BRIEF—FDA formal approval of EUA for COVID-19 Vaccine Janssen

The US Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The EUA allows the COVID-19 Vaccine Janssen, which only requires a single dose, to be distributed in the USA for use in individuals 18 years of age and older.

The announcement came out before mid-night on Saturday, following a unanimous positive vote from an FDA advisory panel on Friday, which evaluated the Johnson & Johnson vaccine.

Acting FDA Dr Commissioner Janet Woodcock commented: “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

In a statement from J&J, the company said it has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the USA.

The company plans to deliver 100 million single-shot vaccines to the USA during the first half of 2021.