It’s important to know both what we know about the new vaccines and what we don’t know.
I’ve practiced for 35 years. I am always honest with my patients, even if conversations are difficult or confrontational. I will also be honest about saying “I don’t know.” This happens when a diagnosis is not readily apparent or when there are limits to the help I can give. With the passage of time, I’ve learned that what we don’t know about medicine outweighs what we do know.
I’ve always been a proponent of older, more established vaccines. However, they are imperfect and, like all medical treatments, can have side effects. Unfortunately, in the conversation about the new COVID-19 vaccines, the tenets of honesty and a willingness to admit ignorance are being compromised.
Operation Warp Speed was remarkable, but it leaves an uncomfortable question: Is it a good thing to rush a vaccine (or medicine) to the public without the usual safeguards? Operation Warp Speed might be a great business objective or military goal, but is it great for a medical treatment?
The pharmaceutical industry, government health authorities, and the media insist the new vaccines are safe and effective. While the initial results are promising, this is not the whole truth. Both honesty and acknowledging ignorance require answering a few questions.
Pfizer and Moderna were the first COVID-19 vaccines to be approved. Both use a new technology called mRNA vaccine, which has never been broadly given to a human population to prevent any disease.
Let that sink in for a moment.
All previous vaccines take a weakened virus or a piece of the virus and inject it into humans to induce an immune response sufficient to prevent a disease. Pfizer’s and Moderna’s vaccines inject mRNA, which is a protein code that instructs the body to make a part of COVID-19’s spike protein that will then induce an immune response.
Our bodies daily use our own mRNA to carry instructions from DNA to make various proteins the body uses. While this new vaccine science sounds intriguing, it has never been tried in humans in this scope. It may be a breathtaking scientific advancement heralding a new path for all vaccines. It may also be less effective or have currently unknown side effects.
So far, the limited study of the vaccines approved for emergency use (one major study for each vaccine approved) has shown some short-term side effects. The vaccine is a two-shot series and side effects were prominent after the second shot. Side effects were more common if the recipient was younger than 65 years old.
Pain at the injection site has usually gone away in 4-5 days. The other side effects resolve, on average, in 2-3 days.
Early reports after giving the vaccine have also included allergic reactions ranging from mild to a few cases of anaphylaxis (serious allergic reaction). Allergy may be to mRNA itself or the lipid nanoparticles/PEG vehicle it is housed in. The long-term side effects are not currently known, as the main study length and follow up have only been four months.
In the main study from Pfizer’s vaccine, 8/17,000 patients got symptomatic COVID-19 in the treatment group during the short follow up. In the placebo group, 162/17,000 patients got symptomatic COVID-19 during the study time. There was also a trend towards those getting the vaccine having a less severe disease and needing less hospitalization.
The Moderna study had 30,000 patients split into treatment and placebo arms. In the vaccine group, 11/15,000 patients came down with COVID-19. In the placebo group, 185/15,000 patients came down with COVID-19.
It was hard to ascertain death avoidance in these small studies. However, the two initial studies are favorable and show a 95% efficacy. Now that more information about the studies is known, Peter Doshi, associate editor of te British Medical Journal, wrote an editorial that the true efficacy may be much lower because the study excluded people with COVID-19 symptoms but a negative test and other factors.
Viruses always mutate and scientists following COVID-19 estimate it mutates, on average, twice a month. Most of these mutations are minor and will likely not change the vaccine effectiveness. These mutations also usually do not make the virus more deadly.
COVID-19 is in the family of Coronavirus that causes the common cold. The pharmaceutical industry has been trying without success for the last two decades to make a vaccine against the common cold. A safe vaccine against the common cold would make some company a lot of money!
One problem in the animal studies on coronavirus family vaccines was “antibody dependent enhancement.” When animals were inoculated, they developed a robust immune response, which is a good result.
However, when the animals were later exposed to the coronavirus against which they were vaccinated, their immune system went into overdrive, and they developed an overwhelming, fatal immune response called a “cytokine storm.” Fatal cytokine storms also happened to some COVID-19 patients when their infection was severe.
Human responses do not always correlate to animal responses. So far, there have been no signs that humans have a cytokine storm when exposed to COVID-19 after receiving the vaccine. Obviously, this would be catastrophic for any vaccine.
A concern that deserves mention is the possibility that a cross-reaction and immunity to other parts of the spike protein could cause auto-immune disease or other problems.
A former Pfizer VP, Dr. Michael Yeadon, who has over 30 years of experience in immunology and drug research, filed a Stay of Action petition with the European Medicine Agency (like our FDA) to halt the trials of mRNA vaccines over concerns it might affect sterility in women.
Yeadon is worried that the mRNA vaccine was coded for a region of the spike protein that was similar to Syncytin-1, which is a protein that is essential for the development of the placenta. If a woman’s body makes antibodies to this protein, she could become sterile when vaccinated for COVID-19. This is a theory, not a proven fact, and no one has studied it. Yeadon’s insistence on more studies to make sure this will not happen seems reasonable.
Medicine is always about a risk/benefit analysis, subject to the first maxim of “do no harm.” Usually, new medicines or new vaccines are used only after multiple studies show over long periods of time (for vaccines, at least five years) prove they’re safe and better than the older treatments.
While the new mRNA vaccines have good initial results and may be a breakthrogh, they should be viewed as experimental and would best be used in high-risk patients (older patients or those with health conditions raising COVID-19 mortality) until we know more. Patients should receive extensive informed consent to understand the risks and benefits. Patients also need to know that if they have a serious complication, Congress already protected the pharmaceutical companies from litigation around emergency vaccines.
The mantra of “safe and effective” is not only incomplete, but it also ignores other pathways out of the pandemic. For healthy people, early outpatient treatments are being developed to treat COVID-19. These would be a safer option than taking an experimental vaccine. Young people (<60 years old) who have very low mortality from COVID-19 should approach getting the new vaccine as if they were consenting to be in an experimental trial of a new vaccine.
Our history shows there are good reasons why new medicines and vaccines are not rushed into widespread use until we have multiple studies and time to assess the safety and efficacy of the new treatments. If the death rate from OVID-19 were much higher, it might make the risks acceptable to try an experimental vaccine. Given that the COVID-19 death rate is a little higher than a bad flu, my opinion is that younger and healthier people need a more rigorous risk/benefit analysis before taking the mRNA vaccines.
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