On February 27, 2021, Emergency Use Authorization (EUA) was granted to Janssen’s (Johnson & Johnson) COVID-19 vaccine (Ad26.COV2.S), by the U.S. Food and Drug Administration (FDA). It is the third COVID-19 vaccine to be approved in the U.S. On Feb. 26, 2021, a unanimous vote by the FDA’s independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended EUA. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) gave its authorization on Feb. 28, 2021, allowing distribution to begin.
The vaccine is given as just one (0.5mL) dose intramuscularly (IM) to prevent COVID-19 in patients 18 years of age or older. The U.S. government will help coordinate the delivery of 20 million doses by the end of March — with a goal of 100 million in the first half of 2021. Janssen is providing vaccine on a not-for-profit basis during the pandemic emergency at $10 per vial charged to the U.S. federal government for 100 million five-dose vials.
The vaccine can be stored at regular refrigeration temperatures 36°to 46°F (2° to 8°C) for a maximum of three months. If stored at -4°F (-20°C) the vaccine will remain stable for up to two years. The EUA is provided with a factsheet for healthcare providers found here. The EUA factsheet that should be provided to recipients and caregivers can be found here.