April 11, 2024

FDA Issues Emergency Use Authorization for Single-dose J&J Vaccine

  • by AGD Washington Advocacy Representative
  • Mar 4, 2021
On February 27, the U.S. 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 Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

The Janssen COVID-19 Vaccine is administered as a single dose, and according to FDA data, is 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination. Unpunctured vials of the Janssen COVID-19 Vaccine should be stored unfrozen at 2°C to 8°C (36°F to 46°F) and can be held between 9°C to 25°C (47°F to 77°F) for up to 12 hours.

The FDA has published a fact sheet for healthcare providers administering Janssen COVID-19 vaccines, as well as a fact sheet for vaccine recipients. Additionally, you can find more information as it relates to the general dentist on AGD’s COVID-19 Vaccine Webpage.

Impact on General Dentistry: The widespread distribution and administration of vaccines for the prevention of COVID-19 are essential to ending the pandemic and allowing dental care delivery to normalize. AGD continues to advocate for dentists to be able to administer the vaccine as distribution broadens out to the general population. In nearly all states, this may require action by the state dental board.