Covid-19 Vaccines — Risks vs Benefits
Jeffrey I. Barke, M.D.
Everyone in the world — quite literally— is by now well aware of the several vaccines being administered to slow the spread of Covid-19. What is forgotten, especially in the United States, is that none of the Covid-19 vaccinations have been “approved” by the Federal Drug Administration.
They are all “unapproved vaccinations.”
All the Covid-19 vaccinations in the United States are being administered under the FDA’s Emergency Use Authorization (EUA) rules that allow healthcare agencies across the United States to distribute and administer vaccines to designated groups.
It typically takes many years to create a new vaccine, and even then success sometimes eludes the best efforts of scientists.
For example, we have no vaccination yet against HIV, hepatitis-c, malaria, or the common cold to name just four illnesses that have long caused misery in many populations. New studies are showing promise with a malaria vaccination - great news if this turns out to be correct.
The vaccines used for the first Covid-19 inoculations, brought to market by Pfizer and Moderna, employ a messenger RNA (mRNA)) technology. Significantly, this is the first time such a mechanism has been used in a vaccine. For the most part, mRNA technology has been used in cancer therapy because of its success in producing various proteins to attack and disrupt certain cancer cells.
Most of the commentary from “health experts” suggested that it was not too much of a leap to use this approach in developing vaccinations. Normally, the DNA in the nucleus of a human cell produces mRNA. The mRNA acts as an instruction manual to create proteins. The mRNA is released from the cell’s nucleus into the cytoplasm of the cell where it travels to the ribosomes to deliver its instructions.
The idea behind its use in an anti-Covid-19 vaccine was to produce a synthetic mRNA that instructed the cell's ribosome protein factory to create a SARS CoV-2 spike protein. The appearance of a spike protein then stimulates our own immune system to create an anti-spike antibody. Technically, then, the use of mRNA in this way is not a true vaccine, but rather a type of immunologic or gene therapy.
The vaccine developed by AstraZeneca for Covid-19 uses a different platform. It takes a piece of genetic material from the SARS CoV-2 virus and inserts it into a common cold virus — an adenovirus. The genetics of the adenovirus vector are altered so it is not infectious. The adenovirus then enters the cell to stimulate the creation of the spike protein.
The good news is that the AstraZeneca vaccine can be stored at normal refrigerator temperatures for up to six months. The bad news is it seems to be less effective than either Pfizer or Moderna. While AZ’s vaccine may become the preferred one in less developed countries because of storage issues, it has shown significant side effects to the point that many European Union countries (including Germany, France, Italy, Spain, and most recently Denmark) have banned its use for fear that it may cause dangerous blood clots.
The new Johnson & Johnson Covid-19 vaccine also uses an adenovirus transport mechanism to get the SARS CoV-2 DNA into our cells in order to create the desired spike protein antibody response. Recently the FDA and CDC put a pause on the use of the J&J vaccine in the United States due to a potentially dangerous blood clot reaction occurring a week or so after receiving the single shot jab.
Warp speed ahead? Not so fast.
Following an 11-day “pause” in the J&J vaccination program, the FDA resumed allowing the use of this vaccine with an added warning of a rare type of blood clot. At least the U.S. regulatory bodies are acknowledging a causal relationship between the J&J vaccine and this rare but serious side effect. As of mid-April, the J & J jab is not approved in the UK. The European Medicines Agency (EMA) decided that a warning about unusual blood clots would suffice on its labels, just as the health agency did for AstraZeneca's Covid-19 vaccine.
Because of these caveats and side notes, is it any wonder that 30% of US healthcare workers are indicating that they will pass on getting any Covid-19 vaccine. Forty percent of Marines in a recent poll are also very wary of getting vaccinated against a disease that most soldiers see as a low risk of having serious consequences compared to what else they face on a day-to-day basis.
Here are more areas of concern about the Covid-19 vaccines that the public needs to take into consideration:
Could the vaccines in use now create asymptomatic carriers who unknowingly transmit the virus to others?
Are the vaccines protective against the new SARS CoV-2 variants — from the UK, South Africa, and Brazil? An Israeli study has shown the Pfizer vaccine may put patients at higher risk for Covid-19 variants. The CDC now reports over 7,000 fully vaccinated people have contracted Covid-19 and over 500 of them required hospitalization. We have now vaccinated over 125,000,000 people in the US. Information about the various variant strains of SARS CoV-2 are still emerging. Some variants may prove dangerous, others not so much.
Does the vaccine put patients at higher risk if the vaccine-induced immunity fails? What are the chances of long- term consequences that have yet to be seen?
Most other vaccine development programs have first used lengthy animal studies to better assure safety in humans. This was not done with any of the new Covid-19 vaccines. Are the clotting problems and other side effects now being studied the consequence of limited animal safety testing?
Is it possible for the synthetic SARS CoV-2 mRNA to be integrated into the human host’s cell genome? It has been seen before. Scientists at Harvard and the Massachusetts Institute of Technology produced findings about wild coronaviruses that raise questions about how viral RNA operates. This DNA-to-mRNA pathway is not always a one-way street. An enzyme called reverse transcriptase can convert RNA back into DNA allowing the latter to be integrated into the DNA in the cell nucleus.
The high efficacy of a controlled study may prove to be very different from the real-world experience when massive numbers of people are involved. For example, data from the Centers for Disease Control and Prevention show that the influenza vaccination efficacy for the 2017-18 season was approximately 38 percent; only 20 percent was achieved in the 2018-19 season; and 39 percent for the 2019-20 season.7 When the influenza vaccination was first introduced in 1938, the efficacy was expected to be much higher than the current numbers.
The CDC data show that the survival rate of those contracting the disease goes up as age goes down. If you are less than 70 years old — the survival rate is 99.5 percent; if you are less than 50 years old — the rate jumps to 99.98 percent; and if you are under 20 years old, the chance of surviving Covid-19 is 99.997 percent. Why then would we consider vaccinating children without long term safety data?
In fact, parents should know that seasonal influenza is a greater risk to the very young than Covid-19. Weighing the benefits versus the risks of accepting the Covid-19 vaccine could be a very difficult choice, especially for the young. It is unlikely, therefore, that I will recommend vaccinations for my young patients to protect them against a virus that more than 99 percent of them would survive should they contract it.
The same companies (and their executives) that look to profit from the vaccines are also immune from all liability. In 1986, Congress passed the National Childhood Vaccine Injury Act (NCVIA). It provides immunity from liability to all vaccine manufacturing companies. Crony capitalism at its best — no liability to the company or its executives should something go wrong while mandating purchase of the product by the public. Many people are working to change this law. Rather than blanket immunity, I would propose establishing national limits to damages along the lines of California’s Medical Injury Compensation Reform Act (MICRA). And, certainly no vaccines should ever be mandated.
Minorities tend to be skeptical of the government and especially of vaccinations administered by the U.S. Public Health Service. Why? The USPHS and the CDC carried out 40 years of secret experiments in a study of syphilis, using black residents as test subjects. Can we overcome such a history to get the vaccine to the most vulnerable in the minority communities?
There is no long-term safety data for these new Covid-19 vaccines. How do we know in a few years we will not see significant problems? We clearly don’t.
The Pfizer CEO is now suggesting a 3rd shot may be necessary and then annual jabs to follow. Have we really studied these vaccines thoroughly?
In 1976 we attempted a mass vaccination program against the swine flu with a newly created vaccine. The vaccination program was aborted after 40 million doses were administered. Over 500 people came down with Guillain-Barré syndrome, a rare neurological disorder and there were 25 deaths associated with the swine flu vaccination. Will the memory of this epic government failure affect the rollout of a new vaccine?
We are now hearing rumblings that the Covid-19 vaccination could be made mandatory for air travel, international border crossings or other activities such as entering a theme park or government building. What could possibly go wrong with that requirement ?
The vaccines are now being tested on children and during pregnancy. This could be potentially dangerous as we simply do not know what the long-term effects of mRNA vaccines or the artificial creation of Covid-19 spike protein antibodies will be on children or during pregnancy.
Could a phenomenon known as antibody-dependent enhancement (ADE) occur with the Covid-19 vaccination. This problem occurs when someone exposed to SARS CoV-2 following vaccination causes a more severe reaction than if the vaccine were never given.
A recent study published in JAMA showed SARS CoV-2 antibodies in breast milk following the onset of the Covid-19 vaccination program in breastfeeding women - what could the long term implications be for the infants?
Does the risk/benefit equation make sense for most people?
The VAERS (Vaccine Adverse Event Reporting System) web site which is run by the CDC and the FDA is showing an alarming rise in reported side effects including over 2500 deaths and thousands of ER visits associated with the Covid-19 vaccinations. This VAERS website requires doctors or patients to voluntarily report side effects - a passive reporting system. It is estimated that only 1% to 10% of all the adverse events are reported to this site as most people and even physicians are unaware of the website's existence.
I am not opposed to vaccinations, per se, including the Covid-19 vaccination. But, I am opposed to any government requirement for the vaccination or any private or public dictate about the vaccine that infringes on a citizen’s freedom of choice. I am also opposed to a vaccine passport that is now being considered as a prerequisite for travel and other commercial activity. I strongly support informed consent for all vaccinations, which currently is not the U.S. standard.
While these questions are being answered and the other caveats mentioned above are resolved, we have to note that we are getting better and better at treating Covid-19: the death rate in terms of population continues to fall, hospital stays for Covid-19 get shorter, and hospital mortality from Covid-19 plummets. Early multi-drug outpatient treatment with repurposed medications is showing great success. There are a greater number of physicians that are embracing this approach and even the press and social media has finally allowed this message to get through its gauntlet.
A Covid-19 vaccine, in other words, should be viewed as one of many tools to combat the pandemic but not as the savior that many believe has arrived. Skepticism is important in science and that approach to these vaccines is no exception.