In the event of a public health emergency, such as the COVID-19 pandemic, the U.S. Food and Drug Administration recognizes the need to accelerate the process of life-saving vaccines and other medical supplies while still maintaining the safety and integrity of the whole process.
In the case of the FDA approving Emergency Use Authorization (EUA) of the COVID-19 vaccine, it simply means that they authorize the early distribution of medical products to the markets.
Does this mean the EUA products are tested first before distribution?
Despite the accelerated process the EUA provides, all products and vaccines still undergo clinical trials. The FDA requires manufacturers to conduct a 3-phase clinical trial with at least half of the phase 3 participants having undergone 2 months of follow-up after completing the trial.
With the COVID-19 vaccine’s case, the FDA required that the “evaluation of EUA request for a COVID-19 vaccine includes the chemistry and manufacturing evaluation, and controls information for the vaccine. Sufficient data should be submitted to ensure the quality and consistency of the vaccine product.”
Ensure your loved one’s safety
As seniors are part of those prioritized for vaccination, we at Aquinas Healthcare — a licensed provider of professional home care services in New Jersey — to maintain constant contact with other healthcare authorities to get continuous updates about vaccine distribution.
Provide your loved ones with an extra layer of protection and care — get them a professional home health aide in Springfield, New Jersey.