The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year.
Ellume signed an agreement with the U.S. Department of Defense (DoD) and the Department of Health and Human Services that would pay the company $231 million to send more than 8 million of its test kits to the U.S. The company agreed to ship 100,000 tests per month from its Australian manufacturing site until its U.S. production facility is up to speed, at which point its U.S. production numbers will reach 19 million per month.
In a Feb. 5 White House briefing, Andy Slavitt, senior advisor for the administration’s pandemic response team, confirmed that Ellume would make available 8.5 million tests by the end of the year. However, another six companies will surge their own manufacture of at-home test kits with the goal of “having millions of Americans being able to access at-home tests” by summer, Slavitt said. “It won't be easy and it is not happening overnight, but today's announcement represents another step in the long journey back to normal life,” he said. Slavitt did not indicate which companies would be contracted to boost production of at-home tests, although the Binaxnow test by Abbott Laboratories of Abbott Park, Ill., is a logical candidate. Abbott won an amended emergency use authorization (EUA) for the test in December 2020.
Mina sees error in delays
However, Harvard epidemiologist Michael Mina had few kind words to say about the plan. Mina, who has repeatedly criticized the U.S. FDA for insisting on molecular test-like levels of sensitivity and specificity for non-diagnostic tests, said, “we don’t have to wait until the summer to get these tests out to people. We could be doing this today.”
Mina said federal officials see at-home antigen tests as non-sensitive compared to polymerase chain-reaction (PCR) testing, which he argued is “the wrong way to look at a test like this. It’s not that this test is not sensitive enough. It’s that the PCR test is not specific. And what I mean by that is that the PCR test is not specific to infectious virus.”
The DPA will be used to increase the supply of vaccinations, but Slavitt also noted that the administration intends to “reduce our long-term dependence on foreign production of supplies that we need to protect our workforce and fight pandemics.”
The COVID-19 vaccination dashboard at the website for the U.S. CDC indicates that just shy of 60 million doses of vaccine have been delivered in the U.S., but only 42 million have been administered. Of that number, approximately 9.5 million have received two doses. Roughly 22 million were the Pfizer/Biontech vaccine, which requires two doses to achieve the full effect, while another 20 million doses were of the Moderna vaccine, which also requires two doses.
The White House has also indicated it will expand the priority rating for the Pfizer vaccine to ensure that the company has priority access to the products and materials it needs to accelerate production. Among the items of interest are filling pumps and tangential flow filtration skid units, a move that should quickly improve vaccine manufacturing. Pfizer may as a result be able to reach its objective of delivering 200 million doses by May, but limitations in equipment and ingredients may be hampering more than just Pfizer’s efforts.
DoD personnel to assist in vaccine roll-out
Slavitt also noted that the DoD has approved a request by the Federal Emergency Management Agency (FEMA) for support from active-duty military personnel to assist in the vaccination effort. The affected military personnel will be arriving in California by Feb. 12, with operations to follow by about three days. Additional vaccination missions by military personnel will soon follow, Slavitt said. In all, FEMA staff will play a role in establishment of 100 mass vaccination sites across the country, although it is not clear how many of these sites will require the assistance of DoD staff. Slavitt characterized this as an “important development in our whole-of-government response.”
One of the chief points of interest for supplies is surgical gloves, and the administration is going to use the DPA to reduce the U.S. dependence on imports. This will entail construction of manufacturing sites, which will eventually boost domestic production to 1 billion nitrile gloves per month, which is only about half the demand. Details of the related contracts will not be made available until those contracts are finalized.
There is legislation in the works on Capitol Hill to assist the federal government’s response, including the Tracking COVID-19 Variants Act of 2021. Sen. Tammy Baldwin (D-Wis.) and Reps. Ami Bera (D-Calif.) and Scott Peters (D-Calif.), said this legislation would “dramatically scale up our efforts to track coronavirus variants” as they emerge. The bill would add $2 billion in funding to the CDC’s Advanced Molecular Detection initiative, part of the public-private partnership known as the Sequencing for Public Health Emergency Response, Epidemiology, and Surveillance (SPHERES) program.