NIH Pauses Eli Lilly COVID-19 Antibody Trial Due to ‘Safety Concerns’
By: Jeremy Loffredo
The National Institutes of Health (NIH) Tuesday paused enrollment in the late-stage clinical trial for Eli Lilly’s COVID-19 antibody treatment. The pause came on recommendation from the independent Data and Safety Monitoring Board (DSMB), which cited safety concerns.
The trial, sponsored by the NIH’s National Institute of Allergy and Infectious Diseases, is part of the NIH’s ACTIV-3 trial to test the experimental antibody treatment on COVID-19 patients who have already been hospitalized.
An NIH spokesperson told The New York Times that patients who had received the antibodies showed a different “clinical status” than those who received the placebo.
According to The Times, the guidelines for the trial include two “stopping rules,” or issues that would require the trial to be paused. One is “futility,” meaning the treatment is proven to have a low chance of working. The trial also can be stopped if patients in one group are faring worse than those in the other.
In a statement, the drug maker said:
“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.
“Importantly, the DSMB also considered the impact of the ACTIV-3 study pause on ACTIV-2 and did not recommend any changes to that study’s design or enrollment.”
This isn’t the first time a government agency has raised concerns about the Eli Lilly antibody trial. In November, the U.S. Food and Drug Administration (FDA) cited quality control issues at the manufacturing plant producing the experimental antibody treatment.
According to Reuters, the FDA classified the problems as the most serious level of violation, resulting in an “Official Action Indicated” notice. That means the “violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” a former associate counsel at the FDA told Reuters.
In an interview with MSNBC, Bill Gates, whose foundation is partnering with Eli Lilly to distribute the treatment to low and middle income countries, said he hopes this safety pause doesn’t “hold back the product.”
The Eli Lilly pause comes just one day after Johnson & Johnson halted its COVID-19 vaccine trials. A participant in that trial suffered what is believed to be an adverse reaction, but the specific illness has yet to be made public.
Related articles by Jeremy:
The above article NIH Pauses Eli Lilly COVID-19 Antibody Trial Due to ‘Safety Concerns’ originated on Children’s Health Defense and has been re-published here on TLB by ‘contribution’ with attribution to the articles author Jeremy Loffredo and Children’s Health Defense.
TLB Editors Note: This is World Mercury Project on steroids! TLB highly recommends you click on the image below, visit this great website, and do whatever you can to help see this vital forum succeed … for the sake of our children !!!
Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.
Stay tuned to …
The Liberty Beacon Project is now expanding at a near exponential rate, and for this we are grateful and excited! But we must also be practical. For 7 years we have not asked for any donations, and have built this project with our own funds as we grew. We are now experiencing ever increasing growing pains due to the large number of websites and projects we represent. So we have just installed donation buttons on our websites and ask that you consider this when you visit them. Nothing is too small. We thank you for all your support and your considerations … (TLB)
Comment Policy: As a privately owned web site, we reserve the right to remove comments that contain spam, advertising, vulgarity, threats of violence, racism, or personal/abusive attacks on other users. This also applies to trolling, the use of more than one alias, or just intentional mischief. Enforcement of this policy is at the discretion of this websites administrators. Repeat offenders may be blocked or permanently banned without prior warning.
Disclaimer: TLB websites contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available to our readers under the provisions of “fair use” in an effort to advance a better understanding of political, health, economic and social issues. The material on this site is distributed without profit to those who have expressed a prior interest in receiving it for research and educational purposes. If you wish to use copyrighted material for purposes other than “fair use” you must request permission from the copyright owner.
Disclaimer: The information and opinions shared are for informational purposes only including, but not limited to, text, graphics, images and other material are not intended as medical advice or instruction. Nothing mentioned is intended to be a substitute for professional medical advice, diagnosis or treatment.