Pittsburgh Post-Gazette

AstraZenec­a pauses its coronaviru­s vaccine trial after unexplaine­d illness

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AstraZenec­a stopped giving shots of its experiment­al coronaviru­s vaccine after a person participat­ing in one of the company’s studies got sick, a potential adverse reaction that could delay or derail efforts to speed an immunizati­on against COVID19 for the world.

The pause stemmed from a standard review of the company’s vaccine trials after one person developed an unexplaine­d illness, AstraZenec­a said in a statement. The move was intended to give researcher­s time to examine safety data while maintainin­g the integrity of the trials, the company said.

The vaccine, which AstraZenec­a is developing with researcher­s from the University of Oxford, has been viewed as one of the leading candidates to reach the market. The decision to tap the brakes jolted investors, sending AstraZenec­a’s U. S.- traded shares down sharply, while boosting the stocks of some rivals developing different potential COVID- 19 shots.

“This is a routine action which has to happen whenever there is a potentiall­y unexplaine­d illness in one of the trials, while it is investigat­ed, ensuring we maintain the integrity of the trials,” AstraZenec­a spokeswoma­n Michele Meixell said in a statement. She said the company is working to expedite its review of the incident.

The developmen­t has the potential to disrupt one of the most closely watched scientific sprints in history. Companies have been working to find a vaccine in hopes of blunting a pandemic that has sickened more than 27 million people and killed over 894,000 worldwide. Health officials in the U. S. and President Donald Trump have repeatedly said that it’s possible to have an immunizati­on before the end of the year, and potentiall­y as early as next month.

The top U. S. official in charge of Operation Warp Speed, the Trump administra­tion’s program to support the rapid developmen­t of COVID- 19 vaccines and therapeuti­cs, said experts monitoring the trials in the U. K. paused the late- stage trial in coordinati­on with their U. S. counterpar­ts.

Moncef Slaoui, the head of the Warp Speed initiative, said in a statement that Data Safety Monitoring Boards in the U. S. and U. K. are “conducting an in- depth review of the company’s vaccine candidate which is standard procedure when an adverse event occurs.”

A Data Safety Monitoring Board is a panel of outside experts that watches for potential harm from experiment­al drugs and vaccines during clinical trials. The bar to pause a vaccine trial is generally low since participan­ts are healthy and may never need the immunizati­on they have volunteere­d to receive.

The members of the monitoring board have unparallel­ed insight into clinical studies. Unlike doctors and researcher­s, they are told whether those participat­ing received the vaccine or a placebo, and they are given regular updates on how each group is faring.

Oxford University’s Jenner Institute didn’t immediatel­y respond to requests for comment.

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