The coronavirus pandemic has seen the rollout of a different vaccines to help curtail the spread of the deadly virus, however a lot of people aren’t aware of the hurdles that the vaccine making companies have to pass through to get an approval. In Nigeria, thousands of people have started taking shots of the vaccine in hopes that they can be immune from the virus.
This article explains how the use of a vaccine comes about in the first place.
Meaning of USA FDA Vaccine Approval
Firstly, let us understand what the FDA is responsible for. The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Before the FDA approves any company’s vaccine, it must determine that the clinical data and other information show that the vaccine is safe and effective for its intended use (i.e to prevent or treat certain diseases) and that the product can be made according to federal quality standards.
Meaning of an Emergency Use Authorization (EUA) Approval
An EUA approval is one of the tools the FDA uses to help make certain medical products available quickly during the COVID-19 pandemic. In certain emergency situations, the FDA can issue an EUA to provide access to medical products that may be potentially used when there are no adequate, approved, and available options.
The EUA process is quite different from an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
More importantly, the risks and benefits of the emergency approval is weighed based on available current data.
By Segun Olarinmoye