As commercial manufacturers push their COVID-19 vaccine candidates through the final phases of clinical trials, researchers at the Walter Reed Army Institute of Research, or WRAIR, are taking their time to develop one that they hope will protect against any coronavirus, from the common cold to COVID.
Manufacturing of the Army's candidate, called Spike Ferritin Nanoparticle, or SpFN, is underway at WRAIR's Pilot Bioproduction Facility in Silver Spring, Maryland, and it is being tested in monkeys, said Dr. Kayvon Modjarrad, WRAIR director for emerging infectious diseases.
Human safety trials are expected to begin "this winter" -- likely in early 2021, Modjarrad said during a media roundtable Wednesday at the Association of the United States Army's annual meeting, held virtually this year because of the pandemic.
"With respect to the timeline of our clinical trial, it all depends on the manufacturing process. That has really been the key to all the vaccines -- how quickly you can scale up manufacturing for the different phases of the clinical trial and beyond that to licensure," Modjarrad said.
WRAIR’s COVID-19 vaccine effort began Jan. 11, the day after Chinese researchers published the coronavirus' genetic sequence, enabling scientists to more fully understand the lethal pathogen.
With that genetic makeup in mind and building on research on the coronavirus that causes Middle East Respiratory Syndrome, or MERS, WRAIR scientists developed SpFN as a protein base -- ferritin -- that can carry one or more spike proteins engineered to block infection and elicit an immune response, according to Modjarrad.
It was first tested in mice, and data is now being collected on its efficacy in monkeys. So far, he said, nothing has "given me pause" about the vaccine’s safety or effectiveness, adding "there's a lot that gives me encouragement."
"I don't want to give premature data," Modjarrad said. "[But] in some ways, we are reaping the benefit of being a little bit later, being a more forward, long-term thinking, second-tier candidate, taking an approach to multiple seasons of COVID-19."
In addition to developing its own vaccine, the Defense Department is supporting development of other candidates from commercial manufacturers through Operation Warp Speed, the Trump administration's effort to field COVID-19 treatments and immunizations.
The Pentagon signed an agreement last month with AstraZeneca to support Phase III clinical trials for the company's vaccine at five U.S. military health care facilities. Within days of announcing the partnership, however, the AstraZeneca vaccine trial was halted after a participant developed an inflammatory disorder known as transverse myelitis. While company officials said the illness was unlikely to be associated with the vaccine "or there was insufficient evidence to say for certain," the research remains on pause in the U.S. It has restarted in the United Kingdom and elsewhere.
Earlier this week, Johnson & Johnson also announced a pause in its vaccine research, saying Tuesday that a participant had experienced an "unexplained illness." The company has not disclosed the nature of the issue.
"We must respect this participant's privacy. We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information," Johnson & Johnson officials said in a release.
Army officials said their goal with SpFN is to develop a universal vaccine that could prevent various types of coronavirus infections, from the common cold to deadly pathogens such as those that cause COVID-19, MERS and Severe Acute Respiratory Syndrome (SARS).
Also, WRAIR scientists are working on genetically engineered spike proteins that could be attached to the SpFN base to fight off any future coronaviruses that may jump from animal to human, just as the SARS-CoV-2 started the current pandemic.
"We are looking at coronavirus spike proteins that have been only isolated from bat populations. ... We are trying to not only be in a reactive mode, but be anticipating the next coronavirus that might emerge from the animal reservoir," Modjarrad said.
He said he expects to have data from WRAIR's study of the vaccine in monkeys in the "next few weeks." The lab will use the information to develop its Phase I safety trials and determine whether one or two doses will be needed to protect against COVID-19.
Widespread pandemics can have a profound effect on military readiness: To date, 49,331 service members, or 3.6% of U.S. forces, have contracted COVID-19; eight have died. As of Oct. 14, 18,423 soldiers, 6,143 Marines, 10,888 sailors, 7,745 airmen, 5,773 National Guard members and 359 unidentified service members assigned to DoD agencies had tested positive.
An additional 22,669 individuals affiliated with the DoD, including dependents, civilian employees and contractors, also have been diagnosed with the coronavirus
Worldwide, more than 38.3 million people have contracted the coronavirus, and 1.088 million have died. There have been nearly 7.9 million cases in the U.S. and 216,169 American deaths, according to Johns Hopkins University.