Vaccine Process for Covid-19
My patients have been curious as to how the entire vaccine procedure has moved from an idea to reality. It is important to note that the U.S. Food and Drug Administration (FDA) has the responsibility to make sure that vaccines are safe, effective and that it is a quality vaccine. The FDA has done this with baby vaccines, childhood vaccines, adult vaccines and has shown that in the past they have been highly effective in preventing hundreds and thousands of disease cases and saved millions of lives. It is the FDA’s Center for Biologics Evaluation and Research (CBER) that is responsible to make sure that before a vaccine is disseminated to the country that the vaccine has been put through a rigourous science and regulatory process that makes sure it is safe to distribute throughout our medical system.
The FDA website tells us that vaccines work by “mimicking” the infectious bacteria or virus that causes the disease. The vaccination stimulates our body’s immune system so that it will build up a defense to prevent or fight against this infectious baceteria or viral organism without causing the disease.
The process starts in a laboratory with scientific research by scientists working with animals to study their reactions. The animal study is known as pre-clinical phase. The process then begins to go to people, which are known as Clinical Studies. There is a Phase I, Phase II and a Phase III, where the scientists determine whether it is safe and effective.
With COVID-19 there have been special considerations and the process has moved more quickly because of the deleterious effects of COVID-19. The FDA has brought together multiple agencies that are involved in bringing a vaccine to market place and this has shortened the time to bring the vaccine to become available today
Simultaneously to the testing and considerations, the FDA is also involved in evaluating the methods for making the vaccines and the facilities that are being used to produce it. Everything is based on information and data from the trials and the facilities. The FDA writes on their website, “Once a manufacturing process is developed that ensures that the vaccine can be produced reliably and consistently, and the preclinical and clinical development programs have been successfully completed, companies submit a Biologics License Application (BLA) to the FDA. A BLA is a comprehensive submission that is submitted to the Agency. It includes preclinical and clinical data and information, as well as details of the manufacturing process and facility(ies).”
This is all done before the vaccines are put up for approval, mass production and dissemination into the public, which has occurred to make the Covid-19 vaccines available.
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