Since the start of the COVID-19 pandemic, scientists and researchers were hard at work trying to develop a vaccine for the virus. On December 11, 2020, the Food and Drug Administration (FDA) enacted the first emergency use authorization (EUA) for the administration of a vaccine to prevent COVID-19. The Pfizer-BioNTech COVID-19 Vaccine was the first to find approval, with Moderna not far behind on December 18, 2020. The single-dose Johnson & Johnson vaccine was approved on February 27, 2021.
Since then, 55.67% of Americans have received full vaccination against the COVID-19 virus (as of October 2021). However, some citizens still have questions about the safety and efficacy of the vaccine. Let's take a look at what it took to create a safe and effective tool in the battle against the deadly virus, as well as the FDA's approval process.
Preparation
Despite the fact that no one could have predicted the pervasive and world-altering COVID-19 pandemic, previous deadly coronavirus diseases like Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) laid the groundwork for the newest flu vaccines. In fact, scientists have been studying virology and respiratory communicable diseases for decades. According to the American Medical Association (AMA), prior research and vaccine developments aided in the speedy development of COVID-19 vaccines.
Because of the vaccinations that were created to aid in previous outbreaks, scientists were able to use the information to get a jump-start on the COVID-19 vaccine. Since the first SARS outbreak in 2003, vaccine researchers have been hard at work developing the most effective ways to prevent dangerous respiratory viruses. So while the development of the COVID-19 vaccination may have seemed alarmingly quick to the general public, it had actually been in the making for over a decade. Here is the typical, heavily regulated FDA process for developing the vaccine:
- Research and discovery
- Pre-clinical
- Phase 1 trial
- Phase 2 trial
- Phase 3 trial
- License and application to the FDA
The effectiveness of the COVID-19 vaccine
The FDA has strict guidelines for approving any kind of medication, especially vaccinations. Even when it comes to emergency approval, there are continual and ongoing reevaluations as the FDA notes its effectiveness in the real world. Here are some factors that the FDA looks for when evaluating "real-world vaccine effectiveness":
- Population host factors: This is how the vaccine impacts people who may have not been included in the trials.
- Virus factors: Potential variants and changes to the original virus.
- Programmatic factors: How well the vaccines are administered and whether the population is adhering to guidelines.
So how effective is the COVID-19 vaccine? The Centers for Disease Control (CDC) reports that those who took both doses saw a reduction in their risk of COVID-19, including severe illness by 90% or more.
How safe is the COVID-19 vaccine?
Because the new vaccine has been developed using research that has been tried, tested and successful for decades, the vaccines are extremely safe. According to the CDC, the COVID-19 vaccine has undergone some of the most rigorous and strict testings in the Center's history. Even still, they undergo intensive monitoring to ensure that the vaccines remain safe and effective.
Millions of people have been safely vaccinated and we are already seeing positive results in communities that have been responsive. According to the U.S. Department of Health & Human Services, vaccinations have led to the prevention of "265,000 COVID-19 infections, 107,000 hospitalizations, and 39,000 deaths among Medicare beneficiaries between January and May 2021."
Both the CDC and the FDA have made research and testing information public in an attempt to dispel any potential vaccine hesitancy. Even if you have already had COVID-19, vaccinations are necessary to help build protection and boost herd immunity.
Worried about getting sick after vaccination? Fear not. According to the CDC, "none of the COVID-19 vaccines contain the live virus that causes COVID-19 so a COVID-19 vaccine cannot make you sick with COVID-19." However, consult your physician to find out more about the possible side effects and your vulnerability level.
To learn more about the safety and efficacy of the COVID-19 vaccine, visit the CDC or the FDA's websites.