AstraZeneca COVID-19 Vaccine Study Put on Hold After Report of a Suspected Adverse Reaction

September 10, 2020 by Christen Aldrich

Filed under COVID-19 for Employers, COVID-19 for the Workforce

Last modified September 11, 2020

According to this article by STAT News, a large, Phase 3 study testing a COVID-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, a frontrunner in the race for a COVID-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”

Clinical holds are not uncommon, however it’s unclear how long AstraZeneca’s might last. The progress of the company’s trial — and those of all COVID-19 vaccines in development — are being closely watched given the pressing need for new ways to curb the global pandemic. There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 COVID-19 vaccine trial known to have been put on hold.

It was not immediately clear what steps were being taken at study sites across the U.S. in response to the hold. Clinical holds in ongoing studies often involve a pause in recruiting new participants and dosing existing ones, unless it’s deemed in the interest of participant safety to continue dosing.

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