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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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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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.

Harry Became Severely Disabled After The Vaccine

Does the crowing of a rooster cause the sun to rise?

Harry: A follower of this blog, recently wrote to me about the experience of his senior friend, Harry. With permission, I relay the story here and add some thoughts.

Harry was 80 years old and living a healthy, robust life. He did his own home improvement projects, he was mobile and drove everywhere--he lived an active life. His only health concern was a bit of a problem with high blood pressure (who doesn’t at his age?) that was well controlled with a statin drug.

But, soon after his third shot (booster), his shoulder in the non-injection arm began stiffening. After that, one side of his groin became very painful and the pain migrated to the other side and then began shooting into his legs. Within weeks, he was unable to walk, relying on a walker or wheelchair. He became home-bound. His painful arm is now useless—he needs to hoist it with his other hand to get dressed. Same with both legs. Harry gets by each day on pain meds, but he is reluctant to take a higher dosage to fully control the pain as it makes him too groggy, so he only sleeps an hour or two at night due to the pain, then catnaps in his recliner throughout the day.

This sudden and quick decline began about a month after his booster shot so he was convinced his new maladies were a consequence of the vaccine.

VAERS: Harry’s case is the sort of case that is reported to the CDC’s Vaccine Adverse Effects Reporting Site or VAERS. When someone begins experiencing untoward health problems soon after vaccination they or their doc can easily report it on the VAERS site, which has served as an early warning system for identifying rare side effects of vaccines since 1990. Thousands of people have reported post-vaccination symptoms, and the site is accessible to anyone. Hence, there is a CDC database listing thousands of reports of health problems following COVID vaccination that you can pull up after a few clicks.

The CDC uses this uncorroborated raw anecdotal information to look for patterns that could point to previously unknown side effects of vaccines. This is common practice for all medicines after they have been approved for use. Data from clinical trials that form the basis for approval or rejection of a new medicine or vaccine only include results from ~40,000 test subjects. That is enough to discover very significant and fairly common side effects. But, after the medicine gets on the market, patient data still are collected in order to see if there are serious side effects that only appear in, say, one out of 250,000 people and that would not be found during the clinical trial on just 40,000 subjects. Remember the COX-2 anti-inflammatory drugs that were widely used in the 90s but were pulled because they were found to cause rare, but serious cardiovascular problems? This was found by collecting post-approval data from a few million people who had taken the drugs. Evaluating data collected after a medicine is on the market is referred to as post-market or Phase IV research. This is what the CDC uses the VAERS database for.

The CDC then digs into the raw VAERS reports to make sense of them. They first confirm the reports and then to see if they are just correlations or causative. Scientists look at further health data on the patients, and look for similar recurring problems in other patients. This also means that the raw data reported on the VAERS site are just that—raw. The raw data you can see on the site have not been confirmed or determined to have actually arisen from a vaccine side effect. In fact, the VAERS web site carries this clear disclaimer:

“VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.”

The task for the CDC then is to separate health complaints that are just coincidental (i.e., that would have happened anyway without the vaccine) from those that are causal (i.e., that were caused by the vaccine). The fact alone that someone vomited a day after being vaccinated cannot be taken as proof that the vaccine caused the vomiting. There is a big difference between correlation, i.e., when two unrelated things happen together, vs causation when one thing leads to the other thing.

But, this is what the vaccine naysayers are doing—they look at the VAERS site and believe that all those raw reports are causative reports showing that the vaccines harm people. In other words, they completely ignore (or do not even read) the CDC disclaimer that the VAERS data are very incomplete and require further investigation before any conclusions can be drawn. When you hear someone on social media, TV, or the radio claim that tens of thousands of people have been seriously hurt by the vaccines, they are basing that claim on an incompetent (and possibly dishonest) use of the raw, uncorroborated VAERS data. I know this because every time I ask someone to back up their claim that the vaccines have injured tens of thousands of people, they eventually cite the VAERS database. When I quiz them further, most clearly have not even looked at the complicated VAERS web site, but are reporting second hand what they have heard elsewhere.

The truth is that few of the VAERS reports have been confirmed to be related to vaccination. Furthermore, the side effects mostly are of the “sore arm” variety, while serious health effects are vanishingly rare. Only about 200 people have actually died from the vaccines. All this compares to the almost 900,000 deaths (and counting) from COVID, and the ~20 million (and counting) cases of long term debilitation from long COVID. Remember, both the deaths and long COVID are prevented by the vaccines.

Back to Harry: Harry developed his debilitating conditions shortly after his third shot and attributed his woes to the vaccine. That is a temporal correlation—the debilitation happened shortly after the vaccine. But, is there anything that proves the vaccine caused Harry’s debilitation?  Well, a deep dive into Harry’s medical condition, like the CDC does into the data in its VAERS data, proves the vaccine did not cause Harry’s condition.

Sadly, a couple of days ago my blog friend told me that recent scans showed a mass on Harry’s lung. He has end-stage lung cancer that has spread to his pelvic bones and shoulder causing severe bone lesions and the pain. He will soon die from untreatable advanced cancer. It seems that Harry has a 50+ history as a smoker. But, he, as well as folks who abuse the VAERS system, totally ignore that kind of history and jump on the less-likely correlation between vaccination and diminishing health as proving a cause and effect relationship between the two. In doing this, people must assume that there could be no other causative factor for any malady that appears shortly after vaccination. Harry himself, ignored his long history of smoking, which is, by far, the leading cause of lung cancer, while the vaccines have been associated with zero cases of cancer.

This is a sad example of the mental gymnastics anti-vaxers resort to in order to confirm their bias against the vaccine. Real data be damned once they see a simple correlation that fits their bias.

Bottom line: Just as the vaccine did not cause Harry’s cancer, the crowing of the rooster does not cause the sun to rise. Both are correlations of events only temporally, not causally related.

Do not buy into the claims that the VAERS shows that people are suffering by the thousands from the vaccines. It is not true.

Don’t Forget The Drugs: An Update

In these pages last March, I reminded readers to be thankful for the vaccines that prevent COVID-19, but to not forget the antiviral drugs that are being developed that might treat the disease. Both vaccines and antivirals are part of the same quiver of weapons we have to fight the pandemic. In that blog post, I mentioned an experimental drug, molnupiravir that was being developed by Merck and Ridgeback Therapeutics. Well, they just posted an encouraging update. It continues to show success at preventing serious disease when given to high-risk people early after infection. Its only side effects were similar to the placebo, meaning it is very safe. In animal studies, the drug also was effective against different CoV-2 variants, including Delta, and against other coronaviruses including SARS and MERS. Molnupiravir is a “prodrug,” which means that it has no activity on its own; rather it is metabolized after ingestion to an active drug that was developed in the early 2000s to treat hepatitis C.

This is a significant step for being able to easily protect high-risk patients at home. The pill that patients take on their own cuts their risk of hospitalization or death by ~50%. The results were so encouraging that the study was halted after consultation with the FDA. Early termination of studies like this is only done when interim data analyses show such good efficacy of a treatment that it would be unethical to continue enrolling subjects, some of whom would receive placebo, thereby being denied an effective therapy.

The drug slows the spread of the virus in infected people by forcing the enzyme that copies the viral genetic material into making so many mistakes the virus cannot reproduce. That, in turn, reduces the patient’s viral load, shortening the infection and damping the type of over-exuberant immune response (cytokine storm) that causes serious problems in many COVID patients. It was not effective when given to already hospitalized, or advanced, patients. It is on track to be approved by the FDA by the end of the year, and would be the first proven and approved oral antiviral drug for treating COVID-19 (neither ivermectin nor hydroxychloroquine have been proven or approved).

The FDA has already cleared another antiviral drug, remdesivir, for treating COVID-19, but it is only used to treat advanced patients who are already hospitalized (interestingly remdesivir was also originally developed to treat hepatitis C and it is also used to treat Ebola). Several lab-produced monoclonal antibody treatments have also been approved by the FDA for treating mild to moderate COVID-19 and they are more successful than molnupiravir at preventing advanced disease. But both remdesivir and the antibody treatments require an intravenous infusion done in a health care setting, making them more complicated and more expensive than just taking a pill at home, which is a decided advantage of molnupiravir. Finally, one of the more effective approved drugs against COVID-19 is the steroid, dexamethasone, but that is only given to very sick patients since its side effects are significant. Therefore, there is much room in the anti-COVID quiver for effective, simple-to-administer drugs such as molnupiravir. Both Pfizer and Roche also have other antiviral drugs that block viral replication in advanced stages of development. Stay tuned.

As of October 5, 2021, the Milken Institute tracker shows that there are 331 “treatments” for COVID-19 in development worldwide. This effort recently got a $3.2 billion boost from the US Antiviral Program for Pandemics, which is a rejuvenated initiative that was started during the MERS outbreak in 2012, but was tabled after MERS fizzled out. Then there is the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, also sponsored by NIH. These programs focus on developing non-vaccine therapies designed to treat not prevent the disease and they include studies of medicines currently used to treat other diseases (including ivermectin, which has yet to be proven effective) as well as studies of new drugs.

While the news about molnupiravir is encouraging, health experts are concerned that the news also could increase complacency regarding vaccines in the vax-hesitant. It is important to realize that prevention (vaccination) is almost always preferable to treatment (drugs).

Get the vax.

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Long Term Side Effects Of COVID Vaccines

In his nearly 30 years studying vaccines, Paul Goepfert, M.D., director of the Alabama Vaccine Research Clinic at the University of Alabama at Birmingham, has never seen any vaccine as effective as the three COVID vaccines — the mRNA vaccines from Pfizer and Moderna, and the adenovirus-based vaccine from Johnson & Johnson that are currently available in the US. He refers to the 90 percent reduction in infections, and 94 percent protection against hospitalization the vaccines confer. 

Despite this undeniable success, most Americans who have not been vaccinated report long-term safety as a major concern. Nearly a quarter of respondents in Gallup surveys in March and April 2021 said they wanted to confirm the vaccine was safe before getting the shot. And 26 percent of respondents in a survey of parents with children ages 12-15 by the Kaiser Family Foundation in April 2021 said they wanted to “wait a while to see how the vaccine is working” before deciding to get their child vaccinated. 

There are several reasons to not worry about such long term consequences of the vaccines. Vaccines are very temporary medicines, making them different from medicines that people take every day, potentially for years, that can have long term safety issues. Further, decades of vaccine history, plus months of data from more than a billion people around the world who have received the current COVID vaccines starting last December, provide powerful real-life proof that there is little chance that any new dangers will arise more than a couple of weeks following the COVID shot. 

Consider the following:

1. Vaccines are eliminated within hours to a couple of days. Unlike many drugs, which are taken daily and chronically, vaccines are generally one (maybe two)-and-done. Medicines you take every day for months or years can cause side effects that only reveal themselves over time. 

Vaccines are designed to deliver a payload that is quickly eliminated by the body. This is particularly true of the mRNA vaccines as I wrote earlier. mRNA is a very unstable molecule that degrades rapidly (within hours) due to ubiquitous enzymes generally known as RNases. So, after a shot, the vaccine lingers just long enough to stimulate an immune reaction, and then the body’s normal mechanisms eliminate it within hours. The only long term effect after the vaccine is eliminated is the immunological memory it leaves behind.

2. Vaccine side effects, if any, show up within hours to a couple of weeks, never longer: No vaccine has ever shown a side effect that appeared more than two months after injection. This is why the FDA requires only two-months of of followup data after injection for Emergency Use Authorization (or six months as an extra precaution for Full Approval).

That is not to say that there have never been safety issues with vaccines. But in each instance, these issues appeared very soon after vaccination. When the oral polio vaccine was first introduced in the US in 1955, it used a crippled form of the polio virus that in very rare cases, about one in 2.4 million recipients, became activated and caused polio. Cases of vaccine-induced polio occurred between one and four weeks after vaccination, none after one month.

In 1976, it was found that in approximately one in 100,000 patients, a vaccine against swine flu was associated with Guillain-Barré Syndrome, in which the immune system attacks the nerves causing temporary paralysis. These cases occurred in the eight weeks after being vaccinated (in contrast the flu itself causes Guillain-Barré Syndrome 17 times more frequently than the vaccine). Eight-weeks is the longest post-vaccine delay for the appearance of a side effect for any vaccine.

3. Real life experience with COVID vaccines: By the time the COVID vaccines were approved for emergency use in the US in December 2020, we already knew what the short-term side effects were from the clinical trials on tens-of-thousands of people. The side effects seen in these studies, and later confirmed in the real-world experience of vaccinating hundreds of millions of people, were mostly simple tolerability issues, like arm pain, temporary fatigue and headache. These side effects occur a day or two after the vaccine and last 24-36 hrs.

As of June 12, 2021, more than 2.33 billion COVID vaccine doses have been administered worldwide, according to the New York Times vaccinations tracker. And as hundreds of millions of people are vaccinated, we can begin to detect the extremely rare side-effects that would not be seen when only tens of thousands of patients had been vaxed. This has not revealed any side effect occurring after two-four weeks following the shot. Thus, the close scrutiny of these hundreds of millions of vaccine recipients make the COVID vaccines perhaps the most studied vaccine in the history of medicine.

We also now know that a few people receiving the AstraZeneca COVID vaccine experienced a clotting disorder known as thrombotic thrombocytopenia. This occurred in just 79 people among more than 20 million people receiving this vaccine in the UK. A smaller number of cases have occurred with Johnson & Johnson’s vaccine as well. These side effects only happened 1-2 weeks following the shot (and clotting problems occur much more frequently following infection). An even rarer side effect, myocarditis, or inflammation of the heart muscle, has been reported in people receiving Pfizer and Moderna COVID-19 vaccines. This effect was found in about one in a million vaccinated people. None of these cases appeared more than a month after the vaccination.

Finally, on July 12, 2021, the FDA announced that in rare cases (100 reports out of 12.8 million shots given in the US), the J&J vaccine might be associated with Guillan-Barré Syndrome. All of these cases appeared about two weeks after injection.

Bottom line: All of this can be boiled down to this: There are no “long term safety issues” with these or any other vaccine. If you don’t have a side effect 2-8 weeks after the injection, you will not have any further vaccine-related problem down the road.

I challenge anyone to name any vaccine that has had side effects more than a few weeks following the shot.

Therefore, it is mind-boggling that people are avoiding COVID vaccines based on an unwarranted hypothetical concern over long term safety, but they are not at all worried about the reality of COVID mortality and the devastation of “long COVID” symptoms seen in 10% of infected people. That is irrational.

Stay tuned:  A multi-post blog series on the “long COVID” or “long haulers” will soon begin in these pages.

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Evidence That Facemasks Prevent COVID-19

As Delta proliferates while the world tries to get back to normal, requirements to wear facemasks in public are also proliferating. The mask mandates are causing no end of consternation in certain segments of the population, which like to claim that there is no evidence that they prevent disease. Their evidence behind this claim is weak and usually boils down to claiming that the virus is similarly prevalent in states with and without mask requirements. For instance, they like to point out that California, with strict mask mandates, has about the same rate of COVID-19 as Florida, which does not have widespread mask mandates.

But, this is not a strong argument. In research, we carefully design studies to compare experimental vs control groups that are as similar as possible in every way except for the variable we wish to test. In other words, we try to isolate the test variable by making all else as equal as possible. This goal for a well-controlled experiment falls apart when comparing California to Florida—they are very different. Differences include age, population and housing density, reliance on public transportation, climate, humidity, and demographics. All of these variables, if not controlled for, will confound the relationship between mask policies and COVID-19 outcomes because each of these variables also affects the spread of disease.

However, comparing counties within a state helps address at least some of these confounding factors since counties within the same state are generally more similar than two different states at opposite ends of the country. Researchers have done just this in Kansas where 21 counties implemented a mask mandate while the others did not. Counties with a mask mandate saw a significant drop in COVID-19 while counties without a mandate saw a 100% increase in new cases during the period of evaluation.

More recently, the ABC Science Collaboration, a partnership between health scientists, K-12 schools and community leaders, in North Carolina collected infection data from >1 million students and staff members between March-June 2021. More than 7000 students and staff caught COVID-19 during that period and contact tracing showed that >40,000 people had close contact with the infected ones. Very few of these close contacts caught the virus and all of them, the infected cases and their close contacts, wore masks. In other words, in schools with mask mandates, there were no outbreaks despite initial COVID infections. And schools are ripe for creating super-spreader outbreaks.

A systematic review and meta-analysis published in The Lancet, examined the efficacy of face masks in reducing the transmission of different coronaviruses (SARS, MERS, and COVID-19). The authors evaluated 39 studies and found that face masks significantly reduced the risk of coronavirus infection compared to no mask wearing.

An article published in the Proceedings of the National Academy of Sciences in January 2021 also reviewed the evidence supporting the use of face masks and similarly concluded that near-universal adoption of non-medical (i.e., cloth) face masks in public could significantly reduce the R₀ value of the virus, which is a measure of how well it spreads. In fact, I earlier discussed in these pages a similar finding by British researchers who concluded that widespread mask-wearing could substitute for herd immunity.

There are several other published studies that reach similar conclusions about facemasks. But, perhaps the most comprehensive study was just reported by researchers at Stanford and Yale. It involved a method called cluster randomization where villages in Bangladesh were randomized to get facemasks or not. It involved some 340,000 people in 600 villages. 100 villages received cloth masks and 200 villages received surgical masks. The remaining 300 villages did not receive any intervention to increase mask wearing. The results showed that increased community masking decreased COVID-19 disease in these real-world settings. Surgical masks performed better than cloth masks at reducing COVID-19 disease, though cloth masks were definitely better than no masks.

On a final note, let me reissue my earlier challenge to anti-maskers: If you really think they do not prevent infection, then next time you have surgery, invite the surgical team to throw the masks out when they open you up.

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Vying With Viral Variants

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The back story: There are four known CoV-2 variants in the US that are more transmissible than the parent strain. They are the UK variant, which is 70% more infectious and 60% more deadly than the original strain. There also are Californian and Brazilian variants that are more transmissible, but it is not yet known if they are more deadly. However, in Brazil, their variant is associated with a significant increase in infections and ICU stays for young, healthy, unvaccinated people. Fortunately, the current vaccines seem to be effective at preventing infection with these strains.

More worrisome is the South African variant that is 50% more transmissible. It is worrisome because the AstraZeneca vaccine is not very effective against this variant, and a very recent, but a small study out of Israel suggests that the Pfizer vax might have reduced efficacy against the S. African variant. It is not yet known if this strain causes more serious disease. These findings provide evidence that mutation can produce new viral strains that can evade the immune response to the viral spike protein.

Two other variants, the so-called New York variant, and a second Brazilian variant have early signs of being more infectious or even being able to reinfect people who previously had COVID-19. Data are still being collected in order to better understand the risk that these variants pose. Stay tuned.

You can follow the variants in the US here.

The bottom line is that the world is in a race to roll out vaccines faster than troubling virus variants can arise. The UK is expected to reach herd immunity​ early next week. Infections there dropped by 60% during March, with deaths dropping more rapidly, indicating that the vaccines are helping prevent severe illness and viral spread. Meanwhile, the US leads the world in total vaccines administered (175 million), with 43% of the adult population having received at least one shot. More than 700 million doses have been administered world-wide.

The major concern is that a too-slow vaccine distribution, such as what has happened in Brazil, will encourage more virulent variants to arise. If we don’t quickly achieve herd immunity across the world, it probably will just be a matter of time before a variant arose that renders the current vaccines useless, and we would have to start over.

What is a world to do? Besides increasing surveillance of viral variants, a couple more prevention initiatives are in the works. One is economic and the other scientific.

Economics of viral mitigation: The economic approach is detailed in an article by the Associated Press Economics Writer, Martin Crutsinger. Basically, the International Monetary Fund (IMF) proposes giving $650 million to support vulnerable countries struggling to deal with a global pandemic. Along with that, the Group of 20 major industrial countries issued a joint statement that announced a six-month moratorium on debt payments by 73 of the world’s poorest countries.

The rationale behind these actions is to ensure that poor countries, where vaccinations are lagging due to lack of resources and infrastructure, can pick up the pace of vaccination. Their lag in rolling out shots is a threat to the whole world, even while wealthy countries are approaching herd immunity. In order to beat the variants, vaccines are needed to quickly create herd immunity and stop viral spread before a variant that can avoid vaccine immunity appears. When countries lag in vaccinations, the virus continues to spread increasing the chance for an immune-avoiding variant to pop up. Such a variant can then spread to countries that are highly vaccinated, starting the pandemic over again because the current vaccines would be ineffective. We would be back at square one.

Science to the rescue: So far, all the vaccines, except one from China, which uses the whole virus, direct the immune response to the viral spike protein that is used to attach to receptors on the surface of cells in your body. The viral variants we are concerned about show mutations in the spike protein that allow them to become more infectious, and in one case, to be less affected by some of the vaccines. In addition to trying to  nip the virus in the bud by quickly building world-wide herd immunity, new vaccine strategies are being developed to quickly respond to newly arising CoV-2 variants, and even to respond to entirely new strains of viruses that will arise in the future.

• One way to do this is to begin developing booster shots as soon as a coronavirus variant becomes a significant concern. With the new mRNA, and adenovirus vaccine delivery technology, this is eminently possible. It just requires scientists around the world being vigilant for new variants. Pfizer, Moderna, AstraZeneca, and Johnson & Johnson have all said they’re starting work on developing booster shots to the known variants.

• Last week, the US government announced a pact with CureVac to tackle variants, pairing artificial intelligence to predict future mutations that can be quickly addressed with modern vaccine technology. London-based GlaxoSmithKline is also working with CureVac on mutant-quelling vaccines.

• Another strategy is to identify viral molecules other than the spike protein that the immune system can recognize. Efforts are underway to test the immunogenicity of what is called the CoV-2 nucleocapsid, or N protein, which wraps itself around the viral RNA. If successful, future vaccines could incorporate both the N and S (or spike) proteins, which would require the virus to mutate both of those genes in order to avoid vaccine-induced immunity, a greatly tougher task for the virus.

• Researchers at Moderna, Novavax, and the University of Oxford are designing multivalent vaccine strategies to protect against multiple CoV-2 variants with a single shot, and even against new viruses that might emerge in the future. A similar strategy is used with the annual flu vaccine, which usually incorporates four different influenza strains in one shot. It is also used with measles, mumps, and rubella vaccines. Some vaccines against pneumonia target as many as 23 variants of that pathogen.

• Finally, a wholly new vaccine technology has shown recent success in animal studies. It works by chemically attaching many short viral protein sequences from different CoV-2 variants, and even from completely different coronaviruses, to engineered nanoparticles that are then injected. In mice, this single vaccine induced an antibody response capable of neutralizing many different coronavirus strains. If successful, this could represent a universal vaccine capable of neutralizing CoV-2 and its variants, as well as other coronaviruses such as SARS and MERS with a single vaccine. And it can be easily modified to quickly respond to future viral epidemics caused by novel coronaviruses or other viruses that will certainly arise. The technology is being developed at Cal Tech using technology developed by collaborators at Oxford University. The nanoparticle platform is a “cage” made from 60 identical proteins. Each of those proteins has a small protein tag that functions like a piece of Velcro to which the viral protein sequences stick resulting in a vaccine nanoparticle with short protein sequences from four to eight distinct coronavirus strains on its surface. If successful, this could prevent infection and disease for several different viruses with a single shot.
  

 We are in a revolutionary era of vaccinology. BioX marches on.

Vaccine Disinformation

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There is a lot of misinformation and downright disinformation out there regarding face masks, hydroxychloroquine, ivermectin, the seriousness of COVID-19, etc. Many of these I already addressed in prior posts (see here and here). In this post, I focus solely on vaccine misinformation and disinformation in hopes my unvarnished explanation of the science might help vaccine skeptics make decisions based on facts rather than on disinformation spread by people with an anti-vaccine agenda, or who want to sell you something.

Several anti-vaccine disinformation themes have been circulating over the past weeks and a friend recently sent me a video by an MD that was full of disinformation and dishonesty. The video was thinly disguised marketing propaganda by Houston-based Dr. Steve Hotze. He is an MD, who does not seem to practice much medicine anymore, but has built an alternative medicine empire that pushes many vitamin and mineral supplement nostrums that he claims is all you need to fight the virus and other diseases. In other words, he advises people to avoid the vaccines and, instead, buy his concoctions. In December 2020, the FDA and FTC sent him a cease-and-desist letter to stop claiming that his supplements can treat diseases, especially COVID-19. The FDA found the products and marketing to be misleading. The FTC found him in violation of interstate transportation laws. I address his several points below, many of which have been echoed by other anti-vaxers.

• The vaccines do not confer immunity to the virus and COVID-19. There is very much evidence that the vaccines do provide immunity against CoV-2 and strongly protect against COVID-19. That evidence is found in the many reports of antibody production, of T cell anti-viral responses, of cytokine responses to the vaccines, and in recently published reports out of Israel that the vaccines retard virus transmission. Then there are the several studies showing that the vaccines strongly prevent COVID-19 disease. Hotze and others provide zero evidence to back their allegations and ignore data that contradict their points.

• These are not vaccines, but experimental gene therapies. The mRNA shots from Pfizer and Moderna, and the modified adenovirus vaccines from Johnson & Johnson and AstraZeneca are indeed vaccines. Researchers whittled down the virus genome to the essential viral spike genetic sequence needed to confer immunity. This means that the minimally effective part of the virus genome, rather than the whole viral genome, is used to provide protection from future infection. Old fashioned vaccines grew batches of viruses and then crippled them so that upon injection, they would infect cells, use their genetic information to express all their viral molecules on the cells, but not spread. The current vaccines simply use the genetic sequence for the spike protein, eliminating all other viral genetic sequences. That single genetic sequence is translated into the spike protein that is expressed on your cell surfaces much like what would have happened with an inactivated, whole virus vaccine. Therefore, the current vaccines are no more “gene therapy” than the whole virus vaccine. Both require expression of viral genes in order to alert the immune system.

Also, the term “gene therapy” conjures images of "Frankenscience." This is wrong. First, vaccines are not “therapy,” which is something that treats a disease after you catch it. Rather vaccines are prophylaxis, which prevents you from catching the disease in the first place. Gene therapy is a still developing field that works to replace, correct, or “knock-out” aberrant genes that cause non-viral health problems.

Furthermore, as I posted earlier, these vaccines are not experimental or hastily developed. They are based on vaccine platforms that have been over a decade in development, and, in some cases, have been used to develop human vaccines to rabies and Ebola. The only novel thing about them is using the CoV-2 spike protein to drive a protective immune response to subsequent infection with the virus. These spike-protein vaccines have been tested in tens of thousands of volunteers in phase 3 trials, and now have been injected into tens of millions vaccine recipients around the world. The vaccines have been wildly successful at preventing COVID-19, and have been proven to be very safe (see below). These are not experimental vaccines, but well developed, and well tested vaccines.

• The vaccines alter your DNA. They absolutely do not. It is biologically impossible for them to do that. I discussed this fallacy in a prior post.

• There is no off switch for the viral gene expression caused by the vaccines. This too is not at all true. No vaccine in history has had its viral genes expressed long term. In fact, your cells continually produce their own mRNA to direct production of cellular proteins that drive cell function. Cells are also full of enzymes called RNases that digest mRNA once it has done its job. Thus, your own mRNA is very short lived in your cells. The same is true for the viral mRNA inserted into cells from an inactivated viral vaccine, from an adenovirus-based vaccine, or from an mRNA vaccine. The mRNA will only last a day or two in your cells before it is digested and permanently disappears. This is the off switch.

• We do not know about the long-term or delayed responses to the vaccines. Yes we do. First, I challenge people who purport to be worried about long-term effects to name one vaccine that has ever had a long-term adverse effect. As I described above, vaccines are short-lived; their only long-lasting legacy are memory T and B cells that protect you from future exposure to the pathogen.

On the other hand, delayed adverse effects were a potential concern when the vaccine was being developed as I described earlier, but that has proven to be of no concern. There is a rare adverse response to prior exposure to a pathogen, whether naturally or via vaccine. This is called Antibody Dependent Enhancement (ADE) of the infection. This was seen with the vaccine against the Dengue virus where the antibody response actually enhanced viral infection in new cells. Because of this, all new vaccines to novel viruses are carefully tested for potential ADE effects.

During the early stages of anti-CoV-2 vaccine development, caution prevailed, and the vaccines were assessed for potential ADE, as reported earlier in these pages. The clinical trials showed absolutely no evidence for ADE. Since then, millions of people around the world have been vaccinated and not a single case of ADE has been found.

Therefore, concern over ADE was theoretical and never became a practical matter. Anti-vaxers who keep bringing this up as a concern, such as Dr. Hotze, and America’s Frontline Doctors choose to ignore demonstrable facts in favor of continued fear mongering and appealing to emotions. A few countries around the world have begun arresting people for spreading such disinformation that disuades people from being vaccinated, which can lead to deaths caused by the disease.

• Many people have died from the vaccines. That is flat wrong, and in fact, the opposite is true. In the US, ~550,000 people have died from recognizable COVID-19 while only nine (out of several million vaccinated people) might have died due to vaccine complications (discussed below). The CDC has a Vaccine Adverse Event Reporting System (VAERS) that lists all reported adverse events and deaths that occur shortly after vaccination, whether or not they are caused by the vaccine. Seeing as how tens of millions od people in the US have been vaccinated, unrelated health problems and deaths are expected to occur by chance. If you blew kisses at 50 million people, several of them would die in the next day or two just by chance. The air kisses did not kill them. The trick is to distinguish chance deaths vs possible vaccine-related deaths.

In order to determine whether a new vax causes adverse health effects, CDC doctors look for recurring patterns. If they see a pattern of similar types of death in certain people they pay closer attention to that group and even back off vaccinating them. With one extremely rare exception with one of the current vaccines as discussed below, these kinds of patterns have not been seen with the current vaccines.

• The COVID vaccines will not eradicate the virus any more than flu vax eradicates flu. This statement by Hotze and others is either dishonest or they are ignorant of basic virology. It ignores the fact that flu rapidly changes every season, making it very hard to eradicate. The statement also ignores the facts that small pox has been fully eradicated by vaccines, and that in the US measles and polio have been eradicated—the only cases we see here come from overseas. Whether or not the COVID vaccines can eradicate CoV-2 depends on how well they work against the viral variants, how quickly the variants arise, and how many people are vaccinated in the next few months.

• Herd immunity caused by natural infection is better than the vaccine. This statement too betrays ignorance of the disease and of vaccinology. Natural immunity to CoV-2 comes with the cost of many deaths and with many more people suffering long-term health problems caused by COVID-19. Again, the vaccines have not been linked to deaths or to lasting health problems. Vaccines are used to confer herd immunity without running the risk of the deadly consequences of the disease. By all measures, the vaccines confer significant protection against the disease and are more reliable than natural immunity where you cannot ensure a uniform level of infection and immunity for everyone.

• Companies are reaping great profits off their lies. Pfizer and Moderna and other vaccine producers are providing the vaccines at cost during the pandemic. They are not profiting from them. Also, Moderna has announced it will not enforce its patents on its vaccine platform, but will share its technology with other companies and researchers during the current pandemic. In contrast, Dr. Hotze and others clearly are using the pandemic for their profit.
  

• Companies are withholding raw data on their vaccines. Raw data for the approved vaccines was shared with two CDC committees consisting of scientists, vaccinologists, pathologists, epidemiologists and statisticians. That raw data was the basis for the emergency authorization of the vaccines (see below). Generally, raw data are only released to CDC and FDA and not to the public. What is released to the public are data summaries in the form of peer-reviewed journal publications and these are coming out and will continue to come out over the next few years.

The above are points Hotze has made and that are often repeated by other anti-vaxers. Below, I address other criticisms and questions about the vaccines that I have heard others, but not Hotze raise.

• The vaccines are not FDA approved. Well, I wonder then who gave the vaccines Emergency Use Authorization (EUA)! True, EUA is not full FDA approval, but EUA approval still comes from 30 FDA experts after a rigorous evaluation of all existing data for efficacy and safety. That is well above the 2-3 experts that typically review science papers for peer reviewed publications. The EUA approval for each vaccine was based on data from about 40,000 subjects enrolled in the late stage clinical trials. Since then, millions more people have been vaccinated and their data continues to be collected and reviewed. Recent reports of this "real world" data continue to support the great safety and efficacy of the vaccines.
• Some vaccines are better than others. The Pfizer and Moderna mRNA vaccines, which were the first tested and approved, showed ~95% efficacy, while the Adenovirus-based Johnson & Johnson vaccine, which was later tested and approved, only showed around 70% efficacy. So, shouldn’t we favor the Pfizer and Moderna vaccines? No. All the currently approved vaccines, including the J&J one, are very effective. And it is impossible to compare the relative efficacy of different vaccines from data obtained in separate trials. In order to gain an accurate comparison of different vaccines, they need to be tested in head-to-head, controlled trials in order to assure that similar patient populations are being tested against the same viral variant. For example, the Pfizer and Moderna vaccines were tested before we noticed viral variants that seem to be more infectious than the original virus. And neither company tested their vaccines in South Africa where one of the more infectious variants is rampant. In contrast, J&J began testing their vaccine after the variants began spreading around the world, and they also tested their vaccine in South Africa. This means that the Pfizer/Moderna vaccines were tested against different strains of the virus than the J&J vaccine, which confounds comparing their relative efficacy.
• Bill Gates is promoting vaccines so he can inject us with microchips to track us. [big sigh]…Yeah, and one of the America’s Frontline Doctors, a group that claims hydroxychloroquine can cure COVID-19, said there is alien DNA in some of our medicines. I don’t waste my time with tinfoil-hat comments.
• The vaccines cause infertility. This is based on bunk-science that began circulating last December. That rumor was solidly debunked by several sources, but the meme has been repackaged into new messages about de-population strategies. I give this the same attention I give to the silly notion that Bill Gates is trying to use the vaccines to microchip us. The vaccines do not cause infertility.

But, what about nursing mothers? Will the vaccines affect their babies? The answer is yes, but in a good way. Since babies are born with a very immature immune system, their first line of defense against pathogens comes from their mother’s antibodies that cross the placenta and that are found in mother’s milk. This “passive immunity” is an important first line of immune defense for newborns. Lactating women who have been vaccinated do show anti-CoV-2 antibodies in their milk, which provides the newborns with a temporary defense against the virus. That is a good thing.

• The AstraZeneca vaccine causes blood clots. Over the past few weeks, 25 patients in Europe, almost all women under the age of 55, who received the AstraZeneca vaccine developed rare blood clots and nine died. The European Medicines Academy (EMA) met to review the data and found that overall clotting in vaccine recipients was less than in the general unvaccinated population. However, there are different clinical types of blood clotting problems, and for two very, very rare types, it was expected that ~2 clotting cases would arise by chance out of the ~20 million vaccinated people. But, 17 cases were reported. This is the kind of adverse event pattern that public health officials look for, as I described above. Again, exercising an abundance of caution, more than 20 European countries paused using the vaccine. However, within a week, the WHO and the EMA had reviewed the data and found that the extremely rare risk of vaccine-associated blood clots was significantly less than the risk of serious health problems from COVID-19 disease and advised that the vaccine be continued.

Final words. The disinformation about the anti-CoV-2 vaccines is disheartening, but seems to have been spawned by the roundly discredited claims by Dr. Andrew Wakefield a few years ago that the MMR vaccine was responsible for autism in kids. For that fraudulent reporting, Dr. Wakefield's paper was retracted and his medical license was taken away. Sadly, the damage was already done and continues today against all vaccines. Vaccines are one of the greatest health protection tools in the healthcare tool box and the naysayers are indeed killing people with their illogical and emotional appeals that are bereft of facts. How to counter such disinformation was a topic in a very recent article in Scientific American. What they recommend is beyond the scope of this post, but I hope that my presentation of the facts and reasoned criticism of anti-vax rhetoric is a step in that direction.

In The Midst Of The Vaccine Frenzy, Let’s Not Forget Drugs

Why drugs? While there is palpable excitement over the great success of several vaccines against the CoV-2 virus, companies around the world also have been developing new anti-coronavirus drugs to treat infections. As of March 5, the Milken Institute tracker reports that 251 vaccines are still in development, and 323 anti-viral drugs also remain under development.

While vaccines have dominated our thoughts in recent weeks, drugs can still play a very important role too. For example, even though we have vaccines for influenza, we also have the drug Tamiflu that shortens and reduces the severity of the flu. The drug is useful when we guess wrong about the strains of flu to vaccinate against each year. It also is used as prophylaxis for people working with the flu virus in clinical and research labs since they often work with flu strains that are not included in the annual vaccines. Also, while we have not been able to develop vaccines against hepatitis C or HIV, due to the quirkiness of those viruses, we have been able to take advantage of their biochemical quirks to develop drugs that now cure hepatitis C and that have turned HIV into a manageable and mild chronic problem rather than a death sentence.

All of this begs two questions; why would vaccines be needed if we had an effective drug against the virus, and why would a drug be needed if we had an effective vaccine against the virus? The answer has to do with the difference between prevention vs treatment. Prevention (i.e., vaccination) is ideal, but it takes time to develop vaccines to novel pathogens; hence, the value of an effective anti-coronavirus  drug to treat novel species of the virus that will arise in the future. Treatment (i.e, with a drug) also is good, but it still is better to prevent disease than to respond to it after you get sick.

So, there definitely remains a significant role for an effective anti-coronavirus drug even while we have successful vaccines. First, some people cannot be vaccinated or they have a compromised immune system that would render a vaccine ineffective. These people need an effective anti-viral drug. Second, as we have seen over the last decade with SARS, MERS, and now CoV-2 and its variants, deadly coronaviruses are popping up that require a swift response by public health folks. Even though the vaccines to CoV-2 were developed in record time, the virus still killed a couple million people around the world and caused untold long-term health problems in millions more before we had the vaccines. Furthermore, the current vaccines very likely will not be effective against the next species of coronavirus that visits us. Current vaccines also might show reduced effectiveness against newly arising CoV-2 variants. In fact, the AstraZeneca vaccine has proven so ineffective against a novel CoV-2 strain that arose in South Africa, that that country no longer uses it. Therefore, having a drug that can be quickly distributed to meet a new coronavirus threat would go a long way to protect us against future outbreaks while vaccines are being developed.

The new anti-viral drugs: More than a year into the pandemic, we have very limited drug options. Hydroxychloroquine showed early promise, but controlled clinical trials showed it to be a bust, as was ivermectin, which the FDA recently disapproved for COVID-19 patients. Only remdesivir has been authorized for use in COVID-19 patients, and it only provides modest benefit in hospitalized patients, reducing their stays by a couple of days. However, recent encouraging, but preliminary, results suggest an effective anti-coronavirus drug might have been found. The pill, molnupiravir, which is being developed by Ridgeback Biotherapeutics and Merck, significantly reduced infectious virus in 182 subjects in a phase 2 clinical trial. After five days of treatment, no virus was detected in any of the treated volunteers, while subjects who received a placebo did show virus. The drug interferes with the biochemistry involved in viral reproduction inside cells, therefore it prevents viral spread. Further study of the new drug is under way.

And four other potential anti-viral drugs are in mid-to-late stage trials at NIH under the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. ACTIV is a public-private partnership program to coordinate research strategy that prioritizes and speeds development of promising COVID-19 treatments and vaccines, and was launched on August 4, 2020. Like the vaccines, these new antiviral drugs are being developed in record time.

The drugs include SNG001 developed by Synairgen; it is an inhalable beta interferon delivered by nebulizer. Beta interferon is a cytokine produced by virally infected cells as a first line defense against viral replication. There also is AZD7442, a long-acting monoclonal antibody combination (AstraZeneca), and Camostat mesilate, an orally administered enzyme inhibitor designed to block CoV-2 from entering cells (Sagent Pharmaceuticals). 

Eli Lilly has also reported positive results with a combination of two antibody drugs, bamlanivimab and etesevimab (who comes up with these names?), that cut COVID-19 hospitalizations and deaths by 70% in recently diagnosed patients. These are anti-CoV-2 antibodies produced in the laboratory and work by mimicking the body’s immune system to give infected patients a head start fighting the disease while their natural immune systems ramp up to deal with a new pathogen. These also were developed as part of the ACTIV program and have been approved by the FDA to treat mild to moderate COVID-19 in people at high risk for severe disease. The feds have purchased large quantities of these Lilly antibody drugs and is making them available to qualified patients at no cost.  Meanwhile, on January 5, 2021 Durham, NC biotech company, Brii Biosciences, launched an ACTIV study on two other investigational lab-produced antibodies designed to neutralize the CoV-2 virus

That leaves a bit over 300 more investigational anti-coronavirus drugs to go.