FDA Expands Probe Into Safety of AstraZeneca's COVID-19 Vaccine - COVID-19 Clinical Trial
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FDA Expands Probe Into Safety of AstraZeneca’s COVID-19 Vaccine

The FDA has expanded its investigation into AstraZeneca’s COVID-19 vaccine to include data from clinical trials of prophylactics based on the same viral vector platform, Reuters reports.  AstraZeneca quickly gained regulatory clearance to resume dosing in the U.K. part of its development program after a case of transverse myelitis triggered a clinical hold. Regulators in Brazil, India and South Africa have also given AstraZeneca the green light to resume. However, the U.S. phase 3 is still on hold.

The FDA reportedly wants to see data from trials of similar vaccines before lifting the clinical hold. AstraZeneca’s COVID-19 vaccine AZD1222 was created by a team at the University of Oxford that previously used the same ChAdOx1 engineered chimpanzee adenovirus in other prophylactics designed to offer protection against infectious diseases including Chikungunya virus, seasonal influenza, malaria, Middle East respiratory syndrome, tuberculosis and Zika virus. 

Hydroxychloroquine Didn’t Prevent Covid-19 Among Health Care Workers in New Study

The malaria drug hydroxychloroquine — which President Trump said he took in the hope of warding off Covid-19 — was found not to prevent infections among volunteers in a study released on Wednesday. The study, which was ended early, included 125 health care workers — some of whom took hydroxychloroquine daily for eight weeks while the others took a placebo.”There was no significant difference in infection rates in participants randomized to receive hydroxychloroquine compared with placebo,” the researchers wrote in the study, published in the journal JAMA Internal Medicine. Based on their findings, the researchers from the University of Pennsylvania wrote that they “cannot recommend the routine use of hydroxychloroquine” among health care workers to prevent Covid-19.

Participants enrolled in the new study from April to July. It found that four of the 64 healthcare workers who were randomly given hydroxychloroquine ended up testing positive for Covid-19 and four of the 61 healthcare workers who were given a placebo tested positive. Among those eight participants who tested positive, six developed symptoms, none required hospitalization and they all clinically recovered from the illness, according to the study.

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