Supriya Munshaw, senior lecturer at the Johns Hopkins Carey Business School has spent years developing expertise in the commercialization of early-stage life science and medical device technologies. She discusses why after years there is no vaccine for other coronaviruses such as MERS and SARS. She reports that an 18-month timeframe for a COVI-19 vaccine is optimistic.
In a recent interview in Johns Hopkins Hub, Professor Munshaw brings the reader a dose of conservative reality that in most circumstances, the development of a safe and effective vaccine can take anywhere from 10 to 15 years for development if starting from scratch. She reports that although there is no vaccine for any coronaviruses (e.g. SARS, MERS or COV-SARS-2), the good news here is that researchers aren’t starting from scratch as they have been working on coronavirus vaccines due to the occurrence of the MERS-CoV and SARS-CoV epidemics. But she cautions that an 18-month time-frame is highly ambitious.
Safety vs. Efficacy—the Balance
In a crisis situation wrought by pandemic, industry, government, and academic research, centers form alliances to expedite vaccines, reports Professor Munshaw. The parties will balance the risks and benefits of an early stage vaccine—balancing efficacy and safety. They will place a heavier weight on safety, hence the first approved vaccine may not be as effective, but they need to be extremely safe—after all, they are administered on healthy people.
The Vaccine/Drug Development Process
Munshaw goes on to explain to the Hub’s Patrick Ercolano the process of vaccine development. First starting with the “exploratory phase” involving basic research “identifying the appropriate antigens, or particles on the virus that can be used to elicit an immune response in the vaccine recipient.” Munshaw reports that on average, this process alone takes from two to four years.
From there, the standard drug development process kicks in—from pre-clinical studies involving animal research through what can be lengthy clinical trials (on humans through three phases). For example, Phase I involves a small group of healthy volunteers to test the vaccine’s safety profile; then on to Phase II where larger groups of individuals are involved for the assessment of safety, dosage, and administration—often involving hundreds to even thousands, explained Munshaw; and Phase III where the industry sponsor tests the disease on thousands of people. Of course the standard challenges are faced all the way through from finding the right investigators to patient recruitment issues. She reminds the audience that “these large vaccine trials can go on for anywhere from one to five years, because you are waiting to see if your vaccinated group has a lower incidence of disease than your placebo group.”
Professor Munshaw notes that such an urgent situation necessitates compromises and trade-offs. Hence surrogate endpoints in Phase III trials can be established that support an expedited pathway. Nonetheless, she points out that even with expedited measures, the last phase is probably going to run a year or two at least.
Once studies are complete, sponsors must scale up manufacturing. Just because regulatory authorities approve, a vaccine doesn’t immediately translate to expedited access. The vaccine must be manufactured in a lean and agile manner to quickly scale up supply to meet the necessary demands. She points to basic flu vaccine shortages—despite planning for those in advance—as examples.
Why is the Coalition for Epidemic Preparedness Innovations Important?
The professor notes that the Coalition for Epidemic Preparedness Innovation (CEPI), the foundation out of Oslo, Norway, takes funds from public, private, philanthropic, and other organizations to finance independent research projects to develop vaccines against emerging infectious diseases. CEPI was conceived in 2015 and formally launched in 2017 at the World Economic Forum (WEF) in Davos Switzerland. It was co-founded with $460 million from the Bill and Melinda Gates Foundation, the Wellcome Trust, and a consortium of nations including Norway, Japan, Germany and the UK.
She noted to the Hub that this is undertaking an important function, coordinating a good deal of vaccine effort discovery worldwide. By identifying and orchestrating funding, partnerships, and collaboration of key stakeholders, research can be accelerated. Professor Munshaw shared an important example: that Moderna, makers of an RNA-based vaccine, was brought together with the National Institute of Allergy and Infectious Diseases to conduct the current Phase I clinical trial.
When the Hub asked about promising COVID-19 vaccine candidates today, the professor mentioned a number of early-stage candidates from Moderna, Inovio, CanSino Biologics, and Shenzhen Genoimmune Medical as leaders of the current phase I clinical trials pack.