We Need an FDA Office of Preparedness and Response.

• Author: Lewis, Enlli
• Position: BRIEFLY NOTED

Operation Warp Speed revolutionized vaccine development. By cutting red tape, the Food and Drug Administration enabled the deployment of life-saving COVID-19 vaccines in record time. It showed how removing unnecessary and time-consuming regulatory barriers can have immense public health and economic value. However, using this approach solely in a time of crisis is an enormous error.

Tenacity and innovation / Prior to Operation Warp Speed, the fastest vaccine to be developed--a mumps vaccine back in the 1960s--took four years. For COVID-19, it took less than one. This success was in large part due to the tenacity and innovation of the FDA's Center for Biologies Evaluation and Research (CBER). In recognition of the urgent need to deploy vaccines and the dire consequences of delay, CBER adopted a streamlined regulatory approach and identified bureaucratic hurdles that could be removed with little detrimental effect on safety and efficacy.

Developing a vaccine is usually a cumbersome process, taking on average 10 years to go from initial vaccine research and development through preclinical and clinical trials. Under Operation Warp Speed, CBER greenlit initial Phase I human testing of vaccine candidates on an accelerated basis (often in the absence of animal data) and enabled large-scale Phase II and III human testing to begin before a full readout of Phase I results became available. Also, CBER quickly issued guidance for pharmaceutical companies that established the evidentiary threshold for demonstrating the suitability of their candidates for Emergency Use Authorization (EUA). By doing so, CBER provided clear expectations to developers regarding the safety and efficacy standards they were required to meet, which reduced regulatory uncertainty for developers and eased the review process by standardizing evidence packages.

To ensure data from vaccine developers were reviewed as quickly as possible, CBER exercised rolling review, examining the data as they became available instead of waiting for the trials to conclude and having the developers submit all their results as a complete package. CBER expanded its review capability, with staff working around the clock to review submissions in real time. These efforts allowed CBER to authorize the Pfizer vaccine within 21 days of its EUA request and Moderna within eight. In comparison, the FDA's existing Priority Review designation aims for action on an application within six months.

Using regulatory...