Exclusive: U.S. health agency may be unprepared to take over COVID vaccine program
WASHINGTON, Jan 7 (Reuters) - The U.S. Department of Health and Human Services (HHS) appears unprepared to assume full responsibility for the nation's COVID-19 vaccine program, including activities currently managed by the Pentagon, according to a draft government watchdog report reviewed by Reuters.
The report cites a failure to ensure HHS has enough staff or a clear timeline for taking over those additional responsibilities.
The COVID-19 vaccine program, dubbed “Operation Warp Speed,” by the Trump administration in May 2020, involved hundreds of officials from multiple agencies.
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 that have been used to inoculate nearly 200 million Americans, as well as shots that have not been authorized for U.S. use.
It continues to oversee approval and funding of other potential COVID-19 vaccines and treatments.
In May 2021, the Biden administration ordered HHS to begin assuming responsibilities of the program shared with the Department of Defense (DOD) by the end of 2021, according to the report by Congress’ auditing agency, the Government Accountability Office (GAO).
The GAO, however, said "it is unclear" whether HHS was prepared to take over the program given that a majority of the Pentagon's current responsibilities - including coordinating vaccine distribution, safeguarding the doses, and offering legal advice to federal agencies involved in the effort - had not been transferred to HHS by late last year.
"Without fully ensuring HHS readiness, HHS and DOD face an increased risk of interruptions in their remaining work, such as addressing ongoing vaccine needs for boosters or for any emerging COVID-19 variants," the agency wrote.
The report found HHS had not ensured "it has sufficient workforce capacity" nor arranged "a schedule to manage the remaining vaccine development, manufacturing and distribution activities," risking a loss of capabilities.
GAO, an independent agency tasked by Congress to audit how federal programs are managed, 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 publish it soon.
Questions about HHS' ability to fully take over vaccine and therapeutic efforts comes as the Biden administration grapples with a record surge in COVID-19 due to the rapidly spreading Omicron variant that is disrupting returns to schools and businesses after the winter holidays.
An HHS spokesperson said the "long-planned" transition had been "successfully" completed on Jan. 1.
"Institutionalizing these functions within HHS ensures we are able to build on the progress to date, retain expertise and skills (including a number of DOD employees that transferred to HHS), and continue providing the necessary tools to the American people to respond to the COVID-19 pandemic," the spokesperson said. The spokesperson declined to discuss the extent to which the Pentagon remains involved in the program.
Before COVID-19, HHS's office of the assistant secretary for preparedness and response (ASPR) was set up to oversee pandemic response. The Trump administration relied heavily on the Pentagon to help with the unprecedented task of producing, purchasing and distributing vaccines nationwide in the months following emergence of the new and deadly coronavirus.
As of last September, DOD had assigned 76 officials from various branches of the military to work on the program, GAO said.
A Pentagon spokesperson told Reuters "HHS has assumed the lead for the COVID-19 vaccine and therapeutic mission," adding that DOD continues to award COVID contracts for medical supplies in conjunction with HHS and is "continuing to provide limited on-the-job training in a few areas to ensure the HHS workforce has all the tools and background information required to ensure the operation is successful."
The Pentagon said it is no longer helping HHS with vaccine transportation.
One top federal official with knowledge of the program's operations said even if HHS has not fully assumed all responsibility, the Pentagon will help ensure a smooth transition.
The official, who was not authorized to speak about it and asked to remain anonymous, called Dec. 31, "an aspirational deadline."
"If HHS is really not ready to assume all of the responsibilities, the government is not going to just drop the ball," the official said.
While the Pentagon has agreed to help select contractors, the administration has not officially settled on any other shared responsibilities and "therefore it is unclear what that support may entail or for how long," the GAO said.
Even with Pentagon support, a Reuters examination revealed problems with oversight of the contracts for COVID-19 vaccines, therapeutics, tests and other medical products.
Less than 20% of the companies awarded contracts were experienced manufacturers with a clean FDA record for their U.S. plants in the two years prior, and four of every five either had no U.S. manufacturing experience, poor domestic inspection results or serious recalls before their awards, Reuters found.
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