Oxford's COVID-19 Vaccine Volunteer Dies

Remigio Civitarese
Ottobre 23, 2020

Pharmaceutical company AstraZeneca formally announced on Wednesday that its Phase III trial in the United Kingdom testing out a vaccine for the coronavirus that causes covid-19 was put on pause, following a report of a serious adverse event among its participants.

The person asked not to be identified because the information isn't public.

Pfizer Inc and Johnson & Johnson are seeking input from a U.S. Food and Drug Administration advisory committee on retaining and attracting volunteers for COVID-19 vaccine trials after a vaccine becomes available, if they know they might receive a placebo.

Brazilian health authority Anvisa said Wednesday that a volunteer in a clinical trial of the COVID-19 vaccine developed by AstraZeneca and Oxford University had died but added that the trial would continue.

Oxford confirmed the plan to keep testing, saying in a statement that after careful assessment, "there have been no concerns about safety of the clinical trial".

The death was reported by news outlet O Globo.

A clinical trial of the vaccine in the US has been on hold for more than a month.

In September, AstraZeneca paused all of its global trials due to an illness in another participant. While temporary pauses in vaccine studies are common, AstraZeneca and Oxford have faced pressure to disclose more information about the United Kingdom episode.

CNN further reported that a spokesman for vaccine maker AstraZeneca declined to comment specifically on reports that a volunteer in its trial of a coronavirus vaccine in Brazil had died, but indicated nothing had happened to justify stopping or pausing the trial. The ministry continues to work with companies to ensure proper vaccine trials are taking place in Japan, he said.

Zydus Cadila and Bharat Biotech are on the verge of completing their phase 2 trials, with Bharat Biotech applying for DCGI approval to start the last stage.

Covaxin is the first indigenous vaccine developed by India against Covid-19 and is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.

AstraZeneca told analysts in early October that it expected the USA study could resume this year and that global approval would be determined by results in tests outside the U.S.

-With assistance from Riley Griffin and Lisa Du.

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