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CORONAVIRUS

Why It Takes So Long To Make A Coronavirus Vaccine

This is what goes into creating a COVID-19 shot that can give us immunity against the virus. (Hint: It's a lot.)

By Jenna Birch
April 30, 2020

As of the end of April, the World Health Organization was tracking 71 coronavirus vaccines in preclinical trials, with five additional candidates already in clinical trials. Given how recently the COVID-19 pandemic began spreading, it might seem promising that there’s already a lot of activity on the immunization front.

With so many potential vaccines in testing, you also may wonder why medical experts say it will take at least 12 to 18 months before one is ready to go. If a coronavirus vaccine did make it to market on such a timetable, it would actually be the fastest turnaround in history. Currently, that record belongs to the mumps vaccine, which was approved for use in just four years back in the 1960s. For Ebola, a vaccine took five years to develop.

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A vaccine must be rigorously tested before the public gets it.

We often think of vaccines as treatments for illness, but they’re not exactly that, said Kelvin Lee, a professor of chemical and biomolecular engineering at the University of Delaware and director of the National Institute for Innovation in Manufacturing Biopharmaceuticals. Vaccines are given to people who are well to keep them from getting sick.

“It’s very different from developing medicine where someone is ill and you are trying to make them better. In a healthy population, you don’t want the vaccine to have negative consequences,” he said.

First, Lee said, researchers will study the virus and attempt to determine which type of vaccine may work best.

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“It’s very different from developing medicine where someone is ill and you are trying to make them better. In a healthy population, you don’t want the vaccine to have negative consequences.”

- KELVIN LEE, DIRECTOR OF THE NATIONAL INSTITUTE FOR INNOVATION IN MANUFACTURING BIOPHARMACEUTICALS

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“You would take a susceptible population, vaccinate some while having a control group, and monitor the effect over time and see if there’s any difficulty,” Cutrell said.

Here, researchers may look for common, short-term side effects and at what dosages those side effects pop up.

“All that has to be done first, and then if Phase 3 shows the vaccine is safe and effective, that’s when you’d look at licensing,” Cutrell said.

Even after you have a working vaccine approved by the Food and Drug Administration, it still takes time to mass-produce and distribute it across the country.

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YULIA REZNIKOV VIA GETTY IMAGES

Scientists might be able to create a COVID-19 vaccine faster than normal.

While it’s hard to say when researchers will have a viable vaccine, there are a few factors that could speed up the timeline for this coronavirus vaccine.

Traditional approaches to creating vaccines ― like the use of chicken eggs ― are proven but not necessarily speedy.

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Scientists will still want to minimize risks and ensure the safest possible rollout of a vaccine. “But given the outbreak globally and the impact it’s having, I can imagine there are ways to design trials to accelerate testing,” Lee said.

There could also be an unconventional study design for the coronavirus vaccine, according to a new report published in the Journal of Infectious Diseases. In place of traditional Phase 3 trials, volunteers at low risk of developing a severe form of COVID-19 ― healthy people without chronic conditions in their 20s, for instance ― might opt in for a “human challenge study.” They could be exposed to the coronavirus, monitored closely and given the best care.

This type of study would involve fewer participants and could be done in less time than a traditional Phase 3. Of course, the idea would need to be rigorously discussed beforehand as ethics rules generally forbid deliberately infecting human beings with a serious disease.

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“A lot of times patients with this virus get sicker in the second week of their illness ― and it’s not the virus, but the immune system that makes them get quite sick,” Cutrell said. “They experience an exaggerated state of inflammation or ‘cytokine storm.’”

Some drugs that might dampen the immune system’s effects are currently in clinical trials.

Then there’s the now-controversial drug hydroxychloroquine, which has “long been used for malaria or inflammatory conditions like rheumatoid arthritis or lupus,” Cutrell said.

Although the drug received a lot of early attention, the studies showing potential benefits for COVID-19 patients have been mostly anecdotal with no control groups to compare against.

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“Before we have effective treatment or vaccine, we will have to behave similarly to South Korea, Singapore or Hong Kong, with widespread access to testing, contact tracing and isolation, quarantining people in cases of potential contact.”

- JAMES CUTRELL, DIRECTOR OF THE INFECTIOUS DISEASE FELLOWSHIP PROGRAM AT THE UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER

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Of course, those countries have still seen second waves of the virus.

“That approach requires constant vigilance,” Cutrell acknowledged. But even as scientists and doctors work to develop effective treatments and a vaccine, he said “thoughtful and incremental” strategies can help us move forward to “a period of more normal activities.”

Experts are still learning about the novel coronavirus. The information in this story is what was known or available as of press time, but its possible guidance around COVID-19 could change as scientists discover more about the virus. Please check the Centers for Disease Control and Prevention for the most updated recommendations.

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