Single-dose vaccine hits trial phase
Johnson & Johnson launched a massive study of its single-dose coronavirus vaccine, which will be tested at sites across the globe and in Boston, marking a major step forward in tackling the pandemic, the company announced Wednesday.
“If everything goes as planned, we are hopeful — it’s not a guarantee — but we are hopeful we will have an answer to this trial at the end of the calendar year or early 2021,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.
Johnson & Johnson has begun dosing up to 60,000 volunteers throughout seven countries and the United States with the goal of showing whether the vaccine reduces cases of moderate to severe COVID-19 safely and effectively.
The vaccine, developed by J&J, BIDMC and other partners, requires just one dose whereas other vaccine candidates require at least two shots.
“If a single shot of this vaccine proves to be safe and effective, then a single-shot vaccine would have substantial practical and logistical advantages,” Barouch said.
The vaccine also does not need sub-zero freezing to stay viable, Barouch said. In its liquid form it can last for several months.
The J&J product is made from a cold virus that has been modified to make copies of the coronavirus’ spike protein, which the pathogen uses to enter cells.
The altered virus can’t replicate in humans, but it induces an immune response that prepares the body for an actual COVID-19 infection.
The study will recruit participants with significant representation from people over age 60, minorities and those with and without comorbidities associated with an increased risk for progression to severe COVID-19.
“This is a major step forward for this vaccine candidate, essentially moving from early phase clinical trials to large efficacy trials,” Barouch said.
He said the timeline of the trial is hard to predict though, as clinical endpoints such as COVID infections are more important than time.
“This is not a timeline driven study, this is an endpoint driven study,” he said.
Johnson & Johnson has committed to manufacturing a billion doses of the vaccine on a not-forprofit basis if proven safe, the company said in a statement.
Alex Gorsky, chairman and CEO of Johnson & Johnson, said in a statement, “This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process.”
Barouch said, “Our hope is that this work will be able to help people and this work will be able to help bring an end to this pandemic.”