BRASILIA (Reuters) – Brazilian health authority Anvisa said on Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University has died, stating it had received data from an investigation into the matter.
The Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, separately said that the volunteer was Brazilian.
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Barely a week after applying for emergency use approval from the FDA for one of its COVID-19 antibody therapeutics, it appears trials for one of Eli Lilly’s therapeutic drugs focused on the virus (Eli Lilly is working on more than just one) have been paused.
News of the trial was broken by a doctor on Twitter before it was swiftly confirmed by several media organizations.
CNBC confirmed that the trial that was paused is for the antibody treatment for which Eli Lilly applied for the EUA, which is probably why the market has reacted so negatively.
Per the NYT report, the government-sponsored clinical trial has been paused because of a “potential safety concern.” The report cited emails that government officials sent on Tuesday to researchers at testing sites, which the company confirmed. The trial was designed to test the benefits of the therapy on hundreds of people already infected with the virus. The company did not say how many volunteers were sick, or any details about their illness.
Eli said in a statement that the independent monitoring board recommended the pause (unlike the JNJ pause announced last night, which was undertaken voluntarily, according to JNJ).
The pause in enrollment comes after Johnson & Johnson confirmed that it had voluntarily paused its Phase 3 vaccine trials after a participant in the 60k person trial came down with an unusual and unspecified illness. An AstraZeneca trial in the US has still not restarted more than a month after issues with a couple of patients caused them to briefly pause all trials around hte world, though all the others have restarted.
Continued at Zerohedge.com