Sunday, May 09, 2021

 

The Safety of US COVID-19 Vaccines

People sometimes ask me if I've gotten a SARS-CoV-2 vaccine yet. My answer is always no. This usually prompts a query as to why I haven't been vaccinated.

My standard answer is that I'm not an anti-vaxxer, I get a flu shot every year. However, I add, I consider it grotesquely unethical for government officials, vaccine manufacturers, and public health and medical professionals to conduct what is essentially a massive experiment* on hundreds of millions of people using relatively new vaccine technologies—mRNA and adenovirus vector vaccines—especially during a global pandemic. I am aware of no reason why Congress and health professionals couldn't and shouldn't have insisted that Operation Warp Speed funds be spent on conventional attenuated virus or viral protein vaccines. That said, until today I usually added that I thought the new technologies would probably prove safe.

* As the FDA notes all of the COVID vaccines in use in the US today have been approved under as investigational drugs under an Emergency Use Authorization. The FDA Letter of Authorization for the Pfizer vaccine says: "Pfizer-BioNTech COVID‐19 Vaccine is for use for active immunization to prevent COVID-19 ... It is an investigational vaccine not licensed for any indication." Its "Investigational New Drug application (IND) number" is 19736. According to the FDA: "Emergency Use IND  allows the FDA to authorize use of an experimental drug in an emergency situation ..."

Today, I actually looked at the CDC's and FDA's Vaccine Adverse Event Reporting System (VAERS) data for the first time. What I learned was pretty amazing.

As you can see from Table 1 below the number of deaths recorded as adverse events associated with COVID-19 vaccines is almost exactly the same as the number of death associated with all other vaccines since 2006 (all VAERS data reported in this post was selected by vaccination year).

Table 1. (VAERS data as of May 10, 2021 for 2006-2021)

Adverse Event Type
Vaccine Type Death Life
Threatening
Permanent
Disability
Sum
COVID-19 3,729 3,362 2,379 9,470
All Other Vaccines 3,733 9,648 9,174 22,555
Sum 7,462 13,010 11,553 32,025

From 2016 through April 30, 2021, there were 4,621 deaths reported as adverse events associated with all vaccines in the US (there's no table in this post for that data).

Table 2 covers 2016-2021 and compares deaths associated with the COVID vaccines and the non-COVID vaccine (Prevnar 13) associated with the most deaths in the same time period. For comparison purposes I also added in the flu vaccine type associated with the most deaths.

As you can see there are far more deaths associated with COVID vaccines even though they have been in use for only a few months. An apples-to-apples comparison would require other data, including the number of doses of each vaccine administered in the selected time period. However, I could not find that data for the non-COVID vaccines although the CDC said that in the 2020-2021 flu season the estimated number of quadrivalent flu vaccines expected to be available was 195 million.

Table 2. (VAERS data as of May 9, 2021; click on images to enlarge)

Table 3 gives the breakdown by COVID vaccine manufacturer of the following combined adverse events: Deaths, Life Threatening, and Permanent Disability. At first glance, it may look like the Janssen (Johnson & Johnson) vaccine is safer but as you can see from Table 4 far fewer doses of that vaccine have been administered.

Table 3. (VAERS data as of May 9, 2021)
 
Table 4. (CDC data as of May 9, 2021)

Combining the data from Tables 3 and 4 we find that there were 11,209 doses (numbers are rounded) of the Janssen vaccine administered for every associated serious adverse event recorded in Table 3. The corresponding count for the Pfizer and Moderna vaccines are 33,951 and 28,423, respectively.

It's interesting to me that I have not read or heard any mainstream reporting on the relatively large, as compared to other vaccines, number of deaths associated with COVID vaccines as adverse events. There are four things to bear in mind about the current numbers: First, an adverse event report is not proof that the vaccine caused the adverse event; Second, the number of adverse events associated with COVID vaccines is tiny compared to the number of adverse events caused by the virus itself; Third, many adverse events including deaths go unreported for a variety of reasons**; and, Fourth, the reporting of adverse events associated with COVID vaccines is just getting started. Who knows how things will look in five or ten years? Hopefully, there will be no great increase adverse events associated with COVID vaccines that emerges long term. Time will tell.

** According to the CDC's VAERS summary page: "VAERS data are from a passive surveillance system. Such data are subject to limitations of under-reporting, reporting bias, and lack of incidence rates in unvaccinated comparison groups." This echoes findings in a workshop summary published in 1994 by the National Academies Press: "As a passive surveillance system, VAERS suffers problems of both underreporting and overreporting. Although health care professionals are required to report some adverse events, specifically, those that are covered by the no-fault component of the Vaccine Injury Compensation Program, there are no provisions for enforcement. It is likely that many events that occur after the receipt of vaccines, like those that occur after the receipt of medications, go unreported."

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There is a March 31, 2021, letter in the medical journal, Circulation Research, titled "SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2" that some COVID and COVID vaccine deniers/skeptics are using innaccurately to scare people about COVID vaccines. For example, HEALTHRANGER says:

The prestigious Salk Institute, founded by vaccine pioneer Jonas Salk, has authored and published a bombshell scientific article revealing that the SARS-CoV-2 spike protein is what's actually causing vascular damage in covid patients and covid vaccine recipients, promoting the strokes, heart attacks, migraines, blood clots and other harmful reactions that have already killed thousands of Americans ... Critically, all four covid vaccine brands currently in widespread use either inject patients with the spike protein or, via mRNA technology, instruct the patient's own body to manufacture spike proteins and release them into their own blood. This floods the patient's body with the very spike protein that the Salk Institute has now identified as the smoking gun cause of vascular damage and related events (such as blood clots, which are killing many people who take the vaccines).
However, in the very first paragraph of the Salk Institute news release it says:

LA JOLLA—Scientists have known for a while that SARS-CoV-2’s distinctive “spike” proteins help the virus infect its host by latching on to healthy cells. Now, a major new study shows that the virus spike proteins (which behave very differently than those safely encoded by vaccines) also play a key role in the disease itself.

The authors of the letter itself conclude with this: "... our results suggest that the S protein-exerted EC damage overrides the decreased virus infectivity. This conclusion suggests that vaccination-generated antibody and/or exogenous antibody against S protein not only protects the host from SARS-CoV-2 infectivity but also inhibits S protein-imposed endothelial injury" (emphasis added). There is a hyperlink to an article in the paragraph I quoted above from the Salk Institute that goes into greater detail on this subject. I recommend reading it.

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In the final analysis one ought always to be skeptical of powerful people and institutions but also of their critics. My read of the data and science is that the new vaccine technology, not the spike protein, is probably more to blame for the comparatively higher rates of adverse events associated with COVID vaccines. I will be cautious going forward but as of now I plan to receive the Novavax vaccine—a more conventional viral protein vaccine type—when it becomes available.

Last revised: 11 May 2021

See also: "The Safety of US COVID-19 Vaccines Revisited"

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