Johnson & Johnson launched a massive human trial of its coronavirus vaccine Wednesday, paving the way for another option as the U.S. preps an immunization campaign to defeat the pandemic.
The Janssen Pharmaceutical Companies of J&J said it plans to enroll up to 60,000 adults at nearly 215 clinical research sites in the U.S. and abroad.
The Trump administration, through its “Operation Warp Speed,” is offering unprecedented support to private drugmakers as it tries to lock down a successful vaccine before the end of the year.
Three companies — AstraZeneca, Pfizer and Moderna — began their phase 3 trials weeks ago and expect to receive data on whether their candidates are effective as soon as late October.
“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after [the virus] 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,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
Many view a vaccine as the most critical tool in getting life back to normal. The coronavirus pandemic that began in Wuhan, China, in December, has devastated economies and killed nearly 1 million worldwide, including 200,000 in the U.S.
J&J is starting its trials roughly two to three months later than competitors, though it says there are advantages to its version.
While other vaccines require two does, “this a potent vaccine in a single dose,” said Paul Stoffels, chief scientific officer at J&J.
It’s also an adenovirus serotype 26 (Ad26) vector-based vaccine that is stored at 2-to-8 degrees Celsius, offering a simpler “cold-chain” than messenger-RNA candidates that must be stored at minus-80 degrees.
The White House is outlining distribution plans for the vaccines that emerge from trials, even though the Food and Drug Administration hasn’t approved any of the candidates to date.
Officials plan to have 100 million doses ready by the end of the year and shots available to every American who wants one by April.
“To have just one candidate vaccine in Phase 3 trials less than a year after a virus was first reported would be a remarkable accomplishment; to have four candidates at that stage is extraordinary,” Health Secretary Alex Azar said. “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.”
