Kessler headed the FDA from 1990 to 1997 under presidents George H.W. Bush and Bill Clinton and currently advises the Biden administration’s transition team on Covid-19 questions.

Unlike Slaoui, who once led vaccine development at UK drugmaker Glaxo-SmithKline – a business the company later shed – Kessler does not have direct experience in vaccines. However, he is credited with being instrumental in the fight against AIDS in the 1990s, working closely with leading US infectious diseases expert Anthony Fauci.

Reports say Slaoui had intended to stay on at OWS as an adviser, but Biden was unhappy with the initiative’s slow speed in distributing vaccines. Despite promises that 20 million doses would be administered by the end of 2020, by mid-January only 11 million doses had been delivered, the Centers for Disease Control and Prevention (CDC) said.

The president-elect has pledged that 100 million Covid vaccine doses will be administered in the US by his 100th day in office. Plans include creating vaccination sites in high school gyms, convention centers and mobile units to reach high-risk populations.

FDA commissioner pick still up in the air

Biden has not yet named a new FDA commissioner to replace Trump’s last appointee, Stephen Hahn. Former deputy FDA chief Joshua Sharfstein, who served in the first term of president Barack Obama, is considered front runner by many.

Appointed by Trump in January 2020, Hahn was criticized widely for acquiescing to the president’s wishes for Emergency Use Authorizations to use hydroxychloroquine or convalescent plasma as Covid treatments.

Until the new commissioner is chosen, another FDA veteran, Janet Woodcock – who is also seen as having a shot at the top job – will take over as interim commissioner. Woodcock currently oversees COVID-19 therapy development as part of Operation Warp Speed. Prior to that, she was director of the FDA's Center for Drug Evaluation and Research (CDER).

Sharfstein may not be the top choice of the US pharmaceutical industry, the trade journal Fierce Pharma speculated, noting that in his tenure at the FDA, he often clashed with drug and device manufacturers over tougher regulations.

The journal said drugmakers might be happier with Woodcock, due to the speed at which branded drugs moved to market while she was at CDER. Under her leadership, the agency approved 90% of new drug candidates in 2019 and 95% in 2018, as recorded in her own annual reports for the two years.

Author: Dede Williams, Freelance Journalist