Pharma giant J&J just launched a pivotal 60,000-person coronavirus vaccine trial, and we could learn if the shot works by the end of 2020
Steve Parsons-WPA Pool/Getty Images
- Johnson & Johnson, the world's largest healthcare company, advanced its coronavirus vaccine candidate into the final stage of clinical trials on Wednesday.
- J&J will recruit up to 60,000 volunteers from around the world, including in the US, South Africa, Brazil, Argentina, Columbia, and Chile, said Paul Stoffels, the pharma giant's chief scientific officer.
- Dr. Anthony Fauci, the nation's top infectious-disease expert, estimated that J&J's trial will likely produce results in December or January.
- Stoffels also said results from an initial 400-person study of the vaccine were positive. He said J&J would publish data within the next two days.
- For more stories like this, sign up here for our daily healthcare newsletter.
Johnson & Johnson started giving its experimental coronavirus vaccine to a huge group of volunteers on Wednesday, marking the final stage of testing for the shot.
J&J, the world's largest healthcare company, is the fourth US-backed program to start these pivotal studies, called phase-three trials. The company is looking to give the shot to 60,000 volunteers around the world, and said we could know whether it works as soon as December.
J&J's vaccine joins experimental shots developed by Moderna, Pfizer and BioNTech, and AstraZeneca and the University of Oxford in beginning the final stage of development.
Unlike these other vaccines, J&J's trial will test a single dose. The other three shots are being tested as a two-dose regimen, with a pair of injections given a few weeks apart.
The $381 billion healthcare giant started early-stage human trials in July in the US and Belgium. While results have not been published from those studies, J&J Chief Scientific Officer Paul Stoffels said the results were positive and encouraging. Stoffels said data would be published within the next two days.
Johnson & Johnson
"We are convinced that a single-dose can be very efficacious," Stoffels said, adding J&J also plans to eventually start another late-stage trial that will test a two-dose regimen.
Read more: Trump's coronavirus vaccine czar told us how Operation Warp Speed decided which 6 candidates to back with massive multibillion-dollar deals
Dr. Anthony Fauci, the nation's top infectious-disease expert, said results from J&J's trial will likely lag a month or two behind studies that got started earlier. Fauci said he anticipates data from phase-three trials that started in July or August, like Moderna's and Pfizer's, to come in November or December.
Fauci leads the National Institutes of Health's infectious disease division, which is helping pay for the trial along with J&J and the US Biomedical Advanced Research and Development Authority.
Fauci estimated that J&J's data would likely come around December or January, while emphasizing that there's uncertainty in when these studies will deliver results. Vaccine studies don't necessarily deliver results after a pre-set length of time. Instead, the timeline depends on how many people get sick with the coronavirus over the course of the trial.
J&J's chief scientist echoed Fauci's timeline.
"We hope to see an endpoint around the end of year or early next year," Stoffels said.
The trial is recruiting volunteers in countries including the US, South Africa, Brazil, Argentina, Columbia, and Chile, he said.
from Business Insider https://ift.tt/3mLrTM0
No comments