Why Are There Stops And Starts In Coronavirus Vaccine And Treatment Trials?
PITTSBURGH (KDKA) -- With their coronavirus treatments and vaccines, drug companies push ahead and pull back.
Eli Lilly is putting its monoclonal antibody treatment trial on pause due to an unspecified safety concern.
"If it was mimicking the symptoms of the actual virus too much or it was having an overly robust reaction," Allegheny Health Network med-peds physician Dr. Jennifer Preiss surmises about the concern.
An independent review board will examine the data. Just last week, Eli Lilly asked the FDA for emergency use authorization for this therapy -- a manufactured immune system protein to neutralize the coronavirus.
It's a competitor of Regeneron's antibody cocktail that the president received. Regeneron has also applied for emergency use authorization for its product.
This comes just a day after Johnson and Johnson interrupted its late-stage vaccine trial because of an unexplained illness in a study participant.
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"This is basically just good science and careful science, and we need to proceed with caution any time we develop a new vaccine," says AHN primary care internist Dr. Marc Itskowitz.
In September, AstraZeneca temporarily stopped its vaccine trial due to a case of spinal cord inflammation.
"I would anticipate that one of these trials is going to stop, and some are going to continue," Dr. Itskowitz said. "That's just the nature of introducing a new vaccine through research."
Pfizer plans to include children as young as 12 in its vaccine study.
"I think it's absolutely necessary. We're not going to give this vaccine to children if we've only tested it on adults," says Dr. Preiss.
The FDA has approved the plans. While severe COVID is rare in children, they can pass the virus to high-risk groups. Pfizer will enroll younger children based on safety data in teens and young adults.
Typically, new vaccines and treatments take years and decades to develop. When it comes to COVID, we're talking months. Stops and starts are inevitable and should be reassuring. It's all part of the safety process.
