Johnson & Johnson Halts COVID-19 Clinical Trials Due to "Unidentified Illness Occurrence"

Temporary Suspension of Phase 3 Clinical Trial Involving 60,000 Participants
Fear Spreads Amid Repeated Clinical Side Effects

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] Johnson & Johnson announced that it has temporarily halted clinical trials of its subsidiary Janssen’s COVID-19 vaccine candidate due to the occurrence of an unidentified illness during the trials. Following adverse events in AstraZeneca’s clinical trials, concerns about vaccine safety are expected to intensify.

According to the New York Times (NYT) on the 12th (local time), Johnson & Johnson stated, "An unidentified illness occurred in one of the volunteers participating in the clinical trial, leading us to decide to fully suspend the ongoing Phase 3 trial." "Internal clinical and safety experts, as well as independent monitoring organizations, will promptly review and evaluate the condition," it added. The company also emphasized, "Unexpected serious adverse reactions to investigational drugs are not uncommon in clinical trials," and "This trial suspension is quite different from the trial hold decisions requested by health authorities such as the U.S. Food and Drug Administration (FDA)."

Johnson & Johnson’s COVID-19 vaccine entered Phase 3 clinical trials last month, enrolling 60,000 participants. It has attracted attention as the largest COVID-19 vaccine trial to date. According to AFP, following the decision to halt the trial, the online registration system allowing 60,000 volunteers to enroll was also shut down.

Previously, Johnson & Johnson’s vaccine candidate signed supply agreements with the U.S. government in August and the European Union (EU) on the 8th of this month, positioning it alongside AstraZeneca, Moderna, and Pfizer vaccines as a leading candidate expected to be marketed within the year. If the illness is confirmed to be a vaccine-related adverse effect, the vaccine’s release within this year is expected to be delayed.

Earlier, AstraZeneca and the University of Oxford’s COVID-19 vaccine candidate also experienced a temporary suspension of its Phase 3 trial after a participant developed transverse myelitis as an adverse effect. The repeated reports of adverse events during clinical trials are raising fears about vaccine inoculation.