Over the weekend, The U.S. Food and Drug Administration authorized Johnson & Johnson’s one-shot COVID-19 vaccine for emergency use. It's now the third vaccine to be distributed across the nation, behind Moderna and Pfizer and their two-shot mRNA vaccines. Nearly 4 million doses of the newly approved vaccine were shipped out across the country on Sunday night, the first dose of which is set to be administered Tuesday.
Deploying another vaccine will mean much to so many: to people itching to get a shot so they can see their grandkids; to the families of the more than 500,000 Americans who’ve died of COVID-19; but also, to the researchers and scientists who’ve worked tirelessly over the past year to help create a solution to our global crisis.
Hanneke Schuitemaker, PhD, the vice president and global head of viral vaccine discovery and translational medicine at Johnson & Johnson, is one of those researchers. She helped develop the vaccine and has since been involved with analyzing the data from the Johnson & Johnson trials. I spoke with her back in April, when she was working 14-hour days to create a vaccine she deeply hoped would work. When her team released first released their phase three trial data showing their study determined the vaccine was safe and effective in January, I reached out to catch up.
From her home office in The Netherlands, Dr. Schuitemaker spoke with me via Zoom in anticipation of the milestone achieved over this past weekend, telling me that her team is happy with their results, and have even carved out time in their schedules to celebrate some of their big wins virtually. But they’re also not done fighting. They’re looking for ways to improve their vaccine, and planning for how they’ll handle the new coronavirus variants sprouting up across the globe. During our call, she leaned in close to her camera, clasped her hands together, like she was about to let me in on a big secret, and said: “There’s always more work to be done.”
Last time we talked in April, you were still in early stages of vaccine development, and had just picked a vaccine candidate to run with but had only tested it on animals at that point. Now, you’re so close to getting emergency approval for your vaccines. How do you feel?
“Indeed, a lot has happened. When we first looked at the data from our phase three clinical trial, it said it was 66% effective overall and 72% effective in the U.S. in preventing symptomatic COVID. This was after we already knew Pfizer and Moderna’s efficacy numbers. At first, we thought — oh, no, this is not 90%. But we then realized, there’s no direct comparison. And our aim was always to have a vaccine that was 70% efficacious after one shot, because we know that is what will make a difference in this pandemic. It will prevent disease significantly.
“When we looked into the data more deeply, we realized that across countries and virus lineages, or variants, we have very high protection against severe COVID-19. About 85%. Full protection against hospitalization. And we had no deaths in the vaccine group, when there were deaths in the group that received the placebo shot in our trial. That is quite an amazing result after one dose.”
What’s been your biggest challenge and your biggest win?
“Keeping everybody focused and energized has been tough, because the work conditions are so challenging. We cannot celebrate our highs because we’re just all by ourselves in our home offices, like everyone. The team is dedicated, but to work day and night and be in the dark about what the results will be for so long? Sometimes it was tough. You get to the end of your rope. You’re tired. You want sleep, and then in your sleep, you’re still dreaming about the vaccine.
“But now, we’re pushing toward FDA emergency approval. What am I complaining about, really? We have a vaccine!”
Did you do anything specific to keep morale up among your team? And how did you practice self-care yourself?
“My team had a daily meeting where we motivated each other. We talked about the progress we were making. And it helped me personally to go walk my labrador, Figo. When I was worried, I’d think, Well, the sun will come up tomorrow, right? Time will help us. Keep breathing.”
Last time we spoke, you were working 14-hour days. Is that still the case?
“Sometimes it’s higher. But of course, I need to eat, sleep, and walk my dog. The time that I work keeps increasing in the evening. My dog is so fed up with it. He has started to bark. He is 11 years old and has never barked, but now realizes he needs to make sound to get some attention. Now I do my evenings with my laptop and him lying at my feet. He deserves attention, and it makes me realize that when this is over, I’ll need to log off and spend some time doing nothing and playing with him.
“Right now, in the Netherlands, we have a lockdown and a curfew, so there’s not much to distract us. So we could just keep pushing and doing our work. It’s not a healthy life. I couldn’t do this forever. But I realize what a privilege it is to be part of this. I need to do all that I can to bring this global pandemic to an end. That weighs much heavier on me than the hours I need to put in. If a vaccine can be rolled out and it helps us get out of this crisis, it’s worth every minute.”
That must be a lot of pressure, right?
“Yes, it was tremendous pressure, especially once the virus variants came into play. We had to get immune response data for all regions in case we saw lower immune responses in areas where there were new variants. Everyone kept asking me where the data was. What can you tell us? When will you know? I was like, I can’t rush this. We need to let people do their work. I was ready to say that my internet broke so I couldn’t take the calls anymore. But that would have been childish. Now I feel more relaxed again, but there’s still a lot of work ahead of us. The trial is still ongoing. We’re working towards the FDA emergency use authorization. There are new challenges.”
You’ve been quoted saying: “Treatments save lives, but vaccines save populations.” Can you tell me more about that philosophy and how it’s kept you going?
“What you see in this crisis is that we can treat people, but we see around the world that the health care system is overwhelmed. So even if you have treatment, there are capacity limits for who can receive it. If we can prevent overwhelm with vaccines, we can save the population from the consequences and suffering of this pandemic. And that’s why we’re working tirelessly. We need herd immunity to save the population.”
What do you think about the vaccine rollout so far?
“I don’t know about for your country, but here it’s going pretty slow. It’s been heartbreaking to see these very old people who’ve felt unsafe for almost a year now. But when they get the vaccine, it gives them back their hopes. They can see their families and meet their grandchildren again.
“But I think we could do a better job. I think we need to produce faster and more. Across the world I think we should do everything to get these vaccines to everybody.”
Will the J&J vaccine help with that?
“Yes. With our vaccine, one shot is enough. It’s great for people in remote areas, because they won’t have to come back after three, four weeks. It can be transported at more favorable temperatures than some of the others. Not saying it shouldn’t be rolled out in the Western world, but I think it has potential to be rolled out in more challenging areas of the world especially, to bring the vaccine to everybody.”
Have you had your vaccine?
“No! It’s funny, people say it’s not fair because I’ve worked on it all year. But I think it is fair. Because everybody is dealing with this crisis. Everybody wants to be vaccinated. I think it makes complete sense that the people who need it the most get vaccinated first. My only risk factor is my 20-year-old son, and I tell him every day to be careful. I’m not at high risk for contracting the virus, so those who are should be vaccinated first.”
Once the process of getting this vaccine authorized is finished, what will you do next? I know you’ve worked in the past on other therapeutic vaccine candidates, like HIV, Ebola, and HPV. Will you go back to that work or focus on new generations of COVID-19 vaccines?
“I’ll do both. I’m so proud of teams that have kept our other vaccine programs going. Our Ebola program is doing well. But we’re also working on next generation COVID-19 vaccines. We need to figure out: Do we need to do an update for the lineages circulating now? As a virologist, I believe there’s an end to what a virus can do mutation-wise. It still needs to bind to its host. The less the virus spreads, it will stop the emergence of new lineages which will get us out of this crisis. At a certain point, a virus needs to accept that it will be neutralized by antibodies and can’t escape any more. But we’re figuring out what our next steps will be.”
Last time we talked, you said when this was all over, you were going to the Alps to hike. Do you think that will happen for you this year? Do you have hope that life will be normal enough for us all to do things like that in the next year?
“Yes, I have two friends, and we said on New Year’s Eve of this year that we’re definitely going to go camping there this year. We’ll do it unless we cannot, due to COVID restrictions. But it’s my hope that we’ll have more immunity so that everybody can move around a little bit more. I’m so ready to hike and think of nothing for at least a week.”
This interview has been condensed for length and clarity.