Johnson & Johnson is now the fourth company to begin late-stage human trials in the U.S. with its COVID-19 vaccine candidate. The company is enrolling up to 60,000 volunteers from around the world to be a part of the trial, but unlike the other top vaccine candidates, this vaccine will be administered in just one dose, a potential game-changer when and if the vaccine is rolled out to the public.
"What's very special here is that it works as a single dose," said Johnson & Johnson's chief scientific officer, Dr. Paul Stoffels. "So we have studied up front in the lab and in animal models and then in volunteers and we have been able to show that with a single dose we get a very good response as well as a good safety profile."
Stoffels noted that the ability to produce a one-dose vaccine will be the culmination of a decade of work developing similar vaccines for other outbreaks, like Ebola and Zika. The potency of the vaccine is extremely important, he said.
"The pandemic goes around and when you want to have influence on the progress of the pandemic, you have to be able to stop it as fast as possible," said Stoffels. "Therefore, a single dose with a fast activity will help limit the pandemic and the transmission faster."
He noted the single dose may also offer study results much faster than a study with a two-dose vaccine. "We can start counting the results after 15 days, so the vaccine protects within 15 days."
"Sixty thousand [participants] to make sure we have a good, robust evaluation of the safety and the efficacy in all parts of society," he said.
That study population will come from over 215 locations around the world and include people of all ages as well as people that are considered high-risk.
"We do it around the world — in the U.S., in Latin America, and in South Africa — so that there is a very good representation from the global population in the study," said Stoffels.
When asked about a potential timeline, he said the company needs four to five months to look through the trial data, which would put researchers on pace for the end of 2020 or early 2021. If trials are successful, he expects the vaccine will be available to high-risk populations in the first quarter of next year.
As drugmakers around the country face questions over the accelerated timeline of vaccine creation, Johnson & Johnson is taking the unusual step of releasing the blueprints of its trials in hopes of raising confidence in its vaccine candidate. Dr. Stoffels said that Johnson & Johnson will release a manuscript with data from earlier phase trials in the next few days.
"A lot of people are nervous about the vaccine and we want to be as open as possible about what we do," said Stoffels, who notes that researchers will be able to review their process to see "how consistently and deeply we have prepared this study in order to evaluate it."
"I think to get confidence we need to be very transparent on everything that's happening within and around this study so that people can learn from it."