When Hanneke Schuitemaker, Ph.D., first heard about a novel coronavirus circulating at the end of December 2019, she never imagined the gravity of what she’d just learned. As the global head of viral vaccine discovery and translational medicine at Janssen, the Pharmaceutical Companies of Johnson & Johnson Companies, Schuitemaker had a professional interest in infectious diseases, and a new virus looked intriguing—from afar. Little did she know that in just a few months, the new pathogen would not only radically alter her work life, but also disrupt her personal life and the lives of nearly every person across the globe.
“When Janssen first announced our intention to work toward a vaccine for COVID-19 [at the end of January 2020], we immediately began to advance our research and development process in the traditional way,” Schuitemaker said. “About a month later, we realized there was no time to lose.”
Since its discovery approximately six months ago, the novel coronavirus that can cause COVID-19 has infected millions and reached more than 200 countries. Janssen is one among dozens of biopharmaceutical companies working around the clock to identify and develop safe and effective vaccines to prevent COVID-19. Building on a substantial platform of previous experience with vaccine development, including efforts to develop an Ebola vaccine during the 2014-16 outbreak in West Africa, Schuitemaker and her team are pushing to get a successful candidate over the finish line as quickly as possible.
“We’re working seven days a week,” Schuitemaker said. “It’s exhausting sometimes, but then you’ll get positive news or strong data, and that gets you back on track.”
Facing The Challenge Amid A Pandemic
Vaccine development is a difficult endeavor. The human body is incredibly complex, and scientists cannot predict how or if a vaccine will respond in an individual immune system. Moreover, different approaches may work better for different pathogens, meaning a wide range of research is needed to improve the odds that one or more vaccine candidates will prove successful.
A pandemic only intensifies these challenges. Given the impact of COVID-19 around the world, Schuitemaker and her team must consider not only a potential vaccine’s clinical effectiveness, but also its manufacturing feasibility. A highly effective candidate brings with it unnecessary barriers if it cannot be easily produced and distributed.
“Vaccine manufacturing and development is something for which I really think you need the biopharmaceutical industry to collaborate with others,” said Schuitemaker, who spent nearly two decades in academia before joining Janssen. “You need so many different functions and partners to get to the finish line, including people who design vaccines, people who do clinical work, regulatory personnel and manufacturing teams. It’s only through collaborations that this type of teamwork takes place.”
Once Janssen committed to researching a COVID-19 vaccine, the team began reviewing previous research in Ebola, human immunodeficiency virus (HIV) and respiratory syncytial virus (RSV). Early on, Schuitemaker remembers trying to choose which candidates to move into real-world testing, based on theoretical models. The pressure to get it right was immense—even with backups, a wrong choice could set them back weeks.
But their informed decisions paid off. By the end of March, Janssen announced it had a potential vaccine candidate that could start clinical trials by the fall.
Training The Body To Develop Immunity
Historically, vaccines work by introducing the body to a weakened or inactive pathogen, or part of a pathogen, so the body can learn to recognize the pathogen and build immunity. Janssen’s vaccine candidate aims to provide the genetic instructions needed for human cells to manufacture a protein—in this case, a spike protein specific to the virus that causes COVID-19—helping to train the immune system to recognize the pathogen, should it encounter the real coronavirus.
To develop their vaccine candidate, Schuitemaker and her team started with a virus that can cause a common cold and stripped out part of its genetic material so that it cannot replicate. The team then added a gene that provides instructions for developing the spike protein characteristic to the novel coronavirus. Schuitemaker hopes that when delivered to the human body, the now-defunct cold virus will act as a “vector” to deliver the genetic information for the spike protein, which will then be produced by the body. This approach is intended to expose the immune system to the spike protein, teaching the body how to recognize, remember and target the COVID-19 virus, without actually causing an infection.
To Test Their Theory, Vaccine Developers Must First Conduct Rigorous Clinical Trials To Demonstrate Their Potential Vaccine’s Safety And Effectiveness Before It Can Be Made Available.
As with any vaccine, biopharmaceutical manufacturers like Janssen work with public health authorities to ensure strict manufacturing and delivery schemes.
“We have experience with developing these types of vaccines that rely on vectors to deliver genetic material,” Schuitemaker said. “That is allowing us to go fast from the beginning to the clinic. We also have manufacturing experience to scale up production quickly.”
Accelerating Research And Development
At the same time Schuitemaker and colleagues are in preclinical development and rapidly preparing for clinical studies, Janssen is making every effort to speed the vaccine development process, by advancing some steps in parallel and making early investments to improve manufacturing capabilities to help speed production. This work is bolstered by partnerships throughout the health care ecosystem, including work with the Biomedical Advanced Research and Development Authority (BARDA) in the U.S.
Without a vaccine candidate with clinically-proven effectiveness, these investments are unique, as they come at significant financial risk for Janssen; normally the company would wait until a candidate showed promise in clinical trials before working to scale up manufacturing. However, the need is too great to wait, Schuitemaker said. The company is doing everything it can to safely “crunch the timeline,” she said.
Getting To The Finish Line
Despite decades of work studying viral outbreaks, including potential pandemics, Schuitemaker said nothing could have prepared her for the current situation. Yet rather than worry, Schuitemaker said she is proud of the way her team has responded, as well as her employer. In April 2020, Janssen announced its goal to supply 1 billion vaccine doses globally, as well as a commitment to bring an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.
“I’m so proud to work for a company that is investing at risk in this area, which allows us to fully work toward developing a successful vaccine,” Schuitemaker said. “Everyone has come to the table with the same goal. It really makes this an exciting area to work in.”
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