U.S. HHS Department may be unprepared to take over COVID vaccine program --draft GAO report

Exclusive: U.S. health agency may be unprepared to take over COVID vaccine program 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. Marisa Taylor,Phil Stewart Reuters

WASHINGTON, Jan 7 (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. ...