FDA puts all hands on deck to review Pfizer-BioNTech Covid-19 shot

FDA puts all hands on deck to review Pfizer-BioNTech Covid-19 shot
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(July 31): US drug regulators are taking an “all-hands-on-deck approach” to reviewing Pfizer Inc and BioNTech SE’s Covid-19 shot for full approval in an effort to persuade as many as possible to get immunized.

The Food and Drug Administration is “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,” agency spokesperson Abby Capobianco said. Acting Director Janet Woodcock has “offered all agency resources to the team to make this happen,” she said.

Pfizer and BioNTech’s vaccine gained emergency use authorization in December, but many people are waiting for the vaccine to undergo a full review before getting it. The Biden administration is working to vaccinate as many as possible as the highly transmissible delta variant spreads across the US, threatening Americans’ return to normal activities.

“We recognize that for some, the FDA approval of Covid-19 vaccines may bring additional confidence and encourage them to get vaccinated,” Capobianco said in the statement. “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.”

Pfizer submitted the application for full approval in early May. The FDA’s plan to expedite review of the Pfizer-BioNTech vaccine was reported earlier by STAT.