As the top viral vaccine researcher for Johnson & Johnson, Hanneke Schuitemaker, Ph.D., is aware of the magnitude of her work right now.
She’s leading a team working around the clock to develop a potential COVID-19 vaccine to stop the spread of the novel coronavirus, known as SARS-CoV-2.
“To have the tools to potentially stop [the virus], that we could be part of the solution, that keeps me going," Schuitemaker told Fierce Healthcare in an interview. "I’m intrigued what technology allows us to do. And I’m curious to see, if we manage to have a successful vaccine, what the world will look like six months from now."
Schuitemaker, who is the global head of viral vaccine discovery and translational medicine for Janssen Vaccines & Prevention, a Janssen Pharmaceutica Company of Johnson & Johnson, has spent her career investigating some of the world's most pervasive infectious diseases including HIV and Ebola.
Schuitemaker’s team has been leveraging its extensive experience with Ebola and Zika to speed up the vaccine development process.
Working at an 'unprecedented' pace
In late March, Johnson & Johnson announced it had a lead COVID-19 vaccine candidate selected from constructs it has been working on since January. Based on the strength of preclinical data, the company was able to accelerate clinical development of that drug candidate.
“It was a tremendous experience to see that our theoretical considerations panned out in the data we generated in the clinical model. It is an emotional moment to get confirmation that we were on the right path,” she said.
Johnson & Johnson was able to accelerate the initiation of human testing of its investigational COVID-19 vaccine, which was initially scheduled to begin in September and was moved up to late July.
Last month, as part of the phase 1/2a study, more than 1,000 adults ages 18 to 55 began to enroll in Belgium.
RELATED: Johnson & Johnson gears up for 60,000-person COVID vaccine trial, the industry's biggest yet
Fierce Healthcare spoke with Schuitemaker, who is based in Leiden, Netherlands, just days after Johnson & Johnson’s initial human testing began in late July.
“That was truly an extraordinary accomplishment and a thrilling privilege to witness the vials on route to Belgium and on their way to the clinical sites,” she said.
Johnson & Johnson now plans to begin what would be the largest, late-stage trial testing of a potential coronavirus vaccine in September, Fierce Pharma reported.
The phase 3 trial would enroll up to 60,000 participants across nearly 180 locations in the U.S. and other countries, twice the enrollment rival vaccine makers Moderna and Pfizer are planning for their own phase 3 tests.
There are more than 200 COVID-19 vaccine candidates in development globally, including more than 20 in human clinical trials. President Donald Trump has vowed to have a shot ready before year-end, although they typically take 10 years or longer to develop and test for safety and effectiveness.
The accelerated pace to develop a potential COVID-19 vaccine is unprecedented, according to Schuitemaker.
RELATED: On heels of U.S. pact, Johnson & Johnson advances COVID-19 vaccine talks with Europe
“We’ve never worked this fast. When dealing with Ebola, we were really challenged for the first in-human study within four or five months. We already had a vaccine candidate ready at the time, and we managed to make that timeline. Then Zika came and we managed to be in clinic, from conception of the vaccine candidate to the first in-human study in nine months. Now we’re trying to beat that by doing it in eight months,” Schuitemaker said in a recent video interview as part of Johnson & Johnson's The Road to a Vaccine video series.
Provided that the investigational vaccine proves to be safe and effective, the company aims to manufacture over 1 billion doses to be distributed globally through 2021.
'No cutting corners'
The company is using the same technology that it has used in the development of its Ebola vaccine and investigational HIV, RSV and Zika vaccine candidates, which involves using an inactivated common cold virus that's not replicating.
The outside of the vaccine always looks the same—the common cold virus Adeno 26—but inside, researchers have different transgenes coding for proteins of the virus against which they are making a vaccine, Schuitemaker said in the Johnson & Johnson interview.
This helps create a vaccine with a known safety profile, she said.
“We have gotten more familiar with the plug and play platform that we have and the knowledge of the tolerability of our vaccine platform and that helps us to go faster,” she said.
The company also has worked to get clinical materials ready in parallel and setting up processes to start manufacturing. “The whole company is truly focused on getting us where we want to be,” she said.
However, she notes that the progress accomplished so far does not guarantee a successful commercial vaccine.
RELATED: Johnson & Johnson pledges 100M coronavirus vaccine doses to U.S. for $10 each
And governments and drugmakers also have to contend with public distrust about the fast pace of vaccine development.
A Reuters/Ipsos poll published back in May found that a quarter of Americans have little or no interest in taking a coronavirus vaccine, with some voicing concerns that the record pace at which vaccine candidates are being developed could compromise safety.
“I know there is growing hesitancy for the use of vaccines. But vaccines have saved so many lives, many more lives than surgery. Prevention through vaccines is really a very successful story,” Schuitemaker said.
Schuitemaker stressed the one thing she wants the public to know: “There has been no cutting corners.”
“We will only put forward a vaccine if we are confident that it is safe and efficacious,” she said. “I hope that people trust us that we are really doing everything that we would normally do.”