WASHINGTON, Jan. 7 (Reuters) – According to a draught government watchdog assessment acquired by Reuters, 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 presently managed by the Pentagon.
The failure to ensure that HHS has enough staff or a clear schedule for taking on those extra tasks is cited in the study.
The program has spent more than $30 billion on vaccine development, manufacturing, and procurement, including vaccines from Moderna Inc (MRNA.O), Pfizer Inc (PFE.N), and BioNTech SE, a German partner, that have been used to inoculate nearly 200 million Americans, as well as shots that are not approved for use in the United States.
It is still in charge of overseeing the approval and funding of other COVID-19 vaccines and treatments.
Hundreds of officials from numerous agencies were participating in the COVID-19 vaccine initiative, nicknamed “Operation Warp Speed” by the Trump administration in May 2020.
According to a report by Congress’ auditing body, the Government Accountability Office, the Biden administration ordered HHS to begin assuming responsibility for the program shared with the Department of Defense (DOD) by the end of 2021. (GAO).
The GAO, on the other hand, said it was “unclear” whether HHS was ready to take over the program because a majority of the Pentagon’s current responsibilities had not been transferred to HHS by late last year, including coordinating vaccine distribution, safeguarding doses, and providing legal advice to federal agencies involved in the effort.
“Without completely guaranteeing HHS readiness, HHS and DOD face an elevated risk of disruptions in their remaining operations,” the government warned. “This includes addressing ongoing vaccine demands for boosters or any emerging COVID-19 variants.”
HHS had not assured “adequate staff capacity” or set up “a schedule to manage the remaining vaccine development, production, and distribution activities,” according to the report, putting its capabilities at risk.
The Government Accountability Office (GAO), an independent organization entrusted by Congress with auditing how government programs are run, declined to comment on the draught. The study was created at the request of the COVID subcommittee of the House of Representatives and is likely to be released soon.
Questions about HHS’ ability to fully take over-vaccination and therapy efforts arise as the Biden administration deals with a COVID-19 outbreak that has broken records due to the quickly spreading Omicron form, which is interrupting school and business returns after the holidays.
The “long-planned” shift was “successfully” accomplished on Jan. 1, according to a representative for the Department of Health and Human Services.
“Institutionalizing these functions within HHS ensures we can build on our progress to date, retain expertise and skills (including a number of DOD employees who transferred to HHS), and continue providing the necessary tools to the American people to respond to the COVID-19 pandemic,” according to the spokesperson. The Pentagon’s involvement in the initiative is still unknown, according to the spokesperson.
MISSION WITHOUT EXPECTATION
HHS’s office of the assistant secretary for preparedness and response (ASPR) was established to handle pandemic response prior to COVID-19. In the months following the revelation of the new and deadly coronavirus, the Trump administration leaned heavily on the Pentagon for assistance with the unprecedented task of creating, procuring, and distributing vaccines across the country.
According to GAO, the Department of Defense has assigned 76 personnel from various branches of the military to work on the program as of September last year.
“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 medical supply contracts 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 informed HHS that it will no longer assist with vaccination transportation.
Even if HHS has not fully inherited all responsibilities, a top government official familiar with the program’s functioning said the Pentagon will assist in ensuring a smooth transfer.
The individual, who wanted to remain anonymous because he was not authorized to speak about it, described Dec. 31 as “an aspirational deadline.”
“The government will not simply drop the ball if HHS is not ready to assume all of the obligations,” the official said.
While the Pentagon has promised to assist in the selection of contractors, the administration has not yet decided on any additional shared obligations, so “it is unclear what such support may involve or for how long,” according to the GAO.
Reuters found difficulties with oversight of the contracts for COVID-19 vaccines, medicines, testing, and other medical products, even with Pentagon support.
According to Reuters, 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 five had no U.S. manufacturing experience, poor domestic inspection results, or serious recalls prior to their awards.