Johnson & Johnson’s potential vaccine for the novel coronavirus entered the final stage of clinical trials, the fourth vaccine candidate to be designated as Phase III by the Trump administration’s Operation Warp Speed.
Up to 60,000 adult volunteers will be enrolled for the single-dose vaccine trial across 215 clinical research locations, according to the National Institutes of Health. Though months behind other candidates, it is the largest scale trial thus far and may yield sufficient data for results by the end of this year, according to Johnson & Johnson chief scientific officer Paul Stoffels.
“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a statement.
“It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose,” Fauci continued.
Stoffels said the company is preparing to manufacture 1 billion doses of the vaccine candidate for next year. “We’re convinced that a single dose could be very efficacious,” he said. Moderna, Pfizer, and AstraZeneca are also in Phase III clinical trials but require return visits for a second shot to elicit a protective immune response from those enrolled.
President Trump celebrated the “Big news” on Wednesday, tweeting, “Numerous great companies are seeing fantastic results. @FDA must move quickly!”
Health and Human Services Secretary Alex Azar called the Johnson & Johnson development an “extraordinary” accomplishment. “By building a portfolio of candidate vaccines, Operation Warp Speed is maximizing the chances that we will have substantial supplies of a safe and effective vaccine — and maybe multiple vaccine options — by January 2021,” he said.
The company plans to recruit individuals above the age of 18 across several countries, the U.S., South Africa, Argentina, Brazil, Chile, Colombia, Mexico, and Peru.
