Side Effects and More: COVID-19 Vaccines Unlikely Cause of Reported Deaths

Side Effects and More COVID-19 Vaccines Unlikely Cause of Reported Deaths TrialsiteN

Everything in life is a balance, and in the COVID-19 context, millions of folks need to decide if the risk of severe COVID outweighs any risks from the available vaccines. Clearly, some key factors relate to risk: How old is a person? What is their health condition? What makes sense for an 80-year-old might not be best for, e.g., children, given current knowledge. On February 12, Swiss Policy Research published a look at post-vaccination deaths. According to the adverse event vaccine reporting systems in the US, EU, and the UK, RNA-based vaccines have “been associated” (i.e., not established as a cause) with over 1000 deaths and many thousands of non-trivial adverse events including anaphylaxis and miscarriages. And these numbers are likely an underestimate, “as vaccine reporting systems typically cover only a fraction of adverse events.” Relative to the tens of millions of vaccines given, this rate of death is very small. Yet not much is known about the long-term impact of experimental RNA treatments. Vaccination leader Israel offers some insights; there, seniors who were vaccinated experiences a 92% relative effectiveness rate. Yet Israel’s overall positivity rate has not declined.

A Death in Nebraska

 CDC is investigating in the case of a deceased Nebraska man after his COVID-19 vaccine was listed as one of the causes of death, according to Nebraska’s DHHS. The long-term care resident was in his late forties, “with several coexisting diseases and conditions.” He passed away on January 17, between one to two weeks after his first dose of vaccine. In the big picture, FDA and CDC got 1,170 reports of death among those vaccinated in the US from December 14, 2020 to February 7, a 0.003% mortality rate. Dr. Gary Anthone who is the chief medical officer for Nebraska noted, “Typically, COVID-19 vaccine deaths can be attributed to anaphylaxis and occur within a relatively short period after the vaccine is given, which is why monitoring is done—-While I cannot speculate on this case, when individuals die days or weeks after the vaccine has been administered, it is more likely due to other underlying factors.” Adverse events including deaths are put into the Vaccine Adverse Event Reporting System (VAERS) run by CDC. “This process allows the CDC and FDA to closely monitor and assess any adverse events, for ongoing safety evaluations,” according to Nebraska officials. Dr. Anthone also notes that, “Individuals with high-risk conditions should consult their medical providers regarding vaccination.” 

Overall Side Effects Minor

February 16, Nature waded into the COVID-19 vaccine issue, focusing on what the research tells us so far. Folks worldwide have been getting vaccinated, and there are common reports of temporary headaches or fevers. But these were expected based on the study clinical data. Yet now we have millions being vaccinated versus the thousands in trials, and some reports of rare allergic reactions. Noting the official (and probably true) mantra that, “There is no question that the current vaccines are effective and safe.” And researchers emphasize that the vaccine protection outweighs the possible dangers. Nature tried to examine the prevalence of side effects, using data including reports, “through safety-monitoring systems, such as smartphone apps.” Overall, there was a significant number of minor reactions, including pain at injection site, headache, and fatigue. Only 372 out of a million mRNA doses result in a report of a “non-serious” reaction, this despite clinical data showing 80 percent would at least experience injection-site pain. Of course, side effects are watched much more closely in the trial setting versus mass vaccination, so underreporting is a possibility. 

CDC Reports Adverse Incidents at the Level Expected

Finally, February 19, HCP Live gave us another good snapshot on vaccine safety, “Adverse Event Rate Low in First Month of COVID-19 Vaccine.” Based again on CDC reports, from December 14 to January 13 over 13.7 million doses were given, with 6,994 incidents of adverse events. 90.8 percent were non-serious, while 9.2%, “were classified as serious.” The most frequent events break down as headache, 22.4 percent; fatigue, 16.5 percent; and dizziness, also 16.5%. VAERS registered 113 deaths, with 65 percent in long-term facilities. Per the CDC, “the available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death.” In rare cases, anaphylaxis followed receipt of the second dose, “with 4.5 reported cases of anaphylaxis per million vaccine doses administered.” But the indications so far are that the adverse reactions are in the range of what was expected. “The initial post-authorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events,” according to the CDC. “These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.”

The data reveals that for the vast majority of people the existing COVID-19 vaccines are safe but that doesn’t support one’s family in the rare cases that a rare safety event in fact does occur. The vaccine seems the way to go for a great majority but consult with your physician.