SARS-COV-2

mRNA Vaccines – Truth vs Misinformation

Robert F Kennedy Jr has stopped funding for research to develop new mRNA vaccines because he says they don’t work well for respiratory diseases. He also claims that mRNA vaccines induce mutations in respiratory viruses. He says that even one mutation makes mRNA vaccines ineffective. Here is a link to his video post on X where he makes these claims. He also claims that he has consulted science experts who agree with him about mRNA vaccines.

In this post I will review the real science about mRNA vaccine technology, how mRNA vaccines differ from traditional vaccine technology and also discuss how viruses mutate and why (spoiler alert: they don’t mutate because of mRNA vaccines). Here is a link to a STAT news article that deconstructs Kennedy’s arguments: Kennedy’s case against mRNA vaccines collapses under his own evidence.

Traditional vaccines

There are two types of traditional vaccines, live vaccines and killed vaccines. Both types require growing the target virus in tissue culture. In a live vaccine, the virus is weakened so that infection does not cause the disease when injected into people with healthy immune systems. The MMR vaccine is an example of a live vaccine. It contains weakened strains of measles virus, mumps virus and rubella virus. Killed vaccines use some proteins from the virus to sensitize the immune system to kill the virus when it detects those proteins. the DPT vaccine is an example of a killed vaccine. It contains protein fragments from the diphtheria virus, pertussis (whooping cough) virus and tetanus virus. It is very labor intensive to create a vaccine using these traditional methods. To make enough weakened virus or virus protein fragments to immunize a large population takes a lot of tissue culture and a long time. It usually takes 10-15 years of research and development before new traditional vaccines are ready to use. Manufacturing those already approved vaccines is still very labor intensive.

What is mRNA?

The m in mRNA stands for messenger RNA. The genes in your DNA can’t do anything by themselves. They don’t directly make proteins. Instead they code for messenger RNA. Messenger RNA does the work of making proteins that determine hair color, eye color and all other genetic traits. Each type of messenger RNA is specific for a particular protein. Messenger RNA does not last very long in animal (or human) cells. It lasts from a few minutes to a few hours and then it disappears. The DNA makes more messenger RNA as needed.

How does an mRNA vaccine work?

The advantage of an mRNA vaccine is that the body does all the work of manufacturing the virus protein fragment. No intensive tissue culture is required. mRNA is synthesized in a laboratory. The synthesized mRNA codes for a specific virus protein. In the case of the COVID mRNA vaccine, the mRNA codes for the spike protein. When that mRNA is injected into a muscle, the muscle cells start to make many copies of the spike protein. The immune system recognizes this as a foreign protein and makes antibodies against it as well as sensitizing killer lymphocytes so that they recognize the protein too. Just like the body’s own mRNA, the injected mRNA only lasts for a few minutes to a few hours and then disappears. It never changes the DNA in the cell, because DNA makes mRNA, not the other way around.

How does mRNA vaccine speed up the vaccine development process?

We now have the technology to rapidly determine all the genetic code of a new virus. That sequencing can happen within a few weeks of discovering a new virus. That genetic code allows us to determine which proteins make up the virus particle. We can then decide which viral protein is the best to stimulate immunity to the virus and synthesize an mRNA molecule that will make that protein in human muscle cells. That process is much faster than the traditional method. We had an effective mRNA COVID vaccine within a year of the beginning of the pandemic. That is an absolutely unprecedented time scale in new vaccine development.

Do mRNA vaccines induce mutation in viruses

This is what Kennedy claims and it is absolutely not true. Some viruses, like COVID and flu virus mutate frequently and some like measles virus and polio virus are stable and do not mutate or mutate rarely.. The mutation rate depends on the nature of the virus, not on the vaccine. All vaccines, not just mRNA vaccines for viruses that mutate frequently lose some efficacy over time and the vaccine has to be modified. The viruses that mutate frequently would continue to do that whether a vaccine is available or not. Vaccines do not make viruses mutate faster. Most mutations make the virus less infectious, but the occasional mutation makes the virus more infective. The mutations that are more infective become more frequent and crowd out the older versions of the virus. Measles and polio vaccines prevent infection because the measles and polio viruses stay exactly the same over time.

Safety of mRNA vaccines

The only mRNA vaccine that we have extensive experience with are the ones developed for COVID. Mild reactions were common (sore arm, fever. myalgias) more commonly with the second dose. Rare cases of myocarditis (inflammation of the heart muscle) were reported in younger people. All of these were transient and completely resolved. There is a very tiny chance of having a severe allergic reaction to the vaccine. Out of 8 billion doses administered death due to allergic reaction occurred in 14 people. That is a risk of death of 1.75 x10-9 (1.75 preceded by 9 zeros!).That risk is much, much smaller than the risk of being killed in an auto accident. The risk of death from COVID in unvaccinated people is of course much higher. mRNA vaccines are safe with a minuscule risk of severe side effects.

Why do people still get influenza or COVID even after they have been vaccinated.

Antibodies induced by flu and COVID vaccines are in the blood stream and not as much on the mucus membranes. Although vaccinated people are less likely to get infected with influenza or COVID, the protection rate from infection is less than 100%. Vaccinated people can still get infected with influenza or COVID. The vaccine induced antibodies immediately start fighting the infection. This means that vaccinated people who get infected are much less likely to get severe infections, much less likely to be hospitalized and are much more likely to have mild symptoms. You get a great deal of protection from the vaccine even if you get infected with the virus. Kennedy asserts that if you get infected with the virus, then the vaccine does not work. That is poppycock!

Research into new mRNA vaccines

Researchers can now use AI to develop universal mRNA vaccines for COVID and influenza that could develop immunity to multiple genetic variants at the same time. This technology would mean that new vaccines don’t have to be developed every year to deal with new genetic variants. This technology also might make it possible to develop vaccines for malaria and leptospirosis. It may also be possible to use this technology to develop vaccines that sensitize the immune system to destroy cancer cells.

All of the federal funding for research using this promising technology has been blocked by HHS secretary Robert F Kennedy Jr.

Bottom Line

mRNA vaccines can be developed much faster than traditional vaccines. They are safe and effective at both preventing disease and making disease much milder when infection does occur. mRNA technology has the potential to make universal flu and COVID vaccines, vaccines for malaria and leptospirosis and even vaccines to prevent cancer. It is unconscionable that federal funding for this important research has been halted.

Omicron Variant of SARS-COV-2

I will continue the series of posts on healing relationships, but I think we have enough information about the omicron variant of SARS-COV-2 to spend some time talking about it. In this post I will discuss infectivity, vaccine resistance, and some prevalent misinformation which continues to complicate rational measures to combat the virus.

Infectivity

First a little review on epidemiology. Those of you who want a more complete review can look at my previous post Epidemiology Made Simple. The potential infectivity of any virus or bacteria is described by a number called R0. R0 is the average number of other people that one infected person infects. R0 for the original SARS-COV-2 virus detected in Wuhan, China was about 2.5. That means that on average one infected person infected between two and three other people. The delta variant of SARS-COV-2 has an R0 of about 7. That means that on average one person infected with the delta variant infects 7 other people. The delta variant is almost three times as infectious as the original virus!

So far it looks like the omicron variant has an R0 of about 10. To put that in perspective, the most infectious virus that we know of is the measles virus. It has an R0 of 13. That means the omicron variant is almost as infectious as measles. That is why it is spreading so fast. Cases in the U.K. where omicron is predominant are doubling every two to three days! That makes it almost impossible to limit the spread by contact tracing.

R0 refers only to the potential infectivity of the virus in people who have no immunity. This potential infectivity can be reduced by measures that either increase immunity (such as vaccination or previous infection) and/or that limit the spread of the virus in people such as masking, social distancing and avoiding small, poorly ventilated indoor spaces.

Effectiveness of vaccines for omicron

Effectiveness of vaccines is measured two ways. First is the effectiveness of the vaccine in prevention of infection in the first place. Second and much more important is the effectiveness of the vaccine in preventing hospitalization and death.

Omicron has more than thirty mutations in the spike protein. This means that it looks very different from the original virus isolated in Wuhan. The previous definition of fully vaccinated was two immunizations. Those people who had two vaccinations had about 70% protection from infection with the delta variant, but so far in the U.K. it looks more like 10% protection from omicron infection. Protection from being sick enough to be in the hospital, though is still very good, even without a booster. Having a booster gives about 80% protection from symptomatic infection and about 99.9% protection from hospitalization and death.

Does the omicron variant cause milder disease?

It is too early to be sure about that. Hospitalization rates for people infected with the omicron variant are lower so far, but that is in countries such as the U.K. with very high vaccination rates, or like South Africa that has high numbers of people who have had COVID previously. We don’t yet know the hospitalization rate for the unvaccinated, but hospitalizations are starting to go up in the U.K. and in much of the U.S. What we can say so far is that the omicron variant does not seem to cause more severe disease, but that is all we can say at this point. Because omicron is so contagious, we will see huge increases in case numbers and therefore hospitalizations no matter what the severity of illness omicron causes.

What about children?

There have been a number of articles in the press recently about hospitalizations going up for children with COVID. While that is true, the numbers are still tiny compared to hospitalizations for adults. Children are still at substantially lower risk of symptomatic infection even with the omicron variant. That does not mean that they don’t get infected at all, just that their infections are much more likely to have no symptoms. In a recent large antibody study in Texas (more about this later) a third of the children in the study showed evidence of previous COVID. Over half of those children had no history of any symptoms at all. That is good news for the children, but bad news for adults exposed to them. It appears that infected children without symptoms could be major spreaders of COVID.

Vaccines protect children five to twelve years old as well as they protect adults. The only serious side effect for children is mild inflammation of the heart called myocarditis. This occurs in about one in one million doses, almost never requires hospitalization and goes away by itself.

There has been a great deal of misinformation about the risk of vaccination in children. A U.S. virologist, Dr Robert Malone, has posted a video claiming that the spike protein fragments created by the vaccine are toxic and cause damage to multiple organs in children. This is utterly false. Millions of children have received the Pfizer vaccine and there is not one shred of evidence that there is any organ damage other than the mild transient myocarditis that occurs in one in a million.

Is having had and recovered from COVID as good protection as having a vaccine?

There definitely is some protection from having COVID in the past. It is not as good as protection from the vaccine though, and it tends to wane more quickly than protection from the Pfizer or Moderna vaccine. In the Texas study that I mentioned earlier, called Texas Cares, the University of Texas Health Science Center recruited over 87,000 people in Texas ages 8 to 80. I was a participant in that study. Every participant filled out a survey asking about symptoms of COVID and dates of vaccinations. Then blood was drawn at a local lab at baseline and every 3 months for two more times. The survey was repeated before each blood draw.

Two antibody tests were done on each sample. One test measured the N antibody. People who were positive for N antibody had COVID at some previous time. The other test measured antibodies to the SARS-COV-2 spike protein. The spike protein antibodies are the neutralizing antibodies that protect you from severe illness with COVID. People who had only the spike protein antibody had been vaccinated but had never had COVID. The preliminary results were recently published. What they found was that spike protein antibodies in unvaccinated people with a previous infection peak at 120 days after infection and then decrease. Unvaccinated people with a previous infection overall had lower levels of spike protein antibodies than people who were vaccinated. People who had a previous infection and were vaccinated had the highest levels of spike protein antibodies.

As an example I will use my own data from this study as well as the data from a friend who had COVID but had not been vaccinated. My initial spike protein antibody level was over 300. His was 30. Three weeks after my booster of the Pfizer vaccine I went for the second blood draw. My spike protein antibodies at that blood draw were over 2,500.

This study clearly suggests that COVID vaccines give better protection than previous COVID infection and that boosters cause a big increase in neutralizing antibody. The combination of previous COVID infection and vaccination gives the best protection of all.

Should I wear a mask even if I am vaccinated and boosted?

The omicron variant is so contagious that even vaccinated and boosted people could still get infected even though that infection is likely (but not guaranteed) to be mild. My personal feeling (and the CDC recommendation) is that everyone should continue to mask indoors in public places, like grocery stores, department stores or any other public place indoors where multiple people not known to you congregate. U.S. made N-95 masks are now readily available and provide much better protection than cloth masks.

Bottom Line

The omicron variant is extremely contagious, almost as much as measles. Vaccines, especially with a booster give 80% protection from symptomatic infection and 99% protection from hospitalization and death. Children frequently get infection without symptoms and may serve to spread infection to others. Vaccinating children five to twelve is safe and effective. Having had a COVID infection in the past gives some protection but is less than protection from vaccines. Because omicron is so contagious N-95 masks should be worn in indoor public places regardless of vaccination status.

The Delta Variant: What Does It Mean for Vaccinated and Unvaccinated People

What is the Delta Variant?

SARS-COV-2 is an RNA virus which means it’s genetic code is RNA rather than DNA. The genetic code for SARS-COV-2 is a long chain made up of four different bases. We can think of the four bases as an alphabet that consists of only four letters. These “letters” are A (which stands for adenine), C (which stands for cytosine), U (which stands for uracil and G (which stands for guanine).

Normally SARS-COV-2 makes exact copies of itself inside a human cell and these copies go on to make new virus particles. Very rarely the RNA of the virus makes a mistake when copying itself. An A might be substituted for a G, for example. These mistakes are called mutations. Almost all of these mutations make the virus function less well and they quickly disappear. Once in a great while a mutation occurs that makes the virus work better. When this happens viruses with the mutation spread faster and if they make the virus much more infectious, then the virus with the mutation quickly replaces the old form of the virus without the mutation.

That is exactly what has happened with the Delta variant. It is a mutation that makes the SARS-COV-2 virus much more contagious. Instead of each infected person infecting around 2 others, the Delta variant mutation causes each infected person to infect 5 other people. Because it is so infectious it has spread very quickly and is now the dominant form of the virus in the United States. If you get COVID today, there is a very high probability that you are infected with the Delta variant. There therefore is no need to test any individual infected person for the Delta variant.

Fortunately although the Delta variant of SARS-COV-2 is much more contagious, it does not seem to cause any more serious disease than the old form of the virus, but having a lot more people infected means that a lot more people will get very sick and require hospitalization.

I have already had COVID. Am I protected against the Delta variant?

There is some protection, but probably not very much. Even if you have already had COVID you can get infected again with the Delta variant and you might be much sicker than you were the first time.

I have been fully vaccinated. How protected am I against the Delta variant?

All of the vaccines in the United State that have FDA emergency approval (Pfizer, Moderna and Johnson & Johnson) provide about 80% protection from infection with the Delta variant. That means that out of 100 fully vaccinated people exposed to the virus, 20 will likely get infected. Those twenty people will tend to have no or mild symptoms and will not need to be admitted to the hospital. Very rarely a fully vaccinated person will get very sick and might even die. Rarely means about 1 person out of 1000 fully vaccinated people are hospitalized for COVID and nine out of ten hospitalized patients recover.

Being fully vaccinated makes you much less likely to get infected with the Delta variant and if you do get infected you are likely to have no or very mild symptoms. Vaccination means you have 99.99% protection from severe COVID requiring hospitalization. If everyone wears a mask indoors, the rate of infection for vaccinated people approaches zero. Even if most people are not masking indoors (though they should be) vaccinated people should still wear masks indoors because if they are infected with the Delta variant, even if they have no or mild symptoms, they could still pass the virus on to others.

I am not vaccinated. What is my risk of getting infected with the Delta variant?

If you are exposed to an infected unmasked person indoors and you are not wearing a mask then your chance of infection with the Delta variant is close to 100%. If infected you have a 20% chance of being hospitalized and a 1% chance of dying. That means that of 100 unvaccinated people exposed to the virus almost all of them will get infected. Twenty of those people will be so sick that they have to be hospitalized and one will die. Wearing a mask indoors protects you a little bit, but if everyone wears a mask indoors, your chance of being infected is much less. Obviously, you can’t control what other people do, and in states with low vaccination rates, there are also many fewer people who mask indoors. Your best shot at protecting yourself from getting very sick and perhaps dying is to get vaccinated as soon as you can. In the meantime avoid closed indoor spaces, especially where people are talking loudly or singing. Always wear a mask indoors.

Hospitalization rates are very high in states and counties where vaccination rates are low. Hospitals in those states and counties are almost out of ICU beds and are short on staff to care for desperately ill people. That means that those hospitals may not be able to take care of people who have heart attacks, car accidents or other serious illnesses. Some of those people will die because care is delayed. Although these deaths are not directly caused by COVID, these deaths would not happen if hospitals were not overwhelmed with COVID patients. Therefore another reason to get vaccinated is to take some of the stress off hospital workers who are exhausted and burning out.

Do I need a booster shot if I have been fully immunized?

Good immunity from the vaccines lasts for at least 8 months and probably longer. There is some evidence that immunity from all of the vaccines starts to decrease after 8 to 9 months. Booster shots will be available in mid September, and people who had their second vaccine 8 months or more ago probably should get a booster.

Vaccine Side Effects

By far the most common side effects of all COVID vaccines are fatigue, headache, fever and sore arm. These side effects go away within 24 to 48 hours.

Myocarditis and Pericarditis

The Pfizer and Moderna vaccines rarely cause some heart inflammation. This happens in about 12 people per million vaccinated. It is always mild and almost never requires hospitalization. All cases so far have gone away on their own and there have been no deaths.

Central Vein Thrombosis

The Johnson & Johnson vaccine rarely causes blood clots in a central vein in the brain. This happens in about 7 people per million vaccinated. This is the rate for women under 50. Men and women over 50 have an even lower risk. This can cause death, but if recognized in time can be treated and cured.

To put this risk in perspective, your chance of dying every time you drive a car is about one in one hundred. Almost everyone who drives is willing to accept this level of risk, which is way higher than your risk of death or disability from any COVID vaccine

Vaccine Misinformation

COVID vaccines do not cause infertility in women or men. COVID vaccines do not cause or make you more susceptible to getting COVID. COVID vaccines do not change your DNA. COVID vaccines do not put microcomputers in your body. There have been no unsafe shortcuts in the development of any of the COVID vaccines in use in the United States.

Bottom Line

All COVID vaccines available in the United States are safe and effective. They markedly decrease the risk of infection with the Delta variant and while breakthrough infections do occur, they tend to have no or mild symptoms. Current vaccines give 99.99% protection against getting sick enough to need hospitalization. Severe vaccine side effects do occur but are exceedingly rare and all are curable. The risk of infection with the Delta variant in unvaccinated people is very high as is the risk of hospitalization.

Lies, Anecdotes and Evidence

Lies

Lies are deliberate falsehoods. The person telling a lie knows the truth, but chooses not to tell it. There are several main reasons for lying. The first, and most common is to avoid responsibility or punishment for something you have done. We are all familiar with the young child who lies for this reason. “I did not break the lamp, Mommy. It just fell off the table.” An alternative strategy to avoid blame or punishment involves blaming someone else. “I did not break the lamp, Mommy. Jaimie did it.” The third reason is to manipulate someone else’s behavior to get them to do something that you want. The classic form of this kind of lie is the telephone scam. The caller asks for money and promises to do something he/she has no intention of doing.

Lying is always destructive, but when lying becomes common in the public sphere, and when lies are told by people who would normally be trusted sources of information, then trust is eroded for everyone, even people who are telling the truth. A substantial portion of the public begins to believe that everyone is lying. This clearly happened through most of 2020 with regard to the pandemic.

Sometimes things are called lies that are not. If someone says something they truly believe to be the truth and are later proved incorrect by subsequent evidence, they are not lying; that is they are not telling a deliberate falsehood. An example of this is that early in the pandemic, Dr. Fauci and other experts at the CDC said that universal mask wearing was not necessary. As evidence accumulated, it became clear that this was incorrect; that universal masking markedly reduced coronavirus transmission. Their initial recommendations were incorrect as proved by later evidence, but they were not lies.

Anecdotes

We have all seen articles such as these online: “Physician dies after receiving COVID vaccine”; “Patient gets infected with COVID-19 two weeks after second COVID vaccination”; “Study shows hyrdoxychloroquine prevents COVID-19.”

These are all examples of anecdotes. Anecdotes are stories, based on personal experience or reports of results based on small non-representative samples. Often these stories are dramatic as shown in the examples above.

Our brains are hard-wired to look for patterns. This was very useful in the evolution of our species, because not recognizing patterns was much more likely to be fatal! Unfortunately, this tendency to look for patterns causes us often to see patterns where there aren’t any. That is why people are predisposed to believe dramatic stories that are based on little or no evidence.

Here are a couple of examples not related to COVID-19:

Flu shots can give you the flu

As a family physician I saw this one every fall. Flu shots are given at the beginning of the season when respiratory viruses are becoming more common. Inevitably, some people would get sick with a viral infection shortly after receiving their flu shot. Flu shots, of course, cannot cause flu. They are made of pieces of viral proteins that cannot infect cells in the body. Such is the power of anecdote though that all my scientific explanations made little difference to people who were convinced that the flu shot caused their viral infection.

Childhood immunizations cause autism

Symptoms of autism generally begin about age two. By that age almost all children have received several immunizations. Once again, this is the power of anecdote. Many parents of children diagnosed with autism are convinced that immunizations caused the autism. This hypothesis has been studied in several very large, well designed studies and thoroughly disproved. Many of these parents remained convinced because of their anecdotal experience that immunizations caused their children’s autism.

Physicians and anecdotes

Physicians are not immune to the power of anecdotes. As a matter of fact many continue to prescribe medicines or treatments that have been shown to be worthless or even harmful. Their excuse is almost always that “in my own experience this treatment works” or “I have never seen these harmful side effects in my patients on this treatment.” I have been guilty of this myself. Years ago a study from Canada showed that a simple exam of an ankle injury could rule out a fracture and save getting x-rays on all of these. The first time I tried it, the exam showed no evidence of a fracture, but the patient ended up having a broken ankle. Despite the fact that this was a perfect example of anecdotal evidence, I got an x-ray of every ankle injury for a long time after that.

Evidence

Evidence, as opposed to anecdotes, comes from systematic studies of large groups of people. Evidence helps answer important questions related to health and disease. There are several forms of evidence that are useful. The kind of evidence depends to some extent on the question. Below are brief descriptions of studies that helps us understand and better treat illnesses such as COVID-19.

Double blind randomized controlled trials

There is only one kind of evidence that gives us confidence that A causes B, or that A does not cause B. It is called a double blind randomized controlled trial. Here is how it works. A large number of people are recruited that are representative of the population who might use the treatment. The subjects are randomized into two groups by the equivalent of flipping a coin for each person. Instead of a coin, a computer does the equivalent of a coin flip. Dividing subjects in this way means that each person has an equal chance to be included in either group. One group will get the experimental treatment and the other group, called the control group will get a placebo that looks just like the treatment medicine but does not have any biologic activity (a sugar pill for example). The subjects don’t know whether they are in the treatment group or the control group. They are “blinded” as to which group they are in. The medicines are labeled with a code, so that not even the investigators know who is getting the treatment and who is getting the placebo. That is the investigators are “blinded” to who is in the treatment group and who is in the control group. That is what double blind means. Neither subjects nor investigators know who is getting the treatment and who is getting the placebo.

What is the reason for all this “blinding”? It is called the placebo effect. In any trial there are a number of people who will get better even when they get a placebo. These are not just psychological effects. When the brain thinks it may be getting a medicine, hormones and neurotransmitters show real physical changes and that makes people feel better. People who are giving the medicines can unwittingly increase the placebo effect, which is why the investigators are “blinded” too. At the end of the trial the code is broken so investigators then know who got the treatment and who got the placebo. If the treatment group has statistically more positive results than the control group, then we know the treatment works. If the control group has about the same improvement as the treatment group, then we know that the treatment does not work.

Anecdotal evidence suggested that hydroxychloroquine might work to treat or prevent COVID-19. A double blind randomized trial though showed no effect on either prevention or treatment of COVID-19.

Anecdotal evidence suggested that high doses of vitamin D might prevent COVID-19 or make it milder. A double blind randomized trial showed no effect of vitamin D on prevention or severity of COVID-19

COVID-19 vaccines were also tested in double blind randomized controlled trials. That is why we are confident that they work very well at preventing infection, hospitalization and death.

Double blind randomized trials are expensive and take a long time to get results. It is not practical to do double blind randomized trials on every scientific question. Also, there are some questions that a double blind randomized controlled trial cannot answer. Sometimes a randomized controlled trial would be unethical. That would be the case if using a placebo group would clearly cause harm to that group.

There are other kinds of evidence that help us decide whether it is worth it to do a double blind randomized control trial or that provide useful evidence when placebo controlled trials are impossible or unethical.

Case-Control Studies

This kind of study is used to answer a question about whether exposure to something causes a disease. The. “exposure” is measured in people who already have the disease (cases) and in a group of similar people who do not have the disease (controls). Unlike randomized controlled trials, case-control studies cannot tell whether the exposure causes the disease. They can only show that the exposure is associated with the disease. There is always the possibility that the difference between the cases and controls is related to some difference between cases and controls other than the exposure being measured. Years ago a case-control study showed an association between coffee drinking and pancreatic cancer. People who drink coffee were much more likely to smoke. It was the smoking that caused the increased risk of pancreatic cancer, not the coffee drinking. Systematic differences between cases and controls other than the exposure being measured are called confounders. Confounders that we know about, such as smoking, can be removed from analysis by statistical techniques. In a case-control study, however, there is always the chance that there are confounders we don’t know about. That is why we can never use a case-control study to say the exposure causes the disease or condition.

Another potential problem with case-control studies is called “recall bias.” Let’s say that the exposure we want to measure is sugar intake and the disease we want to measure is diabetes. We ask people in both the diabetic group. (cases) how much sugar they eat in a month and ask the same question for non-diabetics (controls). People are unlikely to remember accurately the amount of sugar they ate in a month. People may tend to minimize how much sugar they eat. This will obviously make the results of the study much less reliable. People tend to remember (recall) things selectively. That is recall bias.

Population Studies

These studies look at whole populations that live in a particular area. They are similar to case control studies in that They look at an exposure (say intake of saturated fats) with a disease (say heart disease). If consumption of saturated fats is different in whole populations of different countries then the incidence of heart disease in those populations will be measured as well.

The best population studies follow populations over time. Like case-control studies, they can only show association, not causation, but sometimes they can be very useful anyway.

The most famous population study, the seven country study by Ancel Keys followed populations in seven countries over many years. This study was the first to show that animal fat intake was associated with heart disease and that high blood pressure was associated with heart disease and stroke.

The Framingham Study followed the population of Framingham, Massachusetts for many years. In addition to confirming the findings of the seven country study, It showed for the first time the association between diabetes and cigarette smoking with heart disease.

Peer Review

Until the pandemic the main way that results of evidence based studies became known to the public was publication in scientific journals. In order to get a study published in a reputable scientific journal, it first has to be looked at by one of the editors of the journal. The editor decides if the study meets the criteria for that journal, and many papers get rejected at this stage. If the editor thinks the study is done well and fits the criteria for the journal, then the editor sends the paper to at least three experts in the field of the authors of the paper. They critique the paper, make suggestions to improve it, and send their comments to the authors and the editor of the journal. Many more papers get rejected at this stage. Sometimes the authors are asked to re-submit their paper after making changes suggested by the reviewers. This whole process is called peer review. This process assures that for the most part only well done studies make it to publication. The other quality control in scientific studies is replication. One study, no matter how well done, may have missed something. If other peer reviewed studies come up with the same results, then we have increased confidence that the findings are real.

Pre-print servers

The peer review process takes a lot of time. It is usually months, sometimes many months between the completion of a study and its publication in a peer reviewed journal. In the midst of the pandemic that was too long. Physicians who were treating desperately ill patients with a new disease needed to know the results of trials quickly. Scientists could publish their results online as soon as the study was completed and before submission of their studies to peer reviewed journals. The websites that allow them to do this are called pre-print servers. This process allows the results of studies to be available to doctors very rapidly, but the quality control of peer review is missing. Results published on pre-print servers should be considered preliminary. Many of them will not make it through the peer review process when they are submitted to scientific journals.

The Media

Most non-scientists do not read scientific journals or pre-print servers. They find out the results of scientific studies through the media. The media serve an essential function in translating the jargon of scientific papers into language that most people can understand. While there are a few excellent journalists who understand how to evaluate scientific papers, for the most part that is not the case. The media look for things that are splashy and they are just as likely to trumpet preliminary findings from pre-print servers as they are to discuss peer reviewed papers in journals. Even if they discuss the findings of peer-reviewed papers, they often emphasize the positive and do not report the author’s caveats about how carefully to interpret the findings.

I refer you back to my previous post about reliable media sources of medical information

Bottom Line

Lies are deliberate untruths, but when lying comes from sources that we usually can trust, that creates distrust of all sources, even ones that tell the truth.

Anecdotes are compelling stories based on personal experience or reports of small non-representative groups. Our brains are programmed to look for patterns, even when those patterns are figments of our imagination.

Reliable evidence is based on trials of large numbers of people who are representative of the population at risk of disease. Double blind randomized controlled studies are the gold standard of reliable evidence, but other kinds of studies can give good information as well.

Media reports of scientific studies can be useful, but definitely need to be taken with a grain of salt. Some media sources are much better than others.

The Terrible Toll of the Pandemic

Hope is in the air. Effective vaccines came sooner than anyone thought possible, and it is likely that the United States will reach herd immunity sometime in mid summer. That means that people will be able to gather again, travel on mass transit and airlines safely again, be able to hug our grandparents. This has been described as returning to normal. Many people seem to think that life will be just like it was before the pandemic. Nothing could be further from the truth.

Deaths

There are more than 500,000 families in the US who have lost loved ones to the pandemic. That is a staggering number and is in some ways incomprehensible to us. We have never experienced in our lifetimes death on this scale, not even in world wars. The numbers are so large that they begin to make us numb. We cannot allow that numbness to take over. One out of three people in the U.S know someone who has died from COVID-19. Each one of those 500,000 families lives with the existential reality that their loved ones are gone from their lives forever. They have holes in their hearts that will scar over with time (lots of time) but that will never disappear. Even if you believe in an afterlife, these families will live the rest of their lives with the knowledge that they will never see their loved ones again in this life. What makes these deaths even more traumatic for families is that their loved ones died alone. They could not be at the beside holding their hands. Those who got to say goodbye at all had to do it via FaceTime or Zoom. Nor is the death toll over. Over 1400 people died of COVID-19 yesterday.

These are our friends, our neighbors and it is our responsibility to do what we can to ease their suffering as best we can. Mostly that means just being there and listening to their stories. It is easy to turn away or to offer platitudes about healing. Seeing someone else suffer is painful, but we must not turn away. Instead of asking how we can help, we just need to help, to be there, to be present.

Sometimes poetry is the best way to truth. Over 400 years ago John Donne wrote a poem about how death affects a community. Bubonic plague (the Black Death) had decimated England with ongoing and recurring epidemics for years. We would do well to pay attention to his words today:

No Man is an Island
No man is an island entire of itself; every man
is a piece of the continent, a part of the main;
if a clod be washed away by the sea, Europe
is the less well as if a promontory were, as
well as any manner of thy friends or of thine
own were; any man’s death diminishes me,
because I am involved in mankind.
And therefore never send to know for whom
the bell tolls; it tolls for thee.

Post-COVID Syndrome

Of those who have survived COVID-19, up to 30% have something called post-COVID syndrome. This occurs more frequently in women. It is characterized by shortness of breath, brain fog, episodes of rapid heartbeat with minimal exertion and severe fatigue. This can occur even when the symptoms of the acute COVID were mild. It is becoming clear that it affects hundreds of thousands of people who have had COVID. Many of these people are so sick that they are unable to work. This syndrome can last for months. There is an excellent article in The Atlantic that describes this syndrome and how devastating it can be.

PTSD among Health Care Workers

Health care workers have worked tirelessly to care for desperately ill people in hospitals. Three thousand of them have died from COVID-19 as a result. They have had to watch many of their patients die and have had to serve as the stand-ins for family who could not be there. They worked until they were exhausted and came back the next day to do it again. This is a recipe for PTSD and 1 in 4 of them are suffering from classic symptoms of PTSD. This is unfortunately the new normal for them.

The Unequal Economic Impact

Some of us have suffered very little economic impact from the pandemic. Low wage workers, who are disproportionally people of color have lost their jobs in large numbers. Many of them worked in the hard hit hospitality sector. These low wage workers are not likely to get their jobs back for 2-3 years. They have continuing food insecurity and are likely to become homeless in large numbers.

Our New Normal

Even with a successful vaccination campaign that frees us from our enforced physical isolation, many people will continue to suffer. It essential for those of who have escaped COVID-19 and who have avoided financial ruin to step up and help those who have and continue to suffer. We must contribute in every way we can both financially and by volunteering our time and expertise.

All of us have suffered from the pandemic in one way or another, even if we have escaped having COVID. As we emerge from our enforced isolation the experience of the past year should remind us that life is precious and transient and that our relationships with others are even more precious. Our political differences are small potatoes compared to this.

Coronavirus Variants: How do they Happen and What do they Mean?

Coronavirus Replication

The genetic code for the SARS-COV-2 virus is RNA rather than DNA. RNA can make copies of itself just like DNA, so the coronavirus can make copies of its RNA genetic code using the machinery of the cell that it infects. In fact, when the spike protein of the virus attaches to the ACE2 receptor on the surface of the cell, it injects only the viral RNA into the cell. The viral RNA then begins to use the cell machinery to make thousands of copies of itself. At the same time, the new viral RNA starts to make the proteins that form the capsule and the spike proteins. These assemble themselves into new complete virus particles that can go on to infect other cells.

The “alphabet” that makes up the viral RNA molecule has only 4 different “letters” (called nucleotides). These are adenine (A), guanine (G), cytosine (C) and uracil (U). These nucleotides are combined in different sequences in the viral RNA. SARS-COV-2 has about 30,000 nucleotides. Different segments of these 30,000 letters code for all the virus proteins, including the spike protein that allows the virus to attach to the ACE2 receptors on the surface of human cells.

Mutations

SARS-COV-2 RNA makes some enzymes that ensure that the RNA is copied exactly. The letters for the RNA copies are in exactly the same sequence as the original RNA. This “safety check” is not perfect, but it’s pretty close. It probably works 99.99% of the time. Every now and then though the copying process accidentally substitutes one letter for another, say a G instead of an A. This is a completely random process. The virus does not “try” to make these mistakes (in fact it does not “try” to do anything). Even though these mistakes happen only .01% of the time, .01% of billions of virus particles ends up being a lot! The vast majority of these mistakes (mutations) either have no effect on the code for the proteins, or they adversely affect the proteins that the RNA makes and makes the virus less able (or unable) to infect other cells. Once in a blue moon, however, the mistake changes the spike protein in such a way that it attaches more efficiently to the ACE2 receptor on the cell surface. That means that this particular version of the virus becomes more infectious. Since it is easier for this new version to infect cells, it quickly proliferates and eventually replaces the original version of the virus. It then becomes what is called a variant.

When the virus is infecting lots of people there are more opportunities for variants to occur. In fact, the virus that started the epidemic in New York City was a variant that came from Europe and was much more contagious than the original version of the virus that originated in Wuhan, China.

We only find variants when we look for them. Some countries do a much better job of doing genetic sequencing on a significant percentage of positive coronavirus tests. The UK, for example does genetic sequencing on 10% of their positive tests. The U.S has taken a hit or miss approach, but it looks like we are soon going to get our act together and set up a system similar to that of the UK.

Current Variants

There is no commonly agreed upon convention for naming SARS-COV-2 variants. They are often identified by where they were first discovered. This is not a great way to name variants (witness the attacks on people of Asian descent caused by the term “China Virus”). I will use a naming convention that is most commonly used that names variants in relation to others.

D614G This was the first major variant identified in March of 2020. It was more transmissible than the original virus sequenced in Wuhan, China. It was the major variant in Europe and also caused the original epidemic in New York City. The current vaccines approved in the US work well against this variant. Monoclonal antibodies, which prevent serious disease if given within 10 days of getting COVID-19, also work well against this variant.

B.1.1.7 This variant was first identified in the UK. It is also more infectious and more transmissible. It has been identified in the US and is rapidly replacing the D614G variant. Vaccines and monoclonal antibodies also work against this variant,.

Cal.20C This is a more transmissible variant that has been identified in California. It has only recently been identified and it is not clear yet whether vaccines or monoclonal antibodies work as well against this variant

B.1.351 This variant first appeared in South Africa. It is the most worrisome, because it shows some resistance to currently available vaccines, and monoclonal antibodies don’t seem to work at all. It has been identified in the US.

P.1 This variant is circulating in Brazil. Not as much is known about it, but it seems to have the same mutation as the B.1.351 South African strain. It is apparently causing re-infection in people who had COVID-19 previously and recovered.

HOW MUCH SHOULD WE WORRY ABOUT VARIANTS?

The major concern about these variants is that they are more contagious and spread faster than the original form of the virus. The B.1.351 and P.1 strains are of particular concern because the monoclonal antibodies that worked so well for people at risk with early COVID-19 do not seem to work at all with these two variants. That means that people who get infected with these variants are more likely to get seriously ill and more likely to die.

The vaccines currently approved for use in the U.S. seem to work slightly less well at preventing infection from these two variants, but they still protect nearly 100% in preventing hospitalization and death. Vaccine companies are working on a booster shot that will work better against the resistant variants. Such a booster can be developed rapidly and does not have to be tested in thousands of people like the original vaccines. Such booster shots could be available in a few months. The problem is that currently only 9% of the U.S. population has received two doses of vaccine and only about 2% have had COVID-19 and recovered. Even that 2% may still be at risk of reinfection with B.1.351 and P.1.That means that 91% of Americans are still susceptible to infection with these variants, which are likely to spread rapidly.

We can prevent another surge of hospitalizations and deaths if we continue masking and social distancing for a few more months at which time we should be close to herd immunity from vaccinations. The actions of Texas and Mississippi in eliminating all restrictions are very worrisome (and very unwise). A surge in these states will not be limited to residents of those states. People travel and people congregate. Texas and Mississippi are essentially putting the whole country at risk of another surge. More people will be hospitalized and more people will die. I expect we will start to see an increase in cases in these two states in about 3-4 weeks. Hospitalizations will start to increase in about 6 weeks and deaths in about 2-3 months. I would love to be proved wrong, but we have played this tune before several times, and we know the outcome.

Bottom Line

The new variants are more transmissible and harder to treat. The three vaccines approved for use in the U.S. do not prevent infection quite as well with the new variants, but are still very effective at preventing hospitalization and death. Developing booster shots that work better against the new variants will be a fairly rapid process. In the meantime, until you can be vaccinated, masking and social distancing are essential to prevent another surge in cases, hospitalizations and deaths. Texas and Mississippi are putting the whole country at risk. If you live in those states please continue to wear masks in public, maintain social distance, and avoid closed indoor spaces until you can be vaccinated. Any of the three vaccines will keep you out of the hospital and keep you from dying of COVID-19.

Misinformation about SARS-COV-2 and COVID-19 – How to Recognize Misinformation

One more piece of misinformation about masks – Copper

In the last post I did not include one more common piece of misinformation about masks. There are many masks advertised on television that tout the fact that they contain copper. While it is true the SARS-COV-2 does not last as long on copper surfaces, there is no evidence that copper in masks makes any difference. Rather than spending your money on a copper containing mask, focus on finding well fitting masks with a tight weave and multiple layers.

How to recognize misinformation on websites and social media

Here are some organizations/people who consistently provide misinformation

  1. Association of American Physicians and Surgeons. This is an impressive sounding name, but it is actually a right wing group that has promoted a number discredited medical ideas. These include: AIDS is not caused by HIV; being gay reduces life expectancy; abortion is associated with breast cancer; vaccines cause autism (thoroughly discredited by well designed randomized controlled trials).
  2. America’s Frontline Doctors. This group is actually headed by a dentist. They promote treatments like hydroxychloroquine and nutritional supplements to treat COVID. One of the leaders of this group was recently arrested for storming the Capitol. There is actually a legitimate group called America’s Frontline Physicians that promotes evidenced based medical care.
  3. Dr. Joseph Mercola. Dr. Mercola is an osteopathic physician who markets dietary supplements and medical devices, most of which are of questionable health benefit. All of these are marketed through his website and/or through a number of books that he has written. He claims that mRNA vaccines are gene therapy, and also that COVID-19 is not caused by SARS-COV-2.
  4. Fox News, Breitbart and Newsmax often provide misleading information about COVID-19 or downright misinformation

It is not possible, of course to address all the sources of misinformation on the web and social media. We are in the middle of an ‘infodemic’ of misinformation. There are some ways, however to recognize what is likely to be misinformation.

  1. Any website or social media post that promotes a simple cure or prevention for COVID-19 is likely misinformation, especially if the treatment being promoted is a vitamin, a supplement, hydroxychloroquine or azithromycin.
  2. Any website or post that implies that mRNA vaccines are dangerous or are gene therapy is certainly misinformation
  3. COVID-19 is a complex disease and we are learning more about it all the time. Any website or post that makes things sound simple is probably misinformation

Reliable sources of information about COVID-19 and SARS-COV-2

  1. CDC (website cdc.gov). The CDC has the best scientists and epidemiologists in the world. The previous administration tried to censor the information from the CDC and often undermined it. The current administration has stopped this practice. Information changes as we learn more about COVID-19 and SARS-COV-2, but the CDC website has the most up to date science based information and recommendations.
  2. Mayo Clinic (website mayoclinic.org). The Mayo Clinic site has lots of reliable information about COVID-19 and it is presented in a way that is geared for patients and non-physicians.
  3. WebMd (website webmd.com). This website is designed to provide information on many medical conditions including COVID-19. It is easy to search for specific information.
  4. STAT news (website statnews.com). This news service specializes in current developments in health and disease and has many useful and interesting articles on COVID-19 and SARS-COV-2.
  5. Major news organizations, specifically New York Times; Washington Post; Los Angeles Times; Boston Globe.

If you receive a post or tweet from a friend that you think might be information, please do not share it with your friends. This is how misinformation spreads like a disease. If you have a question about whether what you are seeing is misinformation, use the comment section of this post to ask about it. I will aggregate these and respond in another post or posts.

Misinformation about SARS-COV-2 and COVID-19 -Misinformation about Masks and Treatment

Misinformation about Masks

Mask Misinformation 1: Masks don’t work, so there is no point in wearing one

This is false, of course. The most recent information is from a review of all the studies about mask use from the Journal of the American Medical Association. The conclusion is that masks decrease the risk of catching COVID-19 by 70%. Masks that fit snugly, have more than one layer, and have a tight weave are the most effective. Masks especially protect other people when they are worn by people who are infected. They also, however, protect the wearer from becoming infected. Since people are most infectious before they develop symptoms, universal mask wearing provides the most protection for everyone. Here is a link to the article in JAMA.

Mask Misinformation 2: Masks can make you sick

The claim is that bacteria build up inside the mask and that can cause infection. There is absolutely no evidence to support this claim. People who wear masks have no higher incidence of any infection than people who don’t wear masks. People who consistently wear masks, though, have a 70% lower chance of catching COVID-19 than people who do not wear masks consistently.

Misinformation about Treatment

Treatment Misinformation 1: Hydroxychloroquine and/or azithromycin prevent and treat COVID-19

This is one of those pieces of information that is like a zombie. No matter how much it is discredited, it never seems to die. There have been a number of very well designed studies to evaluate hydroxychloroquine as both a treatment and for prevention of COVID-19. All of these studies show absolutely no effect of hydroxychloroquine for either treatment or prevention of COVID-19. The same is true of azithromycin. There is no evidence of any effect for treatment or prevention for it alone or in combination with hydroxychloroquine. People who took hydroxychloroquine in these studies had more side effects and actually did worse than the control patients who did not get hydroxychloroquine.

Treatment Misinformation 2: Large doses of vitamin D prevent COVID-19

There is some evidence that people who have below normal levels of vitamin D have a slightly increased risk of serious COVID-19. Low levels of vitamin D are more likely to occur in northern latitudes where there is less sunshine. There is no evidence that people with normal vitamin D levels benefit from taking extra vitamin D for either treatment or prevention of COVID-19. If you live in the north, it might be worthwhile to ask your physician to check a vitamin D level. If you live in the south you are very unlikely to have anything other than a normal vitamin D level, so a test is probably not worth it.

Treatment Misinformation 4: Nutritional supplements such as vitamin C and zinc help prevent and treat COVID-19

Once again, there is no evidence that vitamins and nutritional supplements either prevent or treat COVID-19. A recent article in the Journal of the American Medical Association reported on a randomized controlled trial (the gold standard in study designs) evaluating vitamin c and zinc as treatment for mild COVID-19. The trial showed no effect. Here is a link to that article.

Prevention

The only interventions that have been show to prevent COVID-10 are wearing a well fitted cloth mask with multiple layers, social distancing of six feet or more, and avoiding closed indoor spaces. Vaccines have been shown to prevent serious disease. It is possible that they also prevent infection, but it will be several more months before we can be confident of that.

Treatment

There are several treatments that have proven to be somewhat effective in the treatment of COVID-19:

  1. Remdesivir has a modest effect on decreasing duration of illness.
  2. High dose steroids, such as dexamethasone are helpful in people hospitalized with severe disease.
  3. Monoclonal antibodies (bamlanivimab, casirivimab and imdevimab) are helpful in high risk people who have early COVID-19.

There are no “natural” medicines that treat or prevent COVID-19. Hydroxychloroquine and/or azithromycin are ineffective for treatment or prevention and hydroxychloroquine seems to cause increased harm.

In the next post I will talk about how misinformation spreads on social media and how to recognize it. I will also provide some reliable online sources of real information about SARS-COV-2 and COVID-19.

Misinformation about SARS-COV-2 and COVID-19 – Vaccine Misinformation

Introduction

In this post and the ones that follow I will try to accomplish several goals. I have been fielding a lot of requests to comment on misinformation about COVID-19. This misinformation falls into several categories, so the first thing I will do is to detail each one of these, explain why they are not true, and give the correct information. It will be impossible to respond to all the misinformation out there, because it proliferates sort of like weeds in a garden. A second goal of these posts will be to discuss how misinformation proliferates, primarily on social media. The third goal will be to provide some reliable sources of information that can always be trusted. Here goes!

Misinformation about vaccines

Vaccine Misinformation 1. The new vaccines (mRNA vaccines) are not true vaccines because they cause the body to make components of the virus rather than making fragments of the virus in a lab. mRNA vaccines are gene therapy and permanemtly alter your DNA.

First lets talk about the definition of a vaccine. A vaccine is anything that causes immunity to a disease other than being infected with the disease itself.

There can be many ways to do this. One way is to make a weakened form of the virus or bacteria and actually infect people with it. This is called a live attenuated vaccine. Measles vaccine and smallpox vaccine are examples of this. A more common method today is to use a piece of the virus or bacteria that cannot reproduce, so it can’t cause infection. This is called an inactivated vaccine. The inactivated piece of virus or bacterium causes the immune system to make antibodies against the fragment of the virus or bacterium. This allows the immune system to immediately recognize infection with the live virus or bacterium and destroy it before it becomes established in the body.

The old way to make inactivated vaccines required being able to grow the virus in the lab, figure out which part would stimulate the immune system, make lots of copies of that part, and then inject it into people. This was a very time consuming process. The shortest time to develop a vaccine like this was the mumps vaccine, and that took 10 years.

New technology allows us to quickly figure out the entire genetic sequence of the virus. The coronavirus, SARS-COV-2, happens to have a sequence of only RNA, not DNA. In a normal cell, RNA is a “messenger” from the DNA in the nucleus of the cell. The RNA actually makes the proteins that the cell needs. The RNA from SARS-COV-2 takes over the cell machinery and makes viral proteins and more viral RNA that assemble themselves into thousands of new virus particles. The cell eventually ruptures and dies, releasing the thousands of virus particles that go on to infect other cells and repeat the process.

The genius of the messenger RNA (mRNA) vaccines is to use the way the virus RNA makes proteins against it. By injecting only a piece of viral RNA, the muscle cells near the injection site take up the RNA and make thousands of copies of one of the virus proteins, called the spike protein. Since the whole viral RNA is not there, the whole virus can’t be made and no cells can be infected. The immune system makes antibodies against the spike protein made by those muscle cells. Instead of the laborious and time consuming process of making pieces of viral protein in a lab, the body does all the work using the fragment of viral RNA to make the protein that causes immunity. The DNA in the cell is never touched or altered, so this is not gene therapy. Furthermore, the fragment of viral RNA used in the mRNA vaccines is very unstable and falls apart soon after it causes the muscle cells to make copies of the spike protein.

Thus, by the definition of a vaccine mRNA vaccines are true vaccines. They cannot cause infection. They never affect DNA, so therefore are not gene therapy. They fall apart in a few hours. They have been shown to be very safe and effective at creating immunity and preventing illness from COVID-19.

Vaccine Misinformation 2. mRNA vaccines insert nano-computers into your body that can track you

This is probably a misunderstanding of the fact the the mRNA vaccine is enclosed in a little lipid (fat) particle to keep it from being immediately degraded by the body’s enzymes. These little fat globules are very small, so they are called nano particles. There are no computers, nano or otherwise in the mRNA vaccines.

Vaccine Misinformation 3. mRNA vaccines cause infertility

mRNA vaccines are only absorbed by muscle cells near the injection site. They do not circulate in the bloodstream and cannot possibly affect any part of the reproductive system in men or women.

Vaccine Misinformation 4. Covid-19 is a mild disease and side effects from vaccine are worse than the disease.

Eighty percent of people who get COVID-19 have relatively mild symptoms or no symptoms and recover completely. That leaves 20% (two out of every 10 people) who get serious disease many requiring hospitalization. Even if the overall death rate is only 1%, that is 10 times the death rate from influenza. At this point in the pandemic, COVID-19 is the leading cause of death in the United States. Serious side effects from the COVID vaccines are extremely rare. About 1 person in a million gets a severe allergic reaction called anaphylaxis. This always occurs in the first 20 minutes after administering the vaccine and is easily treated with an epinephrine shot. Mild symptoms are common including pain at the injection site, low grade fever, muscle aches, and fatigue. These almost always disappear within 24 to 48 hours.

COVID-19 is a serious, life threatening disease for two out of 10 people that get it. Vaccine side effects are common but mild and self-limited. Serious side effects are very rare and easily treated.

In the next post I will discuss misinformation about mask wearing, the origin of the virus, as well as a few common miscellaneous pieces of misinformation.

SARS-COV-2 Vaccine Update

In a previous post about when we might expect an effective vaccine for SARS-COV-2, I said it would be unlikely that a vaccine would complete phase 3 trials and be approved by early 2021. I love being wrong about that prediction! There are three vaccines that have been shown to be highly effective in phase 3 trials, and at least two of them are likely to be approved before the end of 2020. The third one will likely be approved within the next month or two. Each vaccine requires two doses and each has certain advantages and disadvantages. I will briefly describe those for each of the three vaccines below.

Pfizer-BioNtech vaccine

This vaccine was developed by a collaboration between a U.S. pharmaceutical company, Pfizer, and a German biotech company, BioNtech. It uses a technology that has never been used in a licensed vaccine before called mRNA (messenger RNA).

Traditional vaccines require growing the virus in tissue culture and then breaking down the virus into components that will stimulate the immune system to make antibodies. It is a very labor intensive process to make these viral components, and they have to be intensely purified to make them safe and effective.

Messenger RNA that codes for certain SARS-COV-2 proteins can be chemically synthesized in large quantities. When injected into the upper arm, these mRNA molecules are absorbed into muscle cells, and then the muscle cells begin to make the SARS-COV-2 spike proteins. The immune system recognizes these as foreign invaders and develops antibodies against them. The genius of this approach is that the body manufactures the viral components itself rather than the labor intensive process for traditional vaccines.

One problem with this approach is that mRNA molecules are very fragile and easily fall apart. The Pfizer-BioNtech vaccine must be stored at -94 degrees. This requires a special freezer. It will be a challenge to distribute this vaccine to a large number of people, particularly in the developing world where such freezers are expensive and unavailable

Data from phase 3 trials show an efficacy of 90%. That means that that there were nine infections in the people who got the placebo vaccine for every one infection in the people who got the real vaccine. That is extraordinary. The flu vaccine, for example has only about 50% efficacy.

Moderna vaccine

This vaccine was developed by a U.S. pharmaceutical company based in Massachusetts. It is also an mRNA vaccine and also has an efficacy of 90%. Moderna used a special trick to avoid having to use super cold storage required by the Pfizer-BioNtech vaccine. They enclosed the mRNA molecules inside little lipid (fat) membranes. This makes the Moderna vaccine more stable so that it can be stored at normal freezer temperatures of zero degrees.

Oxford-AstraZeneca vaccine

This vaccine was developed by the British pharmaceutical company, Oxford and will be manufactured by the U.S. pharmaceutical company, AstraZeneca. Rather than injecting mRNA directly, the company used a cold virus isolated from Chimpanzees. They deleted 20% of the virus DNA, so that it is unable to reproduce inside the human body. They replaced that 20% with genes that manufacture the SARS-COV-2 spike protein. The virus enters the human cells and then the cells manufacture the spike protein. Once again, the immune system recognizes this spike protein as a foreign invader and makes antibodies against it.

The efficacy data for this vaccine is a little puzzling. Because of a manufacturing error, AstraZeneca made some vials that contained only a half dose of the vaccine. People who got the half dose first and then the full dose for the second shot showed a higher efficacy (90%) than those who got two full doses (70%). Moderna and AstraZeneca will have to add more people to their phase 3 trial to resolve this issue. This will delay the application for approval by a month or two. A huge advantage of this vaccine is that it can be stored at refrigerator temperatures.

Side Effects

Side effects in the phase 3 trials were not common, but did include fever, muscle aching, headache and fatigue. These symptoms only lasted a day or two and then resolved completely. There have been no serious or long term side effects reported with any of the three vaccines.

Length of Protection

Because this a novel virus that has been circulating in humans for less than a year, we do not know how long immunity will last. Hopefully it will be at least a year, but at this point that is unknown.

Will vaccines keep me from getting infected and passing the virus on to others?

The only thing that was tested in the phase 3 trials was prevention of symptomatic illness. It is possible that vaccinated people are still susceptible to asymptomatic infection and might still transmit the virus to others. Until this question can be answered, people who receive the vaccine should still practice masking and social distancing.

When will these vaccines be available?

The logistical challenge of manufacturing and distributing any of these vaccines will be daunting. None of these vaccines will likely be available to the general public before this spring or summer.

Should I take a vaccine when it is available and which one?

All three of these vaccines have had rigorous evaluation for efficacy and safety, and the FDA will review all these data independently before approving them. I would strongly recommend taking any of these vaccines once they are approved by the FDA. I certainly intend to do so,