Op-ed by Dr. Thomas Tarter -
We stand at the threshold of worldwide mass vaccination against the COVID-19 virus. A similar worldwide program of vaccination against the smallpox virus began in 1967, and the virus was completely eradicated by 1977. Today, the smallpox virus is confined to research vials in Atlanta, Georgia, and Moscow, Russia. Two million people died of smallpox in 1967, and in the 12 millennia prior to that, smallpox epidemics annihilated entire civilizations.
Unlike 1967, a robust anti-vaccine movement today threatens our ability to make the pandemic a footnote in human history.
Anti-vaccine movements have been with us since the 18th century, and the rationale has changed over time. When vaccination with cowpox (the first smallpox vaccine) was expanding, the uneducated worried about taking on features of cows. With the expansion of religious movements in 19th century America, some preached that vaccines damaged the soul. Also, in this time, vaccination programs were opposed by lower and middle-class citizens, free blacks, and immigrants from tyrannical European regimes as a matter of bodily autonomy and personal freedom. In the 20th and 21st centuries, the anti-vaccine movement has focused on vaccine injury, specifically the autism spectrum disorder. Unlike the 19th century, the modern anti-vaccine movement is now led by educated upper class whites, which has resulted in recent outbreaks of mumps and measles in major universities.
In addition to vaccine injury claims, the safety of the COVID-19 virus vaccines has been questioned because of the unprecedented speed of vaccine development and approval. The other claims are conspiracy ideas that the vaccines will turn us into genetically-modified organisms, and that through the vaccines the government will be able to monitor and control our private lives.
I would like to dismiss these latter concerns out of hand, but these claims are made by seemingly reputable doctors, and are propagated on social media. The conspiracy videos are spreading like a virus and could be responsible for keeping the COVID-19 virus endemic in our country for years to come.
The new COVID-19 virus vaccines are known as “platform” vaccines. This means that the technology is immediately available to rapidly identify segments of the viral genetic material (RNA or DNA depending on the type of virus) that code for proteins that can stimulate an immune response. In the case of the COVID-19 virus, the targets are “spike” proteins, the parts that stick out of the viral envelope. Messenger RNA (mRNA) that codes for the protein of interest can be quickly synthesized in the laboratory. The mRNA requires a delivery vehicle for transfer into the recipient’s cells, a process known as "transfection."
In the case of COVID-19 virus vaccines, the delivery vehicle is a sphere of fat (micro lipid), or a non-replicating virus. After the mRNA is introduced into the cell, the process of spike protein production begins, and the immune system is activated to fight the COVID-19 virus. The mRNA cannot be incorporated into human DNA and is eliminated from the body after a few days. The mRNA vaccines are not new and were first tested in animals in 1993. However, testing in humans has not been done until now.
The safety and efficacy of any drug or vaccine are determined through clinical trials. An independent Data Safety Monitoring Committee reviews the data presented by their statisticians. These committees can, and have, closed clinical trials based on safety. Phase I trials evaluate safety at different doses with a small number of participants. Phase II trials determine safety and efficacy in a larger group of participants. Phase III trials compare efficacy and safety of the vaccine compared to a placebo. These trials depend on measuring events. The event measured with COVID-19 virus vaccines is getting sick and testing positive. The trial time depends on the time it takes to accumulate enough events for statistical significance. If we were not amid a pandemic, a Phase III trial would take many years to accumulate enough events. But we are in a pandemic, and the safety and efficacy data have accumulated rapidly.
Development and testing of the COVID-19 virus vaccines have NOT been rushed. The platform technologies were available and ready for a viral epidemic or pandemic, and the clinical trials overseen by Data Safety Monitoring Committees accumulated safety and efficacy data rapidly because of the pandemic.
No vaccine is perfect. An allergic reaction is always a possibility, and every drug on the market has this warning. Serious Adverse Events have not been reported in the Phase III trials of the first two mRNA vaccines to get Emergency Use Authorization from the Food and Drug Administration. The safety profile in the clinical trials is highly encouraging, but after-market monitoring and reporting will be essential to further ensure vaccine safety.
The COVID-19 virus mRNA vaccine is a triumph that has taken decades to develop. Platform technologies for quickly developing antiviral vaccines is one of the greatest achievements in the history of public health.
Every great accomplishment in history has heroes and villains. The villains are those who spread lies about the COVID-19 virus mRNA vaccine. The video doctors have violated their sacred oath to do no harm, and they should be investigated and punished. There are many more heroes than villains in this story who work in academia, industry, and government. We especially owe a debt of gratitude to our heroes that have participated and are participating in the clinical trials. We could not make progress without them.
Addendum:
Since first posting this opinion piece on social media, I have been asked many excellent questions.
1. For a disease that has a 1.8% mortality rate, why do I need a vaccine? The vaccine is about eradicating the virus, like the smallpox example. Although mortality is low, 300,000 out of 17.2M cases as of this writing, the morbidity and costs are staggering. One million Americans have required a ventilator, and 700,000 have required lengthy recovery. Furthermore, ICU capacity is low as of this writing. There are a limited number of healthcare professionals available to take care of the extremely sick, and they are exhausted. Hospital care for COVID-19 ranges from $51,000 to $78,000. We cannot sustain these costs as a country. Without mass vaccination, COVID-19 virus epidemics will continue to pop up in the future causing more mortality, morbidity, strain on our healthcare system and at a high cost. Mass vaccination can eradicate this disease.
2. What are the ingredients of the vaccine? Were fetal cells used in the development? The ingredients are mRNA, lipids, salts and sucrose (table sugar). Early in the development of mRNA vaccines, fetal cell lines were used in research laboratories. Fetal cell lines have not been used in the development of the Pfizer and Moderna vaccines.
3. What are the risks and side effects of the vaccine? In the Phase III trials, no Serious Adverse Events have been reported. But transient pain at the site of injection, fever, chills, fatigue, and muscle ache have been reported in some that have received the vaccine. Serious allergic reactions were reported in two people in Great Britain. If an allergic reaction occurs after the first injection, then a second is not recommended.
4. Will the vaccine work if it needs to be stored at extremely low temperatures? Yes. mRNA is unstable at room temperature. After thawing, it is effective if stored in a refrigerator for 5 days.
Thomas H. Tarter is an M.D., Ph.D., Urologist based in Springfield, Illinois. He also ran for the US Senate in Illinois during the 2020 Republican Primary. His opinion is his own.
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