Sara Alicia Luchini, Moderna Vaccine Safety and Efficacy

Moderna Vaccine Safety and Efficacy

by Sara Alicia Luchini One day, we won’t have to worry about how or when to wear a mask or be concerned with how many people are gathering together. One day, we won’t have to cancel all major life events like weddings, anniversaries, baptisms, and even funerals. One day, we won’t have our hospitals full of COVID-19 patients struggling for their last breath. This one day can happen sooner, because of the creation and deployment of the COVID-19 vaccines. These vaccines were created by highly educated and specialized scientists in the most rigorous and safe guidelines ever held in the history of development of vaccines. It is time we investigate just how safe and effective these vaccines are, so that we all can start living our lives to the fullest. All clinical trials have proven that COVID-19 vaccines have undergone rigorous testing and safety guidelines for administration. When vaccines are created by experts, they must undergo a multitude of scrutiny. This scrutiny comes in the form of testing, questioning, theory, trial, and error, and they must prove that they are safe and effective before the Federal Drug Administration (FDA) will even contemplate reviewing the safety and efficacy of the vaccine. This happens for all vaccines, not just the COVID-19 vaccines. In fact, the vaccines for the novel coronavirus went through the same layers of review and testing as other vaccines. Due to the dire nature of the pandemic, certain barriers to development, related to funding and manufacturing, were removed (CDC, 2021). Therefore, there were no “cut corners” when this vaccine was created, it was created by experts that followed all the same safety and regulations as with all other vaccine creation. The ability for the vaccine to be developed in a shorter amount of time than other vaccines is related to the urgent need for them, where access to funding and resources such as manufacturing were able to be readily available. The cost of creating, manufacturing, testing, and deploying a vaccine is what takes the most time when other vaccines are created. When vaccines are developed, and it takes several years, it is related to the cost of creating and manufacturing. So, when we contemplate the amount of time that it has taken for the development of the COVID-19 vaccines, they are on par for other vaccines, given the amount of funding and resources that have been dedicated to this body of work. The pooling of resources, expertise, knowledge, funding, and other assets is what helped to launch them so quickly. The COVID-19 Vaccine (Moderna) is effective at preventing COVID-19 illness and severe disease. Vaccine effectiveness studies provide a growing body of evidence that mRNA COVID-19 vaccines offer similar protection in real-world conditions as they have in clinical trial settings, reducing the risk of COVID-19, including severe illness, among people who are fully vaccinated by 90 percent or more. That means that once fully vaccinated, meaning after two doses for Moderna vaccine, you would have less than 10% chance of developing severe lifethreatening illness related to the disease process. In addition to providing protection against COVID-19, there is increasing evidence that COVID-19 vaccines also provide protection against COVID-19 infections without symptoms (asymptomatic infections). This is what has made the novel coronavirus so effective at infecting millions of people because it can inoculate and be active in a host (person) and they may not even display symptoms but continue to pass the virus off to others unknowingly. COVID-19 vaccination can reduce the spread of disease overall, helping protect people around you (CDC, 2021). In fact, no cases of severe COVID-19 were reported in the Moderna COVID-19 Vaccine group compared with 30 cases reported in the placebo group (Clinical Trial Data, 2021). In clinical trials, this would be interpreted as fully effective against severe cases of the virus, which is what lands patients in the Intensive

Care Unit and being placed on a ventilator. In a world where we have been so uncertain about how to live or how to reintegrate with our communities, it’s imperative to understand that since we now can be free of severe life-threatening illness, we should rely on the proof ahead of us, that the Moderna vaccine is effective at preventing COVID-19 illness and severe disease. COVID-19 vaccines are effective, even when applied in real world situations, not just in clinical trials. Before the U.S. Food and Drug Administration (FDA) determines whether to approve a vaccine or authorize a vaccine for emergency use, clinical trials are conducted to determine vaccine efficacy. After FDA approves a vaccine or authorizes a vaccine for emergency use, it continues to be studied to determine how well it works under real-world conditions. Within the community we live in, we actively had participation in the development of the COVID-19 vaccine analysis. Marshfield Clinic Research Institute participated in the HEROES-RECOVER trial. This trial was a collaborative effort to determine if these vaccines, when applied in a real-world situation, would be effective or not. Front line workers, emergency care personnel and other health care workers were enrolled into this study. They were fully vaccinated and then deployed into their work environments, which did have documented exposures to COVID-19 virus for extended periods of time. It was found that although these people were placed in situations that exposed them multiple times to the novel coronavirus, they did not contract serious illness. Therefore, vaccine effectiveness for prevention of infection was 90% for full immunization and 80% for partial immunization (Mark, et al., 2021). Real world data from vaccine effectiveness studies have shown that receiving only one dose of these mRNA COVID-19 vaccines provides some protection against COVID-19, at least in the short term. These studies have also shown that for mRNA vaccines, two doses provide better protection than one dose. To receive the most benefit from vaccination, people should get the recommended number of doses of vaccine. The level of effectiveness is outstanding given how recently the development of the vaccine has been, and the number of lives that have been lost due to this virus. While COVID-19 vaccines are working well, some people who are fully vaccinated against COVID-19 will still get sick, because no vaccines are 100% effective. These are called vaccine break through cases. However, data suggest that vaccination may make symptoms less severe in people who are vaccinated but still get COVID-19. mRNA COVID-19 vaccines have been shown to provide protection against severe illness and hospitalization among people of all ages eligible to receive them. This includes people 65 years and older who are at higher risk of severe outcomes from COVID-19 (CDC, 2021). This is why its imperative to achieve what is known as herd immunity. Herd immunity is when the majority of the population is fully immune to a virus, which makes transmission from person to person unlikely. As a result, the whole community becomes protected, not just those that are immune. This is a similar phenomenon that occurs with other diseases such as polio or chicken pox. Unfortunately, the average community in the United States only has a 54% vaccination rate. This is not near the level of herd immunity, and therefore we can not reach this goal of all members in our community being protected from this virus unless millions more become vaccinated. No long-term side effects have been reported with mRNA (messenger ribonucleic acid) vaccines. COVID-19 vaccines are part of the most intensive vaccine safety monitoring effort in U.S. history (CDC, 2021). Moreover, when people scrutinize and ask questions, they can find reliable and unbiased answers as these vaccines have been put through the most extensive testing and monitoring processes. All individuals who received the COVID-19 vaccines are automatically asked to participate in the VSAFE is tool that provides quick health check-ins. These check-ins are conducted daily for one week, monthly for three months, then again at 6

months and one year. Through these check-ins you are asked multiple questions in relation to your health status after receiving any COVID-19 vaccine. All responses are monitored by the CDC and evaluated for data compilation. Depending on an individual’s response to certain questions, the CDC may call to check on people who report a health problem to get more information and submit a report to VAERS (Vaccine Adverse Event Reporting System). This system monitors adverse events that occur after vaccination. VARES is a system that is available for any adverse event reporting after any vaccination. CDC and FDA review the reports for unusual patterns that might indicate a vaccine safety problem needing deeper investigation. All complaints or concerns are taken seriously and investigated properly. Additionally, The Clinical Immunization Safety Assessment Project is a collaboration between CDC and seven medical research centers. CISA consults with U.S. healthcare providers and health departments about vaccine safety, conducts clinical research, and helps investigate safety issues. Also, the Vaccine Safety Datalink is a collaboration between CDC and nine healthcare organizations. Participating sites link patient vaccination and electronic health record data. CDC monitors the data for vaccine safety concerns and research opportunities. So far, all data from these sources have shown that there are no long-term side effects from mRNA vaccines (Baden, et al., 2021). This is a responsibility of each of us must take to record additional realworld data of the monitoring of vaccine administration.

Fighting a global pandemic takes participation for every single person. We cannot effectively combat the novel coronavirus without this impressive development, manufacturing, and deployment of the vaccine. Now that we have this vaccine readily available, with evidence to show its safety and efficacy, it’s up to us to ensure that we are making the best choices for ourselves, our loved ones, and our community. The sooner we can obtain immunity from this virus, the sooner we can resume our normal lives, not the “new normal” that we have all be struggling through. We have all gone through some of the most strenuous events over the last 22 months. Let’s ensure we are looking at the facts, the research, and the proof, that the COVID-19 vaccine is safe and effective against severe illness.

References

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Prevention. https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm.

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