Kansas City research facility is on the front lines of testing a vaccine to prevent COVID-19 and is one of only two laboratories nationwide to test vaccines that could eventually be approved by the Food and Drug Administration (FDA).
The team is conducting clinical trials on a vaccine that, if approved, soon could be FDA-sanctioned to prevent development of the deadly virus, which has infected more than 1.8 million Americans and caused at least 107, 000 U.S. deaths. These statistics make America the most impacted of all countries worldwide.
Dr. John Ervin, who founded The Center for Pharmaceutical Research in 1986, is leading a team that hopes its clinical trials will identify a viable vaccine against the virus in only a few months.
“We feel very honored and privileged,” he said of his group’s selection to test the vaccine.
He attributed the choice to his firm’s reputation as a leading innovator in the development of such vaccines. His firm, whose name recently was changed to Alliance for Multispecialty Research (AMR) Kansas City, has conducted more than 800 clinical trials, more than 100 of which were vaccine trials, according to Clinical Operations Manager Renee Bussen. At least two of the vaccine trials were for the treatment of Ebola, she said. AMR is located on the Missouri side of State Line Road near St. Joseph Hospital, Ervin said.
The end goal of the clinical trials, Ervin said, is to identify a viable vaccine “by the time the second wave hits,” which public health officials are estimating will be in late fall.
Ervin, a Kansas City, Missouri native who now lives in Leawood, Kan., said, during a telephone interview that although the incidence of those infected has fluctuated during the virus’s life in the past few months, officials are bracing for a huge uptick in cases this fall.
The group is focusing on testing a vaccine created by Inovio Pharmaceuticals, which is based in Pennsylvania, Bussen said. Once China released the virus’s genetic structure, the pharmaceutical company quickly developed what they hope is a viable vaccine.
The group currently is testing the vaccine on humans during phase one of the trials, said Ervin, who has an undergraduate degree from Notre Dame and a medical degree from the University of Kansas School of Medicine. Due to the urgency of finding a prevention, the team is skipping phase two and will enter phase three of testing in July, Bussen said.
Following successful trials in phase three, the vaccine could be cleared for FDA approval, Bussen added.
Each phase of testing involves more test subjects and focuses on different aspects, Ervin said. However, two constants during each phase are safety and efficacy, or effectiveness.
Ervin said, “We hope to heck the FDA will accelerate these before the second wave will come.”
He added that it typically takes five to eight years to develop a vaccine, from research and trials to FDA approval. The urgency with which they are working to develop the vaccine has to do with the virus’s transmission rates, which are expected to increase like other communicable diseases, including influenza, which increases each year in late fall.
The clinical trials consist of human test subjects who are given antigens that allow the body to create antibodies to fight the virus, Ervin said.
“They’re not getting anything alive (no live virus is injected),” he said.
Antigens are substances capable of stimulating the body’s immune system to produce lymphocytes, which are infection-fighting white blood cells.
“The immune system will develop antibodies that recognize that stretch of DNA and basically attack the virus and render it inactive,” he said.
Ervin, whose medical specialty is rheumatology, or the diagnosis of disorders of the immune system, confirmed reports that the virus was transmitted from infected bats sold in open-air marketplaces in Hunan, China. He said reports that Chinese lab workers intentionally created the virus are untrue. The virus infected the bats who, when eaten, morphed into a disease that struck humans.
“Bats are full of viruses that mutate,” he said, adding what once was a virus that infected only bats mutated and.”boom–now all of a sudden, the virus is able to infect humans.”
Initial trials involved infecting Rehesus macaques, a type of monkey, with the virus. The monkeys are used, he said, because they share more than 90 percent of their DNA with humans. The monkeys have aided researchers in medical and scientific studies because of their close ties with humans. In the trials with the monkeys, some infected with COVID survived and exhibited antibodies that enabled them to recover, much like some humans, he said. After trials in monkeys, drugs that seemed to cause antibodies to develop were used to test outcomes.
The testing is done in three phases, with more test subjects used as phases advance. Once identified, researchers need to be able to quickly develop mass quantities of vaccinations because “they are going to need to vaccinate the whole world,” Ervin said.
Up to 45 percent of people who contract COVID are “silent spreaders” who have the disease but are not symptomatic. About 80 percent of those who contract the virus have a mild form and require no hospitalization while 19 percent contract a moderate form of the virus and only five percent have serious cases and require respirators.
He echoed public health officials’ claims that the country’s reaction to the virus has been slowed due to “under-testing,” leaving asymptomatic carriers to spread the disease. In addition, some tests used are inaccurate and have resulted in false readings, which also have contributed to the spread.
Another obstacle faced by researchers in developing and testing, is trying to quickly learn all the nuances of the virus and its mode of transmission.
“We’re learning (something new) every day about it,” he said. “I’m getting sick of reading about it, myself,” he said, adding that it’s his responsibility to “keep up with all the latest news.”
In the meantime, before a vaccine is identified, Ervin echoed public health officials’ prevention warnings about the importance of social distancing and wearing masks and gloves and staying away from face-touching.
He urged “all these people who think it’s a hoax” to research historic plagues and diseases that have wiped out tens of thousands of people before vaccinations were developed.
As explanation for how COVID quickly grew from an isolated virus to a pandemic, Ervin said he has posted a cartoon character named Pogo on printed material to illustrate the disease’s transmission. In it, the character states: “We have met the enemy and he is us.”