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How safe are Covid-19 vaccines?
at 29.12.2021The life-saving vaccine promises to be a "safe and effective" solution in the multiple crises caused by the Covid-19 pandemic, especially a "liberating" one that will restore society to normal and relaunch the economy. However, the attribute "safe" is a legal term, as inspired by Peter Doshi, an associate professor of pharmacy at the University of Maryland School of Pharmacy in the United States, in an article published in the New York Times on January 7, 2021. Because there is a kind of omerta of cluttered information and a lack of transparency in vaccinology," ironically appreciates Pierre Biron, professor of Medical Pharmacology at the University of Montreal, referring to the current vaccination campaign.
The new vaccines based on mRNA technology, which some experts consider synthetic pathogens with a therapeutic role rather than vaccines, raise severe medical and legal concerns. Medically, the protocols of the manufacturing companies cannot answer the following fundamental questions: Can the new vaccine prevent covid severe cases? Does it stop the virus from spreading? Is it effective in lowering mortality? Legally, it is concerning that the manufacturers have demanded entire liability from the state authorities for any adverse effects, so vaccinated people must first sign a declaration on their responsibility, assuming any risks.
Vaccines are experimental.
Clinical trials to evaluate mRNA vaccines developed by the pharmaceutical companies Pfizer and Moderna have been approved for 43,931 (Pfizer) and 30,000 (Moderna) participants, and scheduled to run until 2022 (Moderna) and 2023 (Pfizer) (Pfizer). ClinicalTrials.gov describes the Pfizer vaccine's clinical trials [1] and the Moderna vaccine [2]. Based on preliminary results obtained only a few months after the beginning of their studies, they were granted emergency permits in the United States and Europe.
It is important to note that the authorization for emergency use does not imply that the vaccines have been approved for widespread use. Vaccines can only be approved after the trials are completed, and the completion will take about two years. Vaccines are still in the trial stage, so they are considered experimental. Making these experimental vaccines mandatory would violate international human rights conventions and bioethical principles, such as the Helsinki Declaration (1964) and the Belmont Report (1979). In both research and medical practice, the Belmont Report establishes the principles of informed consent.
As a result, these vaccines can be used as a matter of urgency if someone believes that their life is in danger and that the risk is worth taking. However, this is not true for most of the population. According to an article in the prestigious Wall Street Journal, "the risk of dying from Covid-19 is no greater than the risk of being involved in a car accident on the way to work for most people under the age of 65." [3].
Scientific studies back up this claim. For example, a meta-analysis of 113 specialized studies and official statistics from more than 34 geographic locations published in the European Journal of Epidemiology in December 2020 found that the mortality rate (the number of deaths relative to the number of coronavirus infections) is on average: 0.002% at ten years (out of 100,000 children 99,998 survive - the survival rate is 99.998%), 0.01% at 25 years (out of 10,000 young people survive 9,999 - survival rate is 99, 99%) and gradually increases to 0.4% at 55 years (out of 1,000 people 996 survive - survival rate is 99.6%), 1.4% at 65 years (survival rate is 98, 6%), 4.6% at age 75 (survival rate is 95.4%) and 15% at age 85 (survival rate is 85%) [4].
Among the question marks that this vaccine raises, we could mention:
1. We have no idea if they will save lives.
Clinical trials are not carried out to provide this answer. One can find the explanation in an excellent analysis by Peter Doshi, associate editor of the British Medical Journal (one of the world's oldest general medicine publications): "Will Covid-19 vaccines save lives? Current clinical trials are not designed to provide us with this information. [1] According to the article, "ideally, we want an antiviral vaccine to do two things: first, to reduce the chance of becoming seriously ill and being admitted to the hospital, and second, to prevent infection, thereby interrupting disease transmission." (...) On the other hand, clinical trials are not intended to demonstrate either. None of the ongoing tests are intended to detect a decrease in the disease's serious consequences, such as the number of hospitalizations, ATI cases, or deaths. Vaccines aren't even tested to see if they can stop the virus from spreading.
Furthermore, human subjects with co-morbidities (immunocompromised), pregnant and lactating women, children and adolescents, and others were excluded from the clinical trials. "The number of hospitalizations and deaths caused by Covid-19 in the population being tested for an effective vaccine is simply too low in the population being tested for statistically significant differences in a test per 30,000 people." On the other hand, the media uses the reduction of hospitalizations and deaths and the interruption of disease transmission to justify imposing mass vaccination of the population.
Another criticism of pharmaceutical companies' clinical trials can be found in a Forbes article by Dr. William Haseltine, a professor of public health at Harvard University in the United States: "Covid-19 vaccine protocols show that tests are designed to succeed"[2]. However, according to the professor, "infection prevention is not a successful criterion for any of the vaccines" Pfizer, Moderna, and AstraZeneca's protocols do not eliminate the most severe consequences of Covid-19, most people are concerned about: infection generalization, hospitalization, and death.
2. We don't know whether vaccines will prevent the virus from spreading.
We have already seen that we do not know whether the vaccines will stop the virus's spread at this time. Furthermore, Dr. Margaret Hamburg, a former FDA, stated in November 2020: "We don't know if vaccinated people may become infected with Covid-19 and spread the disease, even if they get vaccinated." As a result, they must be aware that they will be required to wear a mask even after vaccination and continue to comply with non-pharmacological preventive measures such as social distancing. [3]
3. There have been no animal studies.
This fact means that we don't know what the long-term risks are. Many attempts at coronavirus vaccines, for example, have failed because, while guinea pigs tolerated the vaccine well in the early stages of testing, they were still subjected to the antibody reaction when exposed to the virus in real life. [4] This phenomenon is referred to as the ADE (Antibody-Dependent Enhancement) phenomenon, which amplifies disease caused by antibodies.
In an article published in the prestigious journal Nature Biotechnology, Ken Garber also expressed this concern: "Developers of Covid-19 vaccines, worried about undisciplined antibodies" [5]. "Concerns persist that Covid-19 vaccines could cause ADE, a rather poorly understood phenomenon that could potentiate the virus's entry into the host cell, thus aggravating the disease," according to the article. According to virologist Kevin Gilligan, senior consultant at Biologics Consulting, who advises serious safety studies, this phenomenon is a "real concern." "Because if we rush things and distribute a vaccine that amplifies the disease on a large scale, it will be worse than not having any vaccinations at all." We also don't know whether the phenomenon of ADE will manifest itself in human subjects once they contract the wild virus because no animal tests have been performed.
4. Possibility of side effects
An October 2020 FDA document presents a long list of severe side effects that could occur after administration of mRNA vaccines: encephalomyelitis (inflammation of the brain and spinal cord), encephalitis, seizures, narcolepsy, myocardial infarction, autoimmune diseases, thrombocytopenia, pregnancy complications, and deaths [6].
Vaccine recipients already reported some of these complications: According to Reuters, a 32-year-old Mexican physician suffered encephalomyelitis after vaccination [7], and a 56-year-old healthy Florida physician suffered severe thrombocytopenia after vaccination, resulting in a hemorrhagic stroke and death [8]. In addition, as of January 15, 2021 [10], 224 emergency admissions due to the vaccine had been reported in the United States, according to data provided by the US Vaccine Adverse Event Reporting System (VAERS) [9]. The Pfizer vaccine, both modern and 1163. [11]
There were 55 reported deaths at 3 million doses, resulting in approximately 18 deaths per 1 million American adults after the first dose. The situation appears to be more severe in the case of the Moderna vaccine, which resulted in 27 deaths among approximately 1 million vaccinated people, compared to the Pfizer vaccine, which resulted in 28 deaths among about 2 million vaccinated people. Although concerning, these findings are an understatement of the actual situation because not all side effects are reported in the VAERS system.
5. Vaccination is not the only option.
Officials claim that there is no effective treatment for treating and preventing Covid-19 infection, despite numerous studies demonstrating that this claim is false. Eleftherios Gkioulekis, a mathematics professor at the University of Texas at Rio Grande Valley, has compiled an impressive collection of articles on Covid-19 infection treatment and prevention. Dr. Zelenko's prevention [13] and treatment [14] protocols, as well as treatments with Hydroxychloroquine, Ivermectin, Vitamin D, Zinc, and Quercitin, are noteworthy. Hundreds of clinical trials around the world have shown that treatment with Hydroxychloroquine or Ivermectin, given early in the symptomatic period, significantly reduces the risk of severe manifestations and complications of Covid-19 infection, implying that widespread use of these drugs would significantly reduce hospitalizations and severe forms of the disease.
6. The total number of fatalities is extremely low.
In November 2020, a Johns Hopkins University (USA) newspaper published a paper about Covid-19 infection-related mortality. Dr. Genevieve Briand [15], Deputy Director of the Master's Program in Applied Economics at Johns Hopkins University, conducted the statistical analysis using data on Covid-19 deaths published by the US Federal Monitoring and Prevention Agency (CDC). Between March and September, 200,000 deaths in the United States were attributed to the Covid-19 infection. This figure has frequently been reported in the press as evidence of an increase in overall mortality due to the pandemic. However, when Dr. Briand compared the number of deaths in 2020 to those in 2014-2019, he noticed a similar pattern. "Not only has Covid-19 infection did not affect elderly mortality, but there has also been no increase in the total number of deaths." These analyses suggest that the number of deaths caused by Covid-19 is not concerning, contrary to popular belief. Covid-19 has almost no effect on mortality in the United States.
Dr. Briand conducted additional analyses to understand the phenomenon better, examining the number of deaths in those years based on the cause of death. Despite the 200,000 deaths attributed to the Covid-19 virus, the total number of deaths in 2020 was like in previous years, owing to a significant decrease in deaths from other causes in 2020 compared to the last two years. According to this analysis, many deaths from heart disease, respiratory disease, influenza, and pneumonia in 2020 have been classified as "Covid-19 deaths." The CDC does consider all Covid-19 deaths to be Covid-19 deaths. Patients who die from other causes (for example, heart disease) but test positive for Covid-19 in the last month before death have Covid-19 listed as the cause of death on their death certificate. However, data [16] contradict this hypothesis, claiming that the mortality rate in the United States would have increased by 12% in 2020 compared to 2019, attributing 350,000 deaths to the pandemic. Which variant is correct will be determined.
Based on seroprevalence studies, the well-known epidemiologist John Ioannidis [17] took a similar approach and published it in the World Health Organization Bulletin in October 2020. According to Ioannidis, the average infection mortality rate is 0.20 percent, and infection mortality rates in different parts of the world are much lower than previously estimated in the pandemic. Such assessments of our country's situation would be highly beneficial.
Ana Gheorghiu
[1]https://www.bmj.com/content/371/bmj.m4037
[2] https://www.forbes.com/sites/williamhaseltine/2020/09/23/covid-19-vaccine-protocols-reveal-that-trials-are-designed-to-succeed/?sh=6eb5cb8e5247
[3] COVID-19 Vaccine Update (covid19conversations.org), p. 72.
[4]https://www.wodarg.com/app/download/9033912514/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_signed_with_Exhibits_geschwa%CC%88rzt.pdf?t=1606870652, p. 4.
[5]https://www.nature.com/articles/d41587-020-00016-w
[6]https://drive.google.com/file/d/17RiwJ__BV06CCFUzzubnvm4nXgUGuq78/view?usp=sharing, p. 17.
[7]https://www.reuters.com/article/health-coronavirus-mexico-vaccines/mexican-doctor-hospitalized-after-receiving-covid-19-vaccine-idUSKBN2970H3
[8]https://www.dailymail.co.uk/news/article-9119431/Miami-doctor-58-dies-three-weeks-receiving-Pfizer-Covid-19-vaccine.html
[9]https://vaers.hhs.gov/data.html
[10] VAERS data will be publicly available one week later (the most recent data that can be accessed is that which was reported by the previous Friday). For example, the data that can be accessed on Friday, January 15th, 2021, are reported until January 8th, not those reported more recently.
[11]https://vaers.hhs.gov/data.html
[12]https://faculty.utrgv.edu/eleftherios.gkioulekas/zelenko/index.html
[13]https://faculty.utrgv.edu/eleftherios.gkioulekas/zelenko/Zelenko-memo-August-prophylaxis.pdf
[14]https://faculty.utrgv.edu/eleftherios.gkioulekas/zelenko/Zelenko-memo-November-updated-protocol.pdf
[15]https://web.archive.org/web/20201126163323/https://www.jhunewsletter.com/article/2020/11/a-closer-look-at-u-s-deaths-due-to-covid-19
[16]https://usafacts.org/articles/preliminary-us-death-statistics-more-deaths-in-2020-than-2019-coronavirus-age-flu/
[17]https://www.who.int/bulletin/online_first/BLT.20.265892.pdf
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