Pharmaceutical giant Pfizer announced last week that it had begun testing multiple versions of an experimental coronavirus vaccine in healthy adults in the U.S., greatly accelerating the vaccine development process, which normally first requires years of testing on animals.
The U.S. trial, part of a partnership with the German biotech company BioNTech, will enroll up to 360 healthy subjects into two age groups, 18 to 55 and 65 to 85. The younger adults will receive versions of the potential vaccine first. Those found safe and effective will then be tested on the older adults.
Kathrin Jansen, 62, head of vaccine research and development for Pearl River, New York-based Pfizer, where she leads a global team of scientists, said the partners could potentially have millions of doses ready by the end of the year, increasing to hundreds of millions in 2021.
"I look at it like a war," she said. "The world is in a race to develop vaccines and therapies against COVID-19, the enemy. Nothing aligns humankind more than a common enemy. We are all in it together."
Coronavirus impact:Many U.S. adults who lost jobs or saw hours cut expected to return
No more handshakes?:How do we replace the ancient greeting if coronavirus keeps us from touching?
While there are about 100 potential COVID-19 vaccines in various stages of development, the Pfizer and BioNTech experimental vaccine is one of only eight that have advanced to human clinical trials worldwide.
Jansen, a microbiologist, played a vital part in the development of Gardasil, the world’s first vaccine to prevent infection with several strains of HPV, a cause of cervical and other cancers, and of Prevnar-13, given to children and adults to protect against life-threatening illnesses including meningitis and pneumonia.
Question: What's different about working on this vaccine?
Kathrin Jansen: Never in my over 25 years of developing vaccines have I seen a collaboration of this magnitude to realize the launch of a clinical trial at this speed. This milestone is a testament to the innovation and collaboration among researchers and colleagues from Pfizer and BioNTech – two very different organizations and cultures – together with unprecedented access to and support from regulatory agencies and other government agencies, and the willingness of companies to go above and beyond what is “normal” for them.
Q: How do you approach this task personally?
Jansen: For me personally, the pandemic is an unacceptable disaster of unprecedented (in recent history) proportions. I feel that I can contribute to try to solve the problem, a sentiment that is shared by our colleagues and scientists around the globe. The quest for a solution is energizing us to a degree probably never experienced before.
Q: How were you able to shorten the time taken to test the vaccine on humans?
Jansen: We worked with regulatory authorities to design a clinical study to evaluate four candidates simultaneously in a small number of subjects with the goal of selecting a vaccine candidate.
Pfizer and BioNTech are testing four different mRNA (messenger RNA, genetic material which carries the instructions for cells to make proteins, can prompt the body to make its own medicine) candidates in our Phase 1/Phase 2 study. Because mRNA can potentially be more rapidly produced than a conventional vaccine, it, therefore, may be the fastest way to address an emerging pathogen during a pandemic.
All four candidates have the potential to become a vaccine and our clinical studies will allow us to select a candidate that is safe and effective.
Q: What are the challenges in trying to develop a vaccine on an accelerated time frame?
Jansen: There is an unprecedented sense of urgency to make what seemed impossible only a couple of months ago now possible. Because Pfizer and BioNTech are trying to do development and manufacturing steps in parallel – instead of sequentially – in a highly compressed time period and before we know whether we have a successful vaccine candidate, resources may become strained.
Q: When do you hope to have the vaccine ready for widespread use?
Jansen: Safety is our number one priority and collecting sufficient safety data takes time. We are working with government agencies around the world and the FDA (Food and Drug Administration) to define a regulatory pathway and timeline for a potential vaccine to address COVID-19.
We are beginning to scale up our manufacturing operations so we can potentially have millions of doses ready by the end of the year in the event we achieve technical and regulatory success.
Q: How many are working on this vaccine?
Jansen: You can probably best compare our teams to a large symphony orchestra, which has all the instruments. Many, many different musicians and a conductor that is working to bring the performance together. The goal is to try to get the various talented players to work together, so that at the end, a beautiful piece of music is created.
There are many hundreds of colleagues – at Pearl River and other sites in the U.S. and Europe – including virologists, biologists, immunologists, bioinformaticians, and manufacturing engineers, in addition to clinical laboratory scientists and clinicians. In addition, we are working closely with our partner BioNTech and many of their scientists and personnel.
Swapna Venugopal Ramaswamy covers women and power for the USA TODAY Network Northeast.Click here for her latest stories. Follow her on Twitter at @SwapnaVenugopal. Support local journalism; go to lohud.com/specialoffer to find out how.