Diana Ernst, RPh

In a statement, the Company noted that the actions being taken are considered “routine” when an unexplained illness is reported in a clinical trial.

Previously, the EUA limited use to patients with severe COVID-19 disease.

The EUA was based on historical evidence indicating some effectiveness with convalescent plasma use in previous outbreaks of respiratory viruses, preclinical data, results from small clinical trials, and data from the National Expanded Access Treatment Protocol sponsored by the Mayo Clinic.

Vaccination with mRNA-1273, Moderna’s coronavirus disease 2019 (COVID-19) vaccine candidate, led to robust immune responses and protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in nonhuman primates.

The FDA has granted Fast Track designation to 2 of Pfizer and BioNTech’s vaccine candidates against COVID-19.

The FDA has issued guidance to assist in the development and licensure of vaccines for the prevention of COVID-19.

Unlike a clinical trial with a control group, the study will focus on collecting data in order to identify appropriate and safe doses; it will not be evaluating the best treatment for COVID-19.