Biden taps D.C. veteran David Kessler for vaccination drive

President-elect Joe Biden fleshed out the team that will try to get America vaccinated Friday, drawing on leading health figures from both prior Democratic and Republican administrations to take on the coronavirus response.

Former FDA Commissioner David Kessler, who served in the first Bush and Clinton administrations, will be the top science official overseeing the vaccination drive. Andy Slavitt, who helped fix the broken HealthCare.gov Obamacare website and then ran Medicare and Medicaid under President Barack Obama, will be senior adviser to the Covid-19 response coordinator, Jeff Zients. Slavitt said he would be working on both messaging to build trust in vaccines and helping coordinate the private sector role in the response.

They will take over at a crucial time, as federal and state officials struggle to distribute millions of doses of the first authorized Covid-19 vaccines. Biden has pledged to administer 100 million doses in the first 100 days of his administration, but has already clashed with senior transition officials over concerns they could underperform. Biden transition officials just this week gained access to some critical Trump administration vaccine planning efforts after being rebuffed for weeks.

The new administration will also rename Operation Warp Speed, which was the Trump team's name for the vaccine and therapeutics accelerator, incoming White House press secretary Jen Psaki said in a tweet.

"We are phasing in a new structure, which will have a different name than OWS," she wrote. "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."

Another person close to the transition said, "The Trump administration left the situation far worse than anyone imagined."

After the Trump administration fell well short of its goal to vaccinate 20 million people by the end of December, just over half that number have received their initial doses as of mid-January while states struggle to get out their supply. The Trump administration this week decided to rush out all available vaccines and make them much more broadly available to Americans 65 and older. But that’s also created new headaches, as demand far exceeds supply or the states’ readiness to immunize that much larger group.

Biden on Thursday evening outlined a $20 billion plan to create community-based vaccination centers, as well as a 100,000-person public health work force. On Friday, he detailed plans for distributing coronavirus shots while acknowledging the complexity of the task ahead.

"This is a time to set big goals, to pursue them with courage and conviction because the health of the nation is literally at stake," Biden said.

The new Covid response team will not require Senate confirmation and can take over immediately after Biden is sworn in on Wednesday — unlike his pick for FDA commissioner, which has not yet been announced. Janet Woodcock, who has been in senior roles at the agency for over three decades and has worked with Kessler, will be named acting FDA commissioner. Kessler has also worked closely over the years with Anthony Fauci, the government’s top infectious disease expert who will be Biden’s chief medical adviser.

Kessler, a co-chair of Biden’s Covid-19 advisory board, along with Biden’s designated surgeon general and pandemic adviser Vivek Murthy has been briefing Biden on the coronavirus throughout the campaign and transition.

“He is basically advising Zients and the president-elect on a daily basis on anything having to do with vaccines," said the person close to the transition.

Biden also announced the members of his science team. Francis Collins will stay on as director of the National Institutes of Health, which he's led since 2009. Eric Lander, a prominent scientist who helped lead the Human Genome Project and is now is president of the Broad Institute, will direct the Office of Science and Technology Policy, which is being elevated to the Cabinet level.

Kessler will replace former pharmaceutical executive Moncef Slaoui, who will step down from leading Warp Speed but will remain on as a consultant for about a month. The transition has also decided to keep on Gen. Gustave Perna to continue overseeing the intricate logistics of vaccine distribution.

Slavitt is not expected to stay long in his new advisory role. With a background in both health tech and policy, Slavitt helped repair the botched Obamacare enrollment site in 2013 and later served as acting head of the Centers for Medicare and Medicaid Services, which also gave him oversight of the Affordable Care Act. Since the Obama administration, Slavitt has remained a prominent advocate for the ACA while it was under assault by Republicans in the Trump era. During the pandemic, he has been very visible on Twitter, podcasts and other outlets highlighting the dangers of the virus and what he saw as the Trump administration's lagging response.

"This is an all-hands-on-deck moment," said Slavitt, who until very recently didn't plan on returning to the government. "After the last 10 months, Americans deserve to know that there will be a team of people working around the clock to right the ship so people can get back to their lives."

Slavitt, who worked with Zients closely during the ACA repair mission, will be working with private groups such as hospitals and pharmacies to coordinate pandemic response.

Warp Speed has spent billions of dollars to secure as many as 900 million doses of Covid-19 vaccines, though most of the options are still in development and ultimately may not prove to work. Two vaccines, from Moderna and Pfizer/BioNTech, are authorized for use.

Kessler will assume his post just as more vaccine options could come to the table. Johnson & Johnson is expected to soon release final safety and efficacy data for its vaccine and file for an emergency authorization from the FDA, within weeks. If it also highly effective, it has some advantages over existing shots: It is easier to ship and store, and only requires one dose. But in the best case scenario, it will take several months to ramp up supply.

During his seven-year run as FDA commissioner in the 1990s, Kessler spearheaded aggressive steps to speed up drug reviews, quickly pull unsafe products from the market, regulate tobacco and improve food labeling.

Though he became a Democratic favorite at the time for strengthening the agency’s regulatory power, Kessler quickly lost favor with Republicans — to the point that 1996 presidential candidate Bob Dole promised to oust the FDA chief if he won office.

Kessler has almost sometimes been at odds with some patient advocacy groups, most notably when he criticized the sweeping, bipartisan 21st Century Cures Act passed with overwhelming congressional support in 2016. The massive law, designed to modernize and speed up the FDA’s regulatory reviews, “would lower standards for the approval of many medical products and potentially place patients at unnecessary risk,” he wrote in an editorial.

But his new role in the administration was warmly praised by Public Citizen, often a critic of the FDA. Its founder Sydney Wolfe said the Kessler’s appointment “importantly matches his public health skills with the greatest international public health crisis of our lifetime, the coronavirus pandemic.” He said Kessler is well placed to oversee the “entire process of development, manufacturing, and distribution of Covid-19 vaccines, therapeutics and diagnostic tests.”

In recent years, Kessler, a pediatrician and lawyer, has campaigned for stronger tobacco and nutrition policies and became an outspoken critic of the Trump administration’s actions at the FDA. Kessler along with other former commissioners wrote that the president was undermining the agency’s credibility and that the FDA should be an independent agency to ward off political influence.

Kessler also serves on the board of the Center for Science in the Public Interest, a consumer advocacy group and food policy watchdog. The New York Times first reported his appointment.

Biden on Friday announced other top members of his Covid response team, including several more Obama administration veterans. They include Yale health law professor Abbe Gluck as special counsel; Vidur Sharma as policy advisor for testing; and Cameron Webb, a doctor and professor of medicine at the University of Virginia who ran an unsuccessful race for Congress against a GOP incumbent last fall, as an adviser on Covid-19 equity.