Q&A: Successes, Shortfalls and Science

Julie L. Gerberding, M.D., M.P.H., is widely recognized as an infectious disease expert and was the first woman to serve as the director of the Centers for Disease Control and Prevention. She is currently executive vice president and chief patient officer at Merck & Co. Inc., where she oversees patient engagement, corporate social responsibility and other responsibilities. Dr. Gerberding took time out of her busy schedule to answer questions from Yale Public Health about COVID-19 vaccines, vaccine policy and the anti-vax movement.

How do we better share the benefits of vaccine development with the rest of the world?

JG: It’s natural for countries to protect their own citizens, but enlightened governments will realize that they also have a humanitarian obligation to help nations with less capacity and capability. One strategy is for each country to commit to supplying a proportion of its countermeasures to a global pool like COVAX [the international cooperative program established to ensure that low- and middle-income countries have fair access to COVID-19 vaccines]. Supply alone is not enough, though. Distribution and uptake are lagging way behind the need. Many countries do not have vaccine distribution systems and immunization programs for adolescents and adults. The program resources they do have are often diverted from existing pediatric immunization activities, resulting in delays, discontinuation, or poor uptake of other vaccines. Also, without trust, vaccine doses will not end up in the arms of those who need them most.

What impressed you most about the expeditious development of COVID-19 vaccines?

JG: Never in the history of the biopharmaceutical industry have so many innovative products entered clinical development this fast. There are more than 800 vaccines, antivirals, medicines and immunologics in clinical development. This reflects not only the advanced state of our biosciences but also the commitment of thousands of investigators. But we didn’t start from scratch in 2020. These scientists are building on years—if not decades—of work, particularly the corona-virus research that commenced in the aftermath of the SARS outbreak in 2003 and the ongoing MERS outbreak.

Merck has been manufacturing COVID-19 vaccines that were developed by other companies. Why did Merck do this?

JG: Companies across the entire biopharmaceutical spectrum have stepped forward to collaborate in unprecedented ways. Planning clinical trial designs and endpoints in conjunction with regulatory agencies, sharing scarce supplies and supporting broad manufacturing agreements exemplify some of the ways that we have pulled together to expedite development and access.

Merck took these steps because we have the capacity, expertise and commitment to contribute whatever we can to speed mitigation and recovery from this pandemic. This is one more example of our core purpose and long tradition of contributing to the solution of global health threats.

Looking back, what do you think was the greatest shortcoming associated with vaccine development and/or distribution?

JG: We probably spent too much time focusing on the absolute number of doses we can produce and much less time thinking about all the other end-to-end requirements which are critical for deploying them in a trusted and equitable manner. Communication with public stakeholders has been particularly problematic, especially in countries where the messages have been distorted by politics and self-serving agendas.

How can we keep children safe and in school while accelerating the pediatric vaccine development and approval process?

JG: Keeping children safe in this pandemic remains a conundrum. We are fortunate that children are less likely to sustain the severe consequences of the virus variants that are circulating so far, but they are certainly not immune to infection and can serve as sources of transmission to other, more vulnerable, people. I hope that children can return to school even if that means that masking is necessary, since we are paying a dear price for the disruption to their education and social development during these important years.

Are mRNA vaccines a quantum leap in vaccine R&D? What additional potential do they hold to create effective vaccines against other pathogens?

JG: We are extremely fortunate that the mRNA vaccine platforms have proven to be so useful for eliciting immunity to the SARS-CoV-2 spike protein. The spike protein is apparently a powerful antigen, and we are taking advantage of that across the portfolio of nearly all the relevant SARS-CoV-2 vaccines. It is premature to predict whether or not an mRNA approach will be useful for other viral infections, but it’s highly likely that the lessons learned from successful vaccines in this pandemic will inform future development.

What can be done to lower the high cost of mRNA vaccines?

JG: The cost of making vaccines improves with increases in the yield and speed of manufacturing. The more doses that are made, the lower the fixed costs per dose. Supply chain and distribution efficiency are also critical factors. Single-dose vaccines, vaccines formulated to allow prolonged storage, and those packaged in the smallest possible footprint will help lower costs as well. Skin patches or oral vaccines could also help.

What can we do to counter the anti-vaccine movement?

JG: There are many factors behind vaccine hesitancy. Cultural, religious and medical reasons can prevent individuals from getting vaccinated—including long-standing mistrust of science and the government. That’s especially an issue in some African American communities.

But more important factors are misinformation—false information that is disseminated without intent to deceive—and even worse, disinformation—deliberately false information intended to deceive, confuse or influence. Political motivations are certainly conspicuous accelerants of their spread on social media. The tragic consequence is that the pandemic continues to propagate and the socioeconomic impact mounts.

Public health schools have been deeply involved in the pandemic. How do you see such contributions expanding and evolving?

JG: Schools have an opportunity to conduct the research and teaching necessary to move us to an advanced framework that reflects our new reality. Our strategic doctrine needs to move from containment to a doctrine that puts much more emphasis on prediction and preemption. Interdisciplinary programs with concentrations in, for example, geospatial monitoring, data sciences, risk com-munications and behavioral economics are all relevant areas for inclusion.