GC Ebola 1 (copy)

Research technicians dispose of materials while doing a cell culture drug screen of Ebola virus in a BSL 4 containment lab at USAMRIID on Fort Detrick in 2012.

A vaccine that recently received approval from the Food and Drug Administration has its roots at Fort Detrick.

Pharmaceutical company Merck announced Friday that ERVEBO, the company’s Ebola vaccine, received approval from the FDA.

The vaccine was shown to be effective in a clinical trial and is already in use in the current outbreak of Ebola in the Democratic Republic of Congo. It is only effective against the Zaire strain of Ebola, according to the Merck press release.

Prior to approval, the vaccine could only be used in emergencies, like the current outbreak, said Dr. John Dye, chief of viral immunology at the U.S. Army Medical Research Institute of Infectious Diseases. With the approval, it can be used as a proactive measure to help prevent outbreaks, instead of responding.

“The approval of the vaccine allows us to get ahead of the virus rather than always playing catchup,” Dye said in an email.

Like the four drugs tested for Ebola treatment, units on Fort Detrick were part of the vaccine’s early development.

The Joint Project Manager for Chemical, Biological, Radiological and Nuclear Medical (JPM-CBRN) helped provide a test that allowed Merck to test human and non-human primate samples. Comparing the two samples is part of the FDA’s requirements for licensure, according to a press release from JPM-CBRN.

The group also worked to lay out a methodology for the safety data collected from the phase 1 clinical trial, the first round of trials, said Col. Ryan Eckmeier, joint project manager for Chemical, Biological, Radiological and Nuclear Medical.

The group also set the methodology that would allow different groups to compare data in an “apples to apples” way, he said.

The team has been working on the creation of the Ebola vaccine since 2004, Eckmeier said. In 2014, there was renewed interest for a vaccine because of the outbreak in West Africa, he said.

It has been a partnership from the beginning, Eckmeier said, including with other units on the fort’s campus.

“No one in this space could do it alone,” he said.

Amy Shurtleff, with USAMRIID, led several studies examining the vaccine in animal models, which is a necessary step to support human clinical trials, USAMRIID spokeswoman Caree Vander Linden said in an email.

USAMRIID was involved with the development of the vaccine early on, Dye said, helping to test the immune response and feasibility.

“We are excited that this product will now be available to help the global community,” Dye said in an email.

Research was also done through the National Institute of Allergies and Infectious Diseases, which has a presence on Fort Detrick, as well as the Walter Reed Institute of Research. Walter Reed falls under US Army Medical Research and Development Command, which is headquartered at Fort Detrick.

Doses of the vaccine will likely be ready by fall 2020, according to the Merck press release. The pharmaceutical company will work with the World Health Organization, the United Nations, the U.S. government and Gavi, the Vaccine Alliance, to determine how to disperse the vaccine.

One group of people who might receive it is military members, Eckmeier said, although that will be determined by the Department of Defense.

This will give soldiers and their family members a level of protection if stationed in an area where Ebola Zaire is prevalent. They will also have some protection if called to provide support in an area experiencing an outbreak, Dye said.

“Having an available Ebola virus vaccine is a huge scientific advance in our attempts to combat emerging infectious diseases,” Dye said in an email.

But even with the advances, Eckmeier was a little hesitant to call the vaccine a “game changer,” noting its limitations against other strains of the virus.

“I would say yes, it is a game changer for Ebola Zaire,” he said.

The vaccine’s existence will not wipe out the disease, he said, noting that with the current outbreak in the DRC, some of the challenges were getting medical help to remote or unsafe areas.

“It’s an additional tool in the toolbox, but it’s a great tool,” he said.

Still, the vaccine is “tremendously important,” Dye said, because it can help decrease the spread of Ebola in Africa, as well as prepare other areas of the world where the virus may spread, as it did in 2014 because of increased air travel.

“While vaccinating the world and eradicating [Ebola] may be a lofty and ambitious goal, having a vaccine that can be employed in future outbreaks to decrease the spread of the virus will have a great impact on this lethal disease,” Dye said in an email.

Follow Heather Mongilio on Twitter: @HMongilio.

Heather Mongilio is the health and Fort Detrick reporter for the Frederick News-Post. She can be reached at hmongilio@newspost.com.

(15) comments

threecents

Perhaps the author of this article can investigate Jayel's claim and settle the controversy.

jayel86

I used to get excited about this stuff but I can only feel bad for all the animals (mostly chimps) that had to die in the most horrific way and not know why. They ship those monkeys in by the bus load. Its one of those behind the scenes things that just isn't right.

gabrielshorn2013

No, they don't. Where do you get your information?

https://www.fda.gov/drugs/nda-and-bla-approvals/animal-rule-approvals

https://en.m.wikipedia.org/wiki/Animal_efficacy_rule

jayel86

Yes they do. quote whatever bs article you want the only way to find a vaccine for humans is to use the closest relative....busloads of them.

threecents

Monkeys, yes. Chimps, no. Busloads, no. https://www.sciencemag.org/news/2017/12/has-biomedical-research-chimpanzees-come-end

jayel86

I get my info from the people that work there.....

gabrielshorn2013

Sure you do (eyeroll). Threecents is absolutely correct below. They may use a few cynos when absolutely required, but NOT chimps. As for the "BS article" as you call it, try reading. That is the official policy for use of animals in such programs. The program must also comply with the Animal Welfare Act, and be regularly inspected, as well as being AAALAC certified.

gabrielshorn2013

See this reference also.

https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/animal-rule-information

threecents

They do use monkeys at Fort Detrick - NEVER CHIMPS - for some research, but not bus loads. That would be way too expensive. Chimps and other apes are way, way, way too expensive. This myth about using busloads of monkeys at Fort Detrick is believed by many longtime residents. I don't know - maybe it was true 60 or 70 years ago, but not more recently.

jayel86

I know a security guard, yes, busloads of chimps....

threecents

That security guard is wrong. Like I said these false rumors about monkeys have been going around Frederick for decades. For me, the chimp angle your security guard came up with is a new one. Here is a link to a 2015 article in the number one US science magazine on why chimps are rarely if ever used anymore in biomedical research anymore in our country. https://www.sciencemag.org/news/2017/12/has-biomedical-research-chimpanzees-come-end

gabrielshorn2013

Thanks for the article three. I remember it from that time. Even back then, research using non-human primates, including chimps, was significantly curtailed.

jayel86

my responses are being deleted for no reason...

gabrielshorn2013

Maybe if you knew what you were talking about, the wouldn't be.

gabrielshorn2013

Congratulations to all the researchers and developers wo participated in bringing this lifesaving vaccine into full cGMP production!

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