According to a draft government watchdog report, the US Department of Health and Human Services (HHS) appears unprepared to take full responsibility for the nation’s COVID-19 vaccine program, including activities currently managed by the Pentagon.

According to the report, there has been a failure to ensure that HHS has enough staff or a clear timeline for taking on those additional responsibilities. Hundreds of officials from various agencies were involved in the COVID-19 vaccine program, dubbed “Operation Warp Speed” by the Trump administration in May 2020.

The program has spent more than $30 billion to develop, manufacture, and purchase vaccines, including those from Moderna Inc, Pfizer Inc, and German partner BioNTech SE, that have been used to immunize nearly 200 million Americans, as well as shots that have not been approved for use in the United States.

It is still in charge of approving and funding potential COVID-19 vaccines and treatments. According to a report by Congress’ auditing agency, the Government Accountability Office, the Biden administration ordered HHS in May 2021 to begin assuming responsibilities for the program shared with the Department of Defense (DOD) by the end of 2021. (GAO).

The GAO, on the other hand, stated that “it is unclear” whether HHS was prepared to take over the program because a majority of the Pentagon’s current responsibilities – such as coordinating vaccine distribution, safeguarding doses, and providing legal advice to federal agencies involved in the effort – had not been transferred to HHS by late last year.

According to the report, HHS had not ensured “sufficient workforce capacity” nor established “a schedule to manage the remaining vaccine development, manufacturing, and distribution activities,” putting the agency’s capabilities at risk.

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

According to an HHS spokesperson, the “long-planned” transition was “successfully” completed on Jan. 1.

“Institutionalizing these functions within HHS ensures that we can build on our progress to date, retain expertise and skills, and continue to provide the American people with the tools they need to respond to the COVID-19 pandemic,” the spokesperson said.

UNPRECEDENTED MISSION 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.

According to GAO, as of last September, DOD had assigned 76 officials from various branches of the military to work on the program. “HHS has assumed the lead for the COVID-19 vaccine and therapeutic mission,” a Pentagon spokesperson told Reuters, adding that DOD continues to award COVID contracts for medical supplies in collaboration 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 has stated that it will no longer assist HHS with vaccine transportation.

According to one top federal official familiar with the program’s operations, even if HHS has not fully assumed all responsibility, the Pentagon will assist in ensuring a smooth transition. The official, who was not authorized to speak publicly and requested anonymity, referred to December 31 as “an aspirational deadline.”

“If HHS is truly unable to assume all of the responsibilities, the government will not simply drop the ball,” the official stated. While the Pentagon has agreed to assist in the selection of contractors, the administration has not officially agreed on any other shared responsibilities, and “as a result, it is unclear what that support may entail or for how long,” according to the GAO.

Less than 20% of the companies awarded contracts were experienced manufacturers with a clean FDA record for their U.S. plants in the previous two years, and four out of every five either had no U.S. manufacturing experience, or had limited U.S. manufacturing experience, poor domestic inspection results or serious recalls before their awards.