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 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 and
Pfizer Inc 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 https://www.reuters.com/world/us/us-reports-nearly-1-mln-covid-19-cases-day-setting-global-record-2022-01-04
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.
[to top of second column] |
 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.
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 https://www.reuters.com/world/the-great-reboot/us-rushed-contracts-covid-19-suppliers-with-troubled-plants-2021-12-02
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.
(Reporting by Marisa Taylor and Phillip Stewart; Editing by Michele
Gershberg and Bill Berkrot)
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