The US government has announced collaborations with Johnson & Johnson and Moderna to simultaneously support clinical testing and the development of production infrastructure for COVID-19 vaccines, according to a statement from the US Department of Health and Human Services.
“Delivering a safe and effective vaccine for a rapidly spreading disease like COVID-19 requires accelerated action with parallel development streams,” says Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA), in the statement. “The rapid progress we are making with industry partners clearly demonstrates a commitment to protecting people at home and abroad.”
Johnson & Johnson announced on Monday (March 30) a joint investment with the US government of $1 billion intended to create the capacity to manufacture more than 1 billion doses of a vaccine, reports Reuters, and the efforts will be funded in part by roughly $420 million from BARDA. The funding will support non-clinical studies, according to the statement, as well as a Phase 1 clinical trial of Ad26 SARS-CoV-2, an investigational vaccine for COVID-19 developed by Janssen, a pharmaceutical subsidiary of Johnson & Johnson. Ad26 SARS-CoV-2 uses the same technology as Janssen’s investigational Ebola vaccine, according to Science, which was made available in the Democratic Republic of Congo in November 2019. The clinical trial for Ad26 SARS-CoV-2 is set to begin no later than this coming fall, and could produce a vaccine available for emergency use in the US in early 2021.
The agency will also support Moderna to get Phase 2 and 3 clinical trials of its COVID-19 vaccine, SARS-CoV-2 mRNA-1273, ready to go as soon as the Phase 1 trial is complete, according to the statement. The Phase 1 study for the vaccine, developed in partnership with the National Institute of Allergy and Infectious Diseases, got underway earlier this month.
Bright tells Reuters that BARDA intends to support five to six vaccine candidates, out of which two or three may be ultimately be successful, and that the goal is to work “as quickly as possible and manufacture enough of [a vaccine] for us and the rest of the world in a very short timeframe.”
Choosing which experimental vaccines to invest in is a bit of a gamble, according to Seth Berkley, chief executive of the Global Alliance for Vaccines and Immunization (GAVI), who tells Reuters, “What you need to do is take an assessment of what the most likely candidates are and invest at risk in those.”
Berkley adds that deciding earlier on which vaccines to support helps to organize manufacturing processes, but that doing so also decreases confidence in whether they will work.
Johnson & Johnson’s chief scientific officer Paul Stoffels confirms in an interview with Science that his company and BARDA are both investing in the research and development phase of the experimental vaccine as well as in manufacturing to create additional capacity. “Of course, it’s step by step—it has to work—but there’s no hesitation now to do everything in parallel,” he says. “When we have clinical data, we will have the capacity to scale up to very large quantities.”