The Food and Drug Administration (FDA) has scheduled 2 upcoming meetings of its Vaccines and Related Biological Products Advisory Committee to discuss new data for the currently available COVID-19 vaccines.
On October 14 and 15, the advisory committee intends to discuss a revision to the Emergency Use Authorizations (EUAs) of the Moderna COVID-19 vaccine and the Janssen COVID-19 vaccine for the administration of a booster dose in individuals 18 years of age and older.
The Moderna COVID-19 vaccine is currently authorized for emergency use for active immunization to prevent COVID-19 disease in individuals 18 years of age and older. In September 2021, the Company submitted initial data to the FDA on the use of a booster dose of the vaccine.
The Janssen COVID-19 vaccine is currently authorized for emergency use for active immunization to prevent COVID-19 disease in individuals 18 years of age and older. Recently, the Company shared new data from its phase 3 ENSEMBLE study (ClinicalTrials.gov Identifier: NCT04614948) evaluating the efficacy and safety of a booster dose of the vaccine.
“The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
The FDA has already authorized the use of the Pfizer-BioNTech COVID-19 vaccine as a single booster dose to be administered at least 6 months after completion of the primary 2-dose series in certain populations.
The Agency is also scheduling an advisory committee meeting for October 26 to discuss revisions to the EUA to allow for administration of the Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age. The Companies recently submitted data from a phase 2/3 trial evaluating a lower dose vaccine (10mcg) for this younger pediatric population.
FDA to hold advisory committee meetings to discuss Emergency Use Authorization for booster doses and COVID-19 vaccines for younger children. News release. US Food and Drug Administration. Accessed October 1, 2021. https://www.fda.gov/news-events/press-announcements/fda-hold-advisory-committee-meetings-discuss-emergency-use-authorization-booster-doses-and-covid-19.