- The Washington Times - Tuesday, October 13, 2020

A pharmaceutical campaign to thwart the coronavirus suffered twin setbacks this week, with Johnson & Johnson pausing its late-stage vaccine trial because of an unexplained illness and a separate drugmaker taking a time-out as it vets a “neutralizing antibody” treatment.

J&J said the trial’s drug-safety monitoring board will analyze the situation, starting with whether the person was in the vaccination arm or placebo side of the trial.

“We’re letting safety protocol follow proper procedure here,” Chief Financial Officer Joseph Wolk told CNBC on Tuesday. “Pauses are something that’s not uncommon.”

He noted that 60,000 people are involved in the study, so an adverse event isn’t shocking.

Also Tuesday, drugmaker Eli Lilly said its data safety monitoring board recommended a pause in the clinical trial of its monoclonal antibody treatment.

It did not say what the safety concern was, exactly, as it carries out the trial with assistance from the infectious-disease branch of the National Institutes of Health.

“Lilly is supportive of the decision by the independent [data safety monitoring board] to cautiously ensure the safety of the patients participating in this study,” the company said.

The hiccups come as the world races to find effective therapies for COVID-19 and a vaccine that can wind down the pandemic that has killed more than 215,000 people in the U.S. alone.

Besides J&J, drugmaker AstraZeneca had to put its phase 3 coronavirus-vaccine trial on hold in early September because of spinal inflammation in a British participant. The trials resumed in other countries but not in the U.S.

President Trump has placed a heavy emphasis on therapeutics and vaccine development for the coronavirus as he seeks reelection. The president says he wants every patient to benefit from the type of monoclonal antibody “cocktail” he received — although his was from Regeneron Pharmaceuticals, not Eli Lilly.

The plan for a vaccine is to get at least one promising candidate approved this fall and inoculate frontline workers by the end of the year, before expanding the effort to the general public through April.

“You’re going to love me even more because we’re years ahead on vaccines and they’re going to be distributed very shortly,” Mr. Trump told Florida supporters Monday. “I mean, frankly, it’s a big political deal going on, where they don’t want it to be before the election. Don’t let it be. But we have great vaccines coming — Johnson & Johnson, Moderna, Pfizer.”

Mr. Wolk said he doesn’t know if the adverse event in the J&J trial is similar to the one reported in the AstraZeneca trial.

The company doesn’t know much yet, he said, since it is up to the independent monitoring board to look into it.

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a written statement.

Mr. Wolk said the J&J trial is on a “pause,” which is different than the regulatory “hold” that U.S. regulators placed on AstraZeneca.

AstraZeneca said health authorities in United Kingdom, Brazil, South Africa, India and Japan have confirmed trials in those countries are safe to resume and is working with the Food and Drug Administration to facilitate the review of information needed to restart in the U.S.

J&J and AstraZeneca are developing vaccines based on a modified virus, or adenovirus, that instructs the body to develop natural defenses. Other companies, such as Pfizer and Moderna, are developing messenger-RNA vaccines.

Mr. Wolk said J&J is “very comfortable” with the safety profile of its platform, noting it has been used to combat illnesses such as Ebola.

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