The US Centres for Disease Control and Prevention’s (CDC) Advisory Committee on Immunisation Practices (ACIP) has recommended the first single-shot COVID-19 vaccine – developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the US FDA.
ACIP is a body of independent health experts that advises the CDC on the types of populations and circumstances for which vaccines should be used.
The ACIP recommendation will be forwarded to the Director of the CDC and the U.S. Department of Health and Human Services (HHS) for review and adoption.
Johnson & Johnson’s single-shot COVID-19 vaccine received EUA from the FDA on February 27, 2021. The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later this year.
“This recommendation follows the FDA’s decision to grant an Emergency Use Authorization for our single-shot vaccine, which has the potential to play a pivotal role in helping to end the COVID-19 pandemic,” said Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.