Because vaccines are designed to be given to millions or billions of healthy people, they must meet extreme safety standards. Even if one person among thousands in a trial gets sick, it may halt the trial.
Some experts told the Times that delays in AstraZeneca’s and J&J’s vaccine trials are comforting in a way, because they show researchers are following proper safety protocols. If a big trial like J&J’s didn’t report an adverse event, “Then you’re concerned that the surveillance system for adverse events isn’t working,” Saad Omer, PhD, director of the Yale Institute for Global Health, told the Times.
But in clinical trials of drugs such as Eli Lilly’s COVID-19 antibody drug, delays are less common, because the people getting the drug are already ill, so a health issue or death wouldn’t be that uncommon, the Times reported. Evidence of an adverse event in drug trials often have to reach a higher bar to stop them.
“I’ve done 50-plus monitoring committees, and it’s quite a rare thing to do,” Tim Friede, PhD, a biostatistician at University Medical Center Göttingen in Germany, told the Times, referring to his role as a safety monitor for drug trials.
The National Institutes of Health has said that Eli Lilly’s trial was halted after the safety board found that patients receiving the drug showed a different “clinical status” than those taking a placebo, but didn’t specify what the difference was.
Read the full article here.
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