- 35 New overrated vaccines
- FDA lowers vaccine effectiveness requirement to just 50%
- Currently, antivax is not a bad option
- American obesity is a problem with any disease
- Operation Warp Speed
- Huge profit potential for drug makers
35 New overrated vaccines
Immunity comes from antibodies and from T cells
I have written about how vaccines trigger 2 types of immune responses. The 1st is an antibody response, and it gets all of the headlines. In response to a virus in the bloodstream, a type of white blood cell called a B lymphocyte manufactures proteins called antibodies. These cells release the antibodies into the bloodstream and attach to the virus. This prevents the virus from entering cells, reproducing, and then destroying the cell.
If a person already has enough protective antibodies when he gets the virus, there will no cell damage. And there are no symptoms, which means that the patient is immune and he will not get sick.
If he had no antibodies and then gets sick, and his body produces enough antibodies after getting sick, there will be no further cell damage. Healthy cells will replace the damaged cells and the patient will recover.
T cells might be more important as antibodies
There is a 2nd type of white blood cell that vaccine scientists discuss, but it is largely ignored by the media. These are T cells, and they might be even more important than B cells. We don’t know yet.
T cells do not make antibodies, but they can still prevent or cure an infection. There are 3 varieties of T cells and they either attack the virus in the bloodstream or destroy infected cells. The bottom line is that they can eliminate the infection.
Like B cells, T cells have memory, but their memory might last much longer. If a person recovers from a viral infection, but sometime later gets exposed again, these T cells will quickly reproduce and either prevent a 2nd illness or make it milder.
When a researcher does a clinical trial of a vaccine, he measures T cells as well as antibodies. This is because the vaccine might create a strong T cell response that might actually give a more lasting and more effective protection than the antibody response. We do not yet know.
We have all had coronavirus infections
I have said a few times that all of us have had coronavirus infections at some point. This is because all of us have had colds, and one of the 4 common viruses that cause the common cold is a coronavirus. About 20% of our colds were caused by coronaviruses. The other 3 types are Rhinovirus, parainfluenza virus, and the RSV (Respiratory Syncytial Virus). About a quarter of common colds are caused by other unidentified viruses.
This is important because everyone knows that some people get very sick from Covid-19 and others have very few symptoms. Scientists wonder if those who do not get sick have T cell immunity from a prior coronavirus infection, like a cold.
Other researchers have found that blood samples from several years ago have a T cell response to SARS-CoV-2, which is the virus that causes Covid-19. This is true even though the virus did not infect anyone until late in 2019. Others have made a similar observation. Therefore some people might have enough crossover immunity from a prior coronavirus infection, like a cold, to prevent a Covid-19 infection or to make the infection be mild.
T cell immunity might turn out to be more important than antibodies. We should know within a year.
Regeneron created what they call an antibody-drug combination. They genetically modified mice to have a human immune system. They took Covid-19 antibodies from these mice and from patients who have recovered to create their REGN-COV2 drug. Their website does not clearly explain how they are producing the drug:
Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. They selected the two most potent, non-competing and virus-neutralizing antibodies to create REGN-COV2 and have scaled up this dual-antibody cocktail for clinical use with the company’s in-house VelociMab® and manufacturing capabilities.
REGN-COV2’s two antibodies bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in recent Science publications. More recent research also demonstrates coverage against the now prevalent D614G variant.
They claim that their research in monkeys shows that the drug prevents the Covid-19 virus from infecting the monkeys. Furthermore, they say that it is an effective treatment after monkeys get infected.
This is not a peer-reviewed study and therefore it is too early to assess its value. However, it is evidence of what I have been saying for awhile. Scientists might not be able to create a safe, effective vaccine that gives immunity that lasts a year or more. While there has been so much news about vaccines, treatments might become more important in the long run, like with HIV infections.
Your immune system overcomes a Covid-19 infection with B cells producing antibodies and T cells attacking the virus and infected cells.
Instead of having your body make antibodies in response to an infection or a vaccine, Regeneron is making those antibodies in a lab for you. Their plan presumably is to give them to you through an IV if you get infected. If this is successful, it will be particularly helpful for elderly or other immune-compromised patients who cannot make enough antibodies to kill the coronavirus.
FDA lowers vaccine effectiveness requirement to just 50%
Because the country is desperate for anything that will increase our safety, the FDA is eager to get vaccines approved. In June, the FDA lowered its requirement for effectiveness for a Covid-19 vaccine to 50%.
But what does 50% effective mean? You can read the article, but it is arcane. The FDA does not mean that 50% of vaccinated people will avoid any symptoms. Instead, it means that in the clinical trials, at least 50% of the vaccinated volunteers did better than those receiving a placebo.
For example, give the vaccine to 1,000 people and a placebo shot to another 1,000 other people. Then, after a few months, find out how many in each group got sick. If 10 of the placebo patients get Covid-19, but only 5 vaccinated people got sick, the vaccine prevented 50% of the infections. Researchers therefore say it 50% effective.
But the FDA guidelines appear to let a drug maker claim 50% effective if 5 got clearly got sick and 5 more had minimum symptoms. They might have had shorter hospital stays or they might have become symptom free a few days earlier. Those 5 would could be said to have benefited from the vaccine, and the drug maker could claim that the vaccine was effective in those 5.
In this instance, both the vaccine and placebo groups had 10 sick people, but 5 of the vaccine people were not as sick as the placebo group. Most Americans would say that the drug company is cheating, but this result appears to meet the FDA guidelines.
All that matters is that there is a statistically significant improvement among the treatment group. There are mathematicians who specialize in making this determination based on the data from the research. However, if you get stung by 10 wasps one day and then only 7 a month later, that is better but you are still going to suffer. In these studies, a little better is the minimum that the researchers need.
Only 42% plan to get vaccinated
Yahoo News/YouGov poll, conducted July 28 – 30 found that only 42%of Americans plan to get vaccinated. Once there is a safe and effective vaccine, that number will go up, but I doubt it will get above 60 – 70% of the population. Many Americans are afraid of vaccines, and this one is being rushed. That makes people less trustful.
If the vaccine is only 50% effective at preventing or reducing the severity of Covid-19 and only 42% get vaccinated, then there might only be about 20% of the population who are no longer carriers. Because each infected person infects 1.5 to 2.5 other people, herd immunity requires about 70% of the population to be immune. We need herd immunity for the total number of infections to gradually shrink and end the pandemic.
No one knows for certain if we need 70%. It might be less than 60%, but 70% is a reasonable bet based on the current death rate.
Dr. Fauci says the US has the world’s worst outbreak
Dr. Fauci is in a difficult position because he has to be careful about what he says because he wants to keep his job. He made comments that speak for themselves this week in a Harvard School of Public Health interview.
Here are some of his quotes:
“[When asked if the US had the worst outbreak in the world] Yeah, it is quantitatively if you look at it, it is. I mean the numbers don’t lie.”
“I mean when you look at the number of infections and the number of deaths, it really is quite concerning.”
“We can do much better, and we can do much better without locking down, and I think that strange binary approach, either you lock down or you let it all fly, there’s some place in the middle when we can open the economy and still avoid these kind of surges that we’re seeing.”
“Any demographic group that’s not seriously trying to get to the endgame of suppressing this, it will continue to smolder and smolder and smolder.”
“The unseemingly things that crises bring out in the world, it brings out the best of people and the worst of people, and getting death threats to my family and harassing my daughters to the point where I have to get security. It’s amazing.”
“I wouldn’t have imagined in my wildest dreams that people who object to things that are pure public health principles are so set against it and don’t like what you and I say, namely in the world of science, that they actually threaten you. I mean, that to me is just strange.”
“There is a degree of anti-science feeling in this country.”
“I think it’s not just related to science, it’s almost related to authority, and a mistrust in authority that spills over, because in some respects, scientists, because they’re trying to present data, may be looked at as being an authoritative figure.”
He was also interviewed by Bloomberg’s Balance of Power this week and he a more sober assessment of his expectations for a vaccine. There are currently 35 vaccines in clinical trials. From what Dr. Fauci is saying, the politicians and media are far too optimistic. It appears that all of the vaccines are overrated and will disappoint most Americans. I assume these are his actual expectations, which are far worse than what the public has been led to believe:
“A 50 – 60% effective vaccine is totally value added if you complement it with public health measures. I’d love to have a 90% effective, but if we get a 50 – 60% effective, I will feel good about that.”
“If you get a vaccine, you will have at least several months protection to get you through a season… If it turns out you need to boost someone, that’s okay too.”
The American people are becoming comfortable with the thought that the disease might be around for a long time. I saw an interview with a guy on the street, and the reported asked him why he wasn’t wearing a mask. He said, “Why bother? We’re all going to get it.”
How to achieve herd immunity?
To reach 70% and herd immunity, if 40% get vaccinated, we need some combination of the 3 following possibilities. Remember, half of the vaccinated people are immune so they contribute 20% of the 70%.
First, 50% of the population has to get infected, which means 160 million infections in the US. But if the death rate is even only 0.5%, then 800,000 Americans will die. Deaths are not going to suddenly stop once there is a vaccine since so many people will not get vaccinated.
Second, a much higher percentage of Americans needs to be vaccinated. That will happen over time once people see that the vaccine is not killing lots of Americans.
Finally, the effectiveness of vaccines must be significantly greater than 50%. Remember, “effective” means either not getting sick, or getting sick but not as sick as non-vaccinated Covid-19 patients. We need 50% of vaccinated people to not get sick at all. That would require an effectiveness of 70% or more because effectiveness includes both people not getting sick and people getting sick, but less sick than non-vaccinated people.
Masks could save 65,000 Americans by Christmas
There was a study in June that showed that masks might reduce infections by 65%. Obviously, N95 masks provide more protection and a single layer of cloth, like a bandanna, provides less.
One sad thought is that the half of the country not wearing masks could save 65,000 lives by the end of the year if they wore masks.
How did I come to that conclusion? Remember, an infected person infects others, and at some point, there is a death. There are models that show that there will be 300,000 American deaths by the end of the year. That is about 140,000 more than today, and it is based on about half of the country wearing masks.
Of that 140,000, about two-thirds will be cause by non-mask wears. If they wore masks, their share of 100,000 would fall to 35,000. That means if they all wore masks, they would save more people in 6 months that what we lost in the Vietnam War.
Shouldn’t everyone want to be a part of saving 65,000 lives in 5 months?What a great accomplishment that would be! This should outweigh any reason to not wear a mask. But it is too theoretical for most people to consider. Also, it would require leadership, which we do not have. Easier to just let them die.
Currently, antivax is not a bad option
I am a physician and I think getting vaccinated is the right choice. The anti-vaxxers are pretty much opposed to all vaccines for a variety of reasons. In the case of the Covid-19 vaccine, the math is currently not much better for the vaccine crowd. But it will get better as the vaccines improve.
We will not have herd immunity until about 70% of the population is immune. They can get their immunity either by recovering from Covid-19 or by getting vaccinated.
There is a 3rd theoretical possibility, but even if it turns out to be possible, the number of people getting it would be too small to factor into this discussion. I mentioned above that some drug companies are working on manufacturing antibodies. Theoretically, a person could become immune for a couple months or more if he received these antibodies through an IV injection.
How bad is the risk of not getting vaccinated?
We need 70% of the population to be immune for the pandemic to begin to slowly disappear. More and more people will keep getting infected until 70% of the population is immune. Then, each infected person on average will infected less than one other person because most of the people whom they encounter will be immune. That will result in the pandemic eventually disappearing.
One of the worst pandemics in history was smallpox in the colonial Americas. It might have killed 90% of native Mexicans. However, we know from past pandemics that probably less than 70% of the population will get infected with Covid-19. It could be only 30 – 50%.
Let’s look at the worst case for vaccines. Assume that only 40% of Americans get vaccinated and that the vaccine prevents the infection in only half of those. That means that 20% of the population could be immune through vaccination. It also means that the remaining 80% of the population would remain at risk of getting infected.
Remember, we need 70% of the population to be immune. Therefore, the other 50% would come from people getting infected. Some of that 50% will be from vaccinated people since only half of them will be immune.
Risk of infection might still be high after vaccination
While this math is not precise, a person not getting vaccinated will have about a 50% chance of getting infected. Of the vaccinated people, half will not be adequately immune and will get infected at about the same rate as non-vaccinated people. Since the population in general has a 50% chance of getting infected and a vaccinated person has a 50% chance of having the same risk as a non-vaccinated person, the risk of infection among all vaccinated people will be 25% (50% of 50%).
While that is twice as good as a non-vaccinated person, is it enough to persuade people to assume unknown risks from the vaccine? I believe those unknown serious risks will occur in fewer than 1% of cases, but since they are unknown, an anti-vaccine person can argue that they are much more common.
As a physician looking at the math, I will get vaccinated
In any case, as a physician who makes decisions on math and data from controlled clinical trials, the math for the anti-vaxxers is not bad here. About half of them will get infected compared to about a quarter of vaccinated people. That difference is not great enough for me to forcefully argue that everyone should get vaccinated.
But if better vaccines come along that completely prevent infection in 70% or more of vaccinated people, and if the risk of serious complications is less than 1 in 1,000, then the arguments in favor of getting vaccinated will have a much stronger mathematical basis. I believe we will get there within a couple years, but by then, the pandemic should be over.
However, the virus might become endemic instead of pandemic. It might just hang around for a decade or more. Remember, our immunity might only protect us for 6 months or so. Maybe a year or two. I suspect that by next year, we will begin to see people who recovered this year from a bad case of Covid-19 get another very bad case of Covid-19. We might need vaccinations every 6 – 12 months for many years.
American obesity is a problem with any disease
The US has more obese people than most countries. The CDC says that 42% of Americans are obese. That is shocking. But at least 20% of the citizens of most developed countries are obese, which also is a depressing thought. Japan is an outlier with an obesity rate of only 4.3%.
Incidentally, 9% of Americans are morbidly obese, which means a BMI of 40 or more and 100 pounds overweight. In case you are wondering if I am downplaying obesity because I might be a fat American, I have only 13% body fat, which is far less than even the average Japanese citizen.
Several people have commented after my Covid-19 reports that obesity is part of the reason why the US is doing so much worse that other countries. Several years from now, epidemiologists will analyze all of the data and determine the significance of each factor contributing to the disastrous pandemic in the US.
Obesity is part of the problem, but lack of leadership is the major factor
Obesity is an important contributing factor in the hospitalizations and deaths in all countries. If we had fewer obese people, we would have fewer deaths.
Our obesity rate is about 50% more than that in the majority of other developed countries. If it was the main factor behind all of our deaths , we might have 50% more deaths. So with 4% of the world’s population, maybe obesity would get us to 6% of the world’s deaths. However, we are at 25%. Therefore obesity accounts for only a small part of the US disaster.
Our lack of leadership from both political parties is by far the most important factor in the number of US infections and deaths. It is the reason why we have had 25% of the world’s deaths with only 4% of the world’s population.
Obese people are more likely to have high blood pressure, diabetes, heart disease, and many other diseases as well. They have less overall reserve, and a stress like a serious infection can be more than they can handle.
I want to share a comment that I sometimes heard in the 1970’s while in medical school at the University of Chicago. It annoyed me at the time and it still does. But it makes the point that obesity is a problem for all diseases. The older residents sometimes explained to me why an obese patient was not doing well by saying that the patient had a case of PPP, which meant Piss Poor Protoplasm.
Although this was dehumanizing and they did not quote any scientific studies to back up their claim, what they were saying is that they strongly believed that obese people with just about any serious disease did worse than non-obese people. Since that time, many studies have validated their crude observation.
American obesity is a problem with any vaccine
In addition to obese people getting sicker from Covid-19, they will probably have a problem with the vaccines as well. Vaccines for the flu, tetanus, rabies, and hepatitis B work less well in obese people, and this will likely be a problem with Covid-19 vaccines.
One obvious reason is that vaccines work best when they are injected into muscle. If a person is very obese, the technician giving the vaccine might have a difficult time knowing whether the needle is in muscle or fat. Consequently, some patients might simply not be vaccinated properly.
Beyond that, obesity affects the immune response. For example, the level of antibodies falls more rapidly in obese people. Also, vaccinated obese people can have less protection from a vaccine. A study of a flu vaccine from the University of North Carolina found that obese vaccinated people were more likely to get the flu. This is true even though they had protective levels of antibodies. Therefore, obesity might also be affecting the T cell component of immunity.
Operation Warp Speed
Operation Warp Speed (OWS) is our government’s attempt to have 300 million doses of Covid-19 vaccine available in January 2021. It also is trying to accelerate the development of other countermeasures, including treatments and diagnostics.
OWS is a partnership among components of the Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD). OWS engages with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA.
As of July 31, the federal government has reached deals to rapidly develop a vaccine with the following 6 companies: AstraZeneca, Johnson & Johnson, Moderna, Novavax, Pfizer, and Sanofi and GlaxoSmithKline.
A vaccine will probably not be the end of the pandemic
To listen to the politicians, all we need is a vaccine. That is rubbish. If the vaccine is as effective as the measles vaccine, then that is true. The measles vaccine is 97% effective at totally preventing the disease, and you do not need booster shots every year. But there has never been a vaccine against any coronavirus that is that effective.
Remember, the FDA will approve vaccines that are only 50% effective. They do not require them to protect for a year and they do not require them to completely prevent symptoms.
Dr. Fauci said he would be happy with vaccine that prevents Covid-19 in only 50% of vaccinated people and creates immunity that lasts only a few months. He is telling us what we should realistically expect. Therefore, I doubt that a vaccine will work as well as those for measles, polio, chicken pox, and many other diseases. It probably will not eradicate the virus.
Consequently, treatment will be very important. I have been saying that it will be more important than a vaccine if the vaccine does not work well, especially in the people who need a vaccine the most. Those are the elderly and others with a limited immune response. Treatment will get a lot more coverage once the vaccines start to come out and everyone becomes disappointed that they did not live up to the hype from the politicians.
Huge profit potential for drug makers
Why are so many companies working on vaccines and treatments?
Do you believe that over a hundred companies are working on a vaccine or a treatment because they want to help humanity? I know you don’t. No for-profit company has that for its business model. They want to make a fortune for their shareholders, and many of the biggest shareholders are the people who run the company.
With so many companies spending so much, what do you have to conclude? That there is a huge fortune to be made for all of them.
Why did so many get started so early? Because they are in the business. Their medical experts understood in January that billions of people would likely get infected. These experts told the leaders of the companies. These leaders trusted the medical experts and acted immediately and aggressively to the virus. Because of their action, the companies will make a fortune.
Incidentally, our medical experts also knew this in January and told our political leaders, but our leaders refused to believe them. Because of their inaction, we will have hundreds of thousands of dead Americans.
The drug companies also knew that immunity to coronaviruses typically lasts only months. Therefore, Covid-19 would be here for many years and possibly decades. That means vaccines and treatments will be needed for decades. Billions of customers, and many will likely need many vaccinations and/or treatments. This is a once in a lifetime opportunity for them to make unimaginable profit.
The drug companies are betting on repeat customers
But if they can prevent the infection with a vaccine or cure it with a treatment, doesn’t their profit end in a year once they have eradicated the disease? It would, if that was true. But it cannot be true or else there would not be so many companies spending so much on this.
They are telling you what Dr. Fauci implied this week and what makes sense to me as a physician. This virus ain’t going away for many years. These companies are expecting lots of repeat business and not a one and done sale.
The vaccine companies likely believe that each customer might buy as many as 10 or more vaccinations over the next decade. If a billion people do this and each company makes only $10 per injection, that is $100 billion dollars in sales over the next decade.
Also, a huge number of people cannot produce enough antibodies to prevent the infection. This is especially common in the elderly and people with other medical problems. They will get sick with Covid-19 and need treatment. And the treatment will be very expensive. If a person needs to receive manufactured antibodies, he would get them through an IV. The drug company might make over $1,000 per treatment. And, there might be lots of repeat customers who catch Covid-19 every few years.
A depressing but realistic outcome
After an infection or a vaccination, a person should have enough immunity to prevent a 2nd infection. But for how long? If it turns out that the immunity to this coronavirus is like that to other coronaviruses, we may end up needing 2 or 3 vaccinations a year forever.
But there’s a hitch. We all are getting old, and older people have less ability to produce antibodies after infections or vaccinations. Therefore, what might happen is that once we are in our 70’s or 80’s, it could become standard to check our blood level of antibodies 6 months after our last immunization. If the level falls below what the CDC has determined is needed to prevent an infection, then what? Then getting further vaccines might be useless.
Many of these people will get Covid-19 one or more times after they stop getting the vaccines. But if there is a good treatment, like with IV antibodies, hopefully most will not get very sick and will quickly recover. This is especially true if they are diagnosed early, before they are very sick.
I find this depressing, but unless the vaccines turn out to be much more effective and durable (provide immunity for a year or more) than what appears currently likely, this might be our future for the next decade. Vaccines until we are 80, then a Covid-19 infection every year or two, requiring several days in the hospital and IV antibody treatment. Or, if we are really lucky, maybe they will develop a pill or a shot that cures the disease.
Dr. Brooks’s earlier special reports on the Covid-19 pandemic:
- Covid-19: Heart disease, Russian vaccine, and the end of the hydroxychloroquine hoax
- Many Covid vaccines and treatments, and less flu
- The coronavirus pandemic: Biggest worldwide event of our lifetimes
- Covid-19 pandemic vaccine and its euphoric market impact