Volunteer in Oxford Covid vaccine test dies in Brazil

Yolanda Curtis
October 23, 2020

The US paused trials of the vaccine from AstraZeneca, which is based in the United Kingdom, after reports of serious illness during the UK trial, pending a review from the US Food and Drug Administration (FDA).

"Completing enrollment of the Phase 3 COVE study is an important milestone for the clinical development of mRNA-1273, our vaccine candidate against COVID-19", said Stéphane Bancel, Chief Executive Officer of Moderna in the news release.

40 of the 53 participants who do become ill with COVID-19 need to have received the placebo, which would show that the vaccine is 75% effective.

The death was reported by news outlet O Globo. "Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue", Oxford University told CNN in an emailed statement on Wednesday.

According to CNN, Moderna is the first company to start United States clinical trials of a COVID-19 vaccine. While temporary pauses in vaccine studies are common, AstraZeneca and Oxford have faced pressure to disclose more information about the United Kingdom episode.

While neither ANVISA nor the medical centres involved in the Brazilian volunteer's care would confirm the person's status in the trial, O Globo cited anonymous sources who reportedly said the volunteer was in the placebo group, meaning they did not receive an experimental vaccine.

An AstraZeneca spokesperson said that the company can not comment on individual cases in an ongoing trial due to medical confidentiality and clinical trial regulations. The ministry continues to work with companies to ensure proper vaccine trials are taking place in Japan, he said.

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.

The firm said more than 11,000 are "from communities of color, representing 37 percent of the study population and similar to the diversity of the U.S.at large" - 6,000 are Hispanic or Latino, and more than 3,000 are African-American.

-With assistance from Riley Griffin and Lisa Du.

Other reports by iNewsToday