NB: Admittedly, this post seems a bit out of our area of expertise, but please bear with us, it circles back on follow ups... thank you. Jiri Fiala.
I have had, let’s call them, discussions on various platforms about the efficacy and validity of the various COVID vaccines. After many, many, many posts and comments, arguments, name calling, I realized one thing. That I was guilty of some of the things I was accusing people of: ignorance, knee-jerk reactions and most importantly, not adhering to my own belief system of doing the research. I thought I had, but I clearly missed things. So, I went back to the beginning. Here is what I found.
Vaccines, a brief history1
Immunisation dates back hundreds of years. Buddhist monks drank snake venom to confer immunity to snake bite and variolation (smearing of a skin tear with cowpox to confer immunity to smallpox) was practiced in 17th century China. Edward Jenner is considered the founder of vaccinology in the West in 1796, after he inoculated a 13-year-old-boy with vaccinia virus (cowpox) and demonstrated immunity to smallpox. In 1798, the first smallpox vaccine was developed. Over the 18th and19th centuries, systematic implementation of mass smallpox immunisation culminated in its global eradication in 1979.
Louis Pasteur’s experiments spearheaded the development of live attenuated cholera vaccine and inactivated anthrax vaccine in humans (1897 and 1904, respectively). Plague vaccine was also invented in the late 19th Century. Between 1890 and 1950, bacterial vaccine development proliferated, including the Bacillus-Calmette-Guerin (BCG)(tuberculosis) vaccination, still in used today.
In 1923, Alexander Glenny perfected a method to inactivate tetanus toxin with formaldehyde. The same method was used to develop a vaccine against diphtheria in 1926. Pertussis vaccine development took considerably longer, with a whole cell vaccine first licensed for use in the US in 1948.
Viral tissue culture methods developed from 1950-1985 and led to the advent of the Salk (inactivated) poliovaccine and the Sabin (live attenuated oral) polio vaccine. Mass polio immunisation has now eradicated the disease from many regions around the world.
Progress of polio elimination 1988 and 2014 Image: CDC
Attenuated strains of measles, mumps and rubella (MMR) were developed for inclusion in vaccines. Measles is currently the next possible target for elimination via vaccination.
Despite the evidence of health gains from immunisation programmes there has always been resistance to vaccines in some groups. The late 1970's and 1980's marked a period of increasing litigation and decreased profitability for vaccine manufacture, which led to a decline in the number of companies producing vaccines. The decline was arrested in part by the implementation of the National Vaccine Injury Compensation programme in the US in 1986. The legacy of this era lives on to the present day in supply crises and continued media efforts by a growing vociferous anti-vaccination lobby.
The past two decades have seen the application of molecular genetics and its increased insights into immunology, microbiology and genomics applied to vaccinology. Current successes include the development of recombinant hepatitis B vaccines, the less reactogenic acellular pertussis vaccine, and new techniques for seasonal influenza vaccine manufacture.
Molecular genetics sets the scene for a bright future for vaccinology, including the development of new vaccine delivery systems (e.g. DNA vaccines, viral vectors, plant vaccines and topical formulations), new adjuvants, the development of more effective tuberculosis vaccines, and vaccines against cytomegalovirus (CMV), herpes simplex virus(HSV), respiratory syncytial virus (RSV), staphylococcal disease, streptococcal disease, pandemic influenza, shigella, HIV and schistosomiasis among others. Therapeutic vaccines may also soon be available for allergies, autoimmune diseases and addictions.
View timelines of the history of vaccines2 in preventable disease discoveries and epidemics and vaccine development since the 11th century; participate in activities to learn how vaccines are made and how they work; and access immunisation resources suitable for parents and/or health professionals on The History of Vaccines website developed by The College ofPhysicians of Philadelphia.
The main issue here is the argument over approvals and how vaccines are created and approved. Simply put, this is the part that has many people confused. This also where Bayesian theory comes (bear with me, it gets a little dry) into play:
The History of mRNA2
This is not new technology. In fact, it is about 30 years old. The application, vaccines, is relatively new. Messenger Ribonucleic Acid (mRNA) is the basic building block of life. It is the ‘blueprint’ if you like for our DNA. This came about in 1985, when, a researcher named Katalin Kariko, PhD arrived in the United States from Hungary. She had little success with her idea.
Until, that is, she partnered with Drew Weissman at the University of Pennsylvania. This was 1998, and Dr. Weissman was interested in mRNA to develop a vaccine against HIV. They had several failures before they realised that the natural mRNAs use small amounts of slightly modified nucleotides, in addition to the four standard nucleotides. When they inserted these modified nucleotides in the mRNAs they were using in their research, they noticed that the new modified mRNAs produced proteins efficiently without causing undesirable side effects. They started publishing their research findings in 2005. By 2020 they were working on a vaccine for influenza based on their mRNA technology, just around the time that the coronavirus that causes COVID-19 showed up.
The Next Step
To have something that is ‘market-ready’ from the research stage can take years, or decades. This is what happened. When Karikó and Weissman published their research, around 2005, some companies recognized the implications of their research on vaccine production. Those companies licensed the technology from them. They had already incorporated and had a company that was manufacturing vaccines. Moderna was not the only company working on the mRNA vaccine approach. BioNTech, established in 2008, started working on it as well.
In 2013, it hired Karikó as vice president and started to develop the mRNA technology against a variety of diseases. BioNTech received a big boost in 2018 when Pfizer joined their efforts in research and development. Early on they were developing a vaccine for influenza, and they realised that with the advent of COVID-19, they could change that to develop a vaccine for COVID-19. These insights, from creating a vaccine against HIV and the flu, proved crucial to developing the COVID-19 vaccine.
The critical issue here was to identify the right mRNAsequence to create a vaccine against COVID-19. Because SARS and COVID-19 aresimilar, the research into SARS was critical. Even with that information, andthat the entire COVID-19 genome was published by Chinese researchers in early2020, it was still a challenge. This is where another decades long scientificeffort paid off: There was concern about another outbreak of the flu, notdissimilar to the 1918 pandemic. This has fueled a lot of investment in research around the flu vaccine. Combine that with decades long funding of research into an HIV vaccine. Both were funded, heavily, by the NIH.
This research funding paid off by providing crucial sequenceinformation to target COVID-19. The NIH lab ad been working on HIV vaccinesdesigns for decades and had developed algorithms to identify molecularstructures optimized for vaccines. This approach also predicted a successful vaccine structure against the respiratory syncytial virus. This is what allowed the NIH group to quickly identify stable molecular structures optimized for the mRNA vaccines against COVID-19.
The NIH has maintained a group of 10 university labs throughout the country to help test vaccines against things like the flu. These labs [teams] are known collectively as Vaccine and Treatment Evaluation Units (VTEUs). They include researchers, physicians and nurses dedicated to vaccine studies and testing. Similar locations are also in Europe. As three leading national scientific funding organisations or programmes related to health domain, the NIH and the framework programmes for research and innovation (i.e., Horizon 2020) funded by the EU are significant. The programmes of these organisations have emphasised fostering interdisciplinary studies among scientific disciplines such as life sciences, technical sciences and social sciences to keep their societies better because societal challenges such as health and wellbeing are relevant to multiple disciplines.3 As the mRNA vaccines against COVID-19 were being created, these experts and vaccine networks, in the US and EU, were recruited into rapid vaccine testing, and they enlisted tens of thousands of people, willing volunteers, as test subjects. These tests confirmed that the mRNA vaccines proved to be extremely effective at preventing moderate and severe forms of the disease and its spread.
“The probability that the vaccine was not 100% effective because not all vaccines are 100% effective, versus the vaccine is not 100% effective because it is a new technology and has not undergone proper testing.”
This is a problem that many have regarding the probability of something happening based on inferences. It is the problem at the heart of the various individuals that are anti-mask or anti-vaccine. This also includes medical professionals, as they are not immune to this logic or illogic, if you prefer.
Treatments and Vaccines need FDA approval(?)5,6
When medications are under review the (European Medicines Agency) EMA, there is a human medicines committee (CHMP) that evaluates the clinical trial data as soon as it becomes available. It decides if there is enough evidence for the developer to apply for marketing authorisation. The EMA works in conjunction with WHO to determine which vaccines are the most useful. As well, they have a hand in the decision on which vaccines are included in the EU digital COVID certificate. These are the agencies that work together to move the vaccine programme forward. It is not simply one group or agency it is organizations, agencies and facilities working together to ensure the best possible outcome.
Vaccine development for COVID-19 was fast-tracked globally based on all the previous research, as was outlined above. To say that the system was not properly tested, or approval was falsified, or that the global population, as a whole as one big experiment is not true.
mRNA vaccines are not gene-therapy7
It’s important to remember that the mRNA in the vaccines does not have any instructions that enable the vaccine to enter the cell nucleus, where our DNA is found. It also is not able to insert RNA into the DNA.
DNA is a molecule that contains all the genetic information of a living being. The famous double helix. This information is found in the nucleus and, for humans, contains 46 chromosomes. mRNA carries this information into the part of the cell that surrounds the nucleus (cytoplasm), where the ribosomes produce the protein. mRNA is highly unstable and fragile (as Karikó and Weissman learned), it breaks down quickly.
Why mRNA vaccines if this is the case?
The mRNA vaccine is designed to trigger our immune response by letting our cells make the necessary virus protein. The mRNA initiates the production of the protein necessary to jumpstart our immune system. It cannot interact with our DNA or modify our genes. That said there are some scientists that believe this to be possible (Christian Perrone, for example) Since vertebrates emerged, some 500 million years ago, it isbelieved that fragments of viral chromosomes have succeeded in integrating into human chromosomes. But only viruses that have an enzyme called “reverse transcriptase” are capable of that. COVID does not have that. As a result, the vaccines do not contain that either.
Myth and facts of vaccines
Can vaccines kill you8? Yes, on average, globally from vaccinations the death toll is around 0.15%. So far, from the indications of the global vaccination effort against COVID-19 the death rate seems to be around 0.000004%.
The COVID-19 infection rate, its severity and mortality rate (primarily as a result of comorbidity9) vaccination is the best option to contain COVID-19. It is true that vaccines can cause side effects, but most of the time they are mild, and of short duration. In rare cases they can be more serious, but the benefits far outweigh the risks. Critically, gene manipulation and editing are not part of the side effect.
This is not a perfect article and I have probably left out several things. But that isn’t my goal. My goal was to look at the research and see if I was right in my assessment of the information and data. Am I? I will leave that to the reader to figure out for themselves. As for me, I believe I am as right as I can be in my assessment. I hope this article helps.
Jiri Fiala (all information in this article is correct at time of writing)
All information is correct at the time of this writing