With Moncef Slaoui’s final days as a co-leader of Operation Warp Speed ticking away, President-elect Joe Biden has picked an FDA veteran to guide the COVID-19 vaccine scale-up.
Biden chose former FDA chief David Kessler, M.D., to serve in a role where he'll focus on "maximizing the current supply of vaccines and work with manufacturers to help get more vaccines online as quickly as possible," incoming White House press secretary Jen Psaki tweeted. The Biden team will also do away with the Operation Warp Speed name, she said.
OWS is the Trump team's name for their program. We are phasing in a new structure, which will have a different name than OWS. Many of the public servants will be essential to our response, but urgent need to address failures of the Trump team approach to vaccine distribution— Jen Psaki (@jrpsaki) January 15, 2021
Kessler served as FDA commissioner from 1990 to 1997 under presidents George H.W. Bush and Bill Clinton, and he is an adviser to Biden’s transition team on COVID-19 topics.
Kessler’s appointment comes at a critical time as the U.S. government works to get the first batches of COVID-19 vaccines from Pfizer-BioNTech and Moderna to people most in need. The initial rollout has ginned up all kinds of chaos, including confusion over who should or can get vaccinated, and demand’s outstripping supply.
More vaccines could arrive soon, too. AstraZeneca’s adenovirus-vectored AZD1222 has been cleared in the U.K., but a dosing mix-up in its phase 3 clinical trial has disrupted the shot’s U.S. regulatory plan. AstraZeneca CEO Pascal Soriot has said the company will run additional trials to confirm the vaccine’s efficacy.
Johnson & Johnson’s adenovirus-vectored candidate is also coming up on its efficacy data readout. But word has it that the Big Pharma is falling behind on its manufacturing goal.
Kessler’s not exactly a vaccine expert, but his previous experience with the FDA should help. During his tenure as FDA commissioner, Kessler oversaw the launch of the user fee system as a way to fund and therefore accelerate the new drug approval process, including for vaccines. He also introduced MedWatch, the FDA’s adverse event reporting system. He was also known for efforts against tobacco and on nutrition policies.