US Food and Drug Administration Commissioner Dr. Stephen Hahn said in a statement on Thursday that the Vaccines and Related Biological Products Advisory Committee meeting happening now to discuss the first Covid-19 vaccine emergency use authorization request from Pfizer is "an important step" in the process.
“The FDA recognizes that transparency and dialogue are critical to building public confidence in Covid-19 vaccines,” Hahn said in a statement releases by the FDA, adding that the committee’s open discussion will “help ensure clear public understanding of the scientific data and information that the FDA evaluates to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19.”
Hahn said that the FDA’s career staff have been working “around the clock” to thoroughly evaluate the data and information in the EUA request “in a comprehensive and science based manner.”
“I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it,” he said.
Hahn highlighted that the FDA is considered the “gold standard” regulator of medical products and that its review process is respected worldwide. Normally, this process for vaccines takes months, he said.
“Even though the process has been expedited in association with the review of this EUA, the FDA’s expert review staff has reviewed thousands of pages of technical information,” he said, adding that the materials include clinical trial data, non-clinical data on lab development of the vaccine and manufacturing data. Career officials have been reviewing this data ahead of the meeting, he said.
“Today’s meeting is an important step in the process – allowing outside scientific experts an opportunity to provide valuable advice and input for the agency to consider as part of its final review,” Hahn continued. “Importantly, final decisions about whether to authorize a vaccine for emergency use will be made by FDA’s career officials in the Center for Biologics Evaluation and Research.”
After the meeting, the FDA career staff will take into account the committee input, Hahn said, as they continue to review the EUA request.