OR WAIT null SECS
© 2023 MJH Life Sciences™ and Pharmaceutical Commerce. All rights reserved.
Trump administration goal: ‘substantial quantities of a safe and effective vaccine available for Americans by January 2021’
It has taken months, but it now seems as if the full breadth of the US government has been engaged in fighting the Covid-19 pandemic. The first initiative was the ACTIV (Accelerating Covid-19 Therapeutic Interventions and Vaccines), which was launched by the National Institutes for Health on April 17. Now, the Trump Administration has announced Operation Warp Speed, which subsumes ACTIV and adds almost any federal agency that can lend a hand and—most specifically, the Dept. of Defense.
However, the May 15 White House announcement did not include new funding; rather, it appears at this early stage that it will be overseeing the expenditures already allocated by Congress under the Cares Act, which was signed into law on March 27, as well as funds that can be allocated from existing healthcare spending. Total funding currently available, according to the White House, is nearly $10 billion.
The list of federal agencies involved is instructive: “Operation Warp Speed is a public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of HHS, including CDC, FDA, NIH, and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH's ACTIV partnership for vaccine and therapeutic development, NIH's RADx initiative for diagnostic development, and work by BARDA.”
President Trump designated two leaders for the effort: Moncef Slaoui, a former GSK executive experienced in vaccine development, and General Gustave Perna, former commander of the US Army Materiel Command (AMC). Slaoui will be the “chief advisor” and Perna will be COO.
The HHS announcement of Operation Warp Speed details efforts in development of vaccines, therapeutics and diagnostics; meanwhile a parallel effort will go on in the Defense Dept. in those areas, as well as for production and distribution, and for “security.” The security effort is led by a DoD official from the Chemical, Biologic, Radiologic and Nuclear (CBRN) office—the folks who worry about DoD’s response to bioweapons or weapons of mass destruction.
Mention of DoD security raises questions of how the coordination currently going on internationally within ACTIV will play out in Operation Warp Speed. There has been a lively discussion in policy circles as to where, given a successful vaccine development, the therapy will first be administered. On top of the earlier accusations of the Sars-Cov-2 virus coming out of Chinese, US or other national laboratories, now there are accusations of theft of intellectual property.
To its credit, the setup of Operation Warp Speed looks ahead to manufacturing and distribution of vaccines and the like; planning for scaling up is to begin even before a candidate vaccine is identified. After that, “Once a product such as a vaccine is ready, the Department of Defense's involvement will enable faster distribution and administration than would have otherwise been possible using wholly private medical infrastructure,” says the HHS statement.
Where is CDC?
Looking over the elements of Operation Warp Speed, and trying to envision how its components will make a different, highlights how much of this planning and response had already been worked out, years ago, at the Centers for Disease Control. However, none of the identified administrators of the new effort are from CDC. Apparently, flubbing the development of a reliable diagnostic test (which occurred in the January-February timeframe at CDC) has shunted them to the side within the Washington Beltway. Nevertheless, the CDC site is replete with planning and response documents for (then future) pandemics, and it has a well-exercised function of addressing each year’s flu season.
(By the way, the FDA Vaccines and Related Biological Products Advisory Committee met on March 4 to recommend the mix of flu strains to be included in the 2020-2021 flu season, which is then passed to CDC for development and distribution; it will include two Type A and two Type B strains.)
Looking ahead, one can only hope that NIH, FDA, BARDA and DoD officials, all showing up at some virologist’s laboratory to evaluate vaccine development, will not get into each other’s way.