Creating a vaccine: As fast as safety allows

Person receiving vaccine

“Things really are moving fast,” says Bill Dreitlein, senior director of OptumRx Pipeline and Drug Surveillance. “This type of speed is unheard of in vaccine development.”

To give you an idea how fast things are moving, consider this: The genetic sequence of the virus was published on January 11. By the end of April, scientists were already testing three different vaccines in human trials, according to a report from CNBC. Two more trials were expected to start by the end of May.

“Blindingly fast” new approach

Most vaccines are weakened or inactivated forms of the dangerous virus they protect against. Scientists break down the bug and use those pieces to help the body ramp up its immune response to that bug.

Dreitlein says some COVID-19 vaccine teams are using new methods. They are working with DNA and RNA, viral vectors, recombination protein and more.

“Aside from sheer speed, one of the most striking things about the COVID-19 vaccine landscape is the diversity of technologies,” says Dreitlein.

The RNA/DNA approach is pretty similar to traditional vaccine creation, except at a genetic scale. “They also are using pieces of the dangerous bug,” explains Dreitlein, “Except they are taking tiny bits of the virus’ genome, either DNA or RNA, and using that to help establish the immune response.”

“The advantage of the DNA/RNA approach is that it’s blindingly fast,” says Dreitlein. Chemical & Engineering News reported the first RNA vaccine was designed with a 3D computer program in less than three hours.

“The downside is it’s completely, absolutely new,” says Dreitlein. “We have no idea whether it will work, and we have no idea how or whether we can scale it up to billions of doses.”

Coronavirus vaccine

There is a sort of speed limit: Safety

Dreitlein says the vaccine development process can feel slow, but it follows specific steps for a reason — to keep people safe.

“There is a limit to how fast we can go without compromising on something,” says Dreitlein, “This is particularly important with vaccines, because the real value of vaccines is in helping healthy individuals to prevent disease.”

This chart from the Food and Drug Administration (FDA) shows how drugs must make it through three sets of trials before being considered for approval. Ultimately, there are two requirements a vaccine must meet — it needs to be safe and effective, and the vaccine’s merits must outweigh its risks.

How a new vaccine is developed, approved and manufactured

Before a drug is approved, it will be tested on hundreds, maybe even thousands, of volunteers. The New York Times recently ran a graphic comparing the typical time to approve a vaccine against the COVID-19 vaccine goal. The difference? 15 years.

Given the FDA testing requirements, a timeline of 12 to 18 months is ambitious. If there’s a vaccine by the end of 2021, it will be the result of rapid-speed development.

“The process is important for identifying who may be helped and who may be harmed,” says Dreitlein. “We’re going to have to rely on genuinely evidence-based medicine to beat this disease, even if it doesn’t give us the answers we’d like as fast as we want them.”

Ultimate supply chain challenge

Creating a vaccine, mass producing and distributing it to more than 7 billion people is an enormous undertaking. “The needed manufacturing will be a scale unlike anything ever done in history,” says Dreitlein. “We’re talking the Manhattan Project, plus a moon shot, maybe throw in the Great Wall of China.”

Leaders from both public and private organizations are working to anticipate and overcome practical hurdles. For example, some are working to make sure there will be enough glass vials to hold the vaccine when one is developed.

There’s also the possibility we may need more than one dose for a vaccine to work. “Try to imagine making and distributing 14 billion doses around the planet,” says Dreitlein. “And one more detail — it may need to be refrigerated every inch of the way.”

Vaccines can be elusive. Researchers have been working on vaccines for other viruses — like AIDS and dengue fever — for years without success. That’s why they are working simultaneously to develop COVID-19 treatments that can reduce symptoms. To read more about that effort, check out an earlier blog.

Optum CEO Sir Andrew Witty is on leave to lead the World Health Organization’s vaccine efforts. Click here to read more about his involvement.

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