US pharma company Eli Lilly has paused its COVID-19 trial, making it the second treatment for the virus to be paused within the last 24 hours. Potential safety concerns have compelled Eli Lilly to pause phase 3 trials for the lab-produced antibody drug, reportedly over an unspecified incident, AFP reported.
Just a day before, a late-stage study of Johnson & Johnson's COVID-19 vaccine candidate had been paused while the company investigated whether a study participant's unexplained illness is related to the shot. The pause is at least the second such hold to occur among several vaccines that have reached large-scale final tests in the US. The company declined to reveal any more details about the illness, citing the participant's privacy.
Temporary stoppages of large medical studies are relatively common. Few are made public in typical drug trials, but the work to make a coronavirus vaccine has raised the stakes on these kinds of complications.
Companies are required to investigate any serious or unexpected reaction that occurs during drug testing. Given that such tests are done on tens of thousands of people, some medical problems are a coincidence. In fact, one of the first steps the company said it will take is to determine if the person received the vaccine or a placebo.
The halt was first reported by the health news site STAT.
Final-stage testing of a vaccine made by AstraZeneca and Oxford University remains on hold in the US as officials examine whether an illness in its trial poses a safety risk. That trial was stopped when a woman developed severe neurological symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord, the company has said. That company's testing has restarted elsewhere.
Johnson & Johnson was aiming to enroll 60,000 volunteers to prove if its single-dose approach is safe and protects against the coronavirus. Other vaccine candidates in the US require two shots.
Incidentally, Donald Trump had last week hailed the drug treatment similar to Eli Lilly’s after the American President tested positive for the novel coronavirus. Trump received an experimental antiviral cocktail made by Regeneron through a compassionate use exemption, a recognition of the above-and-beyond standard of care he receives as president.
The safety and effectiveness of the drug have not yet been proven. And there is no way for the president or his doctors to know that the drug had any effect. Most people recover from COVID-19.
“I had tremendous luck with this Regeneron,” Trump said during a telephone interview with Fox Business Channel, his first since he tested positive. “I'm feeling good. Really good. I think perfect.”
It's not the first time the US president has trumpeted an unproven treatment. He spent months painting the anti-malarial drug hydroxychloroquine as a miracle treatment for the virus taking a preventive course himself even though experts have said it is not effective against COVID-19.
Trump hailed the Regeneron cocktail even as Eli Lilly moves forward with its own similar treatment. Eli Lilly formally asked the Food and Drug Administration last week to allow emergency use of its experimental antibody based on early results suggesting it reduces symptoms. Lilly says it could supply as many as one million doses of its therapy in the final quarter of 2020, with 1,00,000 available in October.
The company said in a statement on Monday evening that illnesses, accidents and other so-called adverse events are an expected part of any clinical study, especially large studies, but that its physicians and a safety monitoring panel would try to determine what might have caused the illness.
(With PTI inputs)