- The Trump administration is moving quickly to select the most promising coronavirus vaccine candidates to support with additional funding and assistance as part of its aggressive push to deliver a preventive therapy to the American people by the end of this year or early next.
- Large pharmaceutical companies Johnson & Johnson, Pfizer, Merck & Co. and AstraZeneca, as well as biotech Moderna, are among the companies selected by the White House as part of "Operation Warp Speed," The New York Times and Bloomberg reported Wednesday. Two other companies are also finalists, according to Bloomberg.
- The White House announced Operation Warp Speed in mid-May, revealing that it had winnowed a list of over 100 vaccine candidates and prototypes down to a group of about 14 most likely to succeed. The plan was to narrow that short list further to eight, and to eventually chose between three and five to support for large late-stage trials.
The reported list of Warp Speed finalists isn't all that surprising. Through the Biomedical Advanced Research and Development Authority, or BARDA, the U.S. government has already announced funding for vaccines being developed by Moderna, J&J, AstraZeneca and Merck.
The group also contains some of the most advanced candidates. Moderna was the first U.S. drugmaker to guide its experimental vaccine into clinical testing and has since moved on to a mid-stage trial. AstraZeneca's vaccine, which is being developed by the University of Oxford, is also in Phase 2.
More notable is which companies reportedly aren't finalists, at least currently. Sanofi is one of the top vaccine makers in the world and its candidate received BARDA funding early on. Inovio and Novavax, two U.S.-based biotechs with coronavirus vaccines in human testing, were also not mentioned by The New York Times' and Bloomberg's sources. Shares in both companies fell by double digits Wednesday.
Two other drugmakers are apparently among the final group, Bloomberg said, potentially leaving room for one or more of those candidates to make the cut.
Moderna, Johnson & Johnson, Merck and AstraZeneca declined to comment on the reported selection of Operation Warp Speed finalists, while Pfizer did not respond to BioPharma Dive's inquiries.
A spokesperson for HHS also declined to comment on "information that is marketing-moving."
Inclusion in Operation Warp Speed could matter a great deal to how quickly the selected vaccine candidates advance. Through the program, the U.S. has pledged billions of dollars in funding, as well as extensive support in running large clinical trials and manufacturing the chosen vaccines in parallel.
The effort, which President Donald Trump likened to a modern-day Manhattan Project, is an unusual and exceptionally ambitious bet that the U.S. government can help compress a development process which normally takes many years into just months.
While Moderna and the University of Oxford have successfully designed and advanced vaccines into testing in record time, proving their safety and effectiveness for widespread use requires studies of potentially tens of thousands of people. Running those trials, which will likely span hundreds of hospitals across multiple countries, is a complex undertaking, as is manufacturing enough doses to be ready for any one vaccine to succeed.
A large part of Operation Warp Speed, which is led by former GlaxoSmithKline executive Moncef Slaoui and U.S. Army General Gustave Perna, is providing support for that process "at risk," meaning before testing proves out a vaccine.
The White House's reported choice of finalists, if borne out by an official announcement, leaves some room for technical setbacks.
The five companies are all taking different approaches for their vaccines. Moderna and Pfizer are using a promising, but unproven, technology which relies on messenger RNA, while J&J's, Merck's and AstraZeneca's candidates use types of inactivated viruses to shuttle genetic instructions into cells.
It's not yet clear which technology might be best for protecting against coronavirus infection, and each comes with different advantages and limitations.