What is the testing and approval process for new vaccines?
With the world racing to approve a COVID-19 vaccine, many people are beginning to question the safety of the vaccine and whether or not they should trust the clinical trials and approval process. The concern over rushed testing has led many pharmaceutical companies to reassure the public that they will follow the guidelines set by the U.S. Food and Drug Administration (FDA).
The Steps to Vaccine Development
Before starting clinical trials, the sponsor interested in beginning the trials is required to submit an Investigational New Drug application (IND) to the FDA. Within the IND are descriptions of the vaccine, the method of manufacture, and the proposed clinical protocol for the testing in humans.
The clinical development is a three-stage process that consists of Phase I, Phase II, and Phase III. In Phase I, a trial vaccine is given to small groups of people who are closely monitored. During Phase II, the study is expanded to typically include hundreds of people who are chosen to participate in the testing because of the similar characteristics they share with the people intended for the vaccine. In Phase III, thousands of people are given the trial vaccine and the safety and effectiveness of the vaccine are further documented. During Phase IV formal, the vaccine has already been approved and licensed; however, many vaccines will go through continued studies to monitor the vaccine and its effectiveness. At any stage in the clinical trials, if the data collected raises concern over the safety or effectiveness of the vaccine, the FDA can potentially pause the trials.
Process of Approving the Vaccine
When the three phases of the clinical development have been successfully completed, the Biologics License Application is submitted to the FDA. Within the license application, the safety and effectiveness of the vaccine must be documented to allow the FDA reviewer team to make a decision on whether or not to recommend the approval of the vaccine. During this process, an inspection of the proposed manufacturing facility is also conducted.
After the FDA’s initial review of the license application, the findings of the review are presented to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee will then advise the FDA on the effectiveness and safety of the vaccine. The product labeling is also inspected to ensure that the vaccine will be safely given to the people.
Even after the vaccine is approved by the FDA, the FDA will continue to monitor the production of the vaccine. If asked by the FDA, the manufacturer must be ready to submit their own testing of the safety, potency, and purity of each vaccine lot. In some cases, the FDA will also ask the manufacturer to submit samples of each vaccine lot for testing.
What if there are side effects?
The Vaccine Adverse Event Reporting System (VAERS), a program sponsored by both the FDA and the CDC, will track and analyze reports of side effects occurring after the US-licensed vaccines have been distributed to the public.
Author: Connie Yang (LHS 12th Grade)
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