Former FDA chief David Kessler will helm Operation Warp Speed for Biden

WASHINGTON — President-elect Biden has tapped David Kessler, a former Food and Drug Administration chief and a key adviser to his campaign, to lead the president-elect’s version of the Operation Warp Speed vaccine program, a Biden official told STAT.

Kessler is something of a controversial choice. His list of accomplishments at the FDA — he pushed the agency to expand its role to regulate tobacco, he implemented the user fee system and the adverse event reporting system — is long and bold. But until he began advising the Biden campaign on the pandemic, he had not worked in government for more than 20 years, since serving as Clinton’s FDA commissioner.

Kessler also does not have a background in vaccine development, or in mass vaccination campaigns: Since leaving the government in the 1990s, he has served as dean of two medical schools and written extensively about nutrition. Nonetheless, Kessler has become one of Biden’s most trusted pandemic advisers and has been meeting behind-the-scenes with countless companies offering to help with the vaccine development effort, including those that don’t have an existing contract with the Operation Warp Speed.

Kessler is also serving as co-chair of Biden’s Covid-19 task force and medical adviser for Biden’s inaugural committee.

Kessler will replace Moncef Slaoui, a former pharmaceutical industry executive tapped by Trump for the job, the New York Times first reported. Kessler’s duties will have a larger remit than Slaoui’s previous role as chief adviser to Operation Warp Speed, a transition official told STAT. Where Slaoui focused largely on clinical development of vaccines, Kessler will also work on issues like manufacturing, distribution, and safety.

It’s still unclear exactly how Kessler will split duties with Gen. Gustave Perna, who is Operation Warp Speed’s chief operating officer under Trump. Perna is expected to continue to serve in some capacity during the Biden administration.

Slaoui’s ties to the industry made him controversial with some prominent Democrats; Sen. Elizabeth Warren (D-Mass.) even pushed for his firing. Slaoui, however, will stay on as a consultant under the Biden administration, with a diminished role, to help the transition.

A Biden campaign press release lists Kessler’s new title as chief science officer of COVID Response.

Kessler will take on a major challenge at Operation Warp Speed, which has fallen dramatically short of Slaoui’s original goal to vaccinate 20 million people by the end of last year. Biden has promised to administer 100 million doses within his first 100 days, a goal that even his advisers admit is “aspirational … but doable.”

It’s not immediately clear how Kessler will transform the vaccine effort: The former FDA commissioner has kept a strikingly low public profile over the past months. His few media appearances have largely centered around assuring the American public that coronavirus vaccines are safe and effective.

Kessler was long rumored as one of the top picks for FDA commissioner in the Biden administration. The most likely contenders for that role now, according to current and former FDA officials, are Josh Sharfstein, who served as second-in-command at the FDA in the Obama administration, and Janet Woodcock, the longtime head of FDA’s drug center.

The Biden campaign announced a slew of additional appointments to the Covid-19 vaccine effort Friday as well. They include former acting Centers for Medicare and Medicaid Services administrator Andy Slavitt, who will serve as senior adviser to the COVID Response coordinator; Yale Law School professor Abbe Gluck, who will serve as special counsel; and University of Virginia professor B. Cameron Webb, who will serve as senior policy adviser for Covid-19 equity.