- President-elect Joseph Biden said Friday he has named former Food and Drug Administration Commissioner David Kessler as chief science adviser to his coronavirus response team, replacing Trump administration leader Moncef Slaoui. The team will also include former Medicare and Medicaid acting head Andy Slavitt as a chief adviser.
- During his time as FDA commissioner, Kessler was credited with accelerating the review of early HIV treatments and trying to tighten tobacco regulations. Slavitt, meanwhile, helped fix flaws in the rollout of healthcare marketplaces under the Affordable Care Act while at the Centers for Medicare and Medicaid Services.
- The team continues the work of "Operation Warp Speed," a name that will reportedly be retired, in executing a nationwide public health response to the pandemic, including speeding development of additional vaccines and expanding the nationwide immunization program that's now underway.
Biden's announcement comes at a pivotal moment in the pandemic, with cases, hospitalizations and deaths hitting post-holiday peaks and a vaccination program starting to offer protection for healthcare workers, vulnerable adults and key workers. An early stockpile of vaccines manufactured by Moderna and Pfizer and BioNTech is beginning to be exhausted, potentially putting pressure on the Biden team's efforts.
Operation Warp Speed invested more than $10 billion into funding vaccine development and production, as well as to preorder hundreds of millions of doses. Two vaccines, one from the Pfizer-BioNTech partnership and one from Moderna, were authorized for emergency use by the Food and Drug Administration in December. Delivery and administration began within days of each decision.
The effort hit some early snags, however. States complained the early supply allocations were too small, while a reserve of millions of doses was held back to ensure people could receive the required booster shot. Both vaccines were authorized with a two-dose regimen that resulted in 95% efficacy against COVID-19.
Biden called for release of those reserved doses to expand availability, a call which was quickly followed by Health and Human Services Secretary Alex Azar saying the Trump administration planned to do so. However, the Washington Post reported Friday the reserve doesn't exist, and that current supplies are coming straight from manufacturing lines.
Moderna had delivered 18 million doses to the U.S. government through Jan. 4 and expects to deliver between 85 million and 100 million in the first quarter. Numbers from Pfizer are less precise, but the pharmaceutical giant recently announced it anticipates producing some 2 billion doses for the world in 2021.
Kessler, Slavitt and the rest of the Biden team will be forced to confront short supplies as they seek to quickly bring the pandemic under control. Cases hit a peak of more than 300,000 cases a day last week as infections surged following the holidays, putting hospitals and other healthcare providers nationwide under extreme stress.
There have also been calls to dispense with the phased vaccination rollout, which has prioritized healthcare and essential workers as well as vulnerable adults, and immunize as many people as possible. Furthermore, the White House team could be under pressure to get first doses to as many people as possible and delay the second dose, an approach taken by the U.K. government. FDA Commissioner Stephen Hahn has pushed back against changing the dosing schedule for either vaccine, however.
The job could be made easier if vaccines being developed by Johnson & Johnson, Novavax or AstraZeneca return positive data in coming weeks. The government has access to up to 300 million doses of J&J's vaccine, 100 million of Novavax's, and at least 300 million of AstraZeneca's, although it's not clear when manufacturing plants would be able to deliver those preordered supplies.