Under Section 564 of the Federal Food, Drug and Cosmetic Act, the FDA commissioner may allow use of unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved and available alternatives.
Robertson said once the vaccine receives EUA, the distribution system set up under Operation Warp Speed will begin to operate on the state level. CHI Health and other health care providers then will work with the state to make sure those in need of the vaccine receive it.
He said the vaccine probably will come in waves of shipments. Officials will prioritize who will receive the vaccine first.
Robertson said if authorities are able to vaccinate larger portions of the communities with the new drug, “it will effectively get us to what you have heard as herd immunity.”
Herd immunity is a form of indirect protection from infectious disease that occurs when a sufficient percentage of a population has become immune to an infection, whether through vaccination or previous infections, thereby reducing the likelihood of infection for individuals who lack immunity.
“It is at that point that we will be able to gain control over the virus,” Robertson said.