Coronavirus Pandemic Opinion OPINION: Democrats Discuss — The fight against anti-vaccination theories By Cody Phillips Posted on 4 weeks ago 15 min read 0 0 114 Cody Phillips is a senior studying biological sciences. He is a member of the Ohio University College Democrats. The following article reflects the opinions and views of the author and does not represent the thoughts of the Ohio University College Democrats. This is a submitted column. Please note that these views and opinions do not reflect those of The New Political. Vaccines have been a hot topic of debate for years now, with some people arguing they are dangerous and a violation of rights and others arguing they are safe and ensure rights. The COVID-19 outbreak has brought the conversation about the efficacy and logistics of vaccines back into the public spotlight. Make no mistake, though. A Food and Drug Administration (FDA) approved vaccine will be safe and effective in creating immunity to the virus — all other FDA approved vaccines are safe — regardless of anti-vaxxer propaganda. Anti-vaccine sentiment has existed nearly as long as vaccines themselves. The first vaccine stemmed from Edward Jenner’s experiments demonstrating that immunity could be created against smallpox by injecting a child with the fluid from someone with cowpox blisters. This early idea of a vaccine immediately stirred outrage, which mirrors many concerns from today’s anti-vaccine groups. Apprehension about vaccines stemmed from fears of religious belief violations, personal liberty violations and concerns about sanitation. Gordon Stewart aimed to complete a scientific study to prove vaccines were unsafe, but he instead demonstrated their safety and benefits. The infamous “vaccines cause autism” claim has not only been debunked multiple times but brings into question the biases against people on the spectrum. Nevertheless, people still continue to tirelessly question their personal freedoms and vaccine safety. The most important point to dispelling most anti-vaccine arguments surrounding personal freedoms comes with several Supreme Court cases, includingJacobson v. Massachusetts. Before this case, Massachusetts had an alarming increase in smallpox infections that ultimately ended with the city of Cambridge requiring all adults to receive the smallpox vaccine or face a $5 fine. In response, Pastor Henning Jacobson argued that he had previously been injured by a vaccine and that he and his son should not be forced to receive the vaccine as it violated his rights. After court battles, they eventually made their way up to the U.S. Supreme Court, where the conclusion was that the city had the right to reasonably mandate vaccination against a disease that was causing serious and legitimate health threats to a community. Several years later, similar questions arose when state laws started to require children to be vaccinated before attending public schools. Once again, the Jacobson case justified a vaccine mandate but extended the power to the states to determine what medical conditions warranted exemptions. These court cases drew the conclusions that refusal to get vaccinated put vulnerable people — those who had a high risk of disease contraction or those who could not get vaccinated due to health issues — at risk, and ultimately violated theirs and others’ right to health. The best example of a refusal to vaccinate resulting in the violation of someone else’s rights occurred in 2015 when a woman died of measles linked to a rampant outbreak at the time. This woman had a suppressed immune system because of other medical conditions, but the decreased vaccination rate left her vulnerable to contracting this disease. Unvaccinated people, many of whom come from anti-vaxxer groups, were the reason this woman was not protected against an archaic disease. Not only do vaccines protect personal liberties, but they are also robustly studied and reviewed to ensure safety and effectiveness. A new vaccine typically undergoes six different steps, not including continued review. First, companies must submit an Investigational New Drug Application (IND) to the FDA that has detailed information about the vaccine, manufacturing techniques and quality control tests. Along with the timeline-related information, they must also include preliminary effectiveness research that includes data on the ability of the vaccine to elicit an immune response in animal subjects. The last important piece of the IND is the clinical protocol for human testing, or the steps that will be taken to test and measure the vaccine response. These studies lay out detailed information on how the vaccine is developed and how it will be researched to determine effectiveness and safety. Once the IND is completed, then the companies can begin investigating the vaccine and its effect on human subjects with pre-licensure vaccine clinical trials. This is done in three phases, each expanding on the last, and answers different questions about safety and effectiveness. Phase one utilizes a small, closely-monitored sample pool to determine safety and ability to establish an immune response in humans. Phase two has a larger sample pool, and developers investigate dose ranges and responses to the doses. Phase three uses thousands of people to thoroughly document the effectiveness and safety of the vaccine. If there are serious safety concerns or issues at any point during this process, the FDA can halt studies. In a recent case with the AstraZeneca COVID-19 trials, the company had to temporarily shut down studies to investigate the health issues of one trial subject to ensure the vaccine was not the origin of the problem. These studies are done to demonstrate the effectiveness and safety of the vaccine and to allow for the submission of a Biologics License Application (BLA). Before a license for the vaccine can be given out, the vaccine needs to be safe. If it caused serious health issues, like neurological disorders or death, the vaccine would not continue to the proceeding steps. The BLA is provided to give a clear demonstration of the vaccine working and then allow for a risk and benefit assessment to be conducted. The risk and benefit assessment is done to, once again, determine if it is safe and effective enough to continue production. After the BLA, the FDA will inspect the manufacturing facilities and ensure they comply with regulations and to ensure that every step of the vaccine pre-production is safely done. Assuming the vaccine passes through the clinical trials and after the FDA reviews the BLA, the FDA then decides on presenting it to the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This team of non-FDA experts from many fields reviews everything that has been previously done and provides advice to the FDA for the safety and efficacy of the vaccine. One of the most important things they do is ensuring adequate labeling to explain safety, risk, use and administration of the vaccine. This also allows for a thorough review and understanding of safety and effectiveness. At this point, the vaccine and its production can finally be approved. After going through several inspections, proof-of-concept tests, and safety and effectiveness reviews by many different groups of experts, the vaccine can go to market. Approval of the process does not stop the FDA oversight and safety enforcement. Instead, periodic inspections are conducted, and the FDA can request data on each individual vaccine lot to ensure consistency. Even after approval and distribution, vaccines are still monitored in phase four trials. These studies allow for the monitoring and assessment of the vaccine once it hits the market and is being administered to the public. Additionally, individual people are able to use the Vaccine Adverse Event Reporting System (VAERS) to submit any problems they have with the vaccine. Studying and developing vaccines is long, tedious and expensive. All of this is intentional, however, because it ensures the greatest amount of safety and effectiveness for the public. With biologics, it is imperative that they are safe and reliable. This process ensures safety. If vaccines did not meet all the requirements set by the FDA, they would not be on the market and they would not be recommended to people by health experts. Regardless of the resistance to vaccinations, they are imperative because they protect innocent and defenseless people from diseases that we can and have prevented. Newborn babies, cancer patients, the elderly and people with any number of diseases cannot get vaccinated themselves. Their age and health conditions make vaccines less effective or more dangerous. The only way to help keep them safe is to get vaccinated. By getting vaccinated, we are keeping the people we care about safe and healthy.