The Upcoming COVID-19 Vaccines You Should Wait For
It is like a bad dream, but within 1.5 years, we have reached the stage that governments are discussing mandatory vaccination. Millions and millions of people have already been vaccinated, and some of them have paid a high price by getting very severe side effects, or even by dying from the new mRNA vaccines. In this article, I will discuss what the problems are with the mRNA vaccines and what to do if you don´t want to be vaccinated with one of these mRNA vaccines.
Vaccines 101
To teach our immune system how to handle a new pathogen, we can expose it to an antigen specific to this pathogen. This is how a vaccination works. To make sure that we cannot get sick from the vaccine, we use weakened pathogens, pathogens that are made inactive, or isolate just the antigen from it, which is the crucial part to recognize the pathogen and expose our immune system to it. Our immune system learns how to make the key, and when we are infected with an active pathogen, it will recognize and attack this. Sometimes a vaccine is given in repeated doses to make sure that it is stored in the memory cells. Some pathogens, like tetanus, need a booster after a certain period to make sure our immune system doesn´t forget how to make the antibodies. To make a vaccine safe, we must be sure that the pathogen is inactive and cannot make us sick. In addition, we must be sure that the antigen we present is specific enough for our immune system to recognize it when the real pathogen should enter. This process is complicated, but luckily, we have a long history of making and developing vaccines.
What Is Different With the New COVID-19 Vaccines?
So remember, a vaccine consists of weakened or dead pathogens or particles with the antigen. These viruses or particles are produced under strict circumstances, and it takes time to make them. Due to political reasons, pressure from society, and significant financial interests, there is a lot of motivation to be quick with a COVID-19 vaccine. Because the production of weakened viruses or particles takes time, a workaround is invented. How does this work? A virus infects a cell by attaching to it, then injects a new gene (modified DNA) into the cell, causing the cell to start producing the Spike protein. Basically, your own cells produce the building blocks of the virus in huge numbers. Taking this idea, a complete novel format has been developed as a vaccine for COVID-19, where your own body cells will produce the antigen. This has never been done before, and there is little experience with this kind of vaccine. This type of vaccine is developed by AstraZeneca and the University of Oxford, BioNTech and Pfizer, and Janssen. (Bingham, 2020) Vaccines based on frequently used vaccine formats, such as adjuvanted protein vaccines are developed by Novavax, and by GSK and Sanofi, and inactivated whole viruses developed by Valneva. (Bingham, 2020) However, these will not be available until late in 2021. (Bingham, 2020)
The Problems With the New mRNA Vaccines
In essence, these new mRNA vaccines are not vaccines, but they use genetic modification. And this time, it is not about genetic modification of corn or wheat, but about genetic modification of our own cells. This has never been done before on such a big scale.
Another problem is that this vector is a virus, so it could be very well possible that your immune system will start to attack the vector. So maybe this trick will work once, but a second time you could have immunity against this vector virus.
Viruses can mutate; this means that they change. A well-known example is the influenza virus, which changes every year, hence the yearly new vaccination rounds. The coronavirus also mutates, so the spike protein that your cells will produce as antigens could be useless for the next variant of corona or COVID-19 viruses. Already one variant (N439K) has been isolated, which evades our antibody immunity. (Thomson, Rosen, Shepherd, & et al., 2020) This would make this specific vaccine already useless.
The FDA and EMA conditionally approved the mRNA vaccines on the market, under the remark that these vaccines are still in phase 3 clinical trial. This will be till December 2023. This is important to notice because this is different from how other medication is allowed on the market, which is usually after stage 3 clinical research.
And one last thing you also should be aware of. Pharmaceutical companies will be exempt from COVID-19 vaccine liability claims. (Burger & Aripaka, 2020) The companies are offered protection against potentially substantial liability should COVID-19 vaccines cause real or perceived injuries to people. The pharmaceutical manufacturers do not agree to procurement contracts or ship vaccines without liability protection. According to an AstraZeneca executive, in the company’s bilateral contracts, it has been granted protection against legal claims arising from the use of its vaccine products since it ´cannot take the risk` of liability. (Halabi, Heinrich, & Omer, 2020)
What to Do if You Don´t Want an mRNA Vaccine?
Vaccines based on frequently used vaccine formats, such as adjuvanted protein vaccines, are developed by Novavax, and by GSK and Sanofi, and inactivated whole viruses developed by Valneva. (Bingham, 2020) However, these will not be available until late in 2021. (Bingham, 2020) We are in Q3 of this year, and these vaccines will be getting on the market in the foreseeable future.
Novavax is still in phase 2. The official name is NVX-CoV2373; it is a vaccine candidate that is designed to provide protection against COVID-19. It is engineered from the genetic sequence of COVID-19, and they used recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. It binds efficiently with human receptors targeted by the virus, a critical aspect for effective vaccine protection. NVX-CoV2373 is highly immunogenic in animal models measuring Spike protein-specific antibodies, which are antibodies that block the binding of the Spike protein to the receptor and wild-type virus-neutralizing antibodies. High levels of Spike protein–specific antibodies with ACE-2 human receptor–binding, domain-blocking activity, and SARS-CoV-2 wild-type virus neutralizing antibodies were observed after a single immunization. The catch with this vaccine is that it also uses the spike protein, and research has shown that there are specific downsides to the use of Spike protein.
GSK and Sanofi are developing the Vidprevtyn vaccine. Sanofi is contributing its S-protein COVID-19 antigen based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the SARS-CoV-2 virus. The DNA sequence encoding this antigen has been combined into the baculovirus expression platform’s DNA. Sanofi also uses this technique for their recombinant influenza product. The vaccine uses the SARS-CoV-2 virus spike protein as the vaccine antigen to help the body recognize and ideally fight off the real virus if a person becomes infected. The spike protein helps the coronavirus get into a person’s cells, Phase 3 has started, and they expect the introduction of the vaccine in the second half of 2021. The catch with this vaccine is that it also uses the Spike protein, and research has shown that there are specific downsides to the use of spike protein. Beware, GSK is also collaborating with CureVac, but this is also an mRNA vaccine. Sanofi works together with TranslateBio on an mRNA vaccine.
Valneva develops VLA2001, an inactivated whole virus candidate. Valneva reported positive phase 1/2 trial data for VLA2001 at the beginning of April 2021. VLA2001 was well tolerated, with no safety concerns identified. IgG seroconversion rate was 100% in the high dose group, and neutralizing antibody titers were at or above levels generally seen in convalescent sera at or above levels. Valneva has decided to advance the high dose into the Phase 3 clinical trial based on the data assessed. VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. The inactivated vaccine is a proven approach that has been used for decades. The other advantage is that it will probably give a more general immune response against SARS-CoV-2, rather than rely only on the Spike protein to do this.
Conclusion
New vaccines are on the horizon. These new vaccines do not use the experimental mRNA format, and that is already a significant advantage. Novavax and GSK/Sanofi use the Spike protein as antigen, while Valneva produces the only vaccine that uses the whole inactivated virus. We know that the Spike protein can cause specific problems. I hope this article sheds more light on this specific type of COVID-19 vaccines and makes it possible for you to make a better decision. It also shows that there are positive sides and negative sides concerning vaccines; therefore, vaccines should never be mandatory.
Interesting links:
Before You Take the COVID-19 Vaccine, Read This, It Will Blow Your Mind!
Why Mandatory Vaccination Is a Very Bad Idea
The COVID Vaccine Can Make You Very Sick, And Now We Know Why
References
Bingham, K. (2020). The UK Government’s Vaccine Taskforce: strategy for protecting the UK and the world. Lancet, 1–3. doi:https://doi.org/10.1016/S0140-6736(20)32175-9
Burger, L., & Aripaka, P. (2020, July 30). AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries. Reuters. Retrieved from https://www.reuters.com/article/us-astrazeneca-results-vaccine-liability/astrazeneca-to-be-exempt-from-coronavirus-vaccine-liability-claims-in-most-countries-idUSKCN24V2EN
Halabi, S., Heinrich, A., & Omer, S. (2020). No-Fault Compensation for Vaccine Injury — The Other Side of Equitable Access to Covid-19 Vaccines. NEJM. doi:10.1056/NEJMp2030600
IFPMA. (2019). IFPMA (International Federation of Pharmaceutical Manufacturers & Associations). Retrieved from The Complex Journey Of a Vaccine — The Steps Behind Developing a New Vaccine: https://www.ifpma.org/wp-content/uploads/2019/07/IFPMA-ComplexJourney-2019_FINAL.pdf
Thomson, E., Rosen, L., Shepherd, J., & et al. (2020, November). The circulating SARS-CoV-2 spike variant N439K maintains fitness while evading. bioRxiv. doi:doi.org/10.1101/2020.11.04.355842
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