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, 9 different vaccines were approved either in the EU or in one of 30 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
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 amongs others.
Inactivated vaccines for coronavirus are tested in India under the brand name Covaxin. In Brazil, Turkey and Indonesia CoronaVac is being tested. An alum adjuvant is supposed to increase the immune response in this candidate. 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, but no brand name was announced so far. Three of the candidates are already approved in China, and the Indian candidate is in Phase III trial.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.
The Pfizer and Moderna vaccines are 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 kicks in to combat the virus. 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, 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 immunity 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 vaccine mimics therefore the replication mechanism of a virus with the only difference 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.
An interesting observation comes from the analysis of the Phase I trial data of the Moderna vaccine. At a dose of 100 µg (which is the dose being applied) one of 15 test candidates developed a grade 3 adverse event, defined as an event which prevents daily activity and requires medical intervention. When increasing the dose to 250 µg, it increased to three grade 3 adverse events among 15 test candidates. According to the Companie’s report, all adverse events were transient and self-resolving.5)Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Moderna Website, May 18, 2020
Another 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.6)Jop de Vrieze. Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions. Science Magazine, December 21, 2020
5 Questions Fauci and FDA Need to Answer on Pfizer and Moderna COVID Vaccines. The Defender, December 23, 2020
By January 16 there were 55 cases of death reported in the US after applying a COVID-19 vaccine. Those deaths have occurred after applying the Pfizer and Moderna vaccine alike, and those number of deaths were reported after applying 10.5 million doses of the vaccine.7)55 People Died in US After ReceivingCOVID-19 Vaccines: Reporting System. The Epoch Times, January 16, 2021 In the same timeframe, there were 23 deaths reported in Norway as a result of the vaccine.8)23 die in Norway after receiving COVID vaccine. WBTW News, January 16, 2021 It is difficult to prove how many of those deaths were directly caused by the vaccine, but it seems to get obvious that especially in elderly people the vaccine could possibly cause a fatal adverse effect.
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 partially neutralize the entire vaccine.
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.11)AstraZeneca’s quick Covid-19 vaccine trial restart splits experts. Clinical Trials. October 12, 2020 Failure in transparency of the communication with the FDA was leading also to significant delays in starting the Phase III trials in the US.12)Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner. The New York Times. December 8, 2020 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 subsisted after a 7 day period.13)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.14)Heated Vaccine Debate – Kennedy Jr. vs Dershowitz. Youtube, July 23, 2020
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 is already made available to the public for free, although the phase III trials are not completed so far. Until today there is no safety profile data published about the vaccine. But the public is still skeptic, 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.15)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.16)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. They list a number of 254 clinical trials authorized in the US that were performed with adenovirus viral vector. The first one was done in 1993, trying to treat cystic fibrois, 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, that 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.
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 and entered the 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.17)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 randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial. The Lancet, November 17 2020 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.18)Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine, 1 July 2020 We will need to wait to hear more news about the outcome of their COVID-19 vaccine.
Current data suggests, 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. We have not sufficient experience with mRNA vaccines to say for sure whether they are going to provide long term protection.
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. That far the coronavirus is much more stable than influenza viruses. But there are some mutations reported already that affect the spike protein.
When a virus is mutating, chances increase that antibody-dependent disease enhancement is taking place, where antibodies are wrongly attached to the virus, and is even enhancing the infection.19)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 This reaction may be more common in elderly people and other classes with an impaired immune system response.
That far most scientists are confident that the mutations are not significant enough to cause any problem. But there are already studies underway to determine in which way the existing virus mutations could affect the efficacy of our current vaccines.20)B S Kamps, C Hoffmann. COVID Reference. Edition 2021.6, p. 177,178 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, they will be the ones that are going to be resistant to vaccines and going to spread.21)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.22)Jonathan Smith. Can Covid-19 Vaccines Keep up with an Evolving Virus? Labiotech.eu 27/08/2020 All vaccines based on an inactivated virus as a whole will be quite a bit more reliable in this aspect as well.
One big question will be 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.23)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.24)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.25)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.26)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
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 which 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 be injected into our bloodstream. If that is going to be a blessing or a curse is still going to be seen. For me the inactivated vaccine candidates seen 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 are a classical example for that.
When a new medication enters the market, careful testing is done for several years. Those medications are applied to only a small subgroup of people who carry a certain disease. In case of vaccines, that are applied to an entire population as a whole, with all its diversity involved, much more caution should be applied in the approval process. This is not always happening for regular vaccines, and much less for COVID-19 vaccines who were developed amongst extreme time pressure.
So do we have a safe vaccine available? I think we are not in a position yet to give a sure answer about that, but hopefully the months to come will give us more clarity about the issue. Let´s wait and see!
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.27)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.
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.28)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.29)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.30)Experts send Vitamin D and Covid-19 open letter to world’s governments. Nutraingredients.com December 21, 2020
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.
We have a special opportunity just for you. If you want to receive practical and up to date advice on how to implement an immunity-boosting lifestyle, simply join the Coronavirus Immunity Challenge and prepare yourself to face the pandemic with a bullet-proof immune system.
Coronavirus Immunity Challenge
Martin Neumann was trained for Lifestyle Interventions in 1998 at Wildwood Lifestyle Center & Hospital. Since then he has lectured in different parts of the world about a healthy lifestyle and natural remedies. He is the founder of the Abundant Health website.
|↑1||Covid vaccine: More than 130,000 vaccinated in UK in first week. BBC News, December 16, 2020|
|↑2||COVID-19 vaccine tracker on raps.org|
|↑3, ↑9||Moderna vs. Pfizer COVID 19 Vaccine. Medcram Episode 117|
|↑4, ↑21||The UK has approved a COVID vaccine — here’s what scientists now want to know. Nature, December 3, 2020|
|↑5||Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Moderna Website, May 18, 2020|
|↑6||Jop de Vrieze. Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions. Science Magazine, December 21, 2020|
5 Questions Fauci and FDA Need to Answer on Pfizer and Moderna COVID Vaccines. The Defender, December 23, 2020
|↑7||55 People Died in US After ReceivingCOVID-19 Vaccines: Reporting System. The Epoch Times, January 16, 2021|
|↑8||23 die in Norway after receiving COVID vaccine. WBTW News, January 16, 2021|
|↑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|
|↑11||AstraZeneca’s quick Covid-19 vaccine trial restart splits experts. Clinical Trials. October 12, 2020|
|↑12||Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner. The New York Times. December 8, 2020|
|↑13||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|
|↑14||Heated Vaccine Debate – Kennedy Jr. vs Dershowitz. Youtube, July 23, 2020|
|↑15||Coronavirus: Sputnik V vaccine rushed out to wary Russians. BBC News, December 8, 2020|
|↑16||Adenoviral vaccines. Sputnik V website|
|↑17||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 randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial. The Lancet, November 17 2020|
|↑18||Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine, 1 July 2020|
|↑19||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
|↑20||B S Kamps, C Hoffmann. COVID Reference. Edition 2021.6, p. 177,178|
|↑22||Jonathan Smith. Can Covid-19 Vaccines Keep up with an Evolving Virus? Labiotech.eu 27/08/2020|
|↑23||Liability for the Production and Sale of Vaccines. in Vaccine Supply and Innovation|
|↑24||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.
|↑25||Heated Vaccine Debate – Kennedy Jr. vs Dershowitz, Youtube, Jul 23, 2020|
|↑26||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|
|↑27||People with Certain Medical Conditions. CDC|
|↑28||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|
|↑29||Vitamin D and COVID 19: The Evidence for Prevention and Treatment of Coronavirus (SARS CoV 2). Youtube. December 10, 2020|
|↑30||Experts send Vitamin D and Covid-19 open letter to world’s governments. Nutraingredients.com December 21, 2020|