mRNA

Vaccines: When the Experts Lie But Claim They Are Right

Adapted from Putting Floridians at Risk, a blog post by infectious disease physician and FDA advisor, Paul Offit, MD.

The lie: In October, the Surgeon General of Florida, Dr. Joseph Ladapo, issued a “Provider Alert”, which recommended that the new COVID booster only be given to everyone over 65. This was contrary to the CDC recommendation, which recommends boosting everyone over 6 months of age. Governor Ron DeSantis agreed with Ladapo, amazingly weighing in with this: “Once again, Florida is the first state in the nation to stand up and provide guidance based on “truth,” not Washington edicts.” I guess edicts from Washington automatically are not truth, but those from the Florida Surgeon General, for some reason are, because DeSantis says so. Why does he believe he knows more than the CDC?

Ladapo amazingly claimed that the COVID boosters don’t work. He too seems to know more than the CDC! To back up this spurious claim he cited a study of 2.2 million people from Qatar who got the booster.

Backstory: At first, the vaccines were hoped to prevent spread of the Cov-2 virus as many vaccines do. Early on they did that. But it soon became apparent that vaccine protection waned faster than expected and the virus mutated faster than expected. That combination meant that the vaccines became less effective at preventing virus spread. They still retard infection early after vaccination, but that protection is quickly lost. What they do well is prevent severe illness and death. That is well documented after  a few years of experience with the vaccines and the pandemic. Therefore, the goal of COVID vaccines is to prevent severe disease—to keep people out of the hospital, out of the intensive care unit, and out of the morgue. The Qatar study showed that the booster does exactly that. Protective efficacy against severe disease was about 75 percent. Pretty good.

Back to the lie: Ladapo unprofessionally ignored this main point of the Qatar study—that the vaccine was highly effective at preventing severe disease—and chose to focus on smaller, less significant, less clinically relevant data that minor infections were not affected by the booster. On this selective date editing, he claimed the booster was entirely ineffective. He either ignorantly interpreted the study or did so dishonestly.

Ladapo also falsely claimed that the COVID boosters are unsafe, stating that, “mRNA COVID-19 vaccines present a risk of subclinical and clinical myocarditis and other cardiovascular conditions among otherwise healthy individuals.” This is an oft cited, unsupportable falsehood. The truth is that very mild myocarditis occurs in about 1 in 100,000 mRNA vaccine recipients.  In contrast, myocarditis occurs in roughly 1 in 5,000 CoV-2 infected patients. Also, myocarditis following vaccination is short-lived and quickly resolves on its own, while myocarditis caused by the virus is more serious often requiring medical intervention. Therefore, regarding myocarditis, the benefits of mRNA vaccination far outweigh the risks. Ladapo is being disingenuous citing this is a vaccine danger. And if Ladapo believes that the COVID boosters are ineffective and unsafe, as he claimed, he is, therefore, irresponsible in recommending them for everyone over 65. That would be malpractice.

In the name of standing up to “Washington edicts” and recommending people not be boosted, DeSantis is following unethical medical advice and putting Floridians at unnecessary risk for preventable serious disease. And he wants to be president. If that were to happen, we would then have real complaints about Washington vaccine edicts.

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BioX Wins The Nobel!

“If you start to take Vienna, take Vienna”— Napoleon (reportedly)

What’s the fuss? BioX won the Nobel Prize….er rather it was the mRNA vaccine that won. Correction—it was the scientists, Katalin Karikó and Drew Weissman of the University of Pennsylvania, who developed the RNA technology that went into the novel vaccine who won the prize. But their work directly led to the vaccine, a first fruit of BioX.

Readers of these blog pages might remember that about this time in 2020, that year’s Nobel award for Medicine or Physiology went to three scientists for their decades-long search to discover what caused hepatitis type non-A, non-B. It turned out to be a whole new virus, the hepatitis C virus (or HCV) that took four decades to identify. Even though it still remains a huge health problem, there still is no vaccine for it. I compared that four decade slog just to find the pathogen to how fast the novel viral cause of COVID-19 was found and a vaccine developed—all done in less than a year! I anointed the new biology that did that amazing feat, ‘BioX.’ That was rather prescient of me, since three years later, the co-founders of the COVID vaccine using BioX too were awarded the Nobel Prize.

I dubbed the new amazing post-molecular biology science that enabled such a quick identification of the novel coronavirus and development of a vaccine against it, ‘BioX’ after SpaceX. SpaceX, of course, is the name for the new way space travel is now being done. Shortly before the Nobel award for the discovery of HCV, Elon Musk’s SpaceX took astronauts in an unpiloted vehicle to the International Space Station. Then the launch vehicle, rather than being discarded as usual, was landed, upright, in the center of a bullseye on a barge off the coast of Ireland, to be reused on a future space flight--maybe to Mars? The whole thing was developed in a fraction of the time at a fraction of the cost of what NASA had historically been doing. NASA’s technology was rendered archaic by SpaceX, which introduced us to a new era of space travel.

The breathtaking speed with which a new biology discovered the SARS-CoV-2 virus and then developed a safe and effective vaccine against it ushered in a new post-molecular biology world I dubbed ‘BioX’.

Now the details. But as breathtaking as SpaceX is, it was not developed overnight in a vacuum. It arose on the back of decades of NASA engineering R&D, which included some spectacular failures and even a few tragic deaths. Similarly, as breathtaking as BioX was with the rapid identification of a novel virus and development of the new mRNA vaccines to a wholly new disease, that technology too was built on the back of decades of hard work, punctuated with many failures, but also flavored with impressive perseverance on the part of a few individuals.

There are two major components to the novel COVID vaccines—the mRNA which generates the viral protein to which the immune response is made, and the lipid nanoparticles that encapsulate and protects the fragile mRNA from a world that is hostile to mRNA. Both components took very separate, decades long, twisting, uphill roads to develop. Both nearly met with failure. And both came together with spectacular success. BioX!

  • The mRNA. Weissman, and especially Karikó, languished for years on the fringes of science with a, then, very weird idea of using mRNA to produce drugs or vaccines. Their collaboration began with a chance encounter at a UPenn copy machine in the 90s and went downhill from there as recently told in the Wall Street Jounal. Funding for their work was hard to come by. Karikó was banished to an office on the outskirts of the campus and languished in a non-faculty position for years. At one point, she had to take a demotion to simply keep a job at Penn.

They just could not get their idea to work. The mRNA was too fragile and too short-lived to work with and produce the desired proteins when they tried to express it in cells or animals. The fact is that there are ubiquitous enzymes all around us called RNases that have a ravenous appetite for mRNA. RNA molecules, especially mRNA disappear almost as fast as one can purify or make them, let alone then try to get them into cells in tissue culture or into bodies. On top of that, when naked mRNA is injected into a body, it elicits a powerful immune response that further quickly degrades it. Note that there are several different types of RNA, and mRNA is the most fragile and hardest to work with, but it is the type that provides the message that turns a genetic code into a protein molecule like a spike protein, which is why it is used in the vaccine.

The researchers had great difficulty getting grant funding for their research because no one believed it would go anywhere. When they could produce some data, they had a very hard time finding journals to publish it. No one was interested because no one believe that there was any utility in the whole premise of using mRNA as a therapeutic tool. In the publish-or-perish world of academia, such negative peer pressure usually is the kiss of death. They should have seen the writing on the wall and been teaching high school biology. But for some reason, Karikó continued to have faith in her idea even though no one else did. For some reason, she persevered.

After dogged determination and ignoring all the naysayers, she eventually had a major breakthrough after a doing a simple experiment. They found a simple way to protect the mRNA from the immune response and published this in 2005. It opened the field and colleagues minds about using mRNA as a possible therapeutic tool. But there still was the problem that mRNA was exquisitely sensitive to RNase enzymes that were everywhere—on your fingers, in your breath and blood, even on sterilized surfaces—the enzymes are incredibly stable molecules and very hard to destroy. Life intended mRNA to be short lived molecules, not to be used in vaccines.

It wasn’t until folks paired the immune-stable mRNA of Karikó and Weissman with a way to protect the molecules from RNase enzymes that mRNA vaccines became possible so they could win the Nobel Prize. Lipid nanoparticles did the trick.

  • The lipid nanoparticles. The story behind the development of the lipid nanoparticles used to deliver the CoV-2 viral spike mRNA sequence to cells so they could use their normal gene expression machinery to put the spike protein on their surface and generate an immune response is a long one. In that regard it is quite similar to the long, arduous story behind the development of the therapeutic mRNA. Early on, neither technology was believed possible or useful by the scientists’ peers. Both groups had very hard times getting their scientific feet on the ground. Both nearly failed. I described Karikó’s struggle above and in March 2021 I wrote in these pages about the professional plight of Bob Langer who, in the 70s, had a vision for using liposomes (short for lipid nanoparticles) for delivering fragile bio-molecules and drugs to cells (you can read that post here). Briefly, his idea was to create mini-cells in which to package and protect fragile therapeutic molecules and then deliver them to cells and tissues in the body. The liposomes containing the fragile therapeutic molecules would fuse with the lipid membranes of cells and disgorge their contents into the cells. Many people told him it was not possible and he had his first nine grant applications rejected—and this was a time when medical science research grants were easy to get (when I was in graduate school in the early 80s, NIH grant applications had a 50% success rate. By the time I became a faculty member in the late 80s that dropped to 10%). Langer, like Karikó, also could not get a faculty position because people did not believe in his research. Also like Karikó, for some reason Langer persevered.

Also like Karikó, Langer too succeeded—eventually. It took a long time. The technology he successfully developed was first used to package a drug used to treat a rare genetic disease that causes nerve and heart damage. It also was used to package mRNA for an Ebola vaccine. From an ignominious beginning, Bob Langer became a professor at MIT where there now is a bioengineering lab named after him. That is not quite as nice as winning a Nobel prize, but high recognition still.

Along the way, he also co-founded a small biotech company named Moderna that was focused on developing mRNA vaccines for infectious diseases, cancer and other diseases. Then COVID came calling and Moderna immediately pivoted, and along with BioNTech, NIH, and Pfizer, quickly gave us mRNA vaccines delivered in liposomes that saved millions of lives from COVID.

That is how BioX technology led to the Nobel prize this year.

The bottom line. BioX, like SpaceX, was built on decades of hard research that was punctuated by painful failures, but highlighted by dogged determination. Both technologies, BioX and SpaceX, are here to stay at least until the next amazing thing replaces them. You can bet that that next amazing thing will have been developed on the back of determined researchers who very possibly will be working at the fringe of their professions and may flirt with professional failure early on. You can also bet that the next amazing things will be built on the backbone of SpaceX and BioX. That is how science and engineering painfully progresses.

So, when you hear someone say that the mRNA vaccines are experimental like I very often do, tell them the truth. They were built on decades of hard research going back to the 70s.

Stay tuned for a coming post on the future of BioX, which is here to stay for a while. New mRNA vaccines are being developed for previously vaccine-impossible diseases including HIV, cancer, and various animal diseases. Work also is underway for a universal flu vaccine.

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Is Intentional COVID Vax Disinformation Criminal?

Note: Disinformation is different from misinformation. Disinformation is false information which is deliberately intended to mislead. Misinformation is wrong information spread without malicious intent.

 

“We have met the enemy and he is us.”

--Pogo Possum

Your humble blogger first wrote about vaccine disinformation way back on March 31, 2021, just over two years ago. That was not long after the vaccines, as well as the lies about them began rolling out. Unfortunately, the fiction continues and it is now necessary to provide an update.

In the first quarter of the Monday Night Football game on January 2, 2023, 24 year old NFL player, Damar Hamlin, made a tackle, got up from the play, took a couple of steps, then fell over backward and didn’t rise. He suffered a cardiac arrest and needed to be resuscitated on the field with a defibrillator.

Almost immediately social media came alive with speculation and even outright claims that Hamlin’s collapse was due to the COVID vaccine. Without knowing whether he had even been vaccinated, conspiracy quacks immediately linked old reports of rare post-vax events of cardiomyopathy in young adults and occasional problems with blood clots with Hamlin’s sudden cardiac arrest. They completely ignored other explanations such as how the blow to Hamlin’s chest during the tackle could have caused his heart to fibrillate.

Your still humble blogger attests that this can be a concern to blows to the chest during sporting events. As a 13 year-old, playing first base in a summer league, I was knocked off balance by a runner scrambling to return to the base as the second baseman zinged a fastball to me to pick off the errant opponent after snaring a line drive. The ball hit me square in the chest over my heart and dropped me to ground. I don't remember anything for a few moments, and I was whisked by ambulance to an ER where my heart function was carefully monitored for a few hours before I was released. It was suspected, but not proven, that I had a brief cardiac event but quickly recovered on my own and I was no worse for the wear. It happens.

That conspiratorial chorus in the ether was soon followed by a similarly crazy cacophony of television and radio talking heads also intimating, again without facts, that Hamlin had suffered a vaccine-related cardiac side effect. These pundits included popular host Tucker Carlson who, on his Fox cable show just two days after the game, while Hamlin was still hospitalized in an induced coma, called medical experts “witch doctors” as if he knew more than they did. Dallas cardiologist and anti-vaccine podcaster, Peter McCullough announced on Carlson’s show that ‘vaccine induced myocarditis” likely caused Hamlin’s episode (I guess McCullough was not a “witch doctor” or a “medical expert” according to Tucker's criteria).

Even the very evening that Hamlin collapsed, Charlie Kirk, a radio talk show host, and COVID vax conspiracist claimed on Twitter that many athletes across the country are suddenly dropping like Hamlin did because of the vaccine. And the same evening there was an Instagram post from bodybuilder Louis Uridel showing a screenshot of a tweet stating that Hamlin's cardiac arrest was caused by the COVID vaccine. "24 year old elite athletes in the NFL don't just have a cardiac arrest in the middle of a prime time game," the tweet read. "This is squarely on the back of every single person who pushed that poison…", meaning the vaccine.  

An astonishing statistic is circulating throughout many social media circles claiming that more athletes died suddenly in the last year than have died in the last 38 years, implying that the vaccine is to blame. This originated with the same Peter McCullough who Carlson had on his show right after the football player collapsed. McCullough published a letter on Dec 2022 examining sudden cardiac deaths (SCD) in athletes. The problem, however, is that in his research he did not compare apples to apples. According to an epidemiologist who dug into McCullough’s data, he often compared cardiac events young athletes to events in old athletes(!), he mixed definitions of SCD indiscriminately, he included people who didn’t die of SCD or people who were not even athletes, and he even included people who did not die. But, the damage had been done; McCullough’s letter has spread far and wide and is now conspiracy gospel. Conspiracy buffs don’t really care about data, it is the headlines and talking points confirming their bias that grab and keep their attention. So, the false claim that the vaccine is causing excess deaths in athletes persists.

It is true that most conspiracies are often anchored in some fact, and on that foundation, the rest of the flimsy house of fantasy is constructed with fakery and fraud. Therefore, it is true that some COVID vaccines have been linked to very rare cases of myocarditis in young men. These cases were mostly very mild and were quickly resolved with no medical intervention needed. In fact, many cases were asymptomatic and were only detected because the sufferers participated in the clinical trials of the vaccines. Hence, trial participants were vaccinated and closely followed for adverse effects. This included regular blood draws which revealed that some vaccinated subjects with no physical symptoms at all still showed abnormal levels of a cardiac protein in their blood indicative of myocarditis, which quickly went away. These cases would have been missed completely if they had not been in the vaccine study. After now vaccinating hundreds of millions of people around the world, it is safely concluded that myocarditis following vaccination is very rare (~1 in 100,000) and not a serious problem. In fact, myocarditis following infection occurs seven-times more often than after vaccination, and is more severe. Therefore, it would have been more logical for Tucker Carlson, Charlie Kirk,  Peter McCoullugh, et al., to conclude that Hamlin’s problem resulted from a recent infection rather than a vaccination.

Then there is the blatantly dishonest video documentary, Died Suddenly, that is wildly popular in the anti-vax sector. It was made by Stew Peters and it asserts that people are dying in droves due to the vaccine, which itself was supposedly engineered by an elite cabal to depopulate the planet (seriously!). This video flashes through many alarming news headlines of people dying and shows videos of people collapsing, supposedly after receiving a vaccine. Whole essays have been written rebutting this video (you can read one here), but here are some quick take away points: 

  • Google the news headlines shown in the video and you will learn that many incidents were not caused by the vaccine. In one headline, the person died in a car accident not from the vaccine. Another died before the vaccines were even available! Yet another collapsed during a basketball game, also before the vaccines, but never died. How inconvenient.
  • The video alleges that mRNA vaccines are killing people via blood clots. As “evidence” it simply shows images of blood clots being removed from the blood vessels of cadavers. However, it fails to mention that blood normally clots after death! Ooops. No other evidence for vaccine-induced clots causing widespread death is offered.
  • The video also showed images of a huge blood clot (a pulmonary embolism) being surgically removed from a lung vessel, letting viewers assume the clot was caused by the vaccine. However, the footage was from a 2019 medical education video, that was made, once again, before vaccines were available!

The Died Suddenly documentary is dishonest to say the least, yet it is regularly trotted out as prime evidence for the danger of the vaccines.

If the vaccines are so dangerous, one wonders why the evidence needs to be fabricated!

In the end, COVID vaccines prevented 18.5 million additional hospitalizations and 3.2 million additional deaths in the US. Prevented not caused

Spreading vaccine disinformation can be very lucrative. It can bring in advertising revenue, attract subscribers, and help sell supplements and nostrums.

Twelve people are responsible for 65% of the vaccine disinformation on social media in the US, and they do so for profit. Their impact is mostly seen on Facebook, but there is plenty of vaccine disinformation on Instagram and Twitter as well.  Here are some notable examples.

  • A scientific study published in the science journal, Nature, reported that by far most (25%) of the COVID vaccine disinformation posts come from the organization, Children’s Health Defense, an anti-vaccine organization owned by Robert F. Kennedy, Jr, the 69 year old son of the late Senator, and recently declared Democratic candidate for US president. RFK, Jr., is a long-time opponent of vaccines. Any vaccine. He gained more than 1 million new paying subscribers in 2020 and traffic to his website rose sharply in March 2021 with 2.35 new million visits in response to his anti-COVID vaccine efforts.
  • Joseph Mercola, DO actually claims in hundreds of Facebook articles that the vaccines will alter your DNA and turn you into a viral protein factory. He does this in order to promote the sale of supplements, books, and health food. During the height of the pandemic, he promoted a new website designed to prevent or treat COVID with his alternative remedies. His business has a net worth of $100 million! As I explained earlier in these pages, it is biologically impossible for the mRNA vaccines to affect your cellular DNA in any way. Mercola is selling a flat lie for profit.
  • Steve Hotze, MD a Houston based doctor who used social media to unabashedly tell people to not vaccinate, but rather buy his vitamin and mineral concoctions, which, he claims was all one needed to fight the virus and many other diseases. In his case, the FDA found the products and marketing to be misleading and issued a cease and desist order.

Bottom line. The insidiousness of these charlatans is that while they claim to be saving peoples’ lives, they are causing deaths. The Kaiser Family Foundation found that between June 2021 and March 2022, 234,000 deaths could have been prevented in the US with COVID vaccinations. Vaccine disinformation that convinces people to avoid being immunized against the virus that causes COVID, undoubtedly caused many of these deaths.

How is a death caused by these deceitful claims about vaccines different from a death caused by criminally refusing to give insulin to a diabetic in crises?

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Take Your Vaccine Skepticism To A Cemetery

“Still a man hears what he wants to hear and disregards the rest”

            --Paul Simon, in The Boxer

They say you won’t find an atheist in a foxhole. Well, perhaps you shouldn’t find a vaccine skeptic in a cemetery, either. Bear with me and I will explain.

I have been reading about how vaccine skepticism is growing beyond the COVID vaccine to include other common vaccines against flu, measles, chicken pox, polio, etc. Perhaps this all began with parental resistance to Gardasil, a vaccine against human papillomavirus, or HPV, introduced in 2006. HPV is a sexually transmitted virus that causes genital, anal, and oral cancers. It is the most common cause of cervical cancer. In order to confer maximal and lasting protection, it is recommended that children around 11 and 12 years old be vaccinated. Some parents have railed that this promotes promiscuity. They fret that the vax licenses licentiousness in children, akin to giving them condoms with illustrated instructions in their use. Balderdash!  

While that medical insurrection continues to smolder, along came COVID and the anti-COVID mRNA vaccines accompanied by the surprising resistance of many people against the shots. It is a resistance that seems to be growing and spreading to vaccines in general including those listed above that have long been commonly accepted.

This is concerning because it portends that in the near future, kids will begin coming down with diseases that we have pretty well controlled. In fact, in the last year or so, de novo cases of polio have appeared in the US in unvaccinated people. Before this incipient vaccine resistance, polio had been eradicated in North America, thanks to the vaccine.

It is safe to expect that vaccine resistance will persist, and probably increase as new vaccines are developed to treat cancer and better protect against flu. The mRNA vaccine technology is being used to develop new vaccines against the deadly skin cancer melanoma, and research is underway to also develop vaccines to prevent breast, liver, prostate, and other cancers. This use of modern vaccine technology to prevent cancer is a very novel and promising approach to dealing with malignancy. Anti-cancer vaccines are a potentially exciting new weapon in the armamentarium for the war on cancer. Too bad for those who would reject an effective cancer-preventing vaccine. At least they can fall back on the standard harsh radiation and chemo therapies.

mRNA vaccine technology also is being used to try to develop a universal vaccine against the flu. Flu is a highly malleable virus because there are many strains out that that can mix and shuffle their genetic material. This means that every year, it is a guessing game as to which combination of flu we will contend with—hence the changing flu numbers each year-- H1N3, H2N4, H3N1, etc. Since the Southern Hemisphere’s flu season precedes ours in the North, flu sleuths follow what goes on down there and track which strains make their way Northward, often via migrating birds, and try to predict what flu strains will be prevalent here each year. Then flu vaccines are made based on the best predictions. Usually, the annual flu vaccine is a mix of 2-3 of the flu strains that we are most likely thought to encounter. Some years we better predict which flu strains to vaccinate against than in other years, hence the efficacy of the vaccine can vary from year to year. Therefore, the advantage of a universal vaccine effective against all strains would be to remove this uncertainty and variability. That is the goal of using mRNA technology to take genetic material that is common to all flu strains and package it into lipid particles as pseudo-viral particles to trick the immune system to make an immune response to these parts of the viruses. If successful, this would protect against all flu strains and eliminate the need to guess which strains to vaccinate against. Theoretically.

The point is, vaccine science is moving forward and continues to offer great promise to prevent diseases that have proven very difficult to treat. The vaccine naysayers will miss the boat if they continue their misguided dissent. I suggest that they test their skepticism in a cemetery.

Go to an old cemetery and find the graves of people who died in the 1950s and earlier. See how many headstones belong to children.

Then go to the part of the cemetery where the grave stones are for people who died in the 60s and later and see how many graves are occupied by children.

The sharp drop in the number of childhood deaths after the 60s can largely be attributed to vaccines. Vaccines prevent serious disease and death in children who used to die from meningitis, pneumonia, dysentery, small pox, flu, and other diseases, but now do not. And to those who think that the vaccines are killing people, where are their headstones?

It is always better to prevent disease than to treat it. Vaccines prevent disease. Avoid vaccines if you wish. Darwin might approve.


Unvaccinated People Are 11 Times More Likely To Die Of COVID-19

People who were not fully vaccinated this spring and summer were ~10 times more likely to be hospitalized, and 11 times more likely to die of COVID-19, than those who were fully vaccinated, according to one of three major studies published mid-September by the CDC.

That study did not distinguish between which vaccine the vaccinated cohort received. But, a second study compared the different vaccines and found that the Moderna vax was somewhat more effective in preventing hospitalizations than the Pfizer and J&J vaccines. This assessment was based on the largest US study to date of the real-world effectiveness of all three vaccines, involving about 32,000 patients seen in hospitals, emergency departments and urgent-care clinics across nine states from June through early August. While the three vaccines were collectively 86 percent effective in preventing hospitalization, protection was higher among Moderna vaccine recipients (95 percent) than among those who got the Pfizer (80 percent) or J&J vaccines (60 percent). That finding echoes a smaller study by the Mayo Clinic Health System in August, which showed the Moderna vaccine to be more effective than the Pfizer vax at preventing infections from the Delta variant.

Vaccine effectiveness against infection dropped from 90 percent last Spring, when Delta had not yet gained significant traction, to less than 80 percent from mid-June to mid-July, when Delta began out-competing other viral variants. Importantly, effectiveness against hospitalization and death showed barely any decline during the entire period. Thus, all vaccines remain quite effective and useful in protecting against illness.

Get one!

Why there is a difference in preventing infection between the Pfizer and Moderna mRNA vaccines was discussed earlier in these pages.


The Differences Between The Moderna And Pfizer mRNA Vaccines

Since the vaccines rolled out, people, including me, have talked about the Pfizer and Moderna vaccines as simply being interchangeable versions of mRNA vaccine technology platforms. They both use part of the CoV-2 viral mRNA sequence to temporarily express parts of the viral spike protein on muscle cells in order to stimulate a protective immune response against the live virus. Since mRNA is very unstable and would quickly degrade if it were injected by itself, both vaccines encapsulate it in lipid nanoparticles, or liposomes, which both protects the mRNA and helps it fuse to cell membranes and insert the genetic material into the cells where it is translated into the protein. So, the Pfizer and Moderna technologies are very similar.  But they are not identical. At first blush, the differences appear subtle, but we are learning that they seem to manifest themselves in different, not-so-subtle biological ways. Let’s take a look at the how the vaccines differ.

The formulation: The lipid nanoparticles that carry the mRNA are a bit different between the Pfizer and Moderna vaccine platforms. While the exact formulations are proprietary intellectual property owned by each company, we do have a little bit of information about how they are similar and how they differ. Both platforms are concoctions of several different lipids designed to spontaneously assemble in aqueous solutions into small, “artificial cells” that encapsulate the mRNA payload. The lipids in both vaccines include polyethylene glycol (PEG), which can have multiple effects on the properties of lipid nanoparticles; they can affect particle size and particle stability. Certain PEG modifications can also prolong the blood circulation time of nanoparticles by reducing clearance of the liposomes by the kidneys and by scavenger immune cells called phagocytes.

The Pfizer vaccine also contains two proprietary lipids known as ALC-0315, and ALC-0159 as well as cholesterol, all in a very precise ratio. The Moderna vaccine platform consists of lipids that are not as well-known publically because the company is in litigation over the intellectual property with Arbutus, which developed the lipids that were licensed by Moderna.

Basically, viruses are naturally occurring liposomes encapsulating genetic material. The nanotechnology community has long been trying to create “artificial” virus-like nanoparticles that do not replicate or spread like a live virus in order to deliver fragile molecules, like mRNA, to cells for therapeutic reasons. Therefore, the goal of therapeutic liposomes is to create a virus-like lipid bilayer membrane (see figure) in order to deliver a drug or vaccine payload to cells. Mixing amphiphilic fatty acids, which are lipids where one end is water soluble (hydrophilic), while the other end is not (hydrophobic), in an aqueous solution allows them to spontaneously assemble into virus-like nanoparticles, or mini-cells. A water soluble payload (mRNA in this case) is captured in the central blue area and is protected by the outer lipid membrane. When these artificial cells bump into a live cell, the lipids on the two membranes fuse dumping the therapeutic payload into the cell’s cytoplasm.

There are endless combinations of amphiphilic lipids which can form such pseudo-cells, the properties of which can be modified depending on which lipids are used. For example, the selection of lipids used in both vaccines give the surface of the liposomes a mild positive charge, which facilitates their ability to stick to the negatively charged membranes of live cells.

What all this means is that the specific lipid formulation used in the Pfizer and Moderna vaccines affects the delivery of mRNA to cells, but we do not have enough detail to be able to suss the effects of the different liposome compositions on the efficacy of the vaccine. Those details mostly remain trade secrets. Liposome_scheme-en

lipid nanoparticle mimics a cell bilayer membrane

mRNA sequence. Both the Moderna and Pfizer vaccines use mRNA that encodes part of the spike protein of SARS-CoV-2, which sits on the surface of the virus and binds with the ACE2 receptor on the cell surfaces of many tissues. mRNA molecules are chains of four nucleosides arranged in a gene-specific sequence code that cells then translate into a specific protein. However, when a foreign mRNA is injected into a body, the mRNA itself can be recognized by the immune system and neutralized before it can enter a cell and express its cognate protein. For this reason, both the Pfizer and Moderna mRNA vaccines have been modified to incorporate a synthetic non-natural nucleoside, 1-methylpseudouridine, which reduces the ability of the immune system to recognize the foreign mRNA and improves its stability and expression of its protein.

The spike molecule consists of two protein subunits, the first of which is responsible for the initial binding with ACE2, while the second promotes the fusion between the virus and the cell membranes. The mRNA sequence incorporated into the Moderna vaccine, mRNA-1273, specifically encodes the pre-fusion form of the second spike protein subunit that is found on the surface of the virus before it binds to the ACE2 cell receptor. The mRNA sequence is modified to produce a spike protein with two amino-acid substitutions at positions 986 and 987 on the protein that help to keep it in the pre-fusion state. In contrast, the mRNA utilized by the Pfizer-BioNTech vaccine (BNT162) only encodes part of the spike protein on the first subunit that specifically binds to the ACE2 receptor. Thus, the two vaccines drive immunity to different parts of the spike protein molecule.

Perhaps more importantly, the dose of mRNA in the two vaccines differs. The Moderna vax delivers a 3-fold higher dose (100 mcg) of mRNA compared to the Pfizer vaccine (30 mcg). This  means that more spike protein antigen to stimulate an immune response is expressed from the Moderna shot.

What does it all mean? Initially, these differences in lipid composition, mRNA sequence, and mRNA dose do not seem to affect vaccine effectiveness. Both are extremely effective at protecting against COVID-19 within a few months after the second shot. But, over time, differences in the effectiveness of the vaccines are showing up.

Last month, the Mayo Clinic released a preprint of a large study of 645,109 patients after vaccination. This assessed the level of protection from infection in people vaccinated with the Moderna or Pfizer vaccines, or who were unvaccinated between January–July, 2021. Both vaccines continued to be very effective at preventing hospitalization, ICU admission, and death relative to unvaccinated people over the period of the study. However, prevention against mild to moderate COVID-19 was somewhat lower for both vaccines in July compared to January. Vaccine immunity faded a bit over that time. Importantly, the efficacy of the Pfizer vaccine faded faster over this time compared to the Moderna vaccine. A more recent CDC analysis of COVID-19 emergency room or urgent care visits for ~33,000 people between June-August 2021, when the Delta variant was predominant in the US, showed that overall the vaccines were 86% effective at protecting against serious COVID-19. But, vaccine efficacy for those who received the Moderna vaccine was 92%, while those receiving the Pfizer vax showed 77% protection.

Similar results were found in another study of 196 vaccinated elder nursing home residents in Canada. Compared to those who received the Moderna vaccine, residents who received the Pfizer shot mounted a 3.89-fold lower antibody response. A Belgium study published August 30, also found that the Moderna vaccine stimulated ~3 times the antibody response as the Pfizer vax. This study looked at 1,647 vaccinated workers at a Belgium hospital. Finally, a Qatar study largely found the same thing; that the Moderna vaccine stimulated a more robust antibody response.

What accounts for the different responses to the different vaccines over time? That is impossible to pinpoint at this time. It could be due to the higher dose of mRNA in the Moderna vaccine. The difference in response over time could also be due to the different mRNA sequences the vaccines contain, or due to the slight differences in the chemical composition of the lipid nanoparticles. Or, any combination of the above could drive quantitatively different immune responses.

Most importantly, though, both vaccines continue to work amazingly well against serious COVID disease, hospitalizations and death. Even while the more infectious Delta variant rages around the world in the face of slowly fading vaccine efficacy, about 95% of COVID-19 hospitalizations and deaths today are in unvaccinated people.

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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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Vaccines And Myocarditis In Young People

Rare cases of inflammation of the heart muscle, or myocarditis, have been found in 1,200 younger people (16-24) after receiving an mRNA vaccine, and this has been used by anti-vaxers to further the hysteria around the vaccine. But, if you talk to a pediatric cardiologist you will learn that we should be much more worried about the disease than the vaccine. There simply is no comparison.

The post-vaccine myocarditis is very mild, has caused no deaths, is easily treated with anti-inflammatory drugs, and quickly goes away without lasting problems. On the other hand, COVID-19 can linger for months, and, as of June 9, has caused ~3000 deaths in young people. Because of this, the American Heart Association and American Academy of Pediatrics continue to strongly recommend vaccination for young people.

Myocarditis in young people is not a new thing, and is usually associated with a viral or bacterial infection. One vaccine against small pox has also been weakly linked to myocarditis. People from puberty through their early 30s are at higher risk for myocarditis, according to the Myocarditis Foundation. Males are affected twice as often as females. Most of these cases are very mild and many times people with myocarditis do not even know they have the problem. The incidence of myocarditis in young people peaks this time of year when the coxsackie virus, which can infect the heart, is more common. This means that an undetermined fraction of post-vaccine myocarditis is likely due to concomitant infection with coxsakie virus and not due to the vaccine.

Bottom line: Post-vaccine myocarditis is much ado about next to nothing. This should not cause one to hesitate getting the vaccine, unless the person has another underlying cardiac problem. The mildness of this rare side effect contrasts with the thousands of young people who have contracted serious COVID-19 and have even succumbed to the infection. While severe morbidity and mortality from COVID-19 is rarer in children and adolescents than in older adults, the number of cases in young people has been steadily rising on a weekly basis according to the CDC. This trend will likely accelerate as the more infectious, and possibly more lethal Delta variant becomes dominant in the US. Since most older adults have been vaccinated, that leaves younger people as available targets for the new virus surge. There is no rational reason for 99.9% of people to not be vaccinated.

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COVID-19 mRNA Vaccines Safe For Pregnant Women

I have received a few questions about the safety of the coronavirus vaccines for pregnant and lactating women. I discussed toward the end of one blog post about how maternal immunity can benefit the baby by passing the mother’s antibodies across the placenta and given in mother’s milk, thereby protecting neonates whose immune systems are still developing.

Now, an analysis of the CDC’s Vaccine Adverse Event Reporting System, and the “v-safe after vaccination health checker," and its associated v-safe pregnancy registry, shows that the Pfizer and Moderna mRNA vaccines appear to be safe for mothers and babies. The analysis examined almost 36,000 pregnant women who received one of the mRNA vaccines, and was reported in the New England Journal of Medicine.

Compared to non-pregnant women, pregnant women who were vaccinated reported more injection-site pain, but fewer incidents of headaches, myalgia (muscle pain), chills, and fever. About 14% of vaccinated pregnant women suffered pregnancy loss while about 9% of neonates born to vaccinated women suffered adverse events, and 3% of them were undersized. No neonatal deaths were reported. The important thing is that the incidence of these outcomes was similar to the incidence observed in pregnant women before the pandemic arose. Most of the pregnant women who were evaluated were vaccinated in the third trimester.

The study concluded that the data revealed no obvious warning signals for pregnant women who receive the mRNA vaccines. But, it also advised that followup with women vaccinated earlier in pregnancy is warranted.

Stay tuned.