Exclusive: US Health Agency May Not Be Ready To Resume COVID Vaccination Program

Files containing COVID-19 vaccination plans for various states are stacked on a table as Xavier Becerra, US President Joe Biden’s candidate for Secretary of Health and Human Services, testifies during his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions at the United States Capitol in Washington, USA, February 23, 2021. Leigh Vogel / Pool via REUTERS / File Photo

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WASHINGTON, Jan. 7 (Reuters) – The US Department of Health and Human Services (HHS) appears unwilling to take full responsibility for the national COVID-19 immunization program, including activities currently managed by the Pentagon, according to a draft government monitoring report reviewed. by Reuters.

The report cites a failure to ensure that HHS has enough staff or a clear timeline to take on these additional responsibilities.

The COVID-19 vaccination program, dubbed “Operation Warp Speed” by the Trump administration in May 2020, has involved hundreds of officials from several agencies.

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The program has invested more than $ 30 billion to develop, manufacture and purchase vaccines, including from Moderna Inc (MRNA.O) and Pfizer Inc (PFE.N) and German partner BioNTech SE which were used to inoculate near of 200 million Americans, as well as shots that have not been authorized for use in the United States.

He continues to oversee the approval and funding of other potential COVID-19 vaccines and treatments.

In May 2021, the Biden administration ordered the HHS to begin taking on program responsibilities shared with the Department of Defense (DOD) by the end of 2021, according to the Congressional audit agency report. , the Government Accountability Office (GAO).

The GAO, however, said “it is not clear” whether the HHS was ready to take over the program given that a majority of the Pentagon’s current responsibilities – including coordinating vaccine distribution, safeguarding of doses and the offer of legal advice to federal agencies involved in the effort – had not been transferred to HHS late last year.

“Without fully guaranteeing HHS readiness, HHS and DOD face an increased risk of interruptions to their remaining work, such as meeting ongoing vaccine needs for boosters or for any emerging variant of COVID-19,” wrote the agency.

The report found that the HHS had not ensured “that it had sufficient manpower capacity” or organized “a schedule to manage the remaining activities of development, manufacturing and vaccine distribution ”, risking a loss of capacity.

GAO, an independent agency appointed by Congress to audit the management of federal programs, declined to comment on the draft. The agency prepared the report at the request of the House of Representatives COVID subcommittee and is expected to release it soon.

Questions over the HHS ‘ability to fully support vaccines and treatment efforts come as the Biden administration grapples with a record rise in COVID-19 due to the rapid spread of the Omicron variant disrupting returns in schools and businesses after the winter holidays.

A spokesperson for HHS said the “long-planned” transition was “successfully” completed on January 1.

“The institutionalization of these functions within HHS ensures that we are able to capitalize on the progress made to date, retain expertise and skills (including a number of DOD staff who have transferred at HHS) and continue to provide the necessary tools for the American people to respond to COVID. -19 pandemic, “the spokesperson said. The spokesperson declined to discuss the extent to which the Pentagon remains involved in the program.

UNPRECEDENTED MISSION

Prior to COVID-19, the Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS was established to oversee the response to the pandemic. The Trump administration has relied heavily on the Pentagon to aid it in the unprecedented task of producing, purchasing and distributing vaccines nationwide in the months following the emergence of the deadly novel coronavirus.

As of September, the DOD assigned 76 officials from various branches of the military to work on the program, GAO said.

A Pentagon spokesperson told Reuters “The HHS has assumed leadership of the COVID-19 vaccine and therapeutic mission,” adding that the DOD continues to award COVID contracts for medical supplies in conjunction with the HHS and “Continues to provide limited on-the-job training. in a few areas to ensure that HHS staff have all the basic tools and information they need to make the operation a success. “

The Pentagon has said it no longer helps the HHS with the transport of vaccines.

A senior federal official familiar with the operations of the program said that while the HHS did not fully assume all responsibilities, the Pentagon would help ensure a smooth transition.

The official, who was not authorized to speak about it and asked to remain anonymous, called December 31 an “ambitious deadline”.

“If the HHS is really not ready to take on all the responsibilities, the government is not just going to drop the ball,” the official said.

While the Pentagon has agreed to help select the contractors, the administration has not officially decided on any further shared responsibility and “therefore, it is not known what this support may entail or for how long.” GAO said.

Even with Pentagon backing, a Reuters review revealed problems with monitoring contracts for COVID-19 vaccines, therapeutics, tests, and other medical products.

Fewer than 20% of the companies awarded contracts were experienced manufacturers with a clean FDA record for their US factories in the previous two years, and four in five had no manufacturing experience in the United States, poor national inspection results or serious recalls before their award, Reuters found.

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Reporting by Marisa Taylor and Phillip Stewart; Editing by Michele Gershberg and Bill Berkrot

Our Standards: Thomson Reuters Trust Principles.


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