Safety concerns pause 2 COVID-19 vaccine trials; will they continue?
The Eli Lilly and Johnson & Johnson companies had announced the pause of their coronavirus and therapy ACTIV-3 clinical trials this month due to safety concerns of their candidates.
These trials are being investigated after concerns were flagged by the Food and Drug Administration and the National Institute of Allergy and Diseases, the pause of both trials have been pushed back causing a delay.
The Eli Lilly released a brief statement on explaining the pause of its trial of a monoclonal antibody vaccine using Bamlanivimab and Remdesivir, therefore the trial was designed to test the benefits of the antibody therapy on hundreds of people with COVID-19.
Johnson & Johnson paused their trial after one of the vaccine candidates fell unexpectedly sick, this left the company and the Data Safety Monitoring Board to investigate the illness before resuming the trial.
“Learning more about this participants illness, and it’s important to have all facts before we share additional information.” Says Johnson & Johnson.
The FDA stopped the vaccine trial from continuing due to flagged problems such as safety concerns and major failure of quality assurance.
In a statement made from Johnson & Johnson on Friday, October 23rd, the company announced that they are preparing to resume recruitment in the Phase 3 ENSEMBLE trial after the independent Data Safety and Monitoring Board overlooked the trial.
Johnson & Johnson describes The Phase 3 ENSEMBLE trial as a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single dose of a vaccine versus placebo in up to 60,000 adults.
There is no update on whether Eli Lilly will resume their study, but they acquired the Disarm Therapeutics, a privately held biotech company, to hold the promises for addressing a wide spectrum of neurological diseases.
Eli Lilly made an agreement to acquire Disarm Therapeutics which deals with neurological disorders for an upfront payment of $135 million making an approach to solve axonal degeneration.
“Lilly continues to seek medicines to treat the debilitating pain and loss of function associated with nerve damage. The scientific team at Disarm discovered an important and highly promising approach to combat axonal degeneration.” Says Mark Mintun, Vice President of pain and neurodegeneration research at Eli Lilly.
The good news is that there is another ongoing trial for the COVID-19 vaccine, the AstraZeneca is one of the recent trials that have been approved by the FDA to resume globally.
The AstraZeneca Oxford coronavirus vaccine is another ongoing trial that had been put on hold in mid-September when a study participant developed neurological symptoms caused by transverse myelitis, a serious spinal cord condition.
The FDA authorized the restart of the trial globally with regulators in the United States, Brazil, South Africa, and Japan.
“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic. We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.” Says Pascal Soriot, CEO of AstraZeneca.
Many vaccine trials have been paused for the coronavirus illness; some have stopped, and others have resumed, this will help thousands who are being hospitalized and being affected by this pandemic.