Hahn Testifies to Reassure FDA Independence with Covid-19

A day after news broke that FDA is expected to issue a guidance this week laying out tougher new standards for an emergency use authorization (EUA)of a Covid-19 vaccine, commissioner Stephen Hahn appeared on Capitol Hill to reassure lawmakers and the public that a transparent science- and data-based review, and not political interference, will be behind any Covid-19 vaccine approval or EUA. Under the new guidance (see earlier story), the agency reportedly would ask manufacturers seeking EUA to follow participants in late-stage clinical trials for a median of at least two months starting after they receive a second vaccine shot. And the agency reportedly will also look for at least five severe cases of Covid-19 in the placebo group for each trial, as well as some cases of the disease in older people.

To date, AstraZeneca, Pfizer, Johnson & Johnson and Moderna are conducting Phase 3 trials in the U.S. with an anticipated 30,000 participants enrolled in each trial. Johnson & Johnson’s vaccine is the only vaccine designed for a one-dose administration, whereas the other three vaccines require two doses administered several weeks apart.

The new EUA standards will likely make it next to impossible for a vaccine to be authorized before the election, which continues to be a goal of president Trump. Once FDA receives a submission, the agency will take weeks and possibly months to review the data, Hahn told a Senate Health Education Labor & Pensions Committee hearing. He offered no additional details on the upcoming guidance.

At the hearing, Hahn reiterated current guidance driving clinical trials that are currently underway. He said FDA expects that a Covid-19 vaccine would be at least 50% more effective than placebo in preventing Covid-19 infections among clinical trial participants. “FDA anticipates that clinical trials to demonstrate vaccine efficacy would also be of sufficient size to provide an acceptable safety database,” he said. “However, further pre-licensure safety evaluation may be needed if safety concerns arise during clinical development.”

Hahn told the committee the agency will convene its Vaccines and Related Biological Products Advisory Committee 10/22 “to help ensure an evaluation process that is as transparent as possible, and to help the public understand the FDA’s process for evaluating the safety and effectiveness of new vaccines. We stand ready to rapidly schedule additional meetings of this committee after submission to discuss Biologic License Applications or request for an Emergency Use Authorization for Covid-19 vaccines.” Hahn said every vaccine submission will go before the advisory committee.

To help assure speedy distribution once a vaccine has been approved or authorized, Hahn told the senators that manufacturing and fill finish capacity will need to be scaled up in the U.S. “FDA is committed to working with sponsors by providing timely regulatory advice and technical assistance regarding manufacturing to help support such scale-up activities, including sponsors who may be proceeding at risk to scale-up manufacturing while clinical trials are being completed,” he said.