths among the unvaccinated with no end in sight.

But this isn’t stupid enough. Now we are seeing senior political leaders attacking vaccines for diseases we’ve had under control for ages. We’ve already seen outbreaks of measles in recent years, including one at Disneyland. Last month 17 Georgia state senators proposed banning school mandates for all vaccines including MMR, chickenpox, DtAP, Hep B, Polio and more. It’s amazing that these people don’t believe in science, yet they are probably happy to use a smartphone or get in an airplane.

Sadly there appears to be no vaccine for stupidity on the horizon

The Social Science of Covid

By MIKE MAGEE

As we enter the third year of the Covid pandemic, with perhaps a partial end in sight, the weight of the debate shows signs of shifting away from genetically engineered therapies, and toward a social science search for historic context.

Renowned historian, Charles E. Rosenberg, envisioned a similar transition for the AIDS epidemic in 1989. He described its likely future course then as a “social phenomenon” with these words, “Epidemics start at a moment in time, proceed on a stage limited in space and duration, follow a plot line of increasing and revelatory tension, move to a crisis of individual and collective character, then drift toward closure.”

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The Covid Vaccine’s PR Crisis: Health Innovation vs the Take-Down Power of Disinformation

By JESSICA DaMASSA

Misinformation and disinformation (intentionally wrong information) have plagued the storyline of the Covid19 vaccine since the early days of its development, creating a healthcare communications crisis that has not only stalled U.S. vaccination rates, but has also raised questions about how medical and scientific experts will ever again win trust across audiences and communications platforms that are becoming increasingly fragmented, and sometimes hostile.

Yesterday, on the two-year anniversary of the first Covid case in the U.S., I sat down with Dr. Carlos del Rio, Professor of Infectious Diseases & Epidemiology at Emory University, and Jon Reiner, Editorial Director at 120/80 MKTG, to check-in on the vaccine conversation and, more generally, what we in the health innovation community can learn from this situation as we attempt to introduce other new medicines, breakthrough technologies, and scientific advances to the world.

Dr. del Rio served as a vaccine expert in a public service campaign that 120/80 MKTG put together called “Just the Facts on Vax,” which sought to combat vaccine disinformation early-on with a series of bite-sized, social-media-ready videos that put infectious disease experts front-and-center to answer common questions about the vaccine. The full campaign can be viewed on 120over80 MKTG’s YouTube channel, but can it still have an impact? And, in the grand scheme of things, when it comes to people’s personal health, evolving medical or scientific information, and a litany of communication platforms that can position nearly anyone as an expert, how do real experts build trust? An interesting – and timely – chat about the power of information and the “trusted expert” archetype in the context of one of the most unique healthcare stories of our lifetime.

The “Secret Sauce” – A Comparison of TSMC and Pfizer

By MIKE MAGEE

This week’s Tom Friedman Opinion piece in the New York Times contained a title impossible to ignore: “China’s Bullying Is Becoming a Danger To The World and Itself.” The editorial has much to recommend it. But the item that caught my eye was Friedman’s full-throated endorsement of Taiwan’s “most sophisticated microchip manufacturer in the world,” Taiwan Semiconductor Manufacturing Company (TSMC).

TSMC owns 50% of the world’s microchip manufacturing market, and along with South Korea’s Samsung, is one of only two companies currently producing the ultra-small 5-nanometer chips. Next year, TSMC will take sole ownership of the lead with a 3-nanometer chip. In this field, the smaller the better. (For comparison, most of China’s output is 14 to 28 nanometers.)

U.S. Silicon Valley companies like Apple, Qualcomm, Nvidia, AMD, and recently Intel contract with TSMC rather than produce chips on their own. In addition, the key machines and chemicals necessary to produce the chips are willing supplied to TSMC by U.S. and European manufacturers. TSMC’s secret sauce, according to Friedman, is “trust.” As he writes, “Over the years, TSMC has built an amazing ecosystem of trusted partners that share their intellectual property with TSMC to build their proprietary chips.”

“Trust me” is not a phrase often associated with intellectual property. Consider, for example, Washington Post’s reporting the very same day as Friedman’s under the banner, “In secret vaccine contracts with governments, Pfizer took hard-line in the push for profit, report says.” The article reveals documents in a Public Citizen report that confirms that Pfizer has been maximizing their vaccine profits “behind a veil of strict secrecy, allowing for little public scrutiny… even as demand surges…”

As I describe in my book “Code Blue: Inside the Medical Industrial Complex” (Grove 2020), Pfizer’s focus on intellectual property as a commercial weapon has a history that extends back a half-century.

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The Vaccine Brawl – A Legal Battle in Process

By MIKE MAGEE

The power to mandate vaccines was litigated and resolved over a century ago. Justice John Marshall Harlin, a favorite of current Chief Justice Roberts, penned the 7 to 2 majority opinion in 1905’s Jacobson v. Massachusetts. Its impact was epic.

In 1905, Massachusetts was one of 11 states that required compulsory vaccinations. The Rev. Henning Jacobson, a Lutheran minister, challenged the city of Cambridge, MA, which had passed a local law requiring citizens to undergo smallpox vaccination or pay a $5 fine. Jacobson and his son claimed they had previously had bad reactions to the vaccine and refused to pay the fine believing the government was denying them their due process XIV Amendment rights.

In deciding against them, Harlan wrote, “liberty for all could not exist under the operation of a principle which recognizes the right of each individual person to use his own [liberty]…” 

Of course, a state’s right to legislate compulsory public health measures does not require them to do so. In fact, as we have seen in Texas and Florida among others, they may decide to do just the opposite – declare life-saving mandates (for masks or vaccines) to be unlawful. At least 14 states have passed laws barring employer and school vaccine mandates and imposing penalties in Republican-controlled states already.  

So state powers are clearly a double-edged sword when it comes to health care. 

Questions anyone?

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Can we move on?

By CHADI NABHAN MD, MBA, FACP

Every so often, my cynical self emerges from the dead. Maybe it’s a byproduct of social media, or from following Saurabh Jha, who pontificates about everything from Indian elections to the Brexit fiasco. Regardless, there are times when my attempts at refraining from being opinionated are successful, but there are rare occasions when they are not. Have I earned the right to opine freely about moving on from financial toxicity, anti-vaxers, who has ‘skin in the game’ when it comes to the health care system, the patient & their data, and if we should call patients “consumers”? You’ll have to decide.

I endorse academic publications; they can be stimulating and may delve into more research and are essential if you crave academic recognition. I also enjoy listening to live debates and podcasts, as well as reading, social media rants, but some of the debates and publications are annoying me. I have tried to address some of them in my own podcast series “Outspoken Oncology” as a remedy, but my remedy was no cure. Instead, I find myself typing away these words as a last therapeutic intervention.

Here are my random thoughts on the topics that have been rehashed & restated all over social media outlets (think: Twitter feeds, LinkedIn posts, Pubmed articles, the list goes on), that you will simply find no way out. Disclaimer, these are NOT organized by level of importance but simply based on what struck me over the past week as grossly overstated issues in health care.  Forgive my blunt honesty.

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Everyone Has a Part to Play in Ending Vaccine Hesitancy

Heidi L. Pottinger DrPH, MPH, MA
Felicia D. Goodrum PhD

By FELICIA D. GOODRUM STERLING, PhD and HEIDI L. POTTINGER, DrPH, MPH, MA

The measles outbreak in Washington state this week has brought new attention to the anti-vaccine movement.  In fact, the World Health Organization recently identified “vaccine hesitancy” as one of top threats to global health. In the US, the number of unvaccinated children has quadrupled since 2001, enabling the resurgence of infectious diseases long-since controlled.  In fact, the WHO claims a staggering 1.5 million deaths could be prevented worldwide by improved vaccination rates.

Amidst the media and public health outcry, a mystery persists:  Why has vaccine hesitancy continued, despite years of vigorous debunking of shoddy science?  The answer may lie in a deeply-rooted distrust of doctors and science.

One of the authors of this article, Dr. Pottinger, surveyed hundreds of Arizona parents, from schools with exemption rates greater than 10%, about their perceptions on vaccines. Pottinger and colleagues found the vast majority of the parents surveyed who delayed or chose not to vaccinate their children did so because of true personal beliefs and not convenience.  Specifically, they tended to distrust physicians and information about vaccines or held misperceptions about health and disease, including the idea that immunity by natural infection is more effective or that vaccine-preventable diseases are not severe.

These beliefs, stoked by a fraudulent 2010 study, have proven almost impossible to shake—despite the fact that the debunked study, based on 12 children, was retracted due to serious ethical violations and scientific misrepresentation; authors cherry-picked and fabricated data, and the first author had undisclosed business interests in the vaccine industry.

The failure of many interventions to dispel misinformation demonstrates the power of a complex interaction of confirmation bias, cognitive dissonance, distrust in data sources, and personal experiences and narratives.  Taking them on requires that the healthcare community effectively spread the following messages.

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The Luxury to Choose

The 80 year-old woman lay on her mat, her legs powerless, looking up at the small group that had come to visit her. There were no more treatment options left. The oral liquid morphine we had brought in the small plastic bottle had blunted her pain. But, she would be dead in the coming days. The cervical cancer that was slowly taking her life is a notoriously horrible disease if left undetected and untreated and that is exactly what had happened in this case.

We had traveled hours by van along dirt roads to this village with a team of health workers from Hospice Africa Uganda, the country’s authority on end-of-life care, to visit the woman. She was the second patient of a similar condition I would see that afternoon.

Back home, seeing an 80 year-old woman with advanced cervical cancer, let alone two in the same day, was exceedingly rare. In high-income countries, cervical cancer is a largely treatable disease, especially when caught in the early stages. And it is now preventable thanks to a widely accessible vaccine against Human Papillomavirus (HPV), the infectious agent that causes most cervical cancers, called Gardasil, which is recommended for all pre-teens in the United States.

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Twitter Study of Vaccine Messages: Opinions Are Contagious, But In Unexpected Ways

Remember 2009? The H1N1 pandemic we were all waiting for? I do. I was pregnant; H1N1 was particularly risky for pregnant women. The vaccine wasn’t available until after I had my baby, but when they held a clinic an hour north of where I live, I brought my husband there so we could both get our shots. My infant son was too young to be vaccinated, so I wanted to protect him through herd immunity.

study came out recently on twitter messages from that time. How did pro-vaccine sentiments spread, versus anti-vaccine ones? Which messages were more contagious?

I talked to one of the authors, Marcel Salathe, today. He’s an infectious disease researcher studying the spread and transmission, not (just) of disease, but of information. “We assume people infect each other with opinions about vaccinations,” he said, and the H1N1 scare was a good opportunity to put some of his group’s theories to the test.

They collected nearly half a million tweets about the H1N1 flu vaccine. In 2009, H1N1 wasn’t included in the regular flu shot, and became available partway through flu season as a separate dose. With a possible pandemic looming, people had plenty of motivation to get the vaccine and encourage others to get it—butanti-vaccine sentiments were in circulation too.

The result, striking but perhaps not surprising: negative opinions were more contagious than positive ones. (Specifically, someone who read a lot of anti-vaccine messages was more likely to follow up by tweeting or retweeting negative messages of their own.)

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