A year before the coronavirus outbreak started, researchers from Johns Hopkins University started trying to answer a question that’s taken on new urgency: How do we manufacture billions of vaccine doses in a hurry if there’s a global pandemic?
Some of the world’s brightest minds are hard at work developing potential coronavirus vaccines, but developing a vaccine only gets us halfway to the goal of ending the coronavirus pandemic. Overcoming the production and distribution challenges to inoculate the planet against a new virus in a relatively short time is going to take a similar feat of innovation. So what do we need to do to pump out more vaccines at a faster rate than we’ve ever had to do before?
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We were warned
Epidemiologists, virologists, and public health officials have warned us for years that a pandemic featuring a novel virus is a matter of when, not if. Nancy Connell, Crystal Watson, and Matt Watson are part of a team of researchers at Johns Hopkins University who started thinking through the problem of mass vaccination in a pandemic a year and half ago.
“Our question was, if you had a vaccine available that you know works experimentally, how would you go to two billion doses?” said Connell. “What mechanisms can be used to scale up? Do we need to repurpose existing manufacturing facilities? How difficult is it to repurpose them?”
Unfortunately, just relying on existing manufacturing capability during a pandemic could add unnecessary delays from the time of discovery to mass immunization. In a new article in the journal Vaccine, the Hopkins researchers conclude that “repurposing or building new plants can take months to years”—time that could prove costly in lives and health—and recommend a few options for making pandemic mass vaccination faster, both for the coronavirus and whatever other novel diseases we might face.
“Over the past 20 years or so the science of vaccinology has accelerated remarkably quickly,” Matt Watson, one of the authors, told The Daily Beast. “Unfortunately, the science of how those vaccines are manufactured still lags behind.”
Part of the problem lies in the nature of the market. “One bug, one drug” is the phrase some use to describe the pharmaceutical industry’s approach to vaccine production.
“Most of manufacturing is specific for that vaccine. We have very good flu availability. If this pandemic were a flu pandemic, we wouldn’t be at two billion doses but we could repurpose flu manufacturing around the world on almost every continent,” said Connell.
“I think there are so many economic pressures on this and a lack of incentives for vaccine manufacturers to switch over to a more scalable manufacturing capacity. Even with flu we don’t have that incentive and most manufacturers don’t want to spend the money and the time to switch from egg-based manufacturing,” added Crystal Watson. “We focused a lot on the R&D for discovery and development of vaccines but much, much less on these other parts of the problem.”
Knowing is half the battle
There are about 70 vaccines for the coronavirus in various stages of development right now, according to the World Health Organization. While there’s some hope that, under ideal circumstances, a few of those trials could yield results as early as the fall, most experts don’t expect a vaccine to be ready for another year or year and a half.
“Twelve to eighteen months is a tight timeframe, but there is reason for optimism in view of the unprecedented levels of resources and commitment that are being brought to bear,” Connell says.
Platforms
The problem is that the coronavirus isn’t the flu, and it’s hard to turn on a dime and steer the world’s existing production capacity towards the coronavirus or another future pandemic.
To build a faster, more flexible, and scalable production capacity, the Hopkins authors suggest that we invest more in platform technologies for vaccine manufacturing. Vaccine platforms allow for manufacturers to use the same production equipment for a variety of different diseases rather than having to repurpose or rebuild production lines for each new disease.
Viral vector vaccines are one example. These technologies allow producers to use a common viral vector—a harmless virus that can be introduced into the body as a delivery mechanism. Those vectors can be genetically altered to pump out different antigens for different diseases once injected into the body, allowing for a kind of “plug and play” capability that producers can tweak for different diseases.
Another example are RNA or DNA vaccines. Messenger RNA or mRNA vaccines work by embedding mRNA vehicles like liposomes—small fat bubbles; mRNA carries the genetic instructions that cells need to make tiny protein bits of a virus known as antigens. Instead of using a viral vector to pump out those proteins, mRNA vaccines deliver the antigen instructions to your own cells. Your cells then produce a virus’s antigen giving your immune system the opportunity to safely recognize and learn to attack it if and when you’re ever exposed to the virus itself.
Right now, pharmaceutical company Moderna has already selected an mRNA-based vaccine candidate and has begun human trials in the United States.
“It depends a little on which platform you’re talking about, but you get a little more flexibility in terms of the diseases you’re able to immunize against as well as a little more speed on the production side,” said Matt Wason.
Equity and global distribution
Right now, most of the vaccine-making capacity is in a handful of rich countries. The WHO estimates that five companies in the U.S. and Europe make up about 80 percent of the global vaccine manufacturing capacity, meaning that any coronavirus vaccine production is likely going to be concentrated in the West. Connell and her coauthors argue for a more distributed approach to production both to shorten the distance between where a coronavirus is made and where it’s needed and to make the supply chain more resilient against disruption in any one location or region.
Administration
Even once you have a vaccine made at scale, you still have to administer it to patients, which can add more delays, and the form a vaccine takes can shape how fast and easily it can be administered. In the West, many people are accustomed to injection vaccines that require trained nurses or similar licensed health professionals to administer. By contrast, nasal sprays, liquid vaccines delivered orally, or tiny velcro-like microneedle arrays could make it easier for a broader array of people to deliver vaccines, making administration go much faster.
When being right is awful
Connell, Watson, and Watson are part of a chorus of scientists and researchers who have warned the world about the threat of a pandemic and the problems that addressing it would pose. Prescient as their research has been, there’s no joy in being proved right.
“I wish we’d been wrong,” Matt Watson says.
