Ambitious Timeline for Vaccine Requires Companies to Accept Risks

A Covid-19 vaccine could happen in as little time as nine months as the FDA looks to eliminate “dead space,” the agency’s vaccines chief said Monday.

The comments by Peter Marks, who oversees vaccine regulation as the director of the Center for Biologics Evaluation and Research in the Food and Drug Administration, mark one of the shortest and most ambitious timelines laid out by government scientists at the forefront of the coronavirus response.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, has projected a vaccine would take 12 to 18 months to develop since the outbreak began. But there have been questions about whether the Trump administration is overestimating its ability to fast track a vaccine.

“We have to make sure that whatever comes out of this process meets our high standards for safety and efficacy for vaccines,” Marks said during an Axios event on medical research during a crisis. “That said, in this particular crisis we need to try to move things through very quickly to get there—working meticulously—because there’s just so much at stake here.”

Eliminating what Marks called “dead space” in the process means companies working on potential vaccines would begin producing doses even before clinical trials are complete. While that runs the risk of companies spending money on a treatment the FDA might not approve, it shortens the time needed to make any future vaccine widely available.

“The hope is that by working with those in a way that we haven’t done things exactly the same way in the past, we’ll move the vaccine development forward in a way that could lead to a vaccine in maybe nine months instead of the 12 to 18 months that people have talked about,” Marks said.

A number of relatively promising vaccine candidates exist, Marks said. According to a tracker by Faster Cures, 111 Covid-19 vaccines are now in development, including a few by Johnson & Johnson’s medical research and pharmaceutical development arm Janssen, another being developed by NIAID with Moderna Inc., and a collaboration by Sanofi and GlaxoSmithKline.

“Vaccine manufacturing, it’s not a high-margin business,” Marks said. “So nobody manufactures at risk normally until they know they have a vaccine that’s going to be approvable at least at large-scale manufacturing.”

The “dead space” echoes an approach outlined by Fauci and and Rick Bright, who was recently ousted from the Biomedical Advanced Research and Development Authority in the Department of Health and Human Services.

The FDA is considering all the different authorities to make a vaccine available, whether it’s temporarily approving a candidate for the duration of the public health emergency or issuing a permanent approval.

“It would all depend on what the data showed at the time,” Marks said. “Nobody’s looking to skip any parts of the development program to lead to a safe and effective vaccine.”