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I helped make the Johnson & Johnson vaccine
A health care worker holds a dose of the Johnson & Johnson vaccine against the COVID-19 coronavirus as South Africa resumes its vaccination campaign at Klerksdorp Hospital on February 18, 2021. (Photo by Phill Magakoe / AFP) (Photo by PHILL MAGAKOE / AFP via Getty Images) Over the weekend, the U.S. Food and Drug Administration approved Johnson & Johnson’s one-off emergency COVID-19 vaccine. After Moderna and Pfizer and their two-shot mRNA vaccines, it is now the third vaccine to be distributed nationwide. Almost 4 million doses of the newly approved vaccine were shipped across the country on Sunday evening, with the first dose scheduled to be given on Tuesday. Using a different vaccine means a lot to so many: to people who long to get a shot so they can see their grandchildren; to the families of the more than 500,000 Americans who have died from COVID-19; but also to the researchers and scientists who worked tirelessly over the past year to find a solution to our global crisis. Hanneke Schuitemaker, PhD, Vice President and Global Leader of Viral Vaccine Discovery and Translational Medicine at Johnson & Johnson, is one such researcher. She helped develop the vaccine and has since been involved in analyzing the data from the Johnson & Johnson studies. I spoke to her in April when she was working 14 hour days developing a vaccine that she deeply hoped would work. When her team first released their Phase 3 trial data showing the vaccine was safe and effective in January, I tried hard to get it. From her home office in the Netherlands, Dr. Schuitemaker via zoom with me in anticipation of the milestone reached last weekend and told me that their team is happy with the results and even put time into their schedules to celebrate some of their big wins virtually. But they’re not done fighting either. They are looking for ways to improve their vaccine and planning how to deal with the new coronavirus variants that are on the rise around the world. During our call, she leaned close to her camera, clasped her hands as if to share a great secret with me, and said, “There’s always more to do.” The last time we talked in April, you were yourself still in the early stages of vaccine development and had just selected a vaccine candidate to run with but only tested on animals at this point. Now you are 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 3 clinical trial, it said it was 66% overall and 72% effective in the US at preventing symptomatic COVID. This happened after we already knew Pfizer and Moderna’s effectiveness numbers. At first we thought – oh no, that’s not 90%. But then we noticed that there was no direct comparison. And our goal has always been to have a vaccine that was 70% effective after a shot because we know that will make all the difference in this pandemic. It will significantly prevent disease. “When we took a closer look at the data, we found that we have a very high level of protection against severe COVID-19 across countries and virus lines or variants. Over 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 study. This is an amazing result after one dose. “What was your biggest challenge and your biggest win? “It was difficult to keep everyone focused and energized because the working conditions are so challenging. We can’t celebrate our heights because, like everyone, we are alone in our home offices. The team is dedicated, but working day and night and being in the dark about what the results will be for so long? Sometimes it was difficult. You come to the end of your rope. You are tired. You want to sleep and then in your sleep you are still dreaming about the vaccine. “But now we’re pushing for FDA emergency approval. What am I really complaining about? We have a vaccine! “Did you do anything specific to keep your team up morale? How did you groom yourself?” My team had a daily meeting where we motivated each other. We talked about the progress we had made. And it has helped me personally to go for a walk with my Labrador Figo. When I was worried I thought, Well, tomorrow the sun is up, right? Time will help us. Keep breathing. “When we last talked you worked 14-hour days. Is that still the case? “Sometimes it is higher. But of course I have to eat my dog, sleep and go for a walk. The time I work increases more and more in the evening. Mine Dog is so fed up with it. He started barking. He is 11 years old and has never barked before but now realizes he has to make noise to get some attention. Now I do my evenings with my laptop and lying at my feet deserves attention and it makes me realize that I will have to sign out and spend some time doing nothing and playing with him when this is over. “At the moment we have a lockdown and a curfew in the Netherlands so there isn’t much that can distract us. So we could just keep pushing and do our job. It’s not a healthy life. I couldn’t do this forever. But I realize what a privilege it is to be part of it. I have to do everything I can to end this global pandemic. That burdens me much more heavily than the hours that I have to plan. If a vaccine can be introduced and help us get out of this crisis, it will be worth every minute. “That must be a lot of pressure, doesn’t it? “Yes, it was a tremendous pressure, especially when 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 thought I can’t speed this up. We have to let people do their jobs. I was ready to say that my internet was down and I couldn’t take the calls anymore. But that would have been childish. Now I feel more relaxed again, but there is still a lot of work to do. The process is still ongoing. We’re working on FDA approval for an emergency. There are new challenges. “They were quoted as saying,” Treatments save lives, but vaccines save the population. ” Can you tell me more about this philosophy and how it kept you going? “What you are seeing in this crisis is that we can treat people, but we are seeing all over the world that the health system is overwhelmed. Even if you are undergoing treatment, there are capacity limits to who can receive it. If we can keep vaccines from being overwhelmed, we can save the population from the consequences and suffering of this pandemic. And that’s why we work tirelessly. We need herd immunity to save the population. “What do you think of the introduction of the vaccine so far? “I don’t know anything about your country, but things are moving pretty slowly here. It was heartbreaking to see these very old people feeling insecure for almost a year. But when they get the vaccine, it gives them back their hopes. You can see their families and meet their grandchildren again. “But I think we could do a better job. I think we have to produce faster and more. I think we should do everything around the world to make these vaccines available to everyone. “Will the J&J vaccine help with that? “Yes. One shot is enough with our vaccine. It’s great for people in remote areas as they don’t have to come back after three or four weeks. It can be shipped in better temperatures than some of the others. I’m not saying it isn’t.” should be launched in the western world, but I think it has the potential to be rolled out in more challenging regions of the world to make the vaccine available to everyone. “Have you had your vaccine?” No! It’s funny people say it’s not fair because I’ve been working on it all year. But I think it’s fair Because everyone is dealing with this crisis. Everyone wants to be vaccinated. I think it makes perfect sense that the people who need it most should be vaccinated first. My only risk factor is my 20 year old son and I urge him to be careful every day. I am not at high risk of contracting the virus, so those who do should be vaccinated first. “What will you do next when the process of approving this vaccine is complete? I know you have worked on other therapeutic vaccine candidates like HIV, Ebola, and HPV in the past. Will you return to this job or focus on new generations of COVID-19 vaccines? “I will do both. I’m so proud of the teams that kept our other vaccination programs going. Our Ebola program is going well. But we’re also working on the next generation of COVID-19 vaccines. We need to find out: do we need to update the lines that are now circulating? As a virologist, I believe there is an end to what a virus can do in terms of mutations. It still has to be bound to its host. The less the virus spreads, the more new lineages will emerge to get us out of this crisis. At a certain point, a virus has to accept that it will be neutralized by antibodies and will no longer be able to escape. But we’re finding out what our next steps will be. “The last time we spoke you said when it was all over you went to the Alps to hike. Do you think that will happen to you this year? Do you have any hope that life will be normal enough for all of us to do things like this in the next year? “Yes, I have two friends and we said on New Year’s Eve this year that we will definitely be camping there this year. We’ll do it unless we can’t due to COVID restrictions. But I hope we have more immunity so everyone can move a little more. I’m so ready to hike and don’t think about anything for at least a week. “This interview has been summarized for length and clarity. Do you like what you see? How about a little more R29 grade, right here? Johnson & Johnson’s Single Dose Vaccine FDA ApprovedHow Johnson & Johnson’s Single-Shot Vaccine Works Why are COVID vaccines only available in affluent communities?