Wednesday, October 20, 2021

Ex-FDA chief David Kessler to lead COVID-19 vaccine efforts as head of Operation Warp Speed

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 acceleration program.

Biden chose former FDA chief David Kessler to take the helm at Warp Speed, according to multiple media reports. Slaoui will take a reduced consulting role for a month.

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.


Warp Speed chief Slaoui resigns at Biden’s request as COVID-19 shots are unleashed: report

While Slaoui’s responsibility is mainly focused on vaccine development, Kessler will have a broader job description that also covers manufacturing and distribution.

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 COVID-19 vaccine production lags goals as data readout nears: NYT

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.

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