The Role of the FDA in the Coronavirus Pandemic

As the world awaits the end of the coronavirus pandemic, scientists work hard on developing a cure and a vaccine. The Food and Drug Administration (FDA) will play an important role in approving and moving forward with any treatment or vaccine. There are three primary ways we are dealing with this virus.


States and cities across the country are currently making efforts to contain and prevent the spread of coronavirus. The public has been taught that social distancing or staying away from other people as much as possible, is the key to containing this virus. These efforts, in addition to rigorous hand washing, not touching your face, and the wearing of masks in public are all currently being undertaken in hopes of preventing further spread of the virus.


Scientists are currently working on figuring out an appropriate treatment once somebody contracts the virus. Many people that get the virus suffer only minor symptoms, while some people get seriously ill and require hospitalization. The World Health Organization (WHO) is currently engaged in a solidarity trial that countries around the world are participating in. It is a simultaneous trial of four different possible treatments. In the United States, any treatment would have to be approved by the FDA.

Due to the seriousness of the coronavirus, the FDA has instituted a Coronavirus Treatment Acceleration Program (CTAP). The goal is to move new treatments to patients as quickly as possible. According to the FDA, there are currently ten therapeutic agents in active trials. In addition, the FDA issued emergency authorization for the off-label use of an anti-malarial drug for treatment. Thousands of patients in New York are currently being treated with the drug hydroxychloroquine. However, there is currently no widespread scientific evidence showing that it is an effective treatment.

In order to properly treat a patient, it is important to identify individuals who have the disease. To that end, the FDA is fast-tracking the approval of different coronavirus tests. It is important for there to be accurate and expedited tests in order to effectively treat everyone who has contracted the virus.


The third way of dealing with this virus is through a vaccine. Only a vaccine can really prevent people from getting sick. Dozens of companies and academic institutions are racing to create such a vaccine.  Several different versions are currently being tested on animals. The University of Pittsburgh Medical Center is currently seeking FDA approval of a potential vaccine. Hopefully, the regulatory process will take months instead of years Once they receive FDA approval, they will have to undergo clinical trials. After human trials, the vaccine will be ready for widespread deployment. In addition, there is currently a potential vaccine undergoing Phase 1 clinical trials in Washington state.

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