Johnson & Johnson Becomes Fourth Company To Enter Phase 3 Vaccine Trials In U.S.

( A fourth company is entering Phase 3 trials for a coronavirus vaccine.

Starting Wednesday, Johnson & Johnson will begin the trials in the United States, giving its single-dose COVID-19 vaccine to up to 60,000 adults who have chosen to participate in the study. The trials will be conducted at more than 200 sites both in America and internationally.

This single-dose vaccine was developed by a subsidiary of Johnson & Johnson, Janssen Pharmaceutical Companies.

It’s the fourth vaccine to enter Phase 3 trials in the United States, following Pfizer/BioNTech, Moderna and AstraZeneca. The other three vaccines all require two doses.

On a call Wednesday, the chief scientific officer for Johnson & Johnson, Dr. Paul Stoffels, said:

“We’re convinced that a single dose could be very efficacious.”

Johnson & Johnson’s Phase 1 and Phase 2 trials suggested the single dose was able to provoke an immune response. It was therefore determined that the vaccine was safe to move into the large-scale Phase 3 trial. The first two phases were conducted in Belgium and the United States.

The company’s Phase 3 trial is being done in collaboration with the federal government’s vaccine push, called Operation Warp Speed. In addition to the United States, the trials will be conducted in Colombia, Peru, Mexico, Brazil, Argentina, Chile and South Africa.

Stoffels said that once the vaccine has proven safe in adults, it plans to test it in children as well. The company will also be making public information about the diverse population involved in the study.

A separate Phase 3 trial will be run in conjunction with the UK government. This Johnson & Johnson trial will study how effective two doses of the vaccine is.

The company has previously used the same human adenovirus technology in other vaccines that the European Commission has approved in the past. This includes vaccines for Zika and Ebola. More than 100,000 people have been vaccinated for these diseases through the use of this technology, the company said.

At question is whether this technology would be effective when used to prevent symptomatic COVID-19.

Matthew Hepburn, the vaccine lead of Operation Warp Speed, said:

“Even as Operation Warp Speed was coming together, our National Institutes of Health colleagues really said, as we do multiple vaccines and multiple clinical trials we need to harmonize this process as much as possible. It’s also going to allow us to compare, and that’s great for the Janssen vaccine, but it’s also great for just truly understanding what will protect people from COVID-19, and I think that that insight now is going to pay off for years to come as we address this pandemic.”

If the Phase 3 trials go well — meaning the vaccine is proven effective and safe — Johnson & Johnson said it would expect that the initial doses would be in front of the U.S. Food and Drug Administration for emergency use authorization by early next year.

The company further said that it’s currently on track to make 1 billion doses of their vaccine per year.