The development and deployment of an effective vaccine for COVID-19 could be the turning point in the fight against the deadly pandemic, and companies involved in the process must make specific business and public health considerations simultaneously to help ensure a successful outcome, experts said during a Jan. 25 panel discussion sponsored by the Johns Hopkins Carey Business School and the Hopkins Business of Health Initiative.
During the discussion, a panel of public health experts and vaccine industry executives examined every aspect of the COVID-19 vaccine from discovery to manufacturing to delivery from both a business and health perspective.
“The reality of the situation is that the number of emerging infectious diseases is increasing,” said Bill Enright, chief executive officer of the Oxford, England-based Vaccitech Ltd., a strategic partner with AstraZeneca in developing one of the first COVID-19 vaccine candidates. “This isn’t a one and done; this is a continuing problem that’s going to face us.”
From a business standpoint, Enright said that one consideration is for companies to determine how they’re going to handle more infectious diseases.
“One of the key things here is money,” he said. “It is the key driver for being able to do things quickly. The way that product development is set up across the board is to do things in a series so you’re limiting risk all along the way because we know that a very small percentage of products that enter development will actually make it through to commercialization.”
Regulatory advances also have helped speed the COVID-19 vaccine through the discovery and development process without taking safety shortcuts, added Enright. For instance, government agencies have been more apt to look at innovative clinical trial designs while “working with companies hand-in-hand” on streamlining processes, for example, and on the free flow of information to better support its accessibility to the industry, he said.
Another business consideration regards the infrastructure required for the large-scale commercialization and manufacturing of a vaccine, said Abigail Jenkins, senior vice president and vaccines business unit head at Gaithersburg, Md.-based Emergent BioSolutions Inc.
“Our business was literally designed for a moment like this, one that we hoped would certainly never happen,” Jenkins said of Emergent, a global life sciences company that, among many other partnerships, is working with AstraZeneca on manufacturing and deploying a COVID-19 vaccine.
Emergent “was well positioned” to help address the need for COVID-19 vaccines as it had already been in the business of addressing emerging infectious diseases for the last 20 years, said Jenkins. “We have long-standing partnerships with the U.S. government, as well as international government partners, and we have a reputation of being able to step up and deliver, especially in high-pressure situations like the current pandemic,” she said.
Emergent’s infrastructure is organized into four business units: therapeutics; devices, such as NARCAN, a nasal spray that counteracts opioid overdose; contract development manufacturing (CDMO) to develop and manufacture vaccines for other pharmaceutical companies; and vaccines, the unit Jenkins’ oversees to develop and deliver the company’s own vaccines.
Emergent’s vaccines unit, like the company itself, focuses on unique public health threats, Jenkins explained, and now has vaccines in development or on the market for biological threats, like anthrax and smallpox, for travel health diseases like typhoid and cholera, and existing and emerging infectious diseases like pandemic influenza — “it’s a very specific niche in the market,” she said.
In discussing the most important business elements to consider when it comes to commercializing vaccines, Jenkins noted that companies need to think about the market, the competitive landscape and the manufacturing elements.
Currently, for instance, it’s vital to consider the immediacy of the pandemic and the long-term aspects, as most vaccines have a competitive life span that is far longer than traditional pharmaceuticals. “What’s the competitive landscape and is there an opportunity for differentiation between the products after the immediate need of a vaccine has passed?” she said.
From a manufacturing perspective, while there are many considerations about the clinical efficacy and safety of products, “in the end, a lot of the time, the success of a product can come down to the manufacturing,” said Jenkins. “It can be the rate you accept for getting a product to market, to getting it licensed or approved, and certainly scaling up manufacturing is one of the greatest costs that goes into a product, and over the long term… is something that will ultimately impact the bottom line and profitability.”
Additionally, Emergent’s CDMO unit operates one of the pandemic response manufacturing centers that was established in partnership with the U.S. government in 2012 “for situations just like what we’re facing now,” Jenkins said.
Through this facility in Baltimore, Md., Emergent is manufacturing drug substances for COVID-19 vaccines, either for use in clinical trials or for commercial purposes for other manufacturers. And although this facility has been up and running, ready to respond to a pandemic, Jenkins said that as the current crisis unfolded, “we still had to go from zero to 100 in a very short period of time.”
“We had to set up various manufacturing lines, and suites to accommodate not just one product but a variety of vaccine types, each in various stages of development, while working with a variety of different customers,” she said. “And for those of you in business, you know that customers have different needs, different expectations, unique specifications — and all of that customization certainly added some complexity to the process.”
At the same time, Emergent also had to work closely with the U.S. Food and Drug Administration “as each of these products was literally moving at warp speed under a pathway that previously didn’t exist,” Jenkins said.
Comparatively, things usually would be done more in sequence, and the entire industry was moving more in parallel, she said, adding that this meant Emergent was trying to buy equipment that was in high demand, like bioreactors and freezers, while also trying to claim something as simple as more warehouse space to store items that would be needed for manufacturing. The simultaneous process “became something of an emergency,” she said.
A company’s workforce is also a consideration.
From a staffing perspective, coming in to 2020, Emergent had 1,800 employees across 19 locations globally. When the pandemic hit, the company needed to scale up its employee base by 50 percent, Jenkins said, with 50 percent of those people, or about 400 employees, being needed just to help with the COVID-19 vaccine production effort in the last half of the year.
“That alone, I think, is just a complex business problem,” she said. “You know you need to ramp up, you need to scale up, you need to be able to deliver, and just getting people to do the work can be quite a major undertaking.”
Emergent also had to pull employees with specific expertise in vaccine development and manufacturing from other areas of the company; had to create new safety protocols and procedures; and had to initiate different types of employee safety measures.
“Employee safety was at the forefront of this process,” Jenkins said. “We knew that we couldn’t deliver [a product] without the workforce to do it.”
Another company consideration is management prioritization and business decision-making, according to Jenkins. As a for-profit, publicly traded business, Emergent had to be financially responsible while also being laser focused on its goals and commitments to customers, she said, all while demonstrating care for its employees.
This meant Emergent executives had to make “really hard choices” around what was most important, which in this case was the COVID-19 work. “But it meant that the work of other employees, who were working on other development programs or other important vaccine programs, had to be delayed or deprioritized so that we could transfer resources to the COVID-19 effort,” Jenkins said.
“The employee element is often underappreciated in thinking about commercialization and the business of working in the pharmaceutical industry,” Jenkins added. “It shouldn’t be because we certainly would have failed in executing our business without the hard work, dedication, commitment, and connectivity of our Emergent team.”
There are many other public health-related considerations, said Dr. Reed Tuckson, managing director of Tuckson Health Connections LLC, who highlighted several points about delivering a vaccine and getting people vaccinated.
“There must be a framework and philosophy on who gets it and when,” said Tuckson, who previously served as the executive vice president and chief of medical affairs for UnitedHealth Group and was formerly the commissioner of public health for Washington, D.C. “There should be an attentiveness to fairness, equity and making decisions based upon who are the most vulnerable among us in society.”
There also must be synergy between government and business in deciding on the dissemination of a vaccine, along with cohesive planning between federal and state governments.
Financing and administration are important, too, Tuckson said, as is determining how people connect with the final product. And because the currently approved vaccines require more than one dose, a model is needed to track and ensure people actually get their first and second doses. This is important, he added, because vaccine effectiveness is decreased if both doses aren’t administered as required.
Finally, Tuckson said that post-surveillance monitoring also could be helpful to provide data on next steps and future steps in delivering vaccines during a pandemic. “We are now in a time of great confusion and chaos,” he said.