What You Ought to Know about the COVID-19 Vaccines

On December 2 the Medicines and Healthcare Products Regulatory Agency of the United Kingdom gave temporary authorization for the application of the Pfizer and BioNTech’s COVID-19 vaccine. Between 8 and 15 of December the first dose of the vaccine was applied to 137,897 people in the country.¹⁾Covid vaccine: More than 130,000 vaccinated in UK in first week. BBC News, December 16, 2020 The United States followed soon after, approving the Pfizer vaccine on December 11 and the Moderna vaccine on December 18. In the meantime, 14 different vaccines were approved in a number of different countries.

The rapid pace of the development of those vaccines has made a number of critiques to raise their voices and speak up. Some are vehemently against any vaccination, others are very concerned about the speed of the approval process, and some have even assumed that the vaccines would be able to permanently modify the DNA of the human body. The discussion is very emotional on both sides.

There are some concerns that are for real. But how can we separate the fads from facts? And not all vaccines are made alike. In order to understand what is happening, we need to understand a bit deeper, how vaccines were made traditionally and which new technologies were applied for the COVID-19 vaccines.

Different Vaccine Approaches

Inactivated Vaccines

This approach is multiplying the virus on a cell culture and killing it afterwards with heat, radiation or chemicals. The entire dead virus or fractions of it are then injected into the human body in order to be presented to the immune system, which is able to create antibodies against the virus. Since the dead virus does not replicate and exposure is therefore limited, more than one dose is needed to create the desired effect. The efficiency of the vaccine often decreases over time, and a repeated vaccination may be necessary every few years. This category of vaccines is though the safest option available in relation to side effects, and is used for many years for Hepatitis, polio, influenza and rabies vaccines among others.

Inactivated vaccines for coronavirus are developed in India under the brand name Covaxin. In Brazil, Turkey and Indonesia CoronaVac was tested and approved. An alum adjuvant is supposed to increase the immune response in this candidate. The efficacy of 50,38% is not the best, but even those who get infected are normally not needing hospitalization. In China was developed the BBIBP-CorV vaccine, and with an efficacy of 80% it is the most effective candidate in this category that far. Another vaccine candidate in this category is being developed in Wuhan, China, which was named WIBP-CorV. In Russia the vaccine CoviVac was developed.²⁾COVID-19 vaccine tracker on raps.org Since this technology is used for many years in the development of vaccines, it can be potentially just as safe as any other vaccine in use today. We will see later why they are still not as save as your flu shot.

mRNA Vaccines

The Pfizer and Moderna vaccines were the first two vaccine candidates being approved in the US, and both are in the category of mRNA vaccines. What does that mean?

A virus normally uses spike proteins on their surface to dock onto a human cell and release a messenger RNA sequence into the cell. This mRNA sequence hijacks the human cell and gives instructions to replicate the virus and multiply itself. This process is repeating itself until the immune system starts to recognize the virus and can do an efficient combat. If that process takes too long, the virus can make you pretty sick until the immune system is finally strong enough to win the battle.

In case of the mRNA vaccine, it is mimicking the replication mechanism of a virus in order to produce a part of the virus that the immune system is supposed to recognize. An RNA sequence is synthesized in the laboratory that instructs the human cell to produce just the spike proteins of the virus, which are released into the bloodstream. The immune system is that way exposed to the spike proteins and can therefore create antibodies against the virus.

In order to prevent the immune system from attacking the mRNA before entering the cell, it is encapsulated into a fat membrane, similar to a cell membrane. This allows also for a merging with the cell membrane that will release the mRNA substance directly into the cell. The difference to a real virus is that the resulting proteins are not capable to replicate themselves.

According to preliminary test results, the Pfizer vaccination showed a 90% effectivity to prevent from infection compared to placebo, while the Moderna vaccine showed 94.5% effectivity.³⁾Moderna vs. Pfizer COVID 19 Vaccine. Medcram Episode 117 Compared to the flu vaccines that were never reaching more than a 50% effective rate, this is pretty promising. But there is not enough statistical data available to determine how efficient the vaccine works in elderly people or other vulnerable groups.

The phase III studies of those two vaccines did do a COVID-19 test only on the candidates that developed symptoms. It remains unclear, whether those who are vaccinated are only symptom-free and contribute to an asymptomatic infection of the virus. “In the worst-case scenario, you have people walking around feeling fine, but shedding virus everywhere,” says virologist Stephen Griffin at the University of Leeds, UK.⁴⁾The UK has approved a COVID vaccine — here’s what scientists now want to know. Nature, December 3, 2020

The advantage of this technology is that the vaccine can be produced on a large scale within the laboratory, while conventional vaccines depend on the reproduction of the virus in cell culture, which can be a little bit more time-consuming. The problem is just that this technology is for the first time being applied in human vaccines, and similar to genetically modified foods, the potential long-term side effects of this new technology are still not known. According to the Phase III trials those vaccines are supposed to be safe, but follow-up data is available only for a few weeks of the study period. So we know very little about potential long-term complications related to that technology. We know though that the genetic code of the mRNA for producing the spike protein needs to undergo several alterations in order to work efficiently, and the side effects of all those alterations are not fully known yet.⁵⁾Seneff S, Nigh G. Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19. International Journal of Vaccine Theory, Practice, and Research Vol.2 No.1(2021)

Under normal circumstances, a RNA structure does not influence in any way the human DNA, and will not cause any genetic modifications of your body. However, in the presence of retroviruses like the HIV virus, it could happen that a RNA structure of the vaccine gets transcribed into the DNA of a cell. But even if this happens, the infected cell would be modified to produce spike proteins, but would not replicate to alter the DNA of other cells. A contamination of the human DNA from mRNA vaccines is though highly unlikely.

One problem arises with the fact that the mRNA structure needs to be packed into liponanoparticles. They are associated with a number of allergic reactions. A study in mice found also strong inflammatory responses from those nanoparticles.⁶⁾Ndeupen S. et.al. The mRNA-LNP platform’s lipid nanoparticle component used in preclinical vaccine studies is highly inflammatory. https://doi.org/10.1101/2021.03.04.430128

This problem came up after the Pfizer vaccine was released to the public. Within the first 2 weeks of vaccination, there were already 8 cases of anaphylactic shock reported. Suspicion arises, that the chemical compound polyethylene glycol may be the culprit. This substance is part of the Pfizer as well as the Moderna vaccine, and has never been applied in a vaccine before.⁷⁾Jop de Vrieze. Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions. Science Magazine, December 21, 2020
COVID-19 Vaccines for People with Allergies. CDC, Updated Mar. 25, 2021 A study found the rate of anaphylactic reactions to be at 2.47 cases per 10,000 vaccinations applied, and equally distributed between the Pfizer and Moderna vaccines. They also found that 2.1% of the subjects reported acute allergic reactions.⁸⁾Blumenthal KG, Robinson LB, Camargo CA, et al. Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA. 2021;325(15):1562–1565. doi:10.1001/jama.2021.3976

Another challenge is the distribution of the vaccine. The Pfizer vaccine needs to be stored at -70°C, which is -94°F. After being thawed, it needs to be used in a short time, because it is not very stable at room temperature. The Moderna vaccine is a bit easier at this point, allowing storage at 25°F (-4°C) for a month.⁹⁾Moderna vs. Pfizer COVID 19 Vaccine. Medcram Episode 117

Recombinant Viral Vector Vaccines

In this technology, a virus, normally being an adenosine virus causing the common cold, is being genetically modified in order to lose the ability to replicate inside of humans. Instead of the replication genes, a modified DNA structure is inserted. The modified virus is still capable to attack a human cell and deliver its own DNA structure inside the nucleus of the cell. Similar to the mRNA vaccines, the modified DNA is submitting Messenger RNA structures to the cytoplasm of the cell with instructions to produce the spike proteins of the coronavirus. This again triggers the desired immune system response, so that antibodies are formed and are able to protect from future infections.

The AZD1222 vaccine developed by the University of Oxford and AstraZeneca is the best-known candidate of this vaccine. It is based on a modified chimpanzee adenosine virus, that is shuttling the DNA into the host cell. Here a video explaining the mechanism of the vaccine in detail:

According to the developers, the DNA is modified only on the few infected cells, that are used to replicate the virus, and it will not alter the human genome. But it obviously makes use of genetically modified viruses, and a technology that was never tested on a wide scale on humans. And some scientist do not exclude the potential risk of introducing exogenous DNA in the human genome by this technology.¹⁰⁾C Zhang. et.al. Advances in mRNA Vaccines for Infectious Diseases. Front. Immunol., 27 March 2019 | https://doi.org/10.3389/fimmu.2019.00594

Another problem could arise from the response of the immune system to the vector virus itself. If the immune system starts to attack the vector virus, it will be impaired to deliver its message to the host cells. Using the same vector in both vaccine doses could limit immune response to a certain degree, and in case that the immune system was exposed to the adenosine virus strain before, it could neutralize the efficiency of the vaccine. Using a vector virus that had limited exposure to humans avoids this problem, but brings also unforeseeable risks. And exposure to viruses vary greatly between countries, which means that efficiency could vary greatly between countries.

The vaccine was in the news since the clinical trials were put on hold two times after two participants were facing neurological adverse effects during the trial, something that showed up later on in real world application as well.¹¹⁾AstraZeneca’s quick Covid-19 vaccine trial restart splits experts. Clinical Trials. October 12, 2020 The vaccine is know for its side effects. Some adverse side effects like pain, tenderness, fatigue, fever and headaches were reported by participants for about 60% for each of those symptoms on the day after the vaccine, although most of the symptoms subsided after a 7 day period.¹²⁾Pedro M. Folegati et. al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. The Lancet, Volume 396, ISSUE 10249, P467-478, August 15, 2020 Critiques mention that the placebo group received a meningitis vaccine, which is known for its adverse side effects, and even so the adverse reactions of the AZD1222 vaccine were quite higher.¹³⁾Heated Vaccine Debate – Kennedy Jr. vs Dershowitz. Youtube, July 23, 2020 In some study sites, antiinflammatory medications were applied together with the vaccine, which did not happen in real world applications of the vaccine.

More concerns were arising recently after it was discovered that the vaccine can cause in some cases blood clots and low platelet count within a 2 week period after vaccination. Denmark decided as a result to stop the administration of the vaccine, since they observer about 1 incidence in 40.000 persons vaccinated. Soon after Germany, Italy, France, Spain, Norway, Sweden, Latvia and The Netherlands followed with at least temporary suspension, among others.¹⁴⁾Which countries have stopped using AstraZeneca’s COVID vaccine? Aljazeera, 15 Mar 2021
AstraZeneca vaccine: Denmark stops rollout completely. BBC News, April 14, 2021 A German Scientist was able to pinpoint the mechanism how those blood clots are formed. He discovered that the adenovirus vector can cause a reaction of the platelets, which in turn can trigger a chain reaction that brings the entire immune system out of control, very similar to an autoimmune disease. He concluded that this reaction most likely applies to other viral vector vaccines as well.¹⁵⁾Scientists Find How AstraZeneca Vaccine Causes Clots. WebMD, April 22, 2021

Based on the negotiations with the Oxford University, the vaccine producer AstraZeneca promised to forgo initial profits in order to provide the vaccine at a near cost price. And since the vaccine does not require expensive refrigeration, it is likely to get popular in third world countries.

Another candidate in this category is the Sputnik V vaccine developed by Russia. It supposedly delivers a 91% efficiency rate due to the fact that a different adenosine virus is applied at each of the two doses as the vector virus. The vaccine has its own scandals. President Vladimir Putin has issued emergency authorization in August, when it had been tested only on a dozen of people. Vaccination was made available to the public for free, before the phase III trials were completed. But the public reacted with skepticism, and some vaccination sites had to throw away doses after defrosting, since not sufficient volunteers showed up for vaccination. And technical problems are making the production schedule lagging behind.¹⁶⁾Coronavirus: Sputnik V vaccine rushed out to wary Russians. BBC News, December 8, 2020

Meanwhile, the official site of Sputnik V is trying hard to sell the safety of their technology.¹⁷⁾Adenoviral vaccines. Sputnik V website They claim that adenovirus-based drugs are widely used for more than 50 years, just this does not apply to the use of the adenovirus as a viral vector with all the genetic manipulation involved. The first experiments with DNA vaccines were not made until 1989.¹⁸⁾The True Story of How mRNA Vaccination was Invented. R. W. Mallone They list a number of 254 clinical trials authorized in the US that were performed with adenovirus viral vectors. The first one was done in 1993, trying to treat cystic fibrosis, a rare respiratory disease caused by defective genes. No outcome is reported in the database, leading to the assumption that it was not completed successfully. The first larger study was done in 2004, where 1500 participants received a HIV vaccine to be tested. They cite also a cancer drug using this technology, which was used in China since 2004 in more than 30,000 patients. This was the very first time for this technology being applied on a larger scale, even though it was not in a vaccine setting.

The Sputnik V vaccine was rejected by the Brazilian authorities, since there exists a possibility that the messenger adenovirus starts to replicate inside the body and the vaccine causing an infection inside the body.¹⁹⁾URGENTE: Anvisa reprova importação e aplicação da Sputnik V. Terra Brasil Notícias, 26 de Abril 2021 Furthermore they identified flaws in the production process, in the conducted studies and even the final product. The European Union found also several documentary problems in their study and production process and rejected so far the approval of the vaccine.²⁰⁾Rose M. et.al. EXCLUSIVE European efforts to assess Russia’s Sputnik V vaccine stymied by data gaps. Reuters. July 14, 2021.

Another vaccine candidate called EpiVacCorona was also authorized by Putin, without having yet entered Phase III trials. This shows how national pride is often a motive to override concerns for safety, and that not only in Russia. There is little data about this vaccine available so far, but it seems to be based on synthetically produced protein structures. But even being authorized, it will still take a while until being publicly available. Technically speaking, the production of synthetical proteins can be tricky, so the Russians may end up with two candidates falling behind in the production schedule.

A third candidate of a viral vector vaccine is developed by Johnson & Johnson which concluded in the meantime Phase III trials. The company had developed already an Ebola vaccine using the same technology. A safety trial in 2015 was temporarily suspended after two serious neurological adverse events were reported, one of which was considered as possibly related to vaccination.²¹⁾Andrew J Pollard. et.al. Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomized, observer-blind, participant-blind, placebo-controlled, phase 2 trial. The Lancet, November 17 2020 The Astrazeneca trials were obviously not the first time that those complications arouse with viral vector vaccines. In 2019 they finally launched the Phase III trial, where they planned to enroll 500,000 candidates, but were able to vaccinate only about 60,000 candidates that far. In July 2020 they finally got an emergency authorization from the EU to market the ebola vaccine.²²⁾Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine, 1 July 2020

On April 13 the US paused the application of their COVID-19 vaccine, after 6 cases of blood clots in the brain were reported just few days after applying the vaccine. All six cases occurred among women aged 18–48 years. In this age group it seems to appear at a rate of about 7 cases per 1 million vaccines applied.²³⁾Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine. CDC, April 13, 2021
CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume. CDC, April 25, 2021 The EU and South Africa followed the US in pausing the program, while Denmark decided to stop its use altogether. They said that its risks do not outweigh its benefits, declaring therefore that there are safer vaccine candidates available.²⁴⁾Johnson & Johnson vaccine paused over rare blood clots. BBC News, April 13,2021
Denmark ditches J&J COVID-19 shots from vaccination programme. Reuters, May 3, 2021

There seems to be a common thread among viral vector vaccines, with all of them sharing similar side effects. Cases of anaphylactic shock were also reported in a similar rate like in the mRNA vaccines. There is also the potential for the viral vector to mutate inside the human body and become infectious. This is something that happened with other viral vector vaccines in the past.²⁵⁾Stöhr K. Impfstoffe gegen COVID-19 – Stand März 2021 Another concern is the use of genetically modified human cells to replicate the virus of the vaccine, which obviously cannot replicate on its own. This creates the potential of human DNA contamination as well as other possible contaminants.²⁶⁾Seneff S, Nigh G. Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19. International Journal of Vaccine Theory, Practice, and Research Vol.2 No.1(2021)Considering all the facts, viral vectors seems to be the most complicated and questionable technologies applied amongst the COVID-19 vaccines.

Vaccine Critiques

Initial data suggested, that the Pfizer and Moderna vaccines can give at least 90% protection against the virus. But we do not have enough statistical data to tell whether the protection is that good for elderly people, black and hispanic ethnicities who are disproportionally affected by the pandemic, as well as people with diabetes and other lifestyle diseases. That means, for the groups that are most vulnerable, we have not sufficient statistical data for vaccine efficacy available. Also we do not know how long this immunity will last, since we just started to apply them. A study from Israel suggests that protection for infection is reduced to 75% after 3 months and it dwindled to 16% after 6 months. However, it still showed a 91% efficacy to protect serious illness.²⁷⁾Jeffay N. Israeli, UK data offer mixed signals on vaccine’s potency against Delta strain. The Times of Israel, June 22, 2022 Similar data comes from Quatar where efficacy was at 80% after one month of vaccination and dropped to 20% after six months. Protection against severe illness was again around 90%²⁸⁾Craig E. Pfizer’s Covid vaccine efficacy against infection plunges to just 20% after six months – but protection against severe illness barely dips, study concludes. Daily Mail, October 6, 2020 Seems that antibody protection is waning over time, while beta cells are giving a more long lasting immune protection. That means that serious illness is still prevented by beta cells, but infection is possible due to waning antibodies. In clear language, a vaccine can prevent you from becoming seriously ill, but after some time does not prevent you from getting a light infection or spreading the disease. Pfizer has declared that efficacy of the vaccine is already reduced after 6 months and a booster shot will be needed.²⁹⁾Pfizer says it’s time for a Covid booster; FDA and CDC say not so fast. CNN, July 9, 2021

Another concern is that most vaccines are exposing the immune system to only the spike proteins of the virus. If the virus mutates, it could change the shape of the spike protein and render most of the vaccines ineffective.

At the beginning, scientists were confident that mutations would not be significant enough to cause any problem. In the meantime, two-third of epidemiologist believe that our current vaccines will be rendered ineffective within a year or less.³⁰⁾Two-thirds of epidemiologists warn mutations could render current COVID vaccines ineffective in a year or less. Oxfam International. March 30, 2021 It was shown already that the Astrazeneca vaccine has limited efficacy against the South African mutation of the virus, and the country has stopped applying this vaccine.³¹⁾Jonathan Smith. Can Covid-19 Vaccines Keep up with an Evolving Virus? Labiotech.eu 11/02/2021 A study in Israel suggests that the Pfizer vaccine is less effective against the South African Strand as well.³²⁾Kustin T et.al. Evidence for increased breakthrough rates of SARS-CoV-2 variants of concern in BNT162b2 mRNA vaccinated individuals. https://doi.org/10.1101/2021.04.06.21254882 And other vaccines also showed a reduced efficacy.³³⁾Will SARS Cov-2 Become Resistant to Current Vaccines – Implications | Penny Moore, PhD, YouTube, March 9, 2021

In the meantime the Delta variant is spreading, and being the dominant strain in Israel, it reduced the efficacy of the Pfizer vaccine to 39%, while serious illness was still prevented by 91%.³⁴⁾Jeffay N. Israeli, UK data offer mixed signals on vaccine’s potency against Delta strain. The Times of Israel, June 22, 2022 We do not know though how much of this is due to limited efficacy of the vaccine, and how much due to the waning efficacy over time. Things seems to be worse in the UK where the AstraZeneca vaccine is more prevalent. An analysis of the data in the UK suggests that the effectiveness to protect against death during the spread of the Delta variant was reduced to 68.1%, which is quite lower than other statistics claim.³⁵⁾Jones W. Why is the ONS Claiming Just 1% of Covid Deaths Are in the Vaccinated When PHE Data Shows the True Figure For August was 70%? The Daily Sceptic, 14 September 2021 Considering that the Delta variant is spreading around the world, we can already predict that the vaccine alone will not be sufficient to suppress the next wave of the coronavirus.

And we have not seen such a virus yet under selective pressure. When vaccinations are applied on a larger scale, if any significant mutations occur, the ones that are resistant to vaccines and going to spread.³⁶⁾The UK has approved a COVID vaccine — here’s what scientists now want to know. Nature, December 3, 2020 The French firm Osivax as well as a few other companies are exploring vaccine candidates that will target more than just the spike proteins.³⁷⁾Jonathan Smith. Can Covid-19 Vaccines Keep up with an Evolving Virus? Labiotech.eu 11/02/2021 All vaccines based on an inactivated virus as a whole will be quite a bit more reliable in this aspect as well.

When a virus is mutating, chances increase that antibody-dependent disease enhancement is taking place, where antibodies are wrongly attached to the virus, and are even enhancing the infection. This far this phenomenon was not observed with SARS-Cov2, but it was observed in several studies with the SARS-Cov virus.³⁸⁾Wikipedia: COVID-19 vaccine
Iwasaki A, Yang Y (21 April 2020). “The potential danger of suboptimal antibody responses in COVID-19”. Nature Reviews Immunology. 20 (6): 339–41. doi:10.1038/s41577-020-0321-6
W S Lee et. al. Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies. Nature Microbiology volume 5, pages1185–1191(2020) DOI: 10.1038/s41564-020-00789-5
Eroshenko, N., Gill, T., Keaveney, M.K. et al. Implications of antibody-dependent enhancement of infection for SARS-CoV-2 countermeasures. Nat Biotechnol 38, 789–791 (2020). https://doi.org/10.1038/s41587-020-0577-1 This reaction may be more common in elderly people and other classes with an impaired immune system response. Future mutations of the virus could make all vaccinated persons more vulnerable for this phenomenon, especially if booster shots are involved.

The Danish Scientist Geert Vanden Bossche even theorized that our vaccines are not the right tool to use in the midst of a pandemic. He thinks that the suboptimal immune response after the first dose of the vaccine gives the virus the perfect breeding ground to form mutations while feeling the pressure of the vaccine, but still having enough possibility to replicate. He concludes that similar to bacteria that are antibiotic-resistant, the virus will form mutations that are vaccine resistant as well. He wrote an open letter to the WHO to have a scientific debate about the implications of mass vaccination during the pandemic.³⁹⁾https://www.geertvandenbossche.org/ Critiques admit that in theory such a reaction is possible, but in practice our vaccines supposedly show a strong enough immune response already after the first dose.⁴⁰⁾Jarry J. The Doomsday Prophecy of Dr. Geert Vanden Bossche, McGill University, 24 Mar 2021 They also argue that by reducing the number of infected people, which most governments try to achieve with vaccines, you will reduce the number of mutations. While the truth probably lies in the middle, it shows the need of an open scientific discussion about the global impact of vaccination programs.

Liability Questions

One big question will be the long-term safety of those vaccines. Phase III trials normally take several years, but were short-tracked to a few months. The technologies used for most of the vaccines are fairly new and we do not have much safety data except those short trials. Time will tell how safe they are in relation to long term adverse events as a result to the vaccines. And none of the vaccine manufacturer is willing to take the liability for that.

In the US the liability question was already clearly settled in favor of the producers. A swine flu in 1976 caused some fear that a pandemic similar to the 1918 flu would repeat itself and caused the CDC to issue the development of a nationwide emergency vaccination. Producers agreed to make the vaccine with the condition to be freed from liability. The vaccine was produced and administered within record time to 45 million Americans, but for some unexplainable reasons, the virus did not reappear the following winter. However, about 1 in 100,000 of the vaccinated population developed Guillain-Barré syndrome, and the State had to take care of liability compensation for those cases.⁴¹⁾Liability for the Production and Sale of Vaccines. in Vaccine Supply and Innovation Due to increased pressure from the industry, since October 1988 all vaccine manufacturers are exempt from liability for any vaccine applied in the US. And during this recent crisis, in order to give an incentive, the Secretary of Health and Human Services has given a blanket immunity to all activities related to combatting the COVID-19 virus.⁴²⁾Legal Immunity: A Reward for Innovators Combatting COVID-19. JDSUPRA March 18, 2020
COVID-19 and PREP Act Immunity. The National Law Review. Volume X, Number 358.

During the cold war, the vaccine department of the FDA included military officials in order to facilitate emergency preparation for biological weapons, and until today officials report in uniform. In this context, procedures for emergency authorization of vaccines were approved. Critiques mention also that the regulating authorities in the US are widely undermined by the vaccine production lobby, and that independent studies from universities showing the real side effects of vaccinations are deliberately suppressed. In this context of widespread distrust, it is no wonder that the anti-vaccine movement gained force especially within the United States.⁴³⁾Heated Vaccine Debate – Kennedy Jr. vs Dershowitz, Youtube, Jul 23, 2020

Other countries have more stringent liability laws in relation to vaccines, but in the case of COVID-19 vaccines, no producer is willing to assume liabilities, and no-liability clauses are included in the contracts that are signed with governments. There are now debates going on, how recompensation should be managed for those who develop adverse events as result to the vaccine, especially in poorer countries that are unable to offer such recompensation.⁴⁴⁾Sam Halabi et.al. No-Fault Compensation for Vaccine Injury — The Other Side of Equitable Access to Covid-19 Vaccines. N Engl J Med 2020; 383:e125

Safety Concerns

Those new technologies are a real concern. We have Genetically Modified Foods in use since 1994, and until today there are still studies being done on what kind of side effects this technology is causing on our health. If mankind is trying to improve the plants that God has created perfectly, something is always getting out of balance. Now humanity is going a step further and produces genetically modified viruses to be injected into our bloodstream. If that is going to be a blessing or a curse is still going to be seen. Certainly, we can expect a number of allergic reactions to occur, similar to the ones we see with genetically modified foods. What else they will bring, nobody is able to tell so far. For me, the inactivated vaccine candidates seem to be quite a bit more prudent.

Another problem consists that all studies are done on healthy people and carefully exclude people who show allergic reactions or other adverse health conditions. We have therefore no safety data on how vulnerable people groups react to the vaccine. The anaphylactic shocks happening after the application of the Pfizer vaccines appeared just after wider application, since vulnerable groups were excluded in the trials. An Israeli study found an incidence of 1.2% of cases of shingles appearing in a rheumatic study group after the application of the Pfizer vaccine.⁴⁵⁾Furer V et.al. Herpes zoster following BNT162b2 mRNA Covid-19 vaccination in patients with autoimmune inflammatory rheumatic diseases: a case series. Rheumatology, keab345, https://doi.org/10.1093/rheumatology/keab345 And we have seen more frequently frail and elderly people dying as a response to the vaccine, so those risks should be carefully considered. Side effects that healthy people handle with ease, like fever, nausea and diarrhea can be contributing to a fatal outcome in frail patients.⁴⁶⁾Norway investigates 23 deaths in frail elderly patients after vaccination. BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n149

It is interesting to note that in the Vaccine Adverse Effect Reporting System there are normally reported around 150 deaths per year for all 70 registered vaccines combined. Now for the COVID-19 vaccines we have already close to 6,000 deaths reported in the system, while about half of the American population was getting vaccinated.⁴⁷⁾Original VAERS dataset: https://wonder.cdc.gov/controller/saved/D8/D173F192 According to data of May 2021 this translates to 3.4 deaths for every 100,000 vaccinations applied,⁴⁸⁾Rose J. A Report on the U.S. Vaccine Adverse Events Reporting System (VAERS) of the COVID-19 Messenger Ribonucleic Acid (mRNA) Biologicals. Science, Public Health Policy, and The Law Volume 2:59–80 May, 2021 and the number was probably rising slightly in the meantime. There is no proof that all those cases were necessarily caused by the vaccine, but with about 80% of all adverse effects reported happening within the first 24 hours, the likelihood that they are caused by the vaccine is pretty high. And it is also a known fact that not all adverse effects are getting reported, and some people estimate that the real numbers could be five times higher. Exact numbers we probably will never know, but we can affirm that the COVID-19 vaccines are not as save as your common flu shot.

Because of the known limitations of the Adverse Effect Reporting System, the government has developed an app that allows an easy channel for vaccinated candidates to self report adverse events in a convenient fashion. The resulting data is stored in the V-Safe database. Just this data is not publicly available. Only a select group of the CDC and a few authorized researchers have access to this data. If you have an adverse event after taking the vaccine, you should definitely report it to the VAERS system as well under this link:
https://vaers.hhs.gov/reportevent.html

Robert Malone is a scientist that was involved in the development of the mRNA technology. He made on a LinkedIn post the following statement about the current COVID-19 vaccines:

Once again I feel it necessary to make a clear and unambiguous statement. The data strongly indicate that the experimental genetic vaccines, including the mRNA and recombinant adenoviral vaccines, have saved lives. Many lives.

But it is also increasingly clear that there are some risks associated with these vaccines. Various governments have attempted to deny that this is the case. But they are wrong. Vaccination-associated coagulation is a risk. Cardiotoxicity is a risk. Those are proven, and discussed in official USG communications, as well as communications from a variety of other governments.

Based on what I have seen, I believe that other toxicity risks will become more apparent. These include menstrual irregularities, development of thrombocytopenia, cerebrovascular effects, and reactivation of latent viruses such as clinical shingles.

But we do not know how prevalent these are, and the spectrum of severity is unknown and possibly unknowable because the V-Safe database is not being shared outside of CDC, the VAERS systems is deeply flawed, and we just do not have the comprehensive safety data necessary to accurately evaluate risk/benefit for the various cohorts – elderly, healthy normal adults, immunocompromised, pregnancy, adolescents, children, and infants. Particularly the long term safety data necessary to evaluate risks such as autoimmune complications that may manifest months or years post-vaccination. That is just a sciencefact.⁴⁹⁾LinkedIn Post, https://www.linkedin.com/feed/update/urn:li:activity:6812703149678243841/

Robert Malone

According to Robert Malone, the main problem consists in the large quantity of spike proteins circulating in the body after the vaccine. A study has shown that the spike protein of the virus causes cell damage, independently of the action of the virus itself to attack cells to replicate.⁵⁰⁾Lei Y et.al. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2. Circulation Research. 2021;128:1323–1326 https://doi.org/10.1161/CIRCRESAHA.121.318902 Another study showed that spike proteins are able to influence cell signalling and could lead to PAH, a serious lung disease, blood clotting, coronary artery disease, hypertension and stroke.⁵¹⁾Suzuki Y et. al. SARS-CoV-2 Spike Protein Elicits Cell Signaling in Human Host Cells: Implications for Possible Consequences of COVID-19 Vaccines. Vaccines (Basel). 2021 Jan; 9(1): 36. doi: 10.3390/vaccines9010036 The spike protein can also damage the blood brain barrier and cause unpredictable brain damage, that shows up in several symptoms for the disease and the vaccine alike.⁵²⁾Buzhdygan TP et.al. The SARS-CoV-2 spike protein alters barrier function in 2D static and 3D microfluidic in-vitro models of the human blood-brain barrier. Neurobiol Dis. 2020 Dec;146:105131. DOI: 10.1016/j.nbd.2020.105131 The mRNA and viral vector vaccines are inundating the body with a considerate amount of spike proteins, that seem to be causing in some susceptible people symptoms that are varied in nature and in some ways similar to the disease itself. It is interesting to note that 1/4 of the regular dose of the Moderna vaccine showed a sufficient immune response, indicating the the applied doses may be higher than necessary.⁵³⁾Mateus J et.al. Low dose mRNA-1273 COVID-19 vaccine generates durable T cell memory and antibodies enhanced by pre-existing crossreactive T cell memory. doi: https://doi.org/10.1101/2021.06.30.21259787

A study analyzed the adverse effects recorded within the European Union. They found out that in Poland there were only 16 adverse events recorded for every 100,000 vaccines applied, while in Netherlands this number reached 706 events. They concluded that this extreme difference is due to different reporting standards. They also calculated that according to the the Dutch reporting data there were registered 4,15 deaths and 16,7 severe side effects for 100,000 vaccines applied. Comparing this data with some Israeli vaccination studies, they concluded that we are probably causing 2 deaths from the vaccine to avoid 3 deaths from COVID-19 infections.⁵⁴⁾Walach H. et. al. The Safety of COVID-19 Vaccinations—We Should Rethink the Policy. Vaccines, 2020, 9(7) 693. DOI:10.3390/vaccines9070693

The study caused quite a bit of turmoil, being attacked from many sides. The journal finally decided to retract the paper.⁵⁵⁾Retraction: Walach et al. The Safety of COVID-19 Vaccinations—We Should Rethink the Policy. Vaccines 2021, 9, 693. Vaccines2021, 9(7), 729; https://doi.org/10.3390/vaccines9070729 The main reason mentioned was, that it is not proven that all events recorded in the system were really caused by the vaccine. This is true and we have mentioned this already for the VAERS database. On the other hand, we cannot safely say, how much of under-reporting was happening, which means we are pretty much in the blind to confirm whether things are better or worse than depicted in this study.

We should fairly say that the number of saved lives from vaccinations is also proportional to the degree that a certain country is being hit by the pandemic. If we calculate the number of saved lives for Peru for example, the vaccine will show more benefit than in Israel, that had ten times less deaths during the entire pandemic. Even so there are many variables defining the benefit/risk ratio, we need to discuss more openly the question on how to protect vulnerable groups from possible vaccine side effects.

Analyzing the available data of the VAERS database, it can be seen that adverse effects of the immune system are the most common ones observed.⁵⁶⁾Rose J. A Report on the U.S. Vaccine Adverse Events Reporting System (VAERS) of the COVID-19 Messenger Ribonucleic Acid (mRNA) Biologicals. Science, Public Health Policy, and The Law Volume 2:59–80
May, 2021 That raises concerns about the safety of the vaccines for people with compromised immunity, and we can expect to see autoimmune diseases to be on the rise. This can be possibly caused by the spike protein, from the disease or the vaccine alike.⁵⁷⁾Seneff S, Nigh G. Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19. International Journal of Vaccine Theory, Practice, and Research Vol.2 No.1(2021) Even the CDC admits that we have not sufficient safety data of COVID-19 vaccines for people with autoimmune conditions.⁵⁸⁾Vaccine Considerations for People with Underlying Medical Conditions. CDC, Updated Apr. 23, 2021 And an article from 2018 makes the following statement about mRNA vaccines:

A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity. Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken.⁵⁹⁾Pardi N. et.al. mRNA vaccines — a new era in vaccinology. Nat Rev Drug Discov 17, 261–279 (2018). https://doi.org/10.1038/nrd.2017.243

In Israel was established that the Pfizer vaccine caused a risk of myocarditis in young men that was up to 25 times higher than normal.⁶⁰⁾Israel reports link between rare cases of heart inflammation and COVID-19 vaccination in young men. Science, Jun. 1, 2021 Recently a study from the University of Ottawa Heart Institute found out that in an average 1 in 1000 vaccinated persons in all age groups developed myocarditis.⁶¹⁾Kafil T. mRNA COVID-19 Vaccination and Development of CMR-confirmed Myopericarditis. doi: https://doi.org/10.1101/2021.09.13.21262182 There are also questions about safety of the vaccine during pregnancy, especially during the first trimester.⁶²⁾A study concluded that the abortion rate in the first trimester would be 12.6% and the normal published rate 10-26%. The results are in table 4 of this study:
Shimabukuro TT, Kim SY, Myers TR, et al. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med. 2021;384(24):2273-2282. doi:10.1056/NEJMoa2104983
A reader of the journal found an error and commented the following:
In table 4, the authors report a rate of spontaneous abortions <20 weeks (SA) of 12.5% (104 abortions/827 completed pregnancies). However, this rate should be based on the number of women who were at risk of an SA due to vaccine receipt and should exclude the 700 women who were vaccinated in their third-trimester (104/127 = 82%). We acknowledge this rate will likely decrease as the pregnancies of women who were vaccinated <20 weeks complete but believe the rate will be higher than 12.5%. However, given the importance of these findings we feel it important to report these rates accurately. Additionally, the authors indicate that the rate of SAs in the published literature is between 10% and 26%. However, the upper cited rate includes clinically-unrecognized pregnancies, which does not reflect the clinically-recognized pregnancies of this cohort and should be removed. And some people have raised concerns that the vaccines could cause infertility,⁶³⁾Mowrey B. What Happened in Singapore? Unglossed, June 23, 20221 which is a question that can be statistically proven only in a few years from now.

Conclusion

At the end the decision to vaccinate or not needs to be a personal choice. You need to decide whether you want to take the risk of taking the vaccine or whether you want to take the risk of getting the disease. Which of the risks is more prevalent surely depends on many factors that are individual for each person. People who are in at-risk groups for COVID-19 may tend to be inclined to get vaccinated, but at the other hand, they will be exactly the kind of people who are more vulnerable for adverse effects of the vaccines. For children, we can conclude that the risks outweigh the benefits, since they are rarely getting a severe form of COVID-19. In accordance to that, the vaccination commitee in Germany is speaking that far against a general vaccination of the 12 to 17 years age group.⁶⁴⁾COVID-19 und Impfen: Antworten auf häufig gestellte Fragen (FAQ) Robert Koch Institut, 5.08.2021
Sollten Eltern ihre Kinder nun impfen lassen? Deuschlandfunk 3.08.2021

It is interesting to mention that a study has found that people who already were previously infected by the virus, showed a similar protection to somebody who got the vaccine, and this group did not receive any significant benefit from being vaccinated.⁶⁵⁾Shrestha N. et al. Necessity of COVID-19 vaccination in previously infected individuals. https://doi.org/10.1101/2021.06.01.21258176 Sufficient antibody count was normally found even 9 months after the first positive test.⁶⁶⁾Dorigatti I. et. al. SARS-CoV-2 antibody dynamics and transmission from community-wide serological testing in the Italian municipality of Vo’. Nat Commun 12, 4383 (2021). https://doi.org/10.1038/s41467-021-24622-7 And even though that the antibodies are diminishing in quantity within a few months after infection, it was shown that memory B cells can provide a long lasting immune response that should be effective for years to come.⁶⁷⁾Turner J et. al. SARS-CoV-2 infection induces long-lived bone marrow plasma cells in humans. https://doi.org/10.1038/s41586-021-03647-4 In Israel they found immunity from a former infection even more effective than vaccination to protect against the delta variant.⁶⁸⁾Rosenberg D. Natural infection vs vaccination: Which gives more protection? Israel National News, Jul 13 , 2021 If you already got infected by COVID-19, you can pass your dose to somebody else.

If you decide to get vaccinated, you should prepare yourself to the vaccination with a strong immune system. Be sure you have no flu, cough or other infection for a week before the vaccine. Studies have shown that sleeping well the night before vaccination improve the immune response to the vaccine and decrease possible adverse events. Besides your sleep, follow all other recommendations in the Coronavirus Immunity Challenge. You can minimize much of the inflammatory response by using a tablespoon of flaxseed oil starting 3 days before the vaccine and continuing for 3 weeks after the vaccine. If you feel necessary, you can use an anti-inflammatory drug. N acetyl cysteine can help you a lot to control spike protein damage as well.

I would recommend doing an antibody blood test before vaccination. If the result is positive, you don’t need to be vaccinated. And if you get a vaccine within 3 months of a COVID-19 infection, it may even aggravate your risk for vaccine side effects.⁶⁹⁾Noorchasm H. Death Of An Orthopod From COVID-19: Was It The Virus, Was It The Vaccine, Or Was It Both? medium.com Feb. 14 2021 A study has shown a 3 times increase in adverse events in those who had a prior COVID-19 infection.⁷⁰⁾Knapton S. Covid vaccine side effects up to three times more common in those who have had virus. Telegraph, March 5 2021

Looking at this picture of uncertainties, one may wonder why there is not more discussion about vaccine safety in government circles. What it looks like is that the vaccine is widely viewed as the only way to end the pandemic. Coming from this perspective, many safety concerns, that normally are causing a halt of a vaccination program, are received with much hesitancy, and any discussion that is seriously critiquing the safety of the vaccination programs is considered to be a threat to public safety. For these reasons, an open discussion of these questions is rarely taking place, even in scientific circles.

The driving force for this policy is the belief that getting at least 70% of the population vaccinated, will create herd immunity and will bring the pandemic to an end. In fact, there seems to be evidence that in countries like Israel, where a large enough percentage of the population is vaccinated, the pandemic is declining. But we have already shown that this is not the case for mutations, and until we have controlled the pandemic worldwide, mutations will continue to arise. I believe it is on the time to discuss alternative measures to complement vaccination programs, and to have an open scientific discussion about risk and benefit for certain people groups.

With that many questions still needing an answer, one may question why other protective measures are not being taken more seriously. We know for a long time that people with obesity, type II diabetes, heart disease or cancer are more susceptible to the disease.⁷¹⁾People with Certain Medical Conditions. CDC Why are there no interventions to help those people groups to better control their lifestyle-related diseases? We know that most of those conditions can be prevented or even reversed with a healthier lifestyle. And why are early treatment protocols not being advocated?

There is growing evidence that Vitamin D is playing an important role in improving the immune response against a COVID-19 infection. Studies show that near equator latitudes were affected much less from COVID-19 infections.⁷²⁾Gareth Davis et.al. Evidence Supports a Causal Role for Vitamin D Status in COVID-19 Outcomes. https://doi.org/10.1101/2020.05.01.20087965 Many other studies are available on the correlation between Vitamin D levels and COVID-19 infection rates as well as disease outcome.⁷³⁾Vitamin D and COVID 19: The Evidence for Prevention and Treatment of Coronavirus (SARS CoV 2). Youtube. December 10, 2020 Experts suggest, that a widespread supplementation with 4,000 UI of Vitamin D would be one of the cheapest and most effective interventions to limit the spread of the disease. But governments are still skeptical to accept this evidence, and most regulating agencies are still publishing RDA requirements that are way too low to combat the widespread deficiency.⁷⁴⁾Experts send Vitamin D and Covid-19 open letter to world’s governments. Nutraingredients.com December 21, 2020

Vaccines can reduce your risk for being infected by the virus, but no vaccine can guarantee you a hundred percent protection. There are plenty of cases that persons who were vaccinated got infected and even died of COVID-19. So whether you decide to get vaccinated or not, one of the most important measures you can take to protect yourself is to invest in your immune system. And even for treatment, there is no drug around that can cure the disease. The only thing which will fight off the virus at the end is your immune system.

There are many measures available to strengthen our immune system, and we have it in our own hands to implement them into our lives. For this reason, we have launched the Coronavirus Immunity Challenge on our site. If you have not participated yet, I strongly encourage you to sign up and learn all the insights, so that you can do your part in protecting yourself against this disease.