A Brazilian volunteer taking part in a COVID-19 clinical trial by AstraZeneca and Oxford University has died, Reuters reported citing data from the country’s health authority Anvisa. Shares closed 1.2% lower on Wednesday.
According to the report, Brazil’s health regulator said that AstraZeneca’s (AZN) vaccine trial would continue. Oxford University said in a statement that after careful assessment “there have been no concerns about safety of the clinical trial.” A source familiar with the matter told Reuters the trial would have been stopped if the volunteer who died had been dosed with the COVID-19 vaccine, suggesting the person was part of the control group that was given a meningitis jab.
“Everything is proceeding as expected, without any record of serious vaccine-related complications involving any of the participating volunteers,” the Federal University of Sao Paulo, which is helping coordinate phase 3 clinical trials in Brazil, said in a statement.
So far, 8,000 of the planned 10,000 volunteers in the trial have been recruited and given the first dose in six cities in Brazil, and many have already received the second shot, a university spokesman told Reuters.
In September, a clinical trial of AstraZeneca/Oxford’s vaccine candidate was halted after an adverse event as a UK participant became seriously ill. Since then, the trial has been resumed in the UK, Brazil, Japan, South Africa and India, but in the US it is still on hold. Reuters reported earlier this week that the US COVID-19 vaccine trial is poised to resume as early as this week after the US Food and Drug Administration completed its review.
AZN shares have lost almost 8% over the past month as a result of the halt. (See AstraZeneca stock analysis on TipRanks)
SVB Leerink analyst Andrew Berens recently reiterated a Buy rating on the stock with a $65 price target (26% upside potential) suggesting that the adverse event could have a broader impact and could cause near-term volatility in AstraZeneca’s shares as well as in the stock of other companies with COVID vaccine programs until the exact nature of the event is clear.
As a result, Berens cautions that the overall speed of many of the programs could be affected as the investigation progresses and sponsors become more vigilant, as well as public sentiment regarding the safety of the vaccines once approved.
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