Center halts COVID-19 vaccine trial

Decision is pending AstraZeneca’s safety investigation

Orlando Immunology Center has stopped recruiting volunteers for a coronavirus vaccine clinical trial after British drug-maker AstraZeneca stopped the study because of a report of an unexplained illness in a participant at another location.

All recruitment for the study is on hold until an independent committee concludes its investigation of the adverse reaction. It’s currently unclear if the reaction was caused by the vaccine.

AstraZeneca, which halted the study Tuesday, has not said how long the investigation will take.

The Orlando Immunology Center has recruited 50 patients for the study so far, all of whom have received their first dose of the vaccine or a placebo, said Dr. Edwin DeJesus, the center’s medical director.

The volunteers are being closely monitored and none have reported serious adverse reactions, he said.

“The likelihood that somebody will develop an adverse event should be low,” said DeJesus, during a virtual news conference Wednesday. But because the study volunteers are healthy, “anything that occurs to this population is taken very, very, very seriously until it’s fully investigated,” he said.

OIC is one of more than 60 sites in the U.S. enrolling as many as 30,000 participants for AstraZeneka’s phase 3 trial for the coronavirus vaccine, which has been touted as one of the leading vaccine candidates. The clinical trial, which spans several countries, began its U.S. enrollment on Aug. 31. Volunteers receive two doses of the experimental vaccine, 30 days apart.

AstraZeneca has not released information about the participant with the adverse reaction, but according to the New York Times, the person is in based in the United Kingdom and was diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often caused by viral infections.

The company reported that in the earlier phases of the trial many participants experienced mild or moderate side effects, including chills and muscle ache and headache but there were no serious side effects.

It’s not uncommon for clinical trials to be put on hold when there’s an unexpected adverse re

action in volunteers, but experts have worried that in rush to develop a coronavirus vaccine, federal officials could approve a vaccine before it’s proven safe and effective.

Yet, even though President Trump has pushed for the approval of a vaccine by Election Day, vaccine makers, including AstraZeneca, have signed a pledge to only move forward when their products are safe and effective.

“This ought to be reassuring,” NIH Director Dr. Francis Collins said before a Senate committee.

“When we say we are going to focus first on safety and make no compromises, here is Exhibit A of how that is happening in practice.”