Coronavirus news & views

NIH Launches First Trial Of Nasal COVID Vaccine

"Taking a new step, uttering a new word, is what people fear most.”
― Fyodor Dostoevsky, Crime and Punishment

Earlier in these pages I described how the mucosal immune system is different from the general immune system of the body. Your mucosa (i.e., the lining of your nose, mouth, throat, sinuses, lungs, etc.) has its own robust immune defense and produces different types of antibodies in response to invaders. The nose, mouth and throat are often the first line of defense to airborne pathogens, such as the flu and SARS-CoV-2 viruses. So, when you are infected via the mucosa by an airborne pathogen, it activates a local immune response while eventually sounding an immune alarm for the body-whole. But by the time the infection settles in and the rest of your body responds, it is all-out immunological warfare and you feel crappy (hope I am not being to technical). Sometimes the bug wins too. Too often, especially before we had the vaccines, COVID won, and folks were hospitalized in dire straits with tubes attached to machines keeping them alive, too often failing.

The amazing vaccines we developed in record time were delivered into an arm muscle to stimulate our general body immune response, not our mucosal immunity. This meant that even though we had immunity, the virus could still enter us, set up shop and wait until the general body immune reinforcements arrived. Those reinforcements were quite effective at preventing serious disease, but you still would get ill.

Wouldn’t it be nice if a vaccine could be developed to nip the infection in the bud at the site of entry--in the mucosa--so it could not set up shop at all? That is an idea that has been percolating in the minds of immunologists for a while. It is the idea behind a mucosal vaccine that I described earlier.

But, if it is such a good idea for the CoV-2 coronavirus, why not for flu or other airborne pathogens that have been around much longer? Indeed efforts to develop nasal vaccines for influenza have been ongoing for a couple of decades. But, when is the last time you got a nasal spray vaccine for the flu? The track record has been mixed. The FluMist nasal flu vaccine was approved for kids in 2003. Initially it was a convenient alternative to the injected vaccine. But, it showed limited efficacy in adults. Early on it was deemed just as effective as the standard vaccine in kids, not better as hoped. More recently it was reported to not be so effective. As a result it is no longer recommended by the American Academy of Pediatrics. It clearly did not rise to the hope we had for a nasal flu vaccine.

All the above negativity for the early nasal flu vax doesn’t mean that the idea of a nasal flu vaccine is invalid. Researchers will test different sorts of flu antigens for the nasal approach. FluMist used a live, but attenuated virus in its nasal vaccine. That means kids snorted a live virus that could infect cells but not cause disease. Perhaps a different flu antigen would be more effective? But, frankly, it is hard to get more realistic than a live-attenuated virus.

Nevertheless, another promising new flu nasal vaccine candidate is FluGen’s, M2SR, developed by researchers at the University of Wisconsin-Madison. This vaccine is a bit different because it uses a wholly live virus with an essential replication gene deleted from its DNA. This means the virus is fully functional except it can’t replicate and cause illness. That makes it a little different from the live-attenuated virus. It should stimulate the immune system like a natural infection, but begs the question: how will that be different from the immune response generated from a live attenuated virus? How will that crippled snuffed virus stimulate a different immune protection from the sniffled FluMist attenuated virus? We will see, won’t we? That is why we do such experiments.

Back to COVID. This summer, NIH launched the initial Phase 1 trial to begin testing such a nasal COVID vaccine.

The vaccine. The vaccine is a mouse virus (MPV) in which a piece of the CoV-2 spike protein is expressed. MPV does not cause human disease but does like to stick to human and primate mucosal epithelial cells and should be an effective vector for delivering the spike protein sequence where it can tickle an appropriate immune irritation. In animal studies, the experimental virus was safe and produced a robust immune response in the mucosa lining the nose and respiratory tract of experimental animals. All very encouraging, hence the move to human trials.

The human trial. This is a Phase 1 trial, the first step of any experimentation in humans. Phase 1 trials do not look for efficacy and are done on quite a small number of patients, anywhere from 20-100 subjects who are not tested at all for resistance to the disease. The purpose simply is to look for common safety issues like whether the vaccine causes a general adverse reaction with increasing doses and how well it induces an immune response (i.e., anti-spike protein antibodies) at different doses. Using this information, a Phase 2 study can be designed including more subjects, usually hundreds. This begins to look for more subtle side effects and is the first test of the ability of the vaccine to protect against COVID disease. This would be a controlled trial where experimental vaccine recipients are compared to a control cohort who do not get the nasal vaccine, but probably a placebo. If data collected from this study warrant, then a Phase 3 study is done on thousands of patients to further refine the safety and efficacy profile of the vaccine.

The Phase 1 study that is underway is being led by the National Institute of Allergy and Infectious Diseases and is enrolling 60 subjects at trial sites, which include the Baylor College of Medicine, Houston; The Hope Clinic at Emory University in Atlanta; and New York University on Long Island. The immune responses of volunteers will be followed for one year. So, it will be a while before investigators have the data to begin Phase 2 trials.

Bottom line. This is just the beginning and it will take several years to finish. If successful, this would represent the next generation of COVID vaccine. Finally, as I have often ended my blog posts…

…we will see.

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Deadly Vaccine Disinformation

“There is no vaccine that is safe and effective.”

-RFK, Jr.

Debut: On July 6, 2023, RFK, Jr. (aka “Junior”) made the above minatory quote on a podcast. It sums up his decades-long quixotic crusade against all vaccines and his many more screwball contrarian stands on various topics. Basically, if mainline medicine has an opinion on something, Junior, will claim to have some special knowledge that the opposite is true. For example, he believes that AIDS is not caused by the HIV virus, that 5G cell phone towers causes cancer, that an herbicide causes teens to become transgender, and so on. The reams of scientific evidence  contrary to these special insights of his he simply dismisses as vague, conspiratorial plots invented by “big” government, “big” pharma, and “big” others designed to control you and me, or depopulate the world,….or something.

Unfortunately, there are others like Junior who too readily eschew normal standards of logic and evidence and buy into such febrile musings. Also, unfortunately, such bias-confirming fabulism is dangerous—it costs people their health and lives. Junior is indeed directly responsible for misery and even deaths caused by his vaccine disinformation. I relate two such examples below.

Disinformation is false information which is deliberately intended to mislead. In contrast, misinformation is wrong information that is spread without malicious intent.

Measles: Kennedy played a part in one of the worst measles outbreaks in recent memory—one that caused the deaths of several children. It began in 2018 when two 12-month old infants in American Samoa tragically died when nurses mistakenly prepared the combined measles, mumps and rubella, or MMR, vaccine with expired muscle relaxant rather than with sterile water as they should have. The muscle relaxant killed the children. It was an egregious medical error that should not have happened. The Samoan government overreacted and temporarily suspended the entire vaccination program, which enticed anti-vaccine advocates—including Kennedy and his nonprofit, the Children’s Health Defense—to manipulate the Samoan tragedy for their own interests in order to spread their vaccine disinformation. Junior falsely claimed on his Facebook page that the Samoan tragedy “proved” that the MMR vaccine was deadly. Even after it had become abundantly evident that the MMR vaccine wasn’t responsible for the infant deaths, Junior visited Samoa and met with senior officials to convince them that the MMR vaccine was deadly. Influenced in part by his actions, the Samoan government suspended its measles vaccination program.

As a result, the vaccination rate dropped precipitously from 74 percent in 2017 to 31 percent in late 2018, well below the level needed for “herd immunity.” The next year, 2019, a traveler brought measles to the islands, which precipitated a rapid measles epidemic in the under-vaccinated population (note: measles is the most infectious virus we know. Measles epidemics are explosive). Between September and December of that year, at least 5,700 people contracted the disease and 83 died. Most deaths were in children under four years old, who should have just received their MMR vaccines. During the outbreak, in a 4-page letter to the Samoan prime minister, Junior claimed that the measles deaths were caused by the vaccine, not the virus. But, the deaths were in unvaccinated children! The deaths were wholly preventable and Kennedy should have been held at least partly culpable for this preventable tragedy and the deaths of the children.

Hepatitis B: Junior often claims that the “big” US government is not to be trusted. We can go back and forth on that—it depends on what the topic is. An unfortunate topic of his at one point, however, was the hepatitis B vaccine. In the early 90s, the CDC recommended hep B vaccines for all newborns. Junior, of course, not believing that any vaccine is safe or effective needed to find some way to dissent.  He pointed out that there are only three ways to contract  hepatitis B: 1) from sharing needles as a drug addict, 2) from unprotected sex with a prostitute, or 3) unprotected gay sex. He was correct on these three points, but completely ignored an important fourth group, childen.

If sinning adults are the only ones at risk for catching hep B, why in the world would the CDC recommend the vaccine for newborns? According to Junior’s elastic logic, it was because the prostitutes, drug addicts and promiscuous gay males didn’t want to buy the vaccine so the vaccine makers, Merck and Glaxo, were losing money! And behold, a compliant “big” CDC began recommending the vaccine for newborns so “big” pharma could continue to rake in the dough. This was according to Junior, without any evidence.

Then, Junior also made the accusation that the hep B vaccine was the cause of sudden infant death syndrome, or SIDS! His “evidence” was that SIDS “first appeared” about the time the CDC recommended that infants be vaccinated for hep B. The problem is that SIDS, or crib death, was around way before infants were ever given the vaccine. It was just that the medical establishment was just then beginning to recognize crib death as a recurring pattern with a definite cause and the press began reporting on it. According to Junior’s simple logic, it would be more accurate to blame crib death on the press coverage of it instead of the vaccine itself. Junior and other vaccine disinformation spreaders tend to ignore such inconvenient facts that distract from their preconceived biases. Junior needed to find some way to make the hep B vaccine sinister so he invented a dishonest link between the vaccine and crib death that had just popped up in the news.

Here are more compelling facts that Junior ignored when he spread this disinformation. Before the hepatitis B vaccine was recommended for all infants, every year the virus infected about 18,000 children less than 10 years of age!! What?? If it only infects sexually active adults and drugs users, as Junior claimed, how does he account for this fact? He clearly chose to ignore it! Worse, infection with hep B virus early in life dramatically increases the chance of liver cancer or chronic liver disease later in life.

While it is true that hepatitis B virus usually is transmitted through sexual contact or needle sharing, that isn’t how the virus is transmitted to young children. Babies are infected with hepatitis B during birth to a mother who is infected. And young children can also contract hepatitis B when living with someone who is infected and sharing personal items like toothbrushes. Then, there are several studies that have confirmed that the hepatitis B vaccine is not at all related to SIDS. The most common cause of crib death occurs when babies sleep face down. For that reason, in the early 1990s, at the same time that the CDC recommended the hepatitis B vaccine for babies, the American Academy of Pediatrics launched its “Back to Sleep” program, encouraging parents to lay their babies on their backs at bedtime to prevent crib death. It worked.

So, RFK, Jr falsely claimed, with no data, that the infant hepatitis B vaccine caused SIDS. Meanwhile, the number of babies vaccinated with hep B increased, and the “Back to Sleep” program was implemented to prevent SIDS, and the incidence of SIDS sharply dropped clearly showing Kennedy’s lie. How many kids went unvaccinated and are now walking around with liver cancer thanks to RFK, Jr’s lies?

Other spreaders of deadly disinformation: RFK, Jr. a lawyer, and his anti-vaccine non-profit, the Children’s Health Defense, by far are not the only miscreants spreading anti-vaccine disinformation. But, they are among the top of the “Disinformation Dozen” according to The Hill. This “dozen” is responsible for 65% of the disinformation promulgated on social media platforms according to the Center for Countering Digital Hate. But, since the COVID vaccines arrived on the scene, a number of medical doctors also have jumped on the anti-vaccine bandwagon. A few have been professionally sanctioned. A short rogues’ gallery of the most notable MD scofflaws follows:

1. Sherri Tenpenny—said the COVID vaccines cause “magnetism” and that metal objects would stick to people, and that there was some sort of connection between vaccines and 5G towers. Her medical license was temporarily suspended until she paid a fine for these flagrant lies.

2. Joseph Mercola—one of the “Disinformation Dozen” called the vaccines a “medical fraud” in order to promote his own online supplement business that included unapproved treatments for COVID—a business worth $100 million! The FDA sent several letters warning him about selling unapproved health products and making false claims about COVID treatments. His YouTube account was permanently banned for this disinformation but his alternative drug business thrives.

3. Simone Gold—one of America’s Frontline Doctors, an anti-vaccine group that has been mentioned in these pages, discouraged the COVID vaccines while promoting hydroxychloroquine and ivermectin long after they were proven ineffective and disapproved by the CDC. She was disciplined by the California Medical Board, but kept her medical license.

4. Stella Immanuel—also one of America’s Frontline Doctors also promoted hydroxychloroquine after it had been disapproved. She was disciplined by the Texas Medical Board and had her social media posts removed. Amazingly, she has claimed that 1) alien DNA is being used in medical treatments, 2) gynecological problems are caused by having sex with demons and 3) that vaccines to prevent people from becoming religious are being developed. As of March 2023, she was, by several orders of magnitude, the highest prescriber of ivermectin and hydroxychloroquine in the US. For some reason, she retains her medical license.

5. Lee Merritt—claimed that COVID was a genetically engineered bioweapon designed to exert some sort of social control and that the vaccination dramatically increases the risk of death from COVID itself. The opposite clearly is true. She too  still has her license.

6. Paul Thomas—A pediatrician has spread general vaccine disinformation to his patients, including about the COVID vaccine, causing many of them to get vaccine-preventable diseases. His license was suspended by the Oregon Medical Board for violating standard medical practices.

7. Scott Jensen—A Minnesota state senator and family doc spread disinformation about COVID death certificates and the vaccines. He signed up with America’s Frontline Doctors and faced multiple investigations by the Minnesota Medical Board, which were eventually dropped. He has been banned from several social media platforms for promoting COVID disinformation. He is running for governor.

8. Rashid Buttar—claimed that the vaccine was a depopulation plan and that most people who were vaccinated would be dead by 2025. He has been reprimanded more than once by the North Carolina Medical Board for unprofessional conduct and malpractice. He still practices medicine.

9. Christiane Northrup—Also one of the “Disinformation Dozen,” promotes alternative medicine and anti-vaccine conspiracy theories, especially disinformation about COVID vaccines. She has used Tarot cards to help her diagnose illness and believes that trauma from a past life can cause chronic illness, and that in a past life she lived in Atlantis, etc, etc, etc. She denied the existence of COVID and believes the vaccines contain artificial intelligence that integrates into DNA making the recipient the intellectual property of the vax patent holders. etc, etc, etc.  Her Instragram account was blocked. She voluntarily gave up medical practice in order to write and publicize these ideas.

Bottom line: The insidiousness and even silliness of anti-vaccine charlatans like RFK, Jr and the others is that while they claim to be saving peoples’ lives, they actually are causing deaths. The Kaiser Family Foundation found that in the nine months between June 2021 and March 2022, 234,000 deaths could have been prevented with the COVID vaccines that these charlatans actively worked to prevent.

How is a death caused by deceitful conspiracies about vaccines different from a death caused by criminally refusing to give insulin to a diabetic in crises, or after telling someone that a loaded gun is unloaded? Both are irresponsible and lead to great harm, just like vaccine disinformation does. Why hasn’t RFK, Jr been prosecuted for the preventable deaths of Samoan children from measles? Why do so many physicians engaging in medical malpractice keep their licenses?

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Tattoos and Vaccines: Muddled Thinking And A Good Idea

“Often wrong, never in doubt”  Anonymous

Muddled thinking. Despite reams of evidence to the contrary, including a recent Nobel Prize for the technology, vaccine fabulists, like RFK, Jr, , Robert De Niro, Jenny McCarthy, my own Senator Ron Johnson, and too many others continue to spread intentional disinformation about the safety and efficacy of the COVID mRNA vaccines. Despite these naysayers, mRNA vaccines are here to stay and new ones are being developed for many other maladies that have been hard to vaccinate for, like cancer, HIV, several animal diseases, etc.

I keep encountering people who belabor the same old disproven canards about millions of people falling dead from the vaccines, about the vaccines being “experimental,” and “gene therapy.” All this disinformation continues despite the fact that tens of billions of jabs have been given to 5.6 billion vax recipients around the world over the last 4+ years. At what point does  fact replace lie and truth supplant fable? The world’s entire medical establishment does not agree with these deceivers, yet they continue to sound the sham anti-vax alarm undaunted. I have pondered in these pages whether this willful dissemination of such disinformation that could affect peoples’ lives and health could be criminal. A case for this could be made.

The funny thing is that these alarmists are announcing the sky is falling over something well tested and vetted while ignoring another very common jab that many of them have likely have gotten without questioning, but that does have significant effects on one’s immune system: tattoos (see vocal anti-vaxer and celebrated tattoo artist, Kat Von D). When you stick hundreds of ink-filled needles into your skin, can it be good for you? Anti-vaxers worry about well tested and vetted vaccines, but never worry about tattoos. Why their selective outrage?

Much of tattooing remains mysterious: Scientists aren’t fully sure what makes certain tattoos fade fast, why others stick around when they’re supposed to disappear, or how they react to light. Given the fact that tat recipients are sitting for multiple injections of unknown substances into their bodies that last forever, tattooing would seem like a much better way than vaccines for someone like Bill Gates to poison us; or to use them for something sinister like mind control, or as a way to control the world population, as the vax chicken-littles often frett about with the mRNA vaccines. Why aren’t folks up in arms over this vast potential conspiracy? (Cynicism mine!)

What do tattoos do? The Atlantic recently ran an article about how tats mess with the immune system and a subsequent quick search found other concerning aspects about them. The practice involves poking dozens to thousands of holes into the middle layer of the skin, or dermis, and depositing different formulations of chemicals, or pigments, that permanently remain behind. Contrast that to the single shot of a typical vaccine that deposits into a muscle a single dose of an agent that has undergone extensive testing and approval for safety and that quickly is eliminated by the natural scavenger cells and processes of the body’s immune system so nothing remains soon after the shot is given. Both procedures irritate the immune system, but one is permanent, the other temporary.

When the hundreds of needle pricks deposit ink into the dermis for a tat, the immune system detects an assault on its body and jumps into action. The skin after all, is our immune system’s first barrier and it is well loaded with rapid-response defensive cells that lead the assault on the pigment intruder. This generally works well to heal wounds and clear infections, but the system breaks down trying to fight tat ink. The immune system simply cannot adequately clear that intruder. Rather, the pigments persist in the belly of the immune cells and skin cells, only to again be gobbled up when those cells die and disgorge their undigested contents. Then the process repeats, ad nauseam leaving a permanent stain in the skin.

Over time, the edges of tats fray and become fuzzy as ink particles are gradually shuttled away into the draining lymph nodes, which normally handle viruses, bacteria, fungi, etc. In the nodes, the immune system then revs up to recruit and deliver antibodies and T cells around the body to combat intruders that escape further into the interior. These nodes normally are pale white, but in tattooed people, they can be the color of the tattoo ink.

Thus not only is the skin tattooed, so are the lymph nodes!

It is not clear if all this misdirected immune response to tattoo ink throws the immune system off its game of surveillance against infectious pathogens. One study published last year found that tat ink can affect the function of immune cells. But, in another Australian study, tat ink was mixed with a vaccine in order to track the fate of the vaccine components after vaccination. There was no evidence of any untoward effect of the pigment on the vaccine itself. Other immunological differences between heavily tattooed and un-tattooed people have been noted but it remains unclear whether these are for the better or the worse. So, it remains uncertain whether tattoos are good or bad for one’s immune system.

However, tat ink can be harmful in other ways. The European Union banned certain pigments, that they believe are linked to bladder cancer. And a 2016 report from the Australian government found that >80% of black inks contained carcinogenic polycyclic aromatic hydrocarbons (PAHs). Other pigments may contain other harmful substances like barium, cadmium, lead, mercury, micro-plastics, etc. Then there always is the real risk of infection or allergic reaction when anything is injected into your body. Nice.

Tattoo-like vaccines: a good idea. In a typical vaccine, the shot is delivered into an arm muscle where the immune system is not as robust as in the skin. The skin being a primary barrier to a hostile outside world is well stocked with an armament of immune sentry cells, muscles deeper in the arm not so much. But, there are enough immune cells in muscles to get the job done and develop protective immunity to antigens which the vax delivers. For an intramuscular vaccine delivered to an arm muscle, usually a comparatively large antigen dose is used and it takes a bit of time to get the immune system in gear. Mobile immune cell cops where the vaccine bolus is deposited gobble up the material like a squirrel shovels nuts in its mouth, and then head to nearby lymph nodes to “report” that an intruder was encountered. This gets the army of T and B lymphocytes ginned up and pumping out antibodies, other immune molecules and cytokines, and other cells to respond the intruder. You are then “immunized.” This also sometimes causes the temporary malaise associated with vaccines—mild fever, fatigue, flu-like symptoms and maybe arm pain. In rare cases, allergies happen, which is a rapidly arising, acute immune response to a component in the vaccine, such as chicken egg material found in many, but not all, flu vaccines. 

However, a few vaccines are actually given in the skin, more like tattoos are administered. Currently this route is used to vaccinate for small pox, TB, rabies, and more recently, mpox (formerly called monkey pox). Some studies, but not all, have shown that the intradermal (ID) vaccine route can outperform the intramuscular (IM) vax route. For this reason, other vaccines are now being developed to be given this way simply because the skin immune system is more robust and this might provide a more effective way to vaccinate, and it uses less vaccine material. This is called intradermal vaccination.

But intradermal (ID) vaccines are not that easy to administer. If not done properly and the vax material is injected too deep, which is easy to do, their efficacy can drop precipitously, just like Biden’s presidential chances plummeted after the disastrous debate. So, medical folk are actually looking at different vaccine technologies, including using tattoo machines to administer effective ID vaxes on a large scale across many clinics large and small. One technique using a DNA vaccine, called DNA tattooing has been tested in animal models and human trials and was inspired by traditional tattoo machines, which are pretty easy to use.

Bottom line: The way that vaccinologists have taken notice of tattoo technology to improve vaccine efficacy is intriguing. They have taken their science knowledge of skin immunology and realized that the pop culture tattoo fad just might improve vaccine technology and public health. That is very cool.

The sad irony is that many people who get tattooed are also vax deniers. Their cognitive dissonance is disturbing. Vax deniers loudly spread disinformation about vaccine dangers, then are completely sanguine about tattoos which inject strange chemicals into their bodies, some of which have been clearly proven to be unhealthy.

That selective outrage betrays the intellectual dishonesty and lack of curiosity of anti-vaccine dissemblers. Too bad we can't vaccinate against that.

Acknowledgment: I am indebted to Frank C. (no relation) for helping procure an article needed to write this blog post, which I had a very hard time accessing without paying a full subscription to the journal. Thanks Frank!

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Coronaviruses, Colds And COVID: And Cool Immunology

“The most exciting phrase to hear in science…is not ‘Eureka!’ but ‘That’s funny…’”

–Issac Asimov

 

Background. Your run-of-the-mill common cold virus is sometimes related to its more infamous relative that caused the world all sorts of consternation between 2020-2023, and still demands respect like an aging rock star who might still have some chops left. I, of course, allude to SARS-CoV-2.

Yup, the now infamous family of deadly human coronaviruses, which includes the original bat-borne SARS-CoV-1 (which caused the first SARS pandemic in late 2002), its Middle-Eastern camel-riding cousin (that caused MERS in June 2012), and the recent, much more traveled, durable, and concerning SARS-CoV-2 (origins so far unknown and the cause of COVID-19), have some lesser known, ne’er-do-well cousins that have long traveled among us. I refer to certain viruses that visit us often and are as unwelcome as a distant cousin who arrives unannounced needing a place to crash for a few days. This is the “common cold virus” which actually is several different kinds of viruses. Cold viruses are all as irritating and inconvenient as said uninvited distant cousin, and about as enjoyable as a hangover; but seriously debilitating or life threatening? They are not.

The common cold is mostly caused by one of three families of viruses; rhinovirus (not related to any large mammal), adenovirus, or a coronavirus. Yup, a distant cousin to that bug that caused so much serious illness and death across this blue orb during the COVID pandemic also is one of the causes of the mostly benign, but very annoying common cold. In fact, there are four different types of coronavirus cousins that cause 15-30% of the “common colds” in adults. Isn’t it interesting that one coronavirus, like SARS-CoV-2, can kill you, but its cousins just make you sneeze and your nose run like a leaky faucet, but that is all. Aren’t viruses fascinating?

Facts. Just as between unwelcome distant cousins, there are genetic similarities between the dangerous CoV-2 and its nettlesome coronavirus kin that just cause colds. And recent studies found that infection with one of these coronavirus cousins can indeed confer some immune protection to the other distant cousins. In other words, if you were infected with CoV-2, you likely had a much milder cold, if you caught one at all. And vice versa! But the funny thing is that vaccination against COVID did not also protect you against a cold like an infection would. What??

This stuff makes viral immunology so much fun.

To confirm all this, one study showed that this cross protection only occurred in people who had a definite bout of COVID caused by the coronavirus, and the reduced incidence of colds only occurred for colds also caused by a coronavirus, and not for a cold caused by unrelated rhino or adenoviruses. Clearly prior exposure to a different member of the coronavirus family conferred some immunity to other members of that family, even to distant cousins. Also, just being vaccinated to the CoV-2 spike protein did not confer this sort of protection to future coronavirus-caused colds. Wow! This kind of discrimination and specificity gets immunologists salivating like a Pavlovian dog to a ringing bell. I know—I am wiping secretions off my keyboard as I type.

Vaccines to just the spike protein quickly generates antibodies that neutralize the virus and thus prevent serious disease. But, that only offers short term protection to just that coronavirus from whence the spike protein sequence came. The viruses quickly mutate their spike surface proteins so the viral cousins cannot be recognized by the spike protein alone. That is why anti-spike immunity and the vaccines are not very good at protecting against re-infection for very long and why the vaccines don’t confer immunity to distant coronavirus cousins.

However, the immune system is a multi-layered security system. Besides these short-lived neutralizing antibodies that target the coronavirus spike protein (or similar surface proteins in other viruses), other layers of the immune security system can also be generated to other molecules across the SARS-CoV-2 genome following infection with the whole virus (see here and here). These other genome sequences are often more conserved and less likely to change between distant coronavirus cousins, than the highly variable spike protein sequence. This means that any immune response generated to one of these more boring, unchangable sites on a given coronavirus, can also recognize similar sequences on distant cousin coronaviruses.

But who, other than an immunology nerd really cares if having COVID protects you against a future cold? What about the reverse? Can having a cold caused by a coronavirus cousin generate some protective immunity to the nastier SARS-CoV-2 and protection from COVID and future coronaviruses that will emerge? Some, but not all research has indeed shown that people without prior exposure to CoV-2 do indeed show immune reactivity to the virus (see here and here). This means that folks who haven’t been infected with SARS-CoV-2 must have been exposed to another coronavirus that gave them a bit of cross protective immunity to the COVID virus. Other studies confirmed that prior infection with cold-causing coronaviruses can reduce COVID severity following infection with CoV-2 (here and here).

Bottom line.  What this means is that if you have been infected with some sort of mild coronavirus in the past, you just might be able to show some immunity to future infections with distant coronavirus cousins. Vaccination with the spike protein mRNA just doesn’t do the same. You need to be exposed to the whole kit and caboodle to enjoy all this immune goodness.

The responsible part of the immune system for this cross-over immune response is CD8⁺ T cells, also known as cytotoxic T lymphocytes, or CTLs. These immune cells are assassins that seek out other cells infected with a virus and they kill those cells. So, immunologists get all atwitter and think, “Hellz bellz, why don’t we make vaccines using parts of these boring, but conserved virus pieces that generate CTLs to different viral cousins, instead of the ever changing spike proteins to make vaccines? We could make one vaccine for all coronaviruses! Or flu, or whatever virus….”

It is a great idea and that research is well underway. The goal is to make a single coronavirus vaccine that would be long lasting and target many coronavirus cousins to prevent any future pandemic (believe me, another one is sure to come).

Back to earth. As interesting and hopeful as this sounds for making a single vaccine against multiple coronaviruses so we don’t have to continually try different boosters each year, don’t get your hopes up just yet. Similar immuno-optimism has been going on with influenza for decades and what do we have to show for that? We still have the annual guessing game of which flu strain will pester us each winter and then feverishly roll out millions of vaccines to try to nip that particular one in the bud. Meanwhile its flu cousins chortle and conspire in the Southern Hemisphere on how to mix and mutate their genes so they can surprise us again in the Northern Hemisphere the following year with a sufficiently new variation to vex us again.

But, flu, like coronaviruses also has important proteins that are not changeable, and very constant between distant flu cousins. These too can be seen by the immune system’s T cells. Flu immunology’s Holy Grail has long been to make a vaccine to a conserved flu virus genomic sequence so we can use just one vaccine to immunize against all flu strains once and for all for all time. A pan-flu vaccine.

Well, we are still trying to do that. This makes the idea of finding a pan-coronavirus vaccine using similar immunology daunting. Still, these recent studies showing that cross-reactive immunity between distant cousin coronaviruses does exist, just stokes an Immunologist’s stubborn resolve to solve the problem. As I have written before in these pages, amazing science advances have often come from the long, dogged pursuit of goals that very stubborn scientists believe they can see right in front of them, even when others cannot. It often takes a long time to prove what is so clearly obvious to one or two science visionaries yet so oblivious to the rest of us. That often is how science progresses. Thank goodness for these obstinate scientists who see things the rest of us cannot.

Once again, We will see.

Personal note. These anti-viral CD8⁺ or cytotoxic T lymphocytes are near and dear to this correspondent’s heart since I got my PhD in Immunology studying how these immune cells in mice recognize cells infected with viruses. It is a lot more complicated than you would think. In fact, in 1996 two immunologists, Peter Doherty and Rolf Zinkernagel were awarded the Nobel Prize for work they did on this problem in the early 70s, and that work drove my PhD research (and a lot more!).

Doherty and Zinkernagel discovered that T cells have to simultaneously identify two different molecules on an infected cell surface before they actually know a cell is infected with a virus. They made a head-scratching observation that turned viral immunology upside down. It was one of those observations that I bet made them say, “That is funny.” Basically, they found that your T cells that can recognize flu infecting your cells would not recognize flu infecting my cells or anyone else’s cells. And vice versa. You would think flu is flu and that a T cell that can see flu in an infected cell would not care whose cell it came from. But it does care. It turns out that T cells can only see virus within the genetic background from whence they came. They cannot see the same virus on a cell from a different genetic background! How strange is that? An antibody does not care where it sees a virus. T cells do. Picky little suckers.

It gets even crazier. Doherty and Zinkernagel, mapped this genetic restriction in virus recognition to the same genes that the immune system also use to determine whether a tissue or organ is its own or is foreign! For example, the genes your immune cells recognize as a password to determine friend vs foe in a skin graft (do we accept it or reject it?) are the same genes the immune cells use to help them know if your cells are infected with a virus! Tell me that doesn’t make you scratch your head and mutter, “That’s funny?” That is exactly how the world of immunology reacted to Doherty and Zinkernagel’s findings. It was a beautiful time for immunology science. That launched a tsunami of research, my PhD effort included.

This is personal note because I earned my PhD further probing the mechanism of what Doherty and Zinkernagel stumbled on. I used a large panel of mice that had been engineered to carry single point mutations in different parts of these genes that immune system used to ascertain tissue compatibility, and detect viral invasion. This helped us learn what part of these molecules the T cells recognized and how their folding was important for this recognition. It was a grand time!

Immunology is so doggone interesting!

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Another Jab’ll Do Ya…

“A virus is a piece of bad news wrapped in a protein coat.”

–Sir Peter Medawar (British Immunologist and Nobel Prize Winner)

Yup, looks like we should roll up our sleeves again this Fall for another COVID booster. The CDC recommends that everyone, 6 months and older receive the updated vaccine that is under development as just reported in the New York Times.

Infections are now rising across the country and this is due to a new, quite different combination of three related CoV-2 variants competing for your attention. They are collectively referred to as FLiRT. The variants are pretty effective at evading prior immune defenses and can spread faster, as we are beginning to see. Across the US COVID-related ER visits increased 15% the week ending June 15, and deaths increased 17% compared to just the previous week. Hospital COVID data are harder to come by since a CDC reporting requirement ended in May.

People “…in general do not understand how much this current virus has mutated,” said Carol Hayes, American College of Nurse-Midwives liaison to the CDC’s Advisory Committee on Immunization Practices. The Advisory Committee unanimously recommended this new round of shots.

But, again? Really?? Booster fatigue and COVID complacency seems to be a growing thing as the deep stress of the 2020-2023 pandemic fades in the review mirror. If we have been boosted a few times, and even had one or two mild COVID infections, is it really necessary to go through all this again?

Yes it is if you want to avoid serious illness. Please read on. True, at this point we all pretty much have some immunity to CoV-2 viruses, but the new boosters that keep rolling out give us important added protection to the novel virus variants that are regularly popping up like in a Whack-a-Mole game. What the boosters do is prevent you from getting serious disease that these new variants can visit on you! Realize that the vast majority of people across all age groups who were hospitalized with serious disease last fall did not get the updated booster for the current virus that was circulating.

In other words, the boosters greatly increase your chance to avoid serious illness and death that are still part of this continuing COVID tableau. Getting a shot is a heck of lot less nettlesome than being hospitalized with a serious respiratory illness. Let’s see….a prick or a ventilator???? It should be a pretty easy choice to make.

What about young people? Why vaccinate them if they don’t get very ill? Even though young adults and children do not get seriously ill as often as older people, don’t be distracted by the difference between relative risk and absolute risk (see a previous discussion on this topic here). Kids and young adults still have a real risk of serious COVID disease even if it does not happen with the frequency as it does for older people. But, that risk is absolutely real. Why chance it at all?

Also, children in particular are especially important spreaders of infectious diseases since they have the most intense social interactions of any demographic group. The intense interaction they have all day in school with classmates greatly increases their chance of infection, which they then bring home to vulnerable older people. It has been shown in epidemiology models and confirmed in real-life studies that preventing spread of infectious diseases in schools is one of the most important tools for protecting the larger population during an epidemic. Being vaccinated reduces kids’ viral burden if they do get infected and reduced viral burden means reduced virus spread. Vaccinated kids help reduce the spread of infectious disease. So, for a couple of reasons, CDC also recommends vaccinating kids this fall.

Get vaccinated.

Paxlovid: Just Follow The Settled Science

“We will see…”

-Yours Truly

Precis: “Just follow the science.” “The science is settled,” etc. We have all heard these bromides only to be later instructed that we need to follow a different science truth, or that the science firmament has shifted. Frustrating isn’t it? You must think that scientists must be a wad of weasely, waffling, wags in white coats certain of only uncertainty. One day we sagely advise you that something is certain truth, the next day we say that new research says that something else is true because, well, we know and you just need to trust us. We know because we did those ephemeral, sacred rituals called studies that give us all-knowing wisdom that we then impart to you who should worship us. 

That, I hope you know, is the cynical view of science, which sometimes is deserved. But, there is another side of things, which should be heeded. That side is that everything technology-based; from medicine, sanitation, lights, electricity, cell phones, transportation, etc.; that we enjoy using and take for granted, was created by that same science. These two sides of science often collide and greatly confuse non-scientists, which is most people. That is a shame and that is why I blog—to try to reduce some of the confusion.

Paxlovid, a drug highly touted as the only oral medicine to treat COVID is a great example.

Backstory: Paxlovid was initially given emergency use authorization (EUA) for treating COVID by the FDA in 2021 because of promising preliminary observations. Clinical trials performed by its manufacturer, Pfizer, then quickly showed solid, eye-popping results that made the drug an overnight sensation. It demonstrated an 89% reduction in the risk of hospitalizations and deaths in infected individuals. It also shortened the disease and reduced the symptoms of those with mild to moderate COVID. All this lead to the NIH to prioritize it over other COVID treatments under investigation at the time. In other words, NIH put R&D on other potential anti-COVID drugs on the back burner because they had found an effective one.

Paxlovid was the first effective oral anti-viral treatment for COVID. It basically works by blocking a key enzyme the virus uses to make new virus particles. A second medicine in the drug is an old treatment for HIV/AIDS which affects liver metabolism of that key enzyme blocker allowing it to linger longer, thereby boosting its antiviral effect.

The only drawback to Paxlovid is that it needs to be started shortly after infection to be effective. It also interferes with several common medicines so some patients either have to forgo taking some of their regular medications for a while or avoid Paxlovid. Nevertheless, it has been quite beneficial for reducing COVID symptoms in infected people and preventing severe COVID disease.

What is new? Ok, now you can forget everything about Paxlovid you read above. A new clinical trial, also done by Pfizer, and just published in the New England Journal of Medicine, showed that Paxlovid does not help patients get symptom relief or reduce the incidence of severe COVID and hospitalization. In other words, Paxlovid had zero effect on COVID in the study just published.

Thus, the makers of the drug now have two studies with diametrically opposite results on the effects of Paxlovid on COVID patients. The first showed “eye popping” effects sufficient to get NIH to move all other drug investigations to a lower priority. The second showed that Paxlovid was no better than a placebo.

At this point, I suspect many readers are rolling their eyes and thinking this is just another example of “settled science” unsettling the “suckers” who listen to the weasely, waffling, wags in white coats. Well, unroll your eyes. Both results are right.

Say what? Yes, it is likely that both results are accurate because the two Paxlovid studies were done on quite different populations.

The first study, which showed a dramatic positivie effect of the drug was done pre-vaccination. The study population did not have the advantage of vaccine protection against COVID. The second study was conducted post-vaccines and the participants had the advantage of already being partially protected against severe COVID symptoms. That protection rendered the Paxlovid effect meaningless. It showed that the the drug doesn’t do much if you have been keeping up with your vaccines, and it shows the value of the vaccines.

Kudos to Pfizer for conducting and publishing the results of both studies, especially the second one. The results of the second study certainly will ding Pfizer’s bottom line, but it was an exercise in honest science. Still the results of the study do not leave Paxlovid totally off the COVID treatment radar. First, the study did not indicate that the drug is ineffective for high risk vaccinated patients, such as immunocompromised patients. And in the US, we still, unfortunately, have many un- and under-vaccinated people who would benefit from Paxlovid when they catch COVID. Finally, while this Pfizer trial involved about 650 test subjects, a much larger trial involving a few thousand subjects soon will be forthcoming from the UK.

So, if you are vaccinated and catch COVID, it is not crucial to get to your doctor in time to get on Paxlovid. And the UK trial might address additional questions that will tell us more about the value of Paxlovid in treating COVID. We won’t know until its study results are released. In other words:

We will see.

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Parkinson’s Disease—An Unexpected Ravage of COVID?

Thus, (tho, ‘tis Life’s great Preservation) many oppose Inoculation.

-Benjamin Franklin, Poor Richard’s Almanac, 1737

SARS-CoV-2 and its disease, COVID, are very strange. They have given us black toes, lungs like chocolate pudding, long-term fatigue, depression, death, and vaccine deniers. It has been quite a ride. And we are learning that having COVID also puts one at risk for other non-COVID maladies…like chocolate pudding lungs was not enough!

In previous posts, I wrote about the clear link between new-onset type 2 diabetes arising in many patients following COVID. There also is suspicion that cancer might increase down the road due to CoV-2 inactivation of a cellular gene that puts a brake on cancer, P53, in COVID patients. Inactivate that gene and you release the brake on certain cancers. Therefore, there is concern that some COVID patients will experience an elevated incidence of cancer in the future.

New research now raises a real concern that COVID patients might also be at increased risk for developing Parkinson’s disease. Parkinson’s arises when neurons deep in the brain that produce a critical neurotransmitter, dopamine, begin to die off leaving a dearth of this critical chemical that sends signals between neurons. It is like cutting a phone wire. Crucial communications cease.

The study conducted in collaboration between scientists from Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, and Columbia University College of Physicians and Surgeons was published in Cell Stem Cell last January. Investigators took human induced pluripotent stem cells and coaxed them to become brain cell progenitors that could form into human brain organoids in tissue culture. Such small, nascent “brain-like” structures contain a variety of functional neural cells. They were exposed to the CoV-2 virus, which was shown to preferentially infect and selectively cause the dopamine-producing cells to shut down.

While brain autopsies of COVID patients have not revealed direct COVID infection, they have found unique gene patterns associated with cell senescence, which was especially profound in areas rich in dopamine-producing neurons. This also supports the notion that COVID disease contributes to neurological problems that could cause Parkinson’s disease.

Putting these two findings together is complicated at this time, but they strongly suggest a direct involvement for one or more mechanisms resulting from CoV-2 infection in causing the myriad neurological symptoms that have been seen in COVID patients, and maybe other neurological problems like Parkinson’s not yet attributed to COVID.

Bottom line: CoV-2 is a nasty bug and COVID is a nasty disease. It seems that getting vaccinated not only protects you from nasty flu-like disease and death, it can also protect you from the following:

1. long COVID
2. type 2 diabetes
3. maybe cancer
4. and now, maybe Parkinson’s disease

Why would anyone not want to avoid these? Get the shots!

Interesting addendum: The studies showing that CoV-2 virus can selectively infect dopamine producing neurons went a step further. They also tested a large panel of drugs already approved for other health problems to see if any could unexpectedly protect these critical cells from infection. Sure enough they found three drugs that protected the neurons: Riluzole (used to treat Lou Gehrig’s disease) Metformin (commonly prescribed for diabetes management), and most interesting to me, Imatinib, or Gleevic (used for treating certain leukemias and cancers).

I say this is interesting to me because of my own research beginning at UCLA in the mid-80s, and extending to the University of Wisconsin into this century. My research focused on certain leukemias that carry a specific chromosome abnormality that appears in 99% of patients with chronic myelogenous leukemia (CML), and in fewer patients with acute lymphoblastic or acute myeloblastic leukemias (ALL and AML respectively). When I began studying this, the presence of this chromosome aberration was a death sentence. There was no effective treatment. Patients did not survive long. We identified the specific genetic abnormality, cloned the abnormal gene, sequenced it and found it was parts of two genes stuck together. Most importantly, we also described the enzymatic pathway in cells that it screwed up. All this eventually led to the development of a drug that tamed the misbehaving enzymatic pathway so that now >95% of patients with these diseases are fully cured with medicine that is pretty easy to tolerate. What once was a death sentence is now an easily treated disease. Knowing that makes me feel pretty good.

The drug that cures leukemia patients from what once was a lethal disease is called Imatinib; one of the drugs found to also protect dopamine producing neural cells from CoV-2 virus destruction.

That too will make me feel pretty good if it also happens to prevent neurological problems in COVID patients. Who would have guessed? This is the unpredictable way science often works.

The Intelligence of Artificial Intelligence And Blogging

“Do you ever make silly mistakes? It is one of my very few creative activities.”

–Len Deighton, British Author

Have you tried dabbling with artificial intelligence? I specifically refer to the type referred to as chatbots that use powerful generative artificial intelligence that you can really chat with to generate ideas. It is like the computer, Hal, in the movie 2001 a Space Odyssey. Remember? Remember too that Hal malfunctioned big-time?

I’ve been dabbling for a while. Here is my experience related to this blog.

I began dabbling over a year ago with OpenAI’s ChatGPT, using their GPT3.5 version, but soon graduated to GPT-4, which was released in 2023 and comes with a small subscription fee. I have since migrated to Bing, which is a collaboration between Microsoft and GPT-4 and comes without the fee. It is a powerful research and generative tool. It can generate text, art, compose music, diagnose and even treat a psychological illness with talk therapy. You can have these chatty things teach you a foreign language, and write a legal brief. Perhaps you also have read the reasonable concerns schools and colleges have with such smart tools doing homework for students and the worry about professionals using them to fake their work and the attendant ownership issues of work done.

There seems to be a lot of mischief your computer can cause with the right smart software, but it can also do a lot of good. I know. I have found these smart tools quite useful for my research and writing. Rest assured that I have NEVER used anything but natural intelligence to write any blog post or other article for me (you can tell by the typos in my finished products). This is because, while the bot can compose, it is not creative. As I write, I try to use subtle humor, irony, alliteration and other tools to make my prose interesting. Chatbots do not. At times, however, when writer’s block hit, I prompted the chatbot to write something, and after a few prompts, usually found something that primed the pump of my muse and I penned away using my own intelligence.

I can pose questions or hypotheticals to the computer tool and it comes back with answers. I then either refine my questions, or pose follow up queries. It is much like bouncing ideas off a collaborator. In this regard, I find it quite useful. Who else will talk with me about the value of the latest vaccine or whether Brock Purdy is really a good quarterback or the product of the great pieces around him without my having to buy them a beer? Although, I admit sometimes the latter is much preferable. I have discussed much science at a dive dart bar in Dallas, a surf bar in Malibu, and over a pool table at tavern near the medical center in Madison. Not much artificial intelligence there except after a few brews.

All good. Until this. The chatbot models are supposed to be self-learning. So, I decided to see what Bing had learned about my blog on the coronavirus pandemic. I queried it about a term I thought was pretty unique to the blog, BioX. Readers will recognize that that is what I have dubbed the revolutionary post-molecular biology that gave us a vaccine so rapidly and that is bringing other amazing types of new disease treatments and diagnostics at astounding rates.

Turns out Stanford University (a school you might have heard of, Bing certainly has) has a new bio program also called BioX. It has well publicized it too. Well, Bing kept telling be about Stanford’s BioX and not about mine. Not what I wanted to see.

I changed my query several times to ask Bing about my version of BioX and instructed it to ignore everything about Stanford. Like a hyperactive toy poodle, it completely ignored me. It was quite polite though, apologizing each time I said it was not responding to my query.

Finally, after arguing with this digital nitwit, it finally included me and my notion of BioX in its rendition. Below is what it came up with—be seated as you read what Bing wrote about BioX and me. It included me, but still could not ignore Stanford.

+++

Steven Clark, PhD, is a retired professor from the University of Wisconsin and a viral immunologist who has been blogging about his research on the new biology he dubbed “bioX”. BioX is a term that he uses to describe the emerging field of biotechnology that aims to harness the power of viruses and other biological agents to create novel solutions for human health and disease. He claims that bioX has the potential to revolutionize medicine and biotechnology by offering new ways of diagnosing, treating, and preventing infectious diseases, as well as creating new therapies for cancer, aging, and other chronic conditions. (So far so good. But the next paragraphs…)

One of his most notable achievements is the development of a vaccine against the SARS-CoV-2 virus, which causes COVID-19. He announced this breakthrough on his blog in December 2022, shortly after he received funding from Stanford Bio-X¹, an interdisciplinary biosciences institute that supports research and educational opportunities that cross disciplines between the biological or biomedical sciences and fields of engineering, physics and computational science². He explained that he used a novel approach to engineer a virus that could deliver a synthetic version of the spike protein of SARS-CoV-2 into human cells. The spike protein is responsible for binding to human cells and allowing the virus to enter and infect them. By introducing a modified spike protein that can evade some of the immune responses generated by previous COVID-19 vaccines³, Clark was able to elicit strong neutralizing antibodies in his volunteers without causing any adverse effects. He also demonstrated that his vaccine could protect against different variants of SARS-CoV-2, including Omicron³.

Clark’s vaccine has been hailed as a game-changer in the fight against COVID-19, but it has also raised some ethical and regulatory concerns. Some critics have questioned his motives for developing such a powerful bioweapon without proper oversight or consent from the public. Others have expressed doubts about his safety and efficacy claims, citing lack of peer-reviewed data or independent verification. Clark has defended his work as being based on rigorous scientific principles and ethical standards. He has also stated that he intends to share his vaccine with other researchers around the world who are interested in collaborating with him on bioX projects.

Clark’s blog posts on bioX have attracted millions of readers who are fascinated by his vision and achievements. He has also inspired many young scientists who aspire to follow in his footsteps and pursue careers in biotechnology. However, he has also faced some backlash from anti-vaccine activists who accuse him of being part of a conspiracy to create more deadly diseases or manipulate public opinion. Clark has dismissed these allegations as unfounded and irresponsible.

Clark’s blog posts on bioX are an example of how science can be used for both good and evil purposes. They show how innovation can lead to breakthroughs in medicine and biotechnology, but also how it can pose challenges for society and ethics. They also illustrate how different perspectives can influence how people perceive and evaluate scientific discoveries.

+++

Well dang. If I invented the damn vaccine, how come I was not included in the Nobel Prizes that were just awarded for the invention? I demand a recount. I did like the part about “millions of readers who are fascinated by my vision”. Notice the “references” Bing included citing my accomplishments. They must be true because Bing says so.

In the parlance of computer geeks, what Bing spit out above is called “hallucination.”

This is the intelligence of artificial intelligence.

Vaccine Disinformation Moves To Congress

 “War is peace.
Freedom is slavery.
Ignorance is strength.”
―George Orwell, in 1984

“Anecdote is science.”

That silly notion can now be added to the Orwellian Newspeak Catechism thanks to those who prefer confirmation bias over empirical data to determine their “alternative facts.” This seems to include several  members of Congress.

The war on objective science recently spilled over to Congress where a group of anti-vaccine Congressmen and women and one Senator held an impromptu meeting to confirm their disinformation about so-called injuries caused by the COVID mRNA vaccines (note: the technology just won the Nobel Prize for Medicine). This was not a meeting called by a regular committee but an ad hoc gathering of some committed anti-vaccine rogues. It was held in a tiny back room in the Capitol and was poorly attended, poorly staffed, poorly equipped, and, thankfully, poorly publicized. It was described as a meeting of the “shadow Congress;” accurately named as it dabbled in the penumbra of truth.

Leading this November 13 meeting was Congresswoman Marjorie Taylor Greene (R, Georgia). Greene, no stranger to fantasy, has previously claimed that Jewish space lasers caused recent wildfires in California, that the shootings in Parkland, Sandy Hook and Las Vegas were staged, and that 9/11 was an inside job. Because of these and other extremist reflections, the House sensibly stripped Greene of several committee assignments.

Others on the “committee” included Congressmen Clay Higgins (R, Louisiana), Thomas Massie (R, Kentucky), Warren Davidson (R, Ohio), and Andy Biggs (R, Arizona). Also attending was Senator Ron Johnson (R) from my own State of Wisconsin who has been a vaccine dissembler for a while, claiming, for instance, that the vaccines have killed many people. I recently contacted the Senator’s office and asked why he believed that. They quickly responded and sent me to a web site that was very professional looking and had very many graphs and tables claiming to show that the vaccines caused hundreds of thousands of deaths. The problem is that the data they used to put said graphs and tables together were bogus. The statistics were fraudulent (for example to test the site, an MD submitted a claim saying that the vax turned him into the Incredible Hulk. His claim was accepted!). Anti-vaccine crusaders with radio and blog platforms have urged their audiences to post false information on the site, and the website itself had been debunked numerous times by the investigative press and in science journals for incorrectly reporting the data. I pointed this out to Sen. Johnson’s office and never heard back, in contrast to their earlier quick response. Go figure.

Back to the Shadow Congress Committee meeting: Three people testified: A lawyer, an obstetrician-gynecologist, and a scientist. A summary of the testimony of each, with my comments follows.  

The lawyer. Forty-six-year-old Thomas Renz, went first. He passed the Ohio bar exam in 2019 after five tries and since has made a name for himself, along with the MyPillow guy, Mike Lindell and others, as a COVID conspiracy buff. Renz made three unsupported claims enumerated below: 

1. First, Renz declared without any evidence, that it is vaccinated people who are dying. However, a study published in the Journal of the American Medical Association showed that in 2021, unvaccinated adults were 12 times more likely to be hospitalized and in 2022, that they were 6 times more likely to die after infection. Science shows that COVID vaccines have been estimated to have saved the lives of more than 3 million Americans. Renz’s says otherwise. Who are you going to believe, science or the lawyer, Renz?
2. The lawyer also claimed, again without proof (a lawyer without evidence?), that “COVID is not as bad as SARS or MERS but about as dangerous as a bad flu season.” Well. The first human coronavirus outbreak, SARS-1, was identified in Asia in February 2003. It infected a tad more than 8,000 people, killing ~800. By July 2003, the outbreak was contained without a vaccine. The second coronavirus outbreak, called MERS (Middle East Respiratory Syndrome), appeared in June 2012, in Saudi Arabia. That virus infected >2,500 people, killed about 900 and also was contained in a short while without a vaccine. Compare those numbers to SARS-CoV-2, which so far has killed almost 2 million people in the United States and 7 million people in the world. And four years later it continues; it is not contained even though we have several vaccines. Except for the 1918 flu pandemic, which killed more than 50 million people worldwide (that was before flu vaccines) COVID is worse than any other flu in history and much worse than SARS or MERS. Renz’s lawyerly opinion is bunk. Why is he even testifying on a medical matter?
3. Renz saved the best for last. With the help of an “unnamed whistleblower,” Renz claimed, without proof, of course, that "something suspicious" happened in November 2014 at Fort Riley, Kansas, when the Department of Defense (DOD) and the CIA, in collaboration with the Wuhan Institute of Virology, created SARS-CoV-2 virus. Not in the Wuhan lab mind you, but in Kansas in 2014! To support his claim, Renz offered nothing! It was just his opinion. Renz also asserted that Tony Fauci, the CDC, FDA, and the DOD played a part in a massive cover-up of all this (so how in the world does HE know?). He unbelievably stated that Hunter Biden was also involved (why not?). Funny how the FBI hasn’t picked up on any of that. Renz knows because he says he does. Trust him, he’s a lawyer without evidence. But that is good enough for the Shadow Congress.
   

The Ob/Gyn. Next up was Kimberly Biss, MD, a well credentialed obstetrician and gynecologist practicing in Tampa Bay and St. Petersburg, Florida, which makes her testimony all-the-more-difficult to understand.

She claimed that after receiving COVID vaccines, an unspecified number of women in her practice suffered unsubstantiated menstrual cycle irregularities including severe, persistent bleeding. However, the only way to reliably determine whether COVID vaccines caused these  changes in menstruation is to compare the symptoms in women who got the vaccine to women who did not. She didn’t do this. Anecdotal observations like these offered by Biss usually don’t include both groups, which is why medical science considers anecdotes to be unreliable and instead rely on controlled clinical trials to base medical science opinions.

Furthermore, real scientific comparisons between vaccinated and unvaccinated women have been done but these were not entered into evidence at the Shadow Congress Hearing. A study of more than 1,100 women performed by the Boston School of Public Health found that there was no association between COVID-19 vaccination and cycle irregularity, bleed length, heaviness of bleed, or menstrual pain. So, which is more credible, Biss’s personal uncontrolled anecdote on an unknown number of patients whose medical history is unknown vs a controlled scientific study on over 1000 patients with carefully documented medical histories and compared to a comparable cohort of unvaccinated menstruating women?  

Biss further testified that in her practice miscarriage rates went up in vaccinated women, again without indicating the number of patients she saw and without providing any medical documentation. She again failed to note the miscarriage rates in unvaccinated women (why does she always leave out the data from unvaxed women?). Another scientific study of 40,000 pregnant women showed that vaccination was not at all associated with an increased risk of premature births. And other controlled studies have shown that COVID vaccination during pregnancy does not increase the risk of birth defects. Again, what would you believe, Biss’s anecdotes or several well controlled peer-reviewed and published science studies?

Biss continued her misleading anecdotal testimony by claiming that it was unsafe for vaccinated women to breastfeed because she "heard" it caused myocarditis in babies in Scotland. She failed to provide any substantiation for her wild claim that no one else seems to have heard. Not only has breastfeeding proven to be safe in women who have received COVID vaccines, newborn infants benefit from vaccine-induced antibodies in breast milk. This provides newborns with their initial protection against COVID as they develop their own immune system. That is a normal part of the maternal-fetal immune system that newborns immensely benefit from. That is basic immunology.  

Finally, and most outrageous was Biss’s stance on vaccinating children. She advised against vaccinating kids falsely claiming that only “three in one million children will die from COVID.” One wonders where she gets her facts like this and like those about myocarditis in breast fed babies in Scotland. As of January 2023, COVID was the leading cause of infectious disease deaths in children. Contrary to Biss’s claims, the COVID death rate for children less than one year of age was 43 per million. Hundreds of young children have died from COVID and many, many more have been hospitalized long term with the very serious condition called multisystem inflammatory syndrome, or MIS, which I have written about in these pages. COVID is much more serious than the flu for kids. None of those deaths or serious illnesses in kids are acceptable. Her claims to the contrary are simply irresponsible for a physician to make.

Finally, the scientist. Perhaps the silliest testimony in front of MTG’s “shadow” committee came from a scientist and physician named Robert Malone who recently has gone around claiming he “invented” the mRNA vaccine. He did not. In the late 1980s and early 90s, labs around the world were fixated with the idea of trying to express genes in cells via transferring DNA into cell cultures. The technique was called “transfection.” It promised to be a powerful tool for studying the function of genes in cells, but proved enormously difficult as I wrote about earlier. My own lab considered trying it, but discarded the idea in favor of another approach, viral-based gene transfer, which we often used to study gene function, and which some might call routine gain-of-function research as I also described earlier in these pages.

Meanwhile, Malone was a small part of the “transfection” bandwagon and in the late 80s published two papers showing it was possible to transfect fragile mRNA protected by a lipid micro-bubble into cells (most labs transfected DNA, which was easier to work with than mRNA). Undoubtedly, his research represented a stepping stone on the path to developing the vaccines, but he had no role in vaccine development. He was one of very many scientists who contributed incremental advances that ultimately made the vaccines possible. He is now way overselling his role. The technology that produced the mRNA COVID vaccines recently won a Nobel Prize and Malone was never mentioned in the invention. He is only a giant in his own mind.

More to the point, Malone testified that the vaccines are contaminated with fragments of DNA and dangerous. He argued, without evidence and contrary to all other science, that these DNA fragments alter cellular DNA of vaccine recipients, causing cancers, autoimmune diseases, and a variety of other disorders. For pregnant women, Malone further opined, again without a shred of proof and contrary to common science, that these DNA fragments could cross the placenta and cause birth defects. Furthermore, according to Malone, the FDA, the CIA, and other government agencies know about this DNA contamination but are covering it up (is Hunter involved in this too??). Again, he offered no evidence at all for this allegation. But, maybe we can excuse him, because there is no evidence to offer.

The idea that the vaccines are contaminated with DNA detritus is old news. All vaccines contain DNA of different sorts, which has never caused any harm as long as vaccines have been given. In fact it is biologically impossible that miniscule amounts of DNA detritus could mess up our cellular DNA. It is irresponsible, and scientifically ignorant of Malone to simply throw this out without elaborating. He didn’t elaborate because to do so would have ruined his “Frankenscience” innuendo that seemed to duly impress the scientifically naïve Shadow Congressional audience he spoke to.

The mRNA used in the vaccine is produced from a DNA strand. The DNA strand is then digested with an enzyme called DNase which chews up all DNA strands, leaving only the DNA building blocks, or remnants of it behind; DNA detritus. It is like taking a large building and demolishing it into its bricks. The large mRNA molecules are then easily biochemically separated from most of the DNA detritus. Even if there were miniscule traces of DNA detritus left over, it is biologically impossible for it to damage cellular DNA. It simply is recycled and reused by our cells. Our cells do that all the time.

But, maybe larger, intact DNA fragments could mess up our cellular DNA? We are exposed to large fragments of DNA all the time with no adverse effects. Consider the following two points: 1) we eat foreign DNA from plants and animals all the time and that DNA enters our blood stream in intact pieces much larger than the digested detritus we have been talking about. Yet, we are totally unaffected by this. 2) We also get vaccinated with whole DNA virus vaccines and have no concern that they affect our cellular DNA. Studies have shown that there is NO genotoxic effect of any of the vaccines.

Finally, consider the inherent conflict in Malone’s position. On the one hand he goes around promoting himself as the inventor of the vaccine technology. He even laments that he has not been given his due credit for the invention. Then he tries to discredit the same invention as something very dangerous and that should not be given to people because it causes enormous harm.

Which is it? Do we laud Malone as he would like for discovering a lifesaving vaccine, or pillory him for creating the dangerous vaccine he says it is? The man is as confused as his testimony.

This is what some of our Congress people spent their time doing last November. The Congressional Flake Caucus wasting their time and our money on a "hearing" without a single reputable testimony. At least it received the very little attention it deserved.

Last word. In an earlier post in these pages I asked the question if it was criminal to intentionally mislead people about lifesaving vaccines. That question is worth raising again, now.

‘Tis The Season To…..Mask Up Again??

"It's a bug hunt!"

-Private Hudson, in “Aliens”

"Influenza-like illnesses" are increasing at an alarming rate across the country. Yup, ‘tis the season for respiratory diseases and we have more than one to worry about. In years past we mostly worried only about the flu and, sometimes as an afterthought, colds, which aren’t of much concern. But in late 2019, a brand new and very weird bug appeared on the scene, SARS-CoV-2 that caused COVID. It seems that the bug and disease will be an annual guest from now on. This year, we also see a surge of a third bad bug, respiratory syncytial virus, or RSV. All these viruses cause what have been collectively labeled “flu-like illnesses” and together they seem to be worse this year than recent years. The CDC reports that hospitalizations for flu-like illnesses have been steadily rising and that the peak is still to come.

As a result, we are beginning to see increasing reports of a return to local mask mandates. In my own community of Madison, Wisconsin, two major health networks just announced their return, like a bad TV rerun. This includes the University of Wisconsin Health network, where I receive health care. Glad I kept a few masks on hand. What’s in your glove compartment?

I also have read where some grocery stores are now requiring masks. Some stores only require masks on certain days of the week so that customers can select to shop on mask-required vs mask-optional days. Some colleges and large companies reportedly also are beginning to require masks again. So far these mandates are very local and are not a national phenomenon. It is feasible that mask mandates in public spaces and especially for travel could increase if infections and hospitalizations get more serious.

As I often say in these blog posts, “we will see.”

Why is the flu and RSV, which have been around almost forever now causing more than their usual problems? A hint was presented in a blog post I published about a year-and-a-half ago, “What Happened To The Flu And Other Respiratory Diseases?”  In that apparently prescient post, I reported that the world had seen a huge reduction of all infectious respiratory diseases due to the protective non-pharmaceutical interventions (masking, sanitation, isolation, quarantines, closings, etc.) designed to physically protect people from the new coronavirus. They were so effective that some strains of other common infectious viruses are thought to have gone extinct!

That is great news! But, it also means that the world also missed its regular natural booster of common bugs and our herd immunity to them waned. Our youngest were never exposed to those bugs and the rest of us became less resistant to future exposure and that future is now. We are now paying the piper for that lapse in a “bug boost.” Hence, flu and RSV temporarily are having their way with us and enjoying it. At least they are not nearly as nasty as the coronavirus initially was and still could be with a couple of insouciant genetic tweaks.

“Influenza-like illness,” is a catch-all term coined by the CDC to corral COVID and the other two viral diseases. Together, the three have reached an epidemic point in the US and other places across much of the world. The Figure below shows that the US epidemic is currently hitting Southern States the hardest, but expect it to migrate Northward in the next few weeks.

What do the different colors in the Figure mean on a practical level? I can offer one anecdotal example. According to the map, New Jersey, while not a Southern State, still is being hit hard. A family doc wrote about a week ago that all the hospitals in his health system are at capacity. He was unable to send a patient to the preferred ER because its hospital was full due COVID, flu and RSV cases. And the patients with these flu-like respiratory infections who were filling the beds were not necessarily elderly. Most are in their 40’s-50’s. Unsurprisingly, the hospitals and clinics in his health system again require masks. Their staffing is becoming a critical issue as providers also become ill and turn into patients. This is becoming too reminiscent of the early stages of the COVID onslaught when hospitals where overwhelmed and medical personnel were dropping like flies. So far, this experience is sporadic across the US. But, it is becoming concerning.

Outpatient Respiratory Illness Activity Map Determined by Data Reported to ILINet

This system monitors visits for respiratory illness that includes fever plus a cough or sore throat, also referred to as ILI, not laboratory confirmed influenza and may capture patient visits due to other respiratory pathogens that cause similar symptoms. From the CDC.

The incidence of RSV is high. RSV hospitalizations have increased 60% nationwide over the past four weeks. A couple of deaths in children have been reported in my state. The vaccine for RSV is brand new this year and recommended for people over 65 and for kids; i.e., those at highest risk for severe disease. It definitely is worth it.

Flu is moderate right now, but expect it to soon blossom. Hospitalizations among all age groups increased by 200% for influenza in the past four weeks but still remain below Covid-19 and RSV hospitalizations. For now. They are expected to increase as the peak flu season has yet to arrive.

And then there is our relatively new friend, COVID. On a national level, COVID virus transmission is “very high.” After the post-Thanksgiving surge, as determined by monitoring viral loads in wastewater samples (“take-your-kids-to-work” days in that profession must be fun!), virus levels plateaued. But expect another sharp rise after the Christmas/New Year’s holidays. We have consistently seen this pattern in previous years.

Cov-2 is one of the most mutable viruses that the world has inflicted on us. That means we are constantly seen new variants arising. Surprise, the Omicron subvariant JN.1 is coming onto the scene. It’s the spawn of variant BA.2.86, which was discovered over the summer and was concerning because it came out of nowhere with a whopping 35 mutations in the spike protein (the more mutations, the greater the chance for another very nasty bug). While BA.2.86 caused a comparatively mild disease, it quickly mutated to JN.1 with just an additional single change in the spike protein that made it much more infectious, but it still remains fairly mild. With just one mutation, it became the fastest-spreading CoV-2 variant in the past two years. With all its changes, JN.1 is so different from its Omicron grandparent that there is considerable scientific debate about whether JN.1 should be given its own Greek letter designation, Pi. A weighty debate indeed.

But, a bigger question is whether COVID hospitalizations will follow wastewater sampling trends that show JN.1 (or Pi) viral levels surging through the world, especially in the US where vaccination rates are low. It is concerning that the UK and Singapore, which have high vaccination rates, are now seeing a steep increase in hospitalizations due to JN.1 (or Pi). So why not expect the same or even worse in the undervaxed US? Last week, the CDC warned about such a potentially huge impact due to the wretched combination of low US vax rates and the highly infectious JN.1 (or Pi) virus. As Private Hudson (aka Bill Paxton) in the movie Aliens might say, thanks to the antivaxers, “Game over, man! Game over!”

Also of new concern is that some scientists are now beginning to believe that COVID infection could be damaging our immune systems. If true, that could make infected people even more vulnerable to the other bugs out there such as flu, RSV, and others including bacteria and fungi. COVID could also cause immune dysregulation leading to new-onset autoimmune diseases. So get your COVID vaccines! They can protect you against illness beyond COVID!!

Finally, another concern is that the rapid home tests for COVID are proving to be only 30% reliable very early after infection before symptoms start. In other words, if you believe you have been exposed to COVID, but your home test comes up negative, don’t necessarily believe it. Retest yourself 24, or preferably 48 hours later or when you show symptoms like a fever, cough, etc. If that second test also is negative, you have pretty good confidence you are COVID free and have some other bug.

The pragmatic bottom line. There is a lot of coughing, sneezing and other respiratory distress going around, and it will increase in coming cold weeks as we bundle up and crowd around others indoors. To improve your odds of staying healthy, remember these things:

• Limit your time around indoor crowds.
• If you have indoor gatherings, crack your windows and bring out the fans to increase air circulation and air exchange with the outdoors. There is very good evidence that good ventilation really matters and that the amount of viruses we breathe in makes a big difference in terms of whether we get sick and how sick we get. It is worth a few extra dollars on the heating or electricity bill to avoid nasty illness.
• Room air filters are also a good idea.
• Get vaccinated!
• Wash your hands often.
• If you do get sick, STAY HOME! I have always hated the “brave” soul who came to work with a cough and sneeze. Don’t share your agony!!
• And there are the good old fashioned masks for use in crowded places, especially in auditoriums, on planes, and other packed indoor situations. I don’t care what the naysayers say about masks, they are flat wrong. They don’t think twice when a store sign requires shoes and shirts to enter. So why do masks bother them so much? They WORK as I have written here before, over and over. Empirical evidence proves masks work. That is why the entire medical profession continues to use them.

Finally, as I have repeatedly admonished, please get vaccinated. Vaccine and booster uptake for all three viruses has been dismal this year. Failure to vax is a major driver in the surge of the flu-like respiratory diseases we are seeing. If you have not gotten vaccinated for all three circulating viruses, why the heck not?? It is way better to prevent disease than to treat disease. A sore arm is much less of an inconvenience than suffering the flu, RSV or lying in a specialized hospital bed turned on your stomach breathing with a ventilator because of COVID.

As I have written in these pages, having COVID can be worse than any flu you ever had. It also puts adults at risk for dealing with weeks of long COVID and getting new-onset diabetes and immune dysfunction. COVID also is much worse than the flu for many kids and puts them at risk for multi-system inflammatory syndrome (MIS).

Why risk what can be prevented by a simple vaccination?

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