Maria Elena Bottazzi: Policy and science behind vaccine development

In the Paths to Science Policy series, we talk to individuals who have a passion for science policy and are active in advocacy through their various roles and careers. The series aims to inform and guide early career scientists interested in science policy. This series is brought to you by the GSA Early Career Scientist Policy and Advocacy Subcommittee.

Today, as part of the ECLP Policy and Advocacy Interview Series, I’m with Maria Elena Bottazzi, current Senior Associate Dean of the National School of Tropical Medicine at Baylor College of Medicine.

Could you tell us a little bit more about your career path and your current work at Baylor?

I am an Italian-born, Honduran-raised microbiologist. I received a microbiology and clinical chemistry degree from the National Autonomous University of Honduras. In Honduras, as is the case with most Latin American countries and other low-middle income settings, training at the bachelor’s-in-science level rarely involves experience within molecular biology. So, in order to further understand the molecular and biochemical basis of host-pathogen interactions, I moved to the United States to complete my PhD at the University of Florida, [studying the] molecular basis of pathogenic disease. As I was completing my postdoctoral work at University of Pennsylvania, I realized that my true calling was using all I have learned in the biomedical field to create solutions and develop new interventions for tropical and emerging diseases. So, I decided to enroll in a Master of Business Administration program to hone my business management and organizational skills. Shortly after, I met Peter Hotez (the current Dean of the National School of Tropical Medicine) and realized we were both interested in the same goal: developing global health technologies and translating them from the academic laboratory to the world. We have since worked together with an emphasis on vaccine development and accessibility for developing countries and for diseases that are typically ignored.

You have worked with vaccines and neglected tropical diseases for a while. What has been your own level of involvement in the policy area around these issues? Do you have any advice for young scientists interested in science policy?   

I have been around tropical diseases my whole life. Growing up in Honduras and studying microbiology there, I have always been observing the devastating effects they have on people. But to be fair, my interest peaked around the time I was finishing my higher education. This coincided with the turn of the century, when there was a re-emerging interest in global and tropical health. As I started my professional career, I saw all these policy frameworks being developed around poverty, hunger, education, and other health factors. Yet, as I moved forward with my scientific path, we started seeing how several diseases were being ignored, especially those that affected only tropical countries. I found myself part of a drive towards open science and creating partnerships and collaborations that would make research in tropical diseases accessible and transparent. Very early on, Peter Hotez and I realized that we needed to go beyond the bench: we had to be capable of developing robust products, like vaccines, that would be able to directly help people. Besides our scientific language, we also had to learn policy, business, ethics, and legal languages to serve the community in the best way possible. As scientists, it is difficult to be properly trained on these other dimensions: you are usually focused on the science and presentation skills. Peter Hotez was a great role model for me. He was really interested in the behind-the-scenes of policy making, so I ended up tagging along for the ride. Eventually, I realized I was very interested in scientific policy, so I applied to and got selected for a fellowship with the Leshner Leadership Institute in the American Association for the Advancement of Science. There I got formal training on how to integrate academic sciences and business practices. It is not all about the formal training, however. During my personal time, I also took several courses and met with different people to learn more about pharmaceutical economics, licensing and intellectual property laws, and even how to write legal contracts. This is something I recommend to every early career scientist: make sure that you take advantage of all the resources out there. Branch out from your bench, and learn about things that will help you engage the community and your own science in a much more efficient way! In the real world, you are always surrounded by so many more things than just your science. Always try a holistic approach when it comes to preparing your own career path.

You and Peter Hotez developed a COVID vaccine. Can you tell us more about it and how any regulations impacted your work?

As Peter and I started working on neglected tropical disease vaccine programs, we realized a pattern: funding for these programs dramatically increases when the disease emerges, but then it rapidly decreases as other priorities arise. We decided to take advantage of all the knowledge created during the “golden years” of funding for these rare diseases, and in 2011, we were awarded a grant to tackle a Severe Acute Respiratory Syndrome (SARS) vaccine in case of future outbreaks. Between 2011–2014, we were incredibly successful: we developed and manufactured a candidate for a SARS vaccine and were close to moving into human trials. Then, the 2015 Middle Eastern Respiratory Syndrome (MERS) outbreak happened; the NIH asked us to use the rest of the funding to develop a MERS vaccine instead of moving the SARS vaccine into toxicology trials. By the end of 2016, we had already come up with a prototype vaccine for SARS and for MERS as well; we were ready to start a pathway towards the clinic for these vaccines. Then, suddenly, coronaviruses were not that important anymore; our direct funding for these vaccines stopped as the agencies believed they had other diseases to deal with at that point. Internally, we decided to keep the program alive with some intramural money so all the scientific knowledge wouldn’t be wasted.  

To our surprise, the 2020 pandemic was being caused by a coronavirus family virus with a sequence similar to the SARS virus: we were ready to hit the ground running! Instead of 4 years, it only took us a few months to figure out the COVID-19 prototype vaccine. Since the world was in a state of urgency, we decided to not patent our COVID-19 vaccine technology and offered it as open source for manufacturing to different companies. Sadly, no company in the US or Europe was interested. This was mainly due to both scientific and policy misunderstandings. Our vaccine was based on the spike protein’s receptor binding domain and was produced in yeast, so it was easily scalable. At the time, both pharmaceutical companies and policy makers worked under the false assumption that the whole spike protein must be used, and they would rather fund new technologies such as mRNA-based vaccines because of their perceived speed to develop although they were not nearly as scalable at that time. Although we had pre-clinical trial data proving the high efficiency of our vaccine prototype, big pharmaceutical companies had no interest in it due to both policy and scientific mishaps. Eventually, we received interest from companies in India and Indonesia since they were having a hard time getting access to the mRNA vaccine technologies. These manufacturers shared our same vision to make scalable, affordable, and equitable vaccines for the public. We now have administered more than 100 million doses, making our vaccine one of the most accessible ones out there. Thankfully, we were able to surpass initial hurdles and make the vaccine accessible to those who needed it the most.

As a vaccine expert, do you think we are prepared for the next pandemic? What do you think needs to change regarding current vaccine policies?

One of the main issues during this pandemic was how countries with lots of resources decided to over-stock vaccine doses and disregard the needs of other countries. Nationalism plays a big part in this; everyone wants what is best for their own people first. Yet, as we clearly saw with the failed response to this pandemic, this is not the correct way to go about public health. Even if you vaccinate all your citizens, you will still suffer the downsides of a pandemic if your neighbors and trade partners cannot do the same. We learned the hard way that to get completely out of a pandemic, we need the whole world to work together and help each other.  

I think we learned a lot during this pandemic that will be useful in the future. For example, regulators around the world realized that many steps of the process could be done in parallel instead of sequentially, so we now know that the pipeline to create and manufacture vaccines, or other drugs, can be shorter and more efficient. Yet, we still face a terrible monster: inequality. With high-income countries overstocking vaccine doses, many low-income countries were left without the opportunity to order vaccines. Even after some countries started donating doses for children and senior adults, many low-income countries had their whole health system collapse due to how long it took to access vaccines. In the long run, this deeply affected high-income countries since the world was not able to truly go “back to normal” until most countries had regained control over their health systems. By not making vaccines equitable, we kind of shot ourselves in the foot and prolonged the pandemic far beyond what it could have been if we had made vaccines readily accessible to everyone since the beginning. We learned some lessons from this pandemic; however, we still have much work to do if we want to be prepared for another one. It is not only vaccine accessibility that needs to be more equitable but also vaccine research and regulation. There is a common belief that anything that is manufactured in middle- or low-income countries is, by default, of poor or dubious quality. If we want to be ready, we need to trash that old mentality. Worldwide regulators, like the World Health Organization, should work harder to improve vaccine research, manufacturing, and regulatory enterprises in low-income countries. With COVID, we clearly saw how economic power bought you a ticket to the discussion table. We need to move forward and show that you do not need economic power to have a voice regarding the world’s public health.

Thanks for being with us today. Do you have any final words for prospective scientists in developing countries who think their dream of being a researcher is far-fetched?

No dream is too far-fetched. I would like to tell them that, although it can be hard, they need to leave the impostor syndrome behind. It does not matter if you graduate from your country’s national university or from Harvard. You don’t need a prestigious degree to do great science. You need dedication, passion, courage, and consistency. You have been exposed to very different life stories than the average scientist. You need to take advantage of that cultural intelligence and let it propel you to success. I believe those of us who come from low-income countries are well suited for science; we are accustomed to surviving crisis after crisis, and our resilience is beyond that of anyone else. Our culture, our language, and all our lived experiences are strengths that prepare us for a bright future. Be proud of who you are and where you come from and leverage that to increase your skills. Do a self-evaluation, identify your weak spots, and use all that resilience to move forward. You have all the potential to become successful scientists. Never stop working hard and aiming for the top!