miércoles, 9 de septiembre de 2020

AstraZeneca’s Phase 3 vaccine for Covid-19 put on clinical hold

https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/?utm_source=STAT+Newsletters&utm_campaign=d65d996d15-EMAIL_CAMPAIGN_2020_09_08_09_02&utm_medium=email&utm_term=0_8cab1d7961-d65d996d15-149692869
The Readout
Damian Garde & Meghana Keshavan


AstraZeneca’s Phase 3 vaccine for Covid-19 put on clinical hold

A large, late-stage Covid-19 vaccine trial led by AstraZeneca and the University of Oxford trial has been put on hold, STAT reports exclusively, due to a suspected severe adverse reaction in a U.K. volunteer. 
Clinical holds are not uncommon, and a source familiar with the matter said it’s being placed “out of an abundance of caution.” Another told STAT, however, that this reaction is already impacting other AstraZeneca vaccine trials — as well as trials conducted by other vaccine makers. Researchers are now combing their databases, looking for similar adverse events in other patients.
We still don’t know what sort of adverse reaction prompted the hold, but the trial participant is expected to recover. A phase 1/2 study published in July showed that about 60% of the 1,000 participants given the vaccine had some sort of side effect — though the majority were deemed mild or moderate. 

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