RVNAhealth: COVID-19 Vaccines and the FDA EU

Here is the latest column from the home health care agency RVNAhealth in Ridgefield. The column is written by RVNAhealth's President and CEO Theresa Santoro, (not pictured). This column is about the COVID-19 vaccine, and the U.S. Food and Drug Administration's Emergency Use Authorization.

Here is the latest column from the home health care agency RVNAhealth in Ridgefield. The column is written by RVNAhealth's President and CEO Theresa Santoro, (not pictured). This column is about the COVID-19 vaccine, and the U.S. Food and Drug Administration's Emergency Use Authorization.

RVNAhealth / Contributed photo

With news of at least two vaccines on the near horizon for COVID-19, the U.S. FDA’s “Emergency Use Authorization” (EUA) plays a critical role in timing. But what exactly is an EUA, and how does it differ from normal FDA approvals?

The EUA is a “tool” used to speed up medical product approvals during times of public health emergencies. A major difference between an EUA and typical FDA approval for vaccines is the time required to monitor unexpected side effects in trials. Normally, the FDA requires several months for this stage, but the EUA process requires only two months of data monitoring — a meaningful acceleration. While this may sound concerning, Jess Goodman, M.D., former chief scientist at the FDA, said, “Generally, most safety events occur in the first month or two after vaccination. So, if all the data holds up and is confirmed by the FDA, that'll be good evidence of the safety of the vaccine."

The FDA is currently reviewing efficacy and safety data from Pfizer and Moderna’s final COVID-19 vaccine trials. They are expected to engage in public discussion of results in early December. Following this, the FDA will decide whether to grant an EUA. If granted, the vaccine is authorized to be administered. If granted, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, estimates 20 million of the highest-risk individuals will be able to be vaccinated by year-end and vaccines will begin to be available to everyone by spring 2021.

As for wearing a mask and maintaining distances, Fauci cautions to stay the course. There is still more research to be done on immunity length and vaccine efficacy for vulnerable populations with various conditions. More data and information will certainly continue to flow our way in the weeks to come.