By Daniel R. Lucey M.D., MPH, FIDSA
On Friday, The U.S. Department of Health and Human Services posted a succinct 4-page document titled “Explaining Operation Warp Speed.”
The summary begins by answering three questions: What is the goal [of OWS]? How will the goal will be accomplished? Who is working on OWS? It moves to an informative chronology of specific amounts of funding (16 specific bulleted items) for three aspects of COVID Vaccines (and one antiviral antibody): Development, manufacturing, and distribution. The update ends with answers to three questions: Who’s leading Operation Warp Speed? What are you doing to make these products affordable for Americans? How is Operation Warp Speed being funded?
In my opinion, a few of the key points in this excellent summary include:
- “Operation Warp Speed (OWS) aims to begin delivery of 300 million doses of a safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacture, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures”).
(My note: Thus, OWS is not solely focused on vaccines.)
- “The Administration is committed to providing free or low-cost COVID-19 countermeasures to the American people as fast as possible. Any vaccine or therapeutic doses purchased with US taxpayer dollars will be given to the American people at no cost.”
(My note: A crucial commitment regarding “no cost” to Americans for vaccines or therapeutics “purchased with US taxpayer dollars.”)
- “HHS Secretary Alex Azar and Defense Secretary Mark Esper oversee OWS, with Dr. Moncef Slaoui designated as chief advisor and General Gustave F. Perna confirmed as chief operating officer. To allow these OWS leaders to focus on operational work, in the near future the program will be announcing separate points of contact, with deep expertise and involvement in the program, for communication with Congress and the public”.
(My note: Of particular interest will be the spokesperson(s) for explaining the anticipated COVID-19 vaccine Emergency Use Authorization consideration by the FDA. As noted in the July 31 IDSA Science Speaks post, the only vaccine having ever received FDA EUA was the (approved) anthrax vaccine for 12 months only from 2005-2006 to be used by the Department of Defense. The rationale is provided in this 2005 Federal Register document.)
Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee.He has served as a volunteer medical responder to outbreaks that included the West Africa Ebola crisis. He has collected information on outbreaks starting in 2001 with cases of anthrax in 2001, and including smallpox vaccination 2002, SARS 2003, H5N1 Flu 2004, MERS in 2013, and Ebola in April, 2014, He has gathered, and updated information on the spread of the coronavirus here since Jan. 6.