Editor’s note: The following was written by Dr. Chris Glanton, chief of staff at Peterson Health, to medical staff and is being printed with permission to share with the general public as referenced on Page 1.
Friends and colleagues,
Amidst the fourth surge of COVID-19 I feel it necessary to reach out to thank all of you who are on the front lines of this seemingly never-ending battle. We have seen all too well the toll this is taking on our communities. It is filling up hospitals across the state and the nation and we are increasingly seeing difficulties with transferring patients to higher levels of care, not to mention the nationwide nursing shortages which make treating this disease and our other health problems even more difficult. We all have friends and loved ones who have succumbed to this scourge, and it can feel like there is no light at the end of the tunnel. No one understands the stress you are under. It is straining our healthcare system and your professionalism in the midst of what can seem like overwhelming odds is deserving of our utmost respect.
The nation's current 7-day moving average of daily new cases stands at 133,056, increased 14 percent compared with the previous 7-day moving average. This moving average is 93.9 percent higher compared to the peak observed on July 20, 2020, which was 68,636 cases. The current 7-day moving average is 47.6 percent lower than the peak observed on January 10, 2021 (254,108) and is 1042 percent higher than the lowest value observed on June 18, 2021 (11,651). Based on analysis of specimens collected in the two weeks ending Aug. 14, the CDC estimates the Delta variant accounts for 98.8 percent of all U.S. COVID-19 cases. The Delta variant has been shown to be much more contagious than the original strains we saw in 2020, with an R° of 6 as compared to 2.5 (this means that on average an infected person will spread to 6 people rather than 2.5 people). As of Aug. 19, 359.6 million vaccine doses have been administered, with 199.9 million people or 60.2 percent of the total U.S. population having received at least one dose of the vaccine and 169.6 million people or 51.1 percent of the total U.S. population having received at least two doses.
Much has been made of the adverse effects (AE’s) of vaccines in the lay press and over various social media platforms. As you know Pfizer BioNTech received full FDA approval for its vaccination this week for those 16 and older and the others are still under Emergency Use Authorization, EUA. Sadly, there are still too many unvaccinated and what we are seeing in our hospital in terms of severe disease and death is overwhelmingly in those who have not been vaccinated (more than 95 percent). AE’s have been a major reason why some have been reluctant to get the vaccination. Another is that they have only had EUA, until this week. I’d like to share data regarding AE’s so that you may better explain to your patients or friends/family members who have been reluctant to receive a vaccination the benefits vs risks of vaccination against COVID-19.
Adverse Effect Vaccination COVD-19 Infection
Myocarditis 1 in 20,000 cases 1 in 40 cases
Blood clots (DVT or PE) 1 in 500,000 (in J&J) 1 in 6.25 cases
Guillan Barre Syndrome (GBS) 1 in 128,000 cases (1 in 50-100,000 in general population)
Death 6,718 (reported in VAERS) of 623,244 out of
199.9 million vaccinated 37,259,886 infections
Incidence 0.0033 percent Incidence 1.67 percent
(1 in 29,753) (1 in 59)
The chances of dying from a Lightning strike are 1 in 15,300 (incidence 0.0065 percent) twice as high as dying from vaccination for COVID-19!
Getting COVID-19 puts one at 500 times greater risk of myocarditis than the vaccine.
Getting COVID-19 puts one at 80,000 times greater risk of blood clots than the vaccine.
Getting COVID-19 puts one at 500 times greater risk of death than the vaccine.
There is no credible evidence that COVID-19 vaccination causes infertility or sterility either. It is worthwhile to remember that in the 200 or so year history of vaccinations, we have never had a vaccine that has had onset of a serious or fatal side effect beyond 8 weeks, much less one that is known to cause a lifelong complication such as sterility. This concern was raised by two people initially, a German doctor and epidemiologist named Wolfgang Wodarg (who it is noteworthy in that he has been skeptical about the need for vaccines in other pandemics) and a former Pfizer employee, in a letter (not a study) to the European Union counterpart to the FDA. Their concern was that a protein called syncytin-1 found on placental cells in mammals shares similar genetic sequences to a part of the COVID-19 spike protein and that this similarity might induce antibody mediated destruction of these cells in the placenta causing women to become infertile. This was quickly picked up by various anti-vaccinations blogs and websites and circulated via various social media platforms.
There are two simple ways to dispel this notion:
1. In the randomized controlled trials of the mRNA vaccinations, there were 36 completed pregnancies during the trial period, 18 in the control arm and 18 in the vaccinated arm (no difference)
2. If antibody mediated destruction of placental cells based on this molecular mimicry between the spike protein and Syncytin-1 is the basis of this theory, there should therefore have been a decline in birth rates in 2020 when massive numbers of people, among them, pregnant females, became infected, but there wasn’t. (Note: in order to have a placenta, one must be pregnant, so this shouldn’t affect men; but male sterility has been a concern proposed within social media platforms as a concern although there is no physiologic basis for this).
The Vaccine Adverse Events Reporting System (VAERS) for which the death rate above was pulled is a passive reporting system currently co-managed by the CDC and FDA used as a national early warning system to detect possible safety problems in U.S.-licensed vaccines. It is important to note, that anyone can report an adverse effect or death for any reason in the VAERS system even if they are not a health care professional. This system is not designed to determine if a vaccine caused a health problem or death, but rather to serve as an aid to early detection of unusual or unexpected patterns of adverse events that might indicate a possible safety problem with the vaccine. Because of this, the reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. By its very design, these data are subject to biases.
Consider this for a moment. Amid a world-wide pandemic that has been the center of our lives for the better part of 18 months, we have quickly vaccinated over one half of our entire population, many of whom are elderly and infirm and were at high risk of dying any day anyway when compared to the general population. I would venture to guess that many of you, like me, may not have even been aware of VAERS prior to this year. A reasonable person would expect that this might inflate the numbers (much like many who have criticized the number of COVID-19 related infections and deaths have criticized the reporting as being overly inflated). On any given day, 7,500-9,000 people die in this country with or without this vaccination. That’s 50-60K deaths per week. So, if a random one half of this population were vaccinated, we’d expect based on simple statistics alone to have 25-30K deaths in the week following any vaccination, even if given a placebo saline shot. One of the problems with drawing conclusions from the VAERS data base therefore is that there has not been adequate consideration of the background rate of death and various other maladies which is typically controlled for in clinical trials. Based on criticism of the vaccination for various sources, it’s as if the burden of proof is on the healthcare community to prove the vaccination doesn’t cause death or adverse effects rather than the other way around. This is a considerably biased way of looking at the data; and I don’t believe there is any time in the history of medicine in which this bias has been more obvious. I relied heavily upon this article when considering the death rates and I put it here to welcome you to consider this author’s point-by-point rebuttal in a rebuttal to Steven Kirsh’s article (who proposed that the vaccine is killing people because of the supposed “toxicity” of the spike protein), https://www.covid-datascience.com/post/are-the-mrna-vaccines-really-safe-evaluating-claims-by-steven-kirsch-on-danger-of-spike-proteins .
The second most common reason I’ve heard that patients don’t want the vaccination now or “yet” as they have said, is “I want to wait until it is FDA approved.” For a drug to be FDA approved, the FDA must not only determine whether the clinical data and other information show that the drug or vaccine is safe and effective for its intended use but must also show that the product can be made according to federal quality standards. An EUA is one of many tools the FDA uses to help make certain medical products become available quickly during a public health emergency such as during the COVID-19 pandemic. This process is different than the usual FDA approval process. Under an EUA, under public health emergency circumstances (which must be declared by the Secretary of Health and Human Services), the FDA makes a product available to the public based on the best available evidence without waiting for ALL the evidence that would be needed for full FDA approval or clearance. EUA does not mean that the product is “experimental” or even rushed for that matter. Randomized controlled trials (the best form of evidence) must be available for review and the benefits of the product must still be shown to be outweigh the risks of the product to the individual before it can be rolled out in an EUA. The EUA process, although quicker, doesn’t mean that the FDA cuts corners when it comes to evaluating vaccine data, risks, and benefits. The vaccine must demonstrate clear and compelling effectiveness in a large Phase 3 clinical trial, the last phase of investigation prior to EUA or FDA approval. 70,000 people were enrolled in these Phase 3 trials of mRNA vaccinations prior to EUA and now one of those, Pfizer, has full FDA approval. The level of investigational data and the way it is interpreted differs little between full FDA approval and EUA. Another aspect of full FDA approval is the proof that the company can distribute to the public and that the manufacturer must test all batches of the product, called lots, for safety, potency, and purity. The FDA then reviews this information before the lots can be released.
Initial studies showed 95 percent effectiveness at preventing infection with these vaccines. Based on data from the multitude of doses already given (remember that over half of the 300 plus million American population have already been vaccinated), the vaccine effectiveness is still anywhere from 75-80 percent. A recent pre-print study from the Mayo clinic did show that the Pfizer vaccine effectiveness might be as low as 42 percent for infection but there are flaws with the study. Regardless, the study still shows that both the Moderna and Pfizer vaccinations have 75-81 percent effectiveness at preventing hospitalization, like other studies and our own observations have confirmed. That means severe disease, ICU admission and risk of death.
Can you get the infection if vaccinated? Yes, and that has been reported throughout the world (seen in Israel and Iceland and increasingly here), and this is likely due to the prevalence of the Delta variant. But what is becoming clear is that even though the vaccinations may not prevent re-infection, they are reducing the need for hospitalization and death, which is really what we are all concerned about, and that needs to be the emphasized. Given this and the fact the vast majority of those filling our ICU’s and sadly our morgues is composed of unvaccinated people, it seems to me to be proof enough that the benefit of vaccination outweighs the risks at this time.
I hope this helps you decide about the safety of these vaccinations and hope you can use this when counseling a patient, neighbor, friend, or family member. Right now, I believe these vaccinations have an exceptional track record and have shown they are protecting the vast numbers of the half of the country that have already been vaccinated. The numbers we are seeing now prove to a reasonable degree that they are protecting against Delta. Are there breakthrough infections? Sure! There are breakthrough infections every year with the Influenza vaccination, as one example, sometimes to the tune of 40-50 percent but it hasn’t stopped us from using these vaccines, because they save lives. We even require them to work in health care facilities. Is the vaccine 100 percent safe? No, absolutely not! Nothing we use in medicine is 100 percent safe. I would venture to guess that many of the antibiotics you all use in daily practice are more dangerous than this vaccination.
I think we are at a crossroads with this pandemic. Given the infectivity of the current Delta variant, I believe you are either going to get the vaccination or you will get the infection. The decision you must make for yourself and your patients, is what are the risks of being unvaccinated vs. being vaccinated? I think the data show that the risks of being vaccinated pale in comparison to getting infected. In addition, the longer we wait to get enough people vaccinated within a population to weaken the virus’s subsequent spread (so-called herd immunity), the more likely other variants will arise, which perhaps our current vaccinations won’t protect against. We are already seeing several variants crop up that are resistant to vaccination with current technology. We need to get the message out to patients that vaccination is important because it reduces hospitalizations, and that early notification of their health care providers is critical so that early treatment with monoclonal antibodies can be instituted to prevent severe sequelae of disease. Also, we need to promote easy interventions such as immune stimulators (vitamin D, Vitamin C, Zinc, and Quercetin) to help protect all of us.
Keep up the good fight. I appreciate all of you and what you do and sacrifice daily. I hope this helps.