Pharma Companies Halt COVID Vaccine, Antibody Drug Trials Over Safety Concerns

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An American pharmaceutical company’s late-stage trial of an antibody treatment for the coronavirus has been halted by federal health regulators.

According to CNBC, Eli Lilly had to temporarily cease operations with its new monoclonal antibody treatment over potential safety concerns.

“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,” Eli Lilly spokeswoman Molly McCully told CNBC. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The announcement came less than a day after pharmaceutical giant Johnson & Johnson confirmed that its late-stage coronavirus vaccine trial was also halted after a participant reported an “adverse event.”

Global head of research and development at J&J’s Janssen arm Dr. Mathai Mammen told investors on a conference call Tuesday that the company still has “very little information” on the reason for the holdup, including whether the patient had actually received the vaccine or a placebo.

CNBC cites “medical experts” who note that holdups in medical research and development like this are not uncommon and that the adverse event in the Johnson and Johnson vaccine trial “could be the result of an unrelated illness, and not the drug itself.”

The outlet continues:

The ACTIV-3 trial is designed to test a monoclonal antibody developed by Eli Lilly in combination with Gilead Sciences’ remdesivir, an antiviral with emergency use authorization for the virus. It’s one of several ongoing trials that are part of the National Institute of Health’s “Activ” program, which is designed to accelerate the development of Covid-19 vaccines and treatments. It is also backed by Operation Warp Speed, the Trump administration’s effort to manufacturer and distribute vaccines to fight Covid-19.

Eli Lilly’s drug is part of a class of treatments known as monoclonal antibodies, which are made to act as immune cells that scientists hope can fight the virus. The treatment was developed using a blood sample from one of the first U.S. patients who recovered from Covid-19. AstraZeneca and Regeneron, among other companies, are also working on so-called antibody treatments.

President Donald Trump has championed antibody treatments, specifically Eli Lilly’s, CNBC reports.

“We have these drugs, Eli Lilly and the others that are so good,” the president said earlier this month on Twitter.

“They are in my opinion, remember this, they’re going to say that they’re therapeutic. And I guess they are therapeutic. Some people don’t know how to define therapeutic. I view it different. It’s a cure,” President Trump said. “For me, I walked in. I didn’t feel good. A short 24 hours later, I was feeling great. I wanted to get out of the hospital. And that’s what I want for everybody. I want everybody to be given the same treatment as your president because I feel great.”

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