This week the COVID-19 vaccine is approved in the United States and being distributed around the country. The emergency circumstances accelerated the approval process. Vaccine development and approval is normally a long and complex process, lasting anywhere from 10-15 years.

Stages of Development:

The vaccine development process involves multiple stages. These stages include: Exploratory, Pre-clinical, Clinical Development, Regulatory review and approval, Manufacturing, and Quality control. Each of these general stages play an influential role in a drug’s approval.

Clinical Development:

The clinical development stage is a three-phase process. Phase I consists of small groups of people receiving the trial vaccine. In Phase II the study is expanded and it is given to those who have characteristics like those for whom it is intended for. This includes criteria such as age and physical health. The Phase III trials involve giving it out to thousands of people, testing for efficacy and safety. Here at National Allergy & ENT, our Research department works on Phase III clinical trials involving asthma, allergy, immunology, and ENT related drugs. Our research department is working on clinical trials regarding the COVID-19 vaccine.

The Approval Process:

The U.S. Food and Drug Administration (FDA) is responsible for regulating vaccines in the United States, specifically the Center for Biologics Evaluation and Research. The sponsor of the vaccine goes through a multi-step approval process. This process includes: Investigational New Drug application, pre-licensure vaccine clinical trials, Biologics license application, inspection of the manufacturing facility, presentation of findings to the FDA’s vaccines and related biological products advisory committee, and usability testing of product labeling.

There are COVID-19 vaccines still going through all the necessary steps for approval. If you are looking for more information on this subject or our provider’s expertise on what is best for you, please contact us at (843) 797-8162 or schedule an appointment online.