One of the nation’s first human clinical trials testing a vaccine for the novel coronavirus is producing encouraging results, according to the Seattle-based scientists leading the study.
Researchers at Kaiser Permanente Washington started the phase-one trial on March 16. In this early phase of developing a vaccine, researchers want to ensure mainly that it does not pose serious health risks, and that it does boost immunity.
Dr. John Dunn, medical director for preventive care at Kaiser and a member of the clinical trials team, says the vaccine shows promise on both counts.
“There don't appear to be any serious safety concerns at all associated with any of the three doses of the vaccine. And those people that received the vaccine did produce immune responses with antibody that neutralizes the virus that causes COVID-19,” he says.
The preliminary data, from 45 adults under age 55, shows that more than half had mild side effects, such as chills and headache, and two people reported side effects considered “severe.”
The new preliminary data suggest that the vaccine can produce a healthy immune response -- generally more, in fact, than people who have already recovered from COVID have on average.
The results are among the first data on potential coronavirus vaccines, and are being published in record time. In an accompanying editorial, Dr. Penny Heaton of the Bill and Melinda Gates Medical Research Institute in Massachusetts called the timeline “remarkable.”
“You know, to go from a genetic sequence all the way to having phase one data in six months is nothing short of phenomenal,” Dr. Heaton, who was not involved in the Kaiser study, told KNKX in an interview.
That kind of early vaccine development typically takes three-to-eight years, Heaton said.
The Kaiser vaccine candidate was co-developed by the National Institute of Allergy and Infectious Diseases and the pharmaceutical company Moderna. It uses mRNA, or bits of blueprint of the virus’s genetic code, to trick the body into mounting an immune response to the virus itself.
The vaccine must still go through phase two and phase three trials, which will enroll many more subjects and take months or years.
Dr. Heaton of the Gates Medical Research Institute says we’ll have to wait and see how this vaccine candidate does in those next trials, which are already beginning, as well as whether the researchers can work with similar speed.
“Can the vaccine world be heroic again?” she said. “You know, we have to identify the right dose, we have to get that into phase three. We have to make sure the vaccine works. You have to confirm the safety. You have to scale up manufacturing. That's another six years to eight years of work. So can that be compressed to six or twelve months? That's the question. That's the challenge out there.”