COVID-19

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.

Immunizations: What You Need to Know

This is an update and modification of an old post titled Immunizations. It seems particularly relevant now given the politicization of the whole subject of immunization in the last few years.

Many parents are concerned about the number of immunizations that are recommended for their children and whether all these shots may have some serious long term side effects. Public health recommendations that ignore these concerns have created an adversarial situation that is not helpful for parents or for their children.

To put this in perspective, lets look at the current immunization recommendations for infants and children Number of shots will be placed in parenthesis.

Newborns: Hepatitis B (One shot)

Two Months: Hepatitis B, Tetanus-Diphtheria-Pertussis, H-flu, Pneumonia, Polio, Rotavirus (Six  shots). That’s a lot of needle sticks for a baby! Fortunately there are combined vaccines that reduce the number of shots.  Using the combined vaccines reduces the number of shots at two months from six shots to three shots.

Four Months: Same as two months  except no Hepatitis B (three shots using combined vaccines)

Six Months: Hepatitis B, Rotovirus, Tetanus-diptheira-Pertussis, H-flu,  pneumonia, Polio, flu shot, COVID-19 (four shots using combined vaccines) Another COVID-19 vaccination is recommended 4 weeks after the first one.

One Year: Polio, flu shot, Measles-Mumps-Rubella, Chicken pox, Hepatitis A (Four shots using combined vaccines).

Four Years: Tetanus-Diphtheria-Pertussis, Polio, Measels-Mumps-Rubella, Chicken pox (three shots using combined vaccines).

Nine Years: HPV vaccine. Second dose in 6 months to 1 year. HPV vaccine prevents infection with the wart virus also called human papilloma virus. HPV is the main cause of cervical cancer in women. It is transmitted through sexual intercourse. Given at age 9, the immunity is lifelong so immunizing children (girls and boys) means that as adults, when they become sexually active, there will be much less transmission of HPV and much less cervical cancer in women.

That’s a lot of shots, even with the combined vaccines, not even counting the HPV vaccinations recommended at age nine..  So one question is: Is the benefit of all these shots worth the discomfort to the children (not to mention the parents)?  Another question is: Are there risks (other than temporary discomfort) to giving all these immunizations?  A third question is: Does delaying immunizations for babies reduce any risks?

Let’s take these questions one at a time.

Vaccines clearly save children’s lives, so the answer to the first question is an unqualified yes!  Most parents have never seen a case of polio, or diphtheria, or tetanus (lock jaw).  The reason is that vaccines prevent them.  These were devastating diseases that killed or paralyzed many infants and children. They have not gone away.  If the immunization rate falls, we will see them again. We already have in communities where the immunization rate has fallen below a critical level.  In times past, many children died from pneumonia caused by a class of bacteria called pneumococcus.  The pneumonia shot has virtually eliminated this disease.

I have my own story about the Hemophilus influenza vaccine (Hib).  Until this vaccine came out, I saw at least one child a year with a serious infection from this bacterium. It caused meningitis, joint infections and pneumonia.  The sickest child I ever cared for had H-flu meningitis.  Since the vaccine came out, I have never seen another case.

Rotavirus is a common cause of severe diarrhea and dehydration in infants, and some die from this.  The rotavirus vaccine prevents this disease

Some parents wonder why we give vaccines for measles, mumps, rubella (german measles) and chicken pox.  Most adults over 60 had these infections in childhood and recovered just fine. Unfortunately, lots of people did not do just fine.  Measles can cause infection of the brain and pneumonia, Many people actually died or were permanently disabled by measles. The same story holds for chicken pox.  Rubella (german measles) is a mild, self-limited illness except if a pregnant mother catches  it.  In that case it causes severe birth defects in the baby.

Another question parents often have is why we give hepatitis B vaccine to all children.  Hepatitis B is transmitted by sexual intercourse or by needle stick, but it can also be transmitted to a baby during birth.  The recommendation used to be that we gave hepatitis B vaccine only to babies of high risk mothers. That did not work very well because it was impossible to reliably identify high risk mothers.  If you know for sure that neither parent has a chance of having hepatitis B, then it is reasonable to delay this vaccine until the child is older.  The only way to be sure is for both parents to test negative for hepatitis B antibodies. Since you don’t know and cannot control what sexual experience your child will have later in life, this vaccine should at least be given before puberty.

A final question that parents have is about the COVID-19 vaccine for children. Why do we need to give the vaccine when most children have only mild disease? There are two reasons to give the COVID vaccine to babies. One reason is that although most children have only mild disease, some children get very sick and have to be hospitalized. The other reason we immunize babies and children for COVID-19 is to protect vulnerable adults that they may be exposed to. Most hospitalizations for COVID-19 now are older people and people who have other risk factors such a suppressed immune system, diabetes, COPD and other chronic diseases.

Now lets talk about risks of vaccines.  I’m not talking about mild reactions such as a little irritability, low grade fever, or mild swelling at the site of the shot. That type of reaction is fairly common and self limited.  The real question most parents have is about long term serious risks to immunizations. Here are some questions frequently asked by parents.

1. Do immunizations increase the risk that my child will get autism?  The answer is no.  There is one study often quoted by anti-vaccine groups that reported an association between childhood immunizations and autism.  It turns out that the author of the study faked a lot of his data.  It has been thoroughly discredited and in fact the journal that published it retracted it.  Several very large well designed studies that were designed to answer this question found absolutely no connection between childhood immunizations and autism.

2. Do all these immunizations overstimulate children’s immune systems and increase the risk of autoimmune diseases later in life? The answer again is no.  In order for the immune system to work properly, it is stimulated by literally thousands of environmental substances called antigens during a child’s life.  It makes antibodies against these antigens so that children develop immunities to viruses and bacteria in the environment.  The vaccine antigens represent a tiny fraction of all the antigens in the environment, certainly not enough to cause overstimulation. Studies have shown no connection between immunizations and autoimmune diseases such as multiple sclerosis, lupus, or rheumatoid arthritis

3. What about the mercury preservative in vaccines. Does that cause any long term problems?  The preservative thimersol, which does contain some mercury, has been removed from all vaccines since 1992.  There was no evidence that this caused any problems, but it is nonetheless not an issue anymore.

4. Did some children have severe reactions to the pertussis (whooping cough) vaccine?

The old pertussis vaccine was called a whole cell vaccine. It contained the entire inactivated pertussis germ. There were very rare serious reactions with this vaccine, including high fever and sometimes seizures. Now the pertussis vaccine does not contain the whole germ. It is called an acellular vaccine. Since the acellular vaccine was added to the diphtheria and tetanus vaccines (now called the DTaP vaccine), serious reactions were eliminated.

5. Can COVID-19 vaccine cause decreased fertility or other long term chronic disease?

A tiny number of adolescents who received the COVID-19 vaccine developed some inflammation of the lining around the heart. None of these children were hospitalized and all recovered completely. This did not happen when 6 month old children got the vaccine. There is no evidence whatever that COVID-19 vaccines decrease fertility in women or men. That is one of those pieces of misinformation that grow on the internet like weeds. We have seen no ill effects from the COVID-19 vaccine in infants.

6. Is there any benefit to delaying vaccines until children get older?  Once again the answer is an emphatic no.  There is no evidence of any health benefit to delaying immunizations.  All of the diseases we immunize children against are most dangerous in infancy.  Pertussis (whooping cough) and diphtheria killed many infants before we had vaccines to prevent them.  All the other diseases we immunize against have a much higher chance of causing death in infants.  If you delay your child’s immunizations, you are depending on everyone else getting immunized to protect your child.  Not only is that not fair, but in some communities the immunization rate for infants has gotten low enough that you don’t even have that protection.

Bottom Line: Immunizations for infants and children are safe and effective.  They prevent diseases that used to kill or maim many infants and children. The only downside is the discomfort of multiple shots, which can be significantly ameliorated by using combined vaccines.  Delaying vaccines until children are older is dangerous for the child and provides no health benefits.

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.

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.

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.

Unpacking Mortality from COVID-19

The severity of any disease, especially a new pathogen like SARS-COV-2 is important to measure, especially it’s ability to cause death, which is the ultimate measure of severity. There are two ways to measure mortality from any infection.

Fatility Infection Ratio (IFR)

The proportion of deaths among all infected individuals. To measure IFR one has to know accurately the total number of infections as well as all deaths caused by, the disease. In the midst of a pandemic, with testing variably available and deaths often occurring at home it is impossible to accurately measure IFR.

Case Fatality Rate (CFR)

The proportion of deaths among identified cases. In the early stages of the pandemic, most cases are identified by surveillance and often only the most severe cases are tested. This leads to wide variation in estimates of CFR ranging from 0.1% to as much as 25%.

In fact, it is only possible to accurately measure either one of these fatality rates in retrospect, long after the initial stages of the epidemic. The number of deaths attributed to COVID-19 is almost certainly an underestimate. On the other hand, the number of people who have been infected is also certainly an underestimate. People with mild or asymptomatic infection are unlikely to get tested.

Another problem is that fatality rates from COVID19 are not uniform. Certain groups of people have an increased risk of mortality from COVID-19, so mortality is not uniform across people who are infected.

Excess Mortality

One way to deal with the first problem is to look at excess total mortality rates compared to historical mortality rates. It is very likely that excess mortality during the pandemic reflects the impact on mortality of COVID-19. Even if all of these deaths are not directly attributable to COVID-19, some may reflect unavailability of care at hospitals overwhelmed by COVID patients.

Excess mortality statistics are available through the first 30 months of 2020, which takes us through July 25 of this year. Because of the delay in reporting of death certificates, data for August and September are incomplete. For the US as a whole, there were 207,000 excess deaths for the first 30 months of 2020. This figure suggests that we passed 200,000 deaths from COVID-19 by the end of July whereas the number of reported deaths from COVID-19 at the end of July was 150,000. This was clearly an underestimate. It is also clear from these excess mortality numbers that the mortality from COVID-19 is much higher than from influenza.

Here is a graph of weekly recorded deaths from all causes for the first 30 weeks of 2020. The dark line represent excess mortality for 2020. The gray lines underneath are death rates from the previous 5 years. The spike in the beginning of the top gray line represents the H1N1 influenza epidemic. You can clearly see that even this spike is dwarfed by the excess mortality for the first 30 months of 2020. Here is a link to the website which has these data

Mortality by race/ethnicity

Another way to look at mortality data is to look at mortality by race and ethnicity. The mortality rate for african americans from COVID-19 is twice as high as for non hispanic whites. For native americans the death rate is 1.4 times as high and for hispanics the death rate is 1.1 times as high. These increased death rates by race and ethnicity have nothing to do with genetics. People of color have all sorts of socioeconomic factors that increase their risk of underlying conditions as well as living in crowded housing that make social distancing difficult or impossible. Many have low wage jobs that increase risk of contact with multiple people.

Mortality by age

Risk of dying from COVID-19 increases dramatically with age. Taking age 18-29 as the reference group, here are data from the CDC.

30-39 Risk of death four times higher

40-49 Risk of death ten times higher

50-64 Risk of death thirty times higher

65-74 Risk of death 90 times higher

75-84 Risk of death 220 times higher

85+ Risk of death 630 times higher

Mortality by underlying condition

According to the CDC, 94% of COVID-19 deaths had at least one underlying health condition. These include obesity, chronic lung disease, diabetes, poorly controlled high blood pressure, asthma as well as conditions or medicines that suppress the immune system.

Bottom Line

Mortality from COVID-19 is complicated. Traditional measures of mortality are impossible to obtain in the midst of the pandemic. Excess mortality is the best way to assess the impact of COVID-19 on death rates. Measurements of mortality are also not uniform and are markedly increased in older people, people of color, and those with underlying conditions. Excess mortality statistics clearly demonstrate that the death rate caused directly or indirectly by COVID-19 far exceeds influenza epidemics in recent years. The only pandemic that had similar or worse mortality was the 1918 influenza epidemic.

SARS-COV-2 Vaccines: Hype vs Reality

There have been predictions by the Trump administration and by some news media as well that it may be possible to have an effective preventive vaccine for the SARS-COV-2 virus by this fall. Every even slightly positive report of phase 1 and phase 2 trials have been breathlessly reported in the media. The purpose of this post is to give some reasonable estimates of when and if there could be an effective and safe vaccine for prevention of SARS-COV-2.

How vaccines are tested and developed

Exploratory stage

In this stage academic and federally funded scientists identify antigens (molecules that stimulate the immune system) that might help or prevent a disease such as COVID-19. This stage normally takes two to four years, but because of the tremendous financial resources and number of scientists involved in the exploratory stage, there are many potential vaccine antigen candidates already identified. In fact there are currently 165 vaccine candidates who have completed the exploratory phase.

Animal Trials

Vaccine candidates are often tested in animal models. If the vaccine protects animals from infection then it is more likely to lead to human trials. Vaccine protection in animals though, does not mean the vaccine will work or will be safe in humans. The two coronavirus vaccines that are farthest along in development, the one by Moderna and the one by Oxford have shown protection from pneumonia in mice and monkeys, but the noses of the animals showed just as much virus as monkeys that were not vaccinated.

Phase 1 Trials

In phase 1 trials, a small group of people are given a vaccine to see if the vaccine induces antibodies and if there are any adverse reactions. These involve only 15-20 people. The production of antibodies does not prove the vaccine will be effecting in preventing or reducing severity of infection. Twenty eight coronavirus vaccines have completed phase 1 trials.

Phase 2 Trials

In phase 2 trials the vaccine is given to hundreds of healthy people in different age and risk groups to see if the vaccine acts differently in different groups of people. Phase 2 trials provide more information about antibody production, but do not provide evidence about the effectiveness of the vaccine in the real world. Fifteen vaccines have completed or are currently in phase 2 trials.

Phase 3 Trials

In phase 3 trials, the vaccine is given to thousands of people. Half the people get a placebo injection while the other half get the vaccine injection. Both groups are followed over time to see how many in each group get infection and how severe the infection is. Each group is also monitored for side effects. A vaccine that is safe and effective will show decreased infection in the vaccine group compared to the control group and side effects in the vaccine group should be minimal and not serious. To count as effective, a vaccine would need to be at least as effective as the flu vaccine, which usually has about 50% protection. Nine vaccine candidates are in phase 3 trials. There are no shortcuts for phase 3 trials. Depending on the prevalence of the virus in the population being tested, phase 3 trials are likely to last from 1 to 4 years.

Chances of success

The success rate for vaccines that make it to phase 3 trials is low, around 30%. The good news is that there are a very large number of vaccines in various stages of testing. It is likely that at least two or three of these will turn out to be safe and effective. There is no guarantee that any of the vaccine currently in phase 3 trials will turn out to be safe and effective, and most will likely fail. Although it is possible that we will have a safe and effective vaccine by early in 2021, it is very unlikely.

Risks of emergency approval of vaccines

Russia and China have given emergency approval of vaccines that have not yet completed phase 3 trials. This is very dangerous. The bar for safety for giving a vaccine to millions of healthy people is very high. Short cutting the phase 3 trials has the potential to harm thousands of people with a vaccine that we don’t even know will be effective.

Hopefully the U.S. will not follow suit and the FDA will not approve a vaccine until phase 3 trials are completed and a vaccine is shown to be safe and effective.