Duke University scholars weigh in on challenges of validating, manufacturing a vaccine quickly

Updated: Jun. 24, 2020 at 9:52 PM EDT
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CHARLOTTE, N.C. (WBTV) - Duke-NUS Medical School in Singapore is making progress on a potential vaccine for COVID-19. Scholars with Duke University and Duke-NUS weighed in on the challenges of validating, manufacturing, and distributing a vaccine for widespread use quickly.

Duke-NUS Medical School developing COVID-19 vaccine

Dr. Ooi Eng Eeong is leading the Duke-NUS Medical School clinical trial of a COVID-19 vaccine. Duke-NUS is a graduate medical school in Singapore in collaboration with Duke University and the National University of Singapore.

Dr. Ooi Eng Eeong says the Medical School in Singapore is partnering with San Diego-based Biotech company Arturus Therapeutics to develop the vaccine.

The vaccine will target a spike protein that sticks out of the coronavirus.

“So, these spikes that are sticking out of the virus acts like a key for the virus to unlock and get into the cell. And so that seems like a very good place for us to target the immune response so we can develop antibodies and perhaps killer cells that target this part of the virus. Then we could get immunity against infection,” Dr. Ooi Eng Eeong said.

The vaccine will use an mRNA molecule to protect the cells from infection. Dr. Eng Eeong says RNA replicates itself, which means the vaccine will not need to be administered in high doses.

“So far, the results look good and we will be heading toward the clinical trial within the next few weeks” Dr. Ooi Eng Eeon said.

The Singapore government is funding the research for this vaccine.

Steps in validating a vaccine

Dr. Thomas N. Denny is the Chief Operating Officer of the Duke Human Vaccine Institute. He says when a vaccine reaches clinical trial, it can be tested in humans.

So far, Duke-NUS and Arturus Therapeutics has been in pre-clinical trial phase. In this step, Dr. Denny says the vaccine is tested in animals.

“These are generally performed in animal models where you will vaccinate the animals a number of times. Then at some point, you will challenge them with the organism that you are trying to illicit protection to. And what you will look for is that hopefully the vaccine that you developed at that point, hopefully in a pre-clinical mode, will protect those animals from getting infected,” Dr. Denny explained.

Before moving from pre-clinical to clinical work, Dr. Denny says scientists must decide how the vaccine will be manufactured.

During this part of the process, dosage, administration, and how much to manufacture will be determined., Dr. Denny says this part of the pre-clinical work can take anywhere from 6 to 18 months.

Before manufacturing begins for the clinical trial, Dr. Denny says information will be sent to the Good Manufacturing Principles team.

“That’s where the team will grow and produce and purify this vaccine under extraordinary controlled conditions,” Dr. Denny said. “There is quality control team, and extensive amount of analystics that’s performed, and all this is done in very sterile conditions.”

When the vaccine has met all purification and characteristics it was intended for, it will be sent to hospitals or clinics for the clinical trial portion to begin.

Challenges in manufacturing a vaccine to scale

Dr. David Ridley of Duke University’s Fuqua School of Business says while a clinical trial is in progress, manufacturers could begin investing and preparing to produce the vaccine for widespread use.

It could take upwards of four to five years to have enough supplies, equipment, and other needs to meet production demands.

Under emergency circumstances, it would be helpful for manufacturers to begin preparing to produce vaccines while they are being studied, but because of the high fail-rate, Dr. Ridley says some companies may not want to take the risk.

“For them to go really fast on a vaccine that’s probably never going to work is incredibly expensive. Maybe they can do that over the next year or two, but there is going to be a little foot dragging because it’s so expensive for them to go fast on something that probably isn’t going to work. Because most vaccines that we test in people never make it to market,” Dr. Ridley said.

The U.S. federal government is offsetting some of the risk to companies by funding some clinical trials through the Biomedical Advanced Research and Development (BARDA).

Some companies have already pledged to begin ramping up production in preparation for an approved vaccine.

“Sanofi said they would be able to make a hundred million doses this year and one billion doses next year,” Dr. Ridley said. “That’s really unprecedented because usually you would wait to see if your vaccine is having some success. If you think there is a one in eight change that you’re going to get on the market and you’re already spending tens of millions or hundreds of million of dollars now, that’s kind of crazy. But that’s the kind of crazy world we live in and I salute them for it.”

In addition to manufacturers investing in production ahead of an approved vaccine, Dr. Ridley says supplies needed for the vaccine could be in short supply. He says there are high standards for products used in vaccines because it is injected straight into the bloodstream.

“We can’t underestimate the importance of all these materials along the line, and just like we’ve seen with PPE there might be concern for possible hoarding,” Dr. Ridley said.

Timeline for when a vaccine could make it to the market

Tuesday, Dr. Anthony Fauci said he was cautiously optimistic a vaccine could be available by the end of 2020.

Dr. Ooi Eng Eeong and Dr. Ridley both say that may be too optimistic.

“I think potentially we could get one at the soonest, to me, is this time next year. I think any sooner than that is extremely optimistic,” Dr. Ooi Eng Eeong said.

“I respect that optimism, but will you and I be vaccinated this year? No way,” Dr. Ridley said. “It’s possible that a vaccine will be approved this year, but not at scale. We won’t have a lot of doses of this.”

Reluctance to a newly approved vaccine

In recent years, some Americans have been reluctant to get vaccinated due to various beliefs of detrimental side effects.

Duke University professors are hopeful that people will be receptive to an approved coronavirus vaccine.

“Most of the people living today did not experience wild-type disease when they occurred, Polio or other disease where there are lot of deaths, serious injuries and complications that occurred from these diseases that are now preventable because of vaccines,” Dr. Denny said. “I think today we are seeing just how sick people are getting from a new pathogen like this, COVID-19. So I’m cautiously optimistic that people will weigh the potential of serious illness, sickness, or death of not taking it and be motivated to be receptive of taking a vaccines like this.”

“We have not really communicated what we know about vaccine safety to the public in ways that they would understand. I think we have done a very good job in talking to each other in science, but in language that very few others would follow. I think we as scientist need to do better in explaining what we’ve found and presenting the facts in ways that people could grasp rather than others to rely on social media and that to educate themselves,” Dr. Ooi Eng Eeong said.

“FDA will be very cautious. We have an incredibly high standard for vaccine safety because these vaccines are going into otherwise healthy people. So, side effects are so rare with vaccines and I think the same will be true here. FDA will not want to slow things down bureaucratically … but FDA won’t go so fast that it puts people at any serious risk. So I’m very confident that a vaccine that’s approved will have very little side effects, if any,” Dr. Ridley said.

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