.png)
The US Food and Drug Administration (FDA) announced Friday evening that the recently developed Pfizer-BioNTech COVID-19 vaccine has received emergency use authorization (EUA). The authorization is a major step in the ongoing efforts toward widespread distribution of the vaccine to the public.
On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss the Pfizer-BioNTech COVID-19 vaccine and the consequences of the pharmaceutical giant’s vaccine emergency use authorization request.
As the federal agency tasked with regulating the pharmaceutical industry, the FDA holds advisory committee meetings—as needed—to address a broad range of topics related to the public health and wellness, including vaccines. These meetings provide opportunities for agency officials to hear recommendations from external experts while also serving as a public forum to discuss products being reviewed by the FDA.
The Dec.10 VRBPAC meeting addressed three key issues impacting the outcome of Pfizer-BioNTech’s vaccine emergency use authorization request: risk-benefit assessment of available vaccine data, Pfizer’s planned approach for documenting vaccine effectiveness in vaccinated populations, and the company’s plans for ensuring that ongoing vaccine trials yield reliably accurate results.
In an official statement announcing the VRBPAC meeting, FDA Commissioner Stephen M. Hahn underscored the importance of trust and transparency in vaccine development and deployment.
“The FDA recognizes that transparency and dialogue are critical to building public confidence in COVID-19 vaccines. An open discussion with this committee—available for public viewing and with public input—about the totality of the scientific evidence regarding the safety and effectiveness of Pfizer and BioNTech’s vaccine 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,” said Hahn.
Hahn further acknowledged that the unusually speedy development of the COVID-19 vaccine is at odds with the FDA’s traditional vaccine approval process. “Normally, the review process for vaccines studied in tens of thousands of people takes months,” he admitted.
Still, the FDA chief asserted the agency has done its due diligence in reviewing the vaccine and evaluating the Pfizer’s request for emergency use authorization.
“Even though the process has been expedited in association with the review of this [emergency use authorization], the FDA’s expert review staff has reviewed thousands of pages of technical information…including…clinical trial data, non-clinical data on the development of the vaccine in the lab, and manufacturing data on how the vaccine is made,” Hahn noted.
The VRBPAC—comprised of public health and scientific experts—is not unique in terms of its function as a federally sanctioned review board. In fact, the VRBPAC is one of many such committees that have been formed to support and expedite vaccine approval in the fight against the novel coronavirus.
Over the weekend, another federally sanctioned committee will convene to review vaccine standards. The Advisory Committee for Immunization Practice (ACIP), a US Centers for Disease Control and Prevention (CDC) committee, will meet Saturday to discuss the phased vaccine rollout schedule and clinical considerations such as dosing schedules and if the vaccine can be administered with other approved vaccines. The committee’s recommendations will be submitted to the CDC director for final approval.
Although federal advisory committees like ACIP and VRBPAC are empowered to make official recommendations on matters regarding the COVID-19 vaccine and its distribution, each state is ultimately responsible for its own plan for determining which groups receive priority vaccine access and how vaccine doses will be distributed to citizens. Alabama’s distribution plan can be reviewed on the Alabama Department of Public Health’s website.
Comments