HHS Unveils Vaccine Rollout Details As Dems Seek Oversight

By Kevin Stawicki
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Law360 (September 16, 2020, 6:30 PM EDT) -- The U.S. Department of Health and Human Services unveiled its strategy Wednesday to swiftly distribute COVID-19 vaccines, shortly after House Democrats pushed for more oversight of the Trump administration's multibillion-dollar vaccine campaign as required by the CARES Act.

HHS, along with the U.S. Department of Defense and the Centers for Disease Control and Prevention, said in a report to Congress that Operation Warp Speed is on track to deliver over 300 million doses of an effective vaccine for COVID-19 by January and that public health officials should be preparing themselves for a phased approach to vaccination.

As decisions are made about the efficacy of some vaccine candidates coming out of Phase 3 trials and the treatments await the Food and Drug Administration's stamp of approval, state and local governments must continue to communicate with federal officials about how to handle the rollout, the agency said.

"As part of Operation Warp Speed, we have been laying the groundwork for months to distribute and administer a safe and effective COVID-19 vaccine as soon as it meets FDA's gold standard," Secretary Alex Azar said in a statement. "This in-depth, round-the-clock planning work with our state and local partners and trusted community organizations, especially through CDC, will ensure that Americans can receive a safe and effective vaccine in record time."

After getting stakeholders in gear, HHS said distribution will immediately begin after the vaccine developer files a biologics license application with the FDA to evaluate the vaccine's efficacy. Emergency use authorizations, permitted under the public health emergency Azar announced in January, can also be used to permit some vaccines to go to market before reaching all clinical trials. The report also detailed the steps for providing administrative supplies, data collection and tracking, and the processes Operation Warp Speed will implement.

The vaccine announcement comes during a moment of turmoil for HHS. The agency said Wednesday that assistant secretary for public affairs Michael Caputo, a Trump appointee, decided to take a leave of absence "to focus on his health and the well-being of his family" in the wake of a widely publicized series of social media posts about how career government officials were plotting against the Trump administration. The agency also announced Wednesday that HHS senior adviser Paul Alexander left the agency. Caputo and Alexander came under fire by House Democrats accusing them of interfering with reports about the pandemic produced by the CDC.

House Democrats have been attempting to obtain information for months about Operation Warp Speed. On Tuesday, the House Select Subcommittee on the Coronavirus Crisis asked Azar and Defense Secretary Mark Esper to provide information about the program to the Government Accountability Office.

"GAO's review aims to help Operation Warp Speed accomplish its goals by providing an independent perspective and conveying clear and complete information to Congress and the public," Select Committee Chairman Jim Clyburn, D-S.C., wrote in the letter. "To succeed, it will be critical that the department provides GAO with real-time, ongoing access to information, documents, and officials."

Tuesday's letter followed a series of exchanges between the Select Subcommittee and the GAO about the extent of the agency's authority to review Operation Warp Speed. Responding to lawmakers' request in July that the agency probe the vaccine development program, the GAO said the review was "within the scope of its authority."

Because a significant amount of funds from the Coronavirus Aid, Relief, and Economic Security Act are being funneled into the program, the committee said the agencies must comply with the law that requires consistent oversight of activities related to the coronavirus.

"Providing GAO with access to information, documents, and officials is not only critical to conducting this review — it is also required by law," Clyburn said, noting that even without the additional access afforded by the CARES Act, the GAO also has authority to conduct the review.

Overseeing federal programs is "not novel," Clyburn continued. "We hope that you will view GAO as a resource to aid Operation Warp Speed in reaching its goals."

The select panel asked the agency in August to turn over information about the program to probe potential conflicts of interest. Clyburn said in a series of letters that the process for choosing vaccine candidates has not been transparent and that the rationale for selecting vaccine candidates was not made public by the administration.

In another letter, Clyburn raised concerns about Operation Warp Speed's chief adviser Moncef Slaoui, who was an executive at GlaxoSmithKline and a board member at Moderna. Slaoui resigned from his position as an independent member of Moderna's board of directors.

A spokesperson for the subcommittee declined to comment beyond the letters.

Representatives from the GAO and DOD did not immediately respond to requests for comment.

--Additional reporting by Adam Lidgett and Jeff Overley. Editing by Haylee Pearl.

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