The US Food and Drug Administration is pulling in extra help from across the agency to speed final approval of Pfizer/BioNtech’s coronavirus vaccine, an agency spokesperson told CNN Friday.
“We have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge,” the FDA’s Abby Capobianco told CNN in an email.
“Our ongoing review of the biologics license application for the Pfizer-BioNTech COVID-19 vaccine is moving forward as rapidly as possible in keeping with the high-quality complete assessment that the public expects from the FDA,” she added.
The three vaccines in current use in the United States — Pfizer’s, Moderna’s and Johnson & Johnson’s — have emergency use authorization. Pfizer has filed for full approval in a process known as biologics license application or BLA.
“We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” Capobianco said. She said acting FDA Commissioner Dr. Janet Woodcock was helping reassign people and other resources.
“FDA staff will conduct a thorough review process, while balancing the incredible sense of urgency necessary, both of which are needed to ensure that any vaccine that is authorized or approved meets our rigorous standards for safety, effectiveness, and quality. In this regard, Dr. Woodcock has reiterated her appreciation for the diligence and integrity to this process and offered all agency resources to the team to make this happen.”