‘Out of an abundance of caution’
The late-stage trial of a potential COVID-19 antibody vaccine by Eli Lilly was paused by the National Institute of Health after an unexplained health reaction that a trial patient experienced.
Molly McCully, spokeswoman of the company said that “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 (DSMB) has recommended a pause in enrollment. Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”
The company nor the federal researchers have revealed what the safety concern was about and whether the patient received the vaccine or the placebo.
Pauses in Vaccine Trials
Large trials have a bigger potential for participant patients to experience adverse reactions resulting from an unrelated illness. It is, therefore, not uncommon to find pauses in trials of this magnitude.
Johnson & Johnson also had their trials paused earlier in the week and has explained that “adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”
There are 326 participants hospitalized with COVID-19 who were enrolled in Eli Lilly’s trials that are testing a high-dose version of the company’s monoclonal antibody combined with the drug Remdesivir. The trial is being sponsored by the National Institute of Health.
The company said in a statement that “at this time, only the DSMB has reviewed the data from the trial, and NIH leadership and Lilly remain blinded to the ongoing trial results… Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study.”
Editor’s note on the news about the pause of the Eli Lilly Antibody Trial:
This article is created to inform you of the news about the pause of the Eli Lilly Antibody Trial. If you have questions regarding the news and its updates, please send us a message!
For further information, don’t hesitate to send us an email at Outreach@ConsiderTheConsumer.com, find us on Twitter or Facebook, or even connect with us directly on our website! We look forward to hearing from you all.
Similarly, please check out our current list of Class Actions and Class Action Investigations, here.
Interested in articles like these? Become a subscriber below!