Johnson & Johnson Halts COVID-19 Vaccine Trial Due to 'Unexplained Illness'

By Dana Cruz Oct 13 2020, 05:56 AM EDT

FACT CHECK: Will A COVID-19 Vaccination Be Mandatory Under Federal Law? — Paul Kane/Getty Images

Johnson & Johnson paused its advanced COVID-19 vaccine trial because of an unexplained illness in one of its volunteers.

The drugmaker said that following their guidelines, it will first review and evaluate the participant's illness before pushing forward with their vaccine trial.

According to a statement by Johnson & Johnson, ENSEMBLE independent Data Safety Monitoring Board (DSMB) will look into the vaccine trial participant's illness alongside an internal team of physicians.

Johnson & Johnson added that adverse effects to medication, even those serious, are part of developing a vaccine and conducting a clinical study.

Stat News first reported the pause. The company provided no further details.

Side Effects are 'Normal'

The company said that a "pausing rule" had been met after the illness. A document sent to outside researchers also said the online system used to enroll volunteers has been closed.

J&J's Janssen arm is developing the shot. It's still trying to determine if the illness was related to the vaccine or if it happened to be a coincidence. The nature of the illness was not disclosed.

"We must respect this participant's privacy," the company said. The firm also wanted to gather all facts before sharing additional information about the possible adverse effect.

It added that since the trial is placebo-controlled like other clinical studies, it is unclear what shot the participant received. The company still needs to see if the participant received a placebo or the study treatment.

No Cause for Alarm

Dr. Ashish Jha of Brown University School of Public Health told CNN that such a pause in clinical trials is not a matter of immediate concern.

"It's just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3," she said. She recognized that given the big J&J study of 60,000 people, pauses were expected.

The study also stressed a "significant distinction between a study pause and a regulatory hold. The vaccine study isn't currently on clinical hold, and while J&J said that it normally tells the public about clinical delays, it does not usually say when there are study pauses.

When there is a study pause, recruitment and dosing take a temporary stop. It is a standard clinical trial protocol. Meanwhile, a regulatory hold is required by health authorities like the Food and Drug Administration (FDA).

This is not the first time a COVID-19 vaccine trial was paused because of a patient's adverse reaction. AstraZeneca, which was also on the Phase 3 of its vaccine trial, paused last month because of neurological problems in one of their volunteers in Britain.

The trial has resumed in other countries, but it is still paused in the U.S. as the FDA investigates. The Johnson & Johnson clinical trial started its Phase 3 in September. It is one of the four most advanced vaccines being tested in the U.S.

So far, results show that it only needs one dose. It made federal officials hope the testing of the vaccine could be completed faster than other vaccines.

Its competitors in the vaccine race, the Moderna and Pfizer, require two doses.