There has been some skepticism about the overall roll-out of vaccines and the COVID-19 Vaccination Program. The main concern that most Americans have is safety. How safe is the COVID-19 vaccine? Health professionals have a duty to ensure the safety of all vaccines given to our medical system. It’s easy to adopt the fearful thoughts and feelings of our peers about this particular vaccine. Instead of listening to our friends and family about their COVID-19 vaccine qualms, it’s important that we consider only the facts. We must educate ourselves on the vaccine process and research how they are approved and considered safe. Here is what we know about the safety process of the COVID-19 vaccine:
According to the CDC, the U.S Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUA) for two COVID-19 vaccines that have been cleared as safe through data provided by manufacturers and large clinical trials. FDA professionals have analyzed that the effectiveness of the vaccines outweigh the harm of being infected by the disease.
Through clinical trials, study participants are given the vaccine and analyzed overtime for any adverse effects. These candidates’ data is recorded and stored under the FDA. The CDC reveals that the clinical trials are conducted under a rigorous FDA 2020 guidance document, Development and Licensure of Vaccines to Prevent COVID-19. After the FDA determines the vaccine has met its safety standards, it can be approved through an EUA for the public. The Advisory Committee on Immunization Practices (ACIP) then reviews the data then makes vaccine recommendations to the CDC.
After vaccines are approved, vaccine safety monitoring tools are used for discovering adverse effects or events. The CDC explains that the purpose of this monitoring test is for picking up adverse events that have been overlooked in clinical trials. When medical experts discover an adverse event, it’s studied for true safety concerns. It’s then decided if changes to the U.S vaccine recommendation needs to be made.
Even after this critical process, there are more safety monitoring measures. According to the CDC, these are the additional layers of safety monitoring that evaluates COVID-19 vaccine safety in real time:
V-safe provided by the CDC, is a new smartphone technology that poses as an after-vaccination health checker for people who have received the COVID-19 vaccine.
National Healthcare Safety Network (NHSN) is an acute and long-term care facility monitoring system with reporting to the Vaccine Adverse Event Reporting System.
FDA provides claims-based data for further surveillance and research
There is also general public safety information provided by the CDC and FDA that includes adverse event data and reports from clinical research studies. With confidence this COVID-19 vaccine has been distributed after several research steps and approval guidelines. As we continue to educate ourselves on the safety process of creating vaccines, we can become more confident in the COVID-19 Vaccination Program.
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