Geneva [Switzerland], October 13 (ANI/Sputnik): The World Health Organisation (WHO) believes that safety in research is crucial and is pleased to see developers acting by the rules, the WHO spokesperson told Sputnik regarding Johnson & Johnson suspending its vaccine trials.
The company paused the trials earlier this week due to unexplained illness of one of the participants.
“Safety is the primary focus for vaccine clinical trials. When a potentially unexplained illness occurs in a trial participant, which may or may not be related to the vaccine being evaluated, it is rigorous, routine practice to investigate,” the spokesperson said.
WHO pointed out that suspensions were not unusual during vaccine clinical trials.
“We are pleased to see vaccine developers ensuring the scientific integrity of the trials and abiding by the standard guidelines and rules for the development of vaccines,” the spokesperson said.
Eli Lilly pauses COVID-19 treatment trial for Safety Reasons
Washington [US], October 14 (ANI/Sputnik): The US pharmaceutical company Eli Lilly‘s late-stage trial of its leading monoclonal antibody treatment for the novel coronavirus has been paused by health regulators over potential safety concerns, CNBC reported.
“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board has recommended a pause in enrollment,” the report quoted Eli Lilly spokeswoman Molly McCully as saying. “Lilly is supportive of the decision by the independent (Data Safety Monitoring Board) to cautiously ensure the safety of the patients participating in this study.”
The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with remdesivir, an antiviral medication with emergency use authorization for the virus, the report said.
The trial is one of several that are part of the National Institute of Health’s “Activ” program, which is designed to accelerate the development of novel coronavirus vaccines and treatments. The trial is backed by Operation Warp Speed, the Trump administration’s effort to manufacture and distribute novel coronavirus vaccines.
Eli Lilly is testing a combination of two lab-engineered immune system proteins called monoclonal antibodies to treat severely ill patients with the novel coronavirus disease (VOCID-19). The treatment is similar to the one made by Regeneron that was given to President Donald Trump earlier this month after he tested positive for the novel coronavirus.
The decision by Eli Lilly comes after Johnson & Johnson announced that it learned of an “unexplained illness” in one of the volunteers that caused it to pause its Phase 3 coronavirus vaccine trial on Sunday. (ANI/Sputnik)
(ANI/Sputnik)
