After the US Food and Drug Administration’s emergency use authorization for the COVID-19 vaccine from Pfizer and BioNTech, Holly Fernandez Lynch sheds light on the EUA process.

The agency is holding another meeting December 17th to determine whether they will issue one for the vaccine candidate from Moderna.

EUAs will allow some members of the American public—not just those enrolled in clinical trials—to begin receiving the vaccines. But an EUA is not the same as traditional FDA approval. What exactly is an EUA, and what does this mean for future vaccine distribution and study?

Here, Fernandez Lynch, a bioethicist in the Perelman School of Medicine at the University of Pennsylvania whose work has focused on clinical research, illuminates why the FDA is using this alternative route for authorizing use of vaccines, unpack the power and limitations of the EUA pathway, and lay out the emerging ethical concerns related to vaccine research that this action raises:

  1. An EUA depends on several considerations
  2. Strong results made decisions easier
  3. The EUA process was fast but thorough
  4. An emergency could be lifted without an approved vaccine
  5. Authorization throws a wrench in placebo-controlled trials

Read the full article about vaccine emergency use by Katherine Unger Baillie at Futurity.