Johnson & Johnson launches the final phase of the human trial of COVID-19 single-shot vaccine that includes 60,000 volunteers

Pharmaceutical giant Johnson & Johnson today kicked off the final phase of the human trial of its coronavirus vaccine, paving the way for the United States to make the vaccine available later this year or the beginning of 2021. According to the announcement, the final phase (Phase III) includes 60,000 volunteers with each receiving a single-shot COVID-19 vaccine that potentially would simplify the distribution of millions of doses compared with leading rivals using two doses.

In a joint press conference with officials from the National Institutes of Health and the Trump administration, Johnson & Johnson chief scientific officer Dr. Paul Stoffels said he expects the results of the Phase III trial by year-end or early next year. Other rival vaccines from Moderna Inc MRNA.O, Pfizer Inc PFE.N, and AstraZeneca AZN.L all require two shots separated by several weeks, which makes them much more difficult to administer.

“The benefits of a single-shot vaccine are potentially profound in terms of mass immunization campaigns and global pandemic control,” Dr. Dan Barouch, a Harvard vaccine researcher who helped design J&J’s COVID-19 vaccine, said in a telephone interview.

According to Reuters, Johnson & Johnson’s trial is designed to test for a vaccine that is 60% effective. In the study protocol, that could be determined after 154 people became infected with the virus. Stoffels said the company will start counting cases of COVID-19 infections within the study population 15 days after individuals are vaccinated.

The trial will be overseen by an independent Data and Safety Monitoring Board (DSMB) that will review vaccine safety and effectiveness. In the press conference, Dr. Francis Collins, director of the National Institutes of Health, said all three of the vaccines being organized and supported by the federal government’s Operation Warp Speed – J&J’s, Moderna’s and AstraZeneca’s – share a common DSMB. Pfizer is running its own trial and has a separate DSMB, Collins said.