Public-private programme seeks to deliver coronavirus vaccine by January 2021
The White House has launched another public-private partnership to speed up the development, manufacturing and distribution of vaccines, therapeutics and diagnostics for Covid-19.
Called Operation Warp Speed, the programme, which has been allocated almost $10 billion in federal funding, is intended to have a vaccine ready for US citizens by January 2021.
Time-saving tactics being adopted include using government-designed clinical protocols, rather than ones from industry, and making sure trials to test efficacy and safety are “aligned”. Other shortcuts include carrying out animal testing in parallel with in-human trials rather than before them.
The federal government has also taken on the risk of setting up vaccine manufacturing facilities, even though all of its 14 vaccine candidates are as yet unproven. The plan is to begin manufacture while a vaccine is still in development.
The government is taking a similar gamble on distribution, setting up the complex logistical networks necessary before a vaccine is authorised or approved.
“American industry will squeeze every last inefficiency out of the process and pour every resource we can into this effort,” health secretary Alex Azar said in a press release on 15 May.
President Donald Trump has appointed Moncef Slaoui, a venture capitalist and former head of vaccines at pharmaceutical company GlaxoSmithKline, as chief adviser for the operation. US army general and military logistician Gustave Perna has been appointed chief operating officer.
They will be jointly responsible for thematic teams led by specialist staff drawn from organisations including the Defense Health Agency and the Food and Drug Administration.
In all, the effort will require coordination of at least eight federal agencies, including the Centers for Disease Control and Prevention, the National Institutes of Health, the Department of Agriculture, the Department of Veterans Affairs and the Biomedical Advanced Research and Development Authority.
Speaking at a White House briefing alongside Trump, Azar said that achieving the objectives would be “one of the greatest scientific and humanitarian accomplishments in history”.
The programme follows another public-private partnership focused on R&D for Covid-19 treatments. That NIH-led partnership, which involves 16 pharmaceutical companies and five government agencies, is focused on corporate cooperation.
Operation Warp Speed is intended to narrow 14 vaccine candidates down to eight, which will undergo further testing in early-stage small clinical trials, and then to three to five candidates that will proceed to large trials of their safety and efficacy.
On the same day the programme was announced, a small NIH-backed trial at the University of Oxford in the UK found some success with an experimental vaccine, ChAdOx1, in monkeys.
The trial of the genetically engineered vaccine found evidence that it blocked some replication of the Covid-19 virus and prevented lung damage.