Global Head of Viral Vaccine Discovery and Translational Medicine, Janssen Vaccines
Hanneke Schuitemaker knows exactly when she realized the gravity of the novel coronavirus.
In early February, as the head of vaccine discovery for Johnson & Johnson, she attended the World Health Organization meeting where COVID-19 got its name. But that’s not what made an impression on her. It was meeting and listening to the scientists in the Chinese delegation.
“I could see the fear in their eyes and them not understanding that we were still socializing and not expecting anything,” she said. “I came back from that trip and I told my team we need to go faster because we haven’t seen anything yet. This is going to be big.”
Just six weeks later, J&J’s Janssen vaccine group selected its vaccine candidate. It was another huge moment, she realized. If they got it wrong, the enormous investment of time, talent and money would be lost.
One early validation came on Friday, Sept. 18. Schuitemaker and her team were expecting an FDA decision that would allow a start to phase 3 trials, so she had to be on call for any possible last-minute questions. She made it until a little after midnight, but just couldn’t stay awake any longer. Waking up at 6 a.m. to the email approval was a great feeling of happiness and relief.
“It was the best Saturday of the year,” she said.
J&J’s phase 3 testing has now begun, with 60,000 people enrolled—the largest trial to date among the potential COVID-19 vaccines. Its one-shot regimen stands alone, although J&J is also testing two doses. While early preprint data showed its vaccine produced an immune response at one dose, the trial has since been paused for an "unexplained illness" in a participant.
In an investor's call, J&J characterized the pause as not unusual during large trials, and said that it won't change its vaccine manufacturing plans nor its trial enrollment, which is expected to be complete in two or three months.
Outside the lab, Schuitemaker has become one of J&J’s best-known personalities around the vaccine research. She starred in the J&J series “The Road to a Vaccine,” narrated by journalist Lisa Ling, and has appeared on TV and in media interviews including on MSNBC, CNN, The Wall Street Journal, and even Refinery 29 and Vogue.
Schuitemaker, who lives and works in Leiden, Netherlands, said, “In my country, I was called the ‘symbol of hope,’ and I thought ‘Woah, wait, we’re just doing our work.’ But I do understand that people want to know what’s happening. It been a new experience.”
Schuitemaker began her career in HIV research and spent 19 years at Sanquin, the Netherlands Organization for Blood Supply, beginning in 1989. In 2010, she joined biotech vaccine specialist Crucell, which was later acquired by Janssen. She continues to work on J&J’s HIV vaccine, which recently restarted its phase 3 enrollment, as well as work on other vaccines, including respiratory syncytial virus (RSV).
“As a company, we have a responsibility to not to forget the other problems in the world and to continue to take those on,” she said, adding, “I’m proud the teams have found a way to continue those studies.”
While the ultimate COVID-19 vaccine goal is an effective J&J shot, Schuitemaker said she will be proud no matter the outcome of the company and her team who have worked days and nights doing their best without cutting corners and maintaining the rigor of vaccine development.
“Maybe I’m the one in the news or magazines, but I’m working with a fantastic team of people,” she said. “I am just maybe the symbol of a team of champions.”