2 Covid vaccine trials halted in phase 3 over safety concerns

After Johnson & Johnson paused phase 3 of its Covid vaccine trials due to safety concerns, a second pharmaceutical company has followed suit. Eli Lilly has halted phase 3 trials of a lab-produced antibody treatment, 24 hours after the Johnson & Johnson decision. The Bangkok Post reports that an unspecified incident led Eli Lilly to call a temporary halt to the trials. The day before, Johnson & Johnson paused its phase 3 trials after a participant fell ill. A spokesperson for J&J says the hiatus is temporary.

The 2 delays follow a similar incident with phase 3 trials of a vaccine being jointly worked on by Oxford University and Astra Zeneca, which was briefly delayed last month due to an unexplained illness in one participant. Trials of that vaccine have now resumed globally, with the exception of the US, for reasons unknown. Such snags are par for the course in the final phase testing of vaccine development, particularly as the number of participants is increased significantly to see if very rare side-effects are presented.

A spokesperson for Eli Lilly says the company backs the Data Safety and Monitoring Board in calling a temporary halt to phase 3 trials.

“Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

Eli Lilly’s trial began in August, aimed at recruiting 10,000 participants, across 50 sites, including the US, Denmark and Singapore, using a lab-produced antibody treatment, similar to that developed by Regeneron and used to treat US President Donald Trump recently. Eli Lilly has not given any further information about the safety concern which has paused phase 3.

Meanwhile, a J&J spokesman says such breaks are to be expected in large-scale trials and that reported illnesses or side-effects may be unrelated to the vaccine.

“It’s not at all unusual for unexpected illnesses in large studies over their duration. In some cases, serious adverse events may have something or nothing to do with the drug or vaccine being investigated.”

SOURCE: Bangkok Post