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28-year-old volunteer in AstraZeneca COVID-19 vaccine trial dies

The trial has not been paused as the volunteer did not receive the COVID-19 vaccine but was part of the control group.

Susan Morse, Managing Editor

A volunteer in AstraZeneca's COVID-19 vaccine trial has died, according to Brazilian National Health Surveillance Agency Anvisa, and reported by Reuters.

The volunteer was a 28-year-old physician who treated coronavirus patients in Rio de Janeiro, according to The Washington Post, citing Brazilian newspaper O Globo as its source.

The volunteer did not receive the COVID-19 vaccine, but was in the control group. Half the people in the clinical trial received the experimental vaccine, and the other half received an established meningitis vaccine. The volunteer is believed to have received the meningitis vaccine. The cause of death has not been released.

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AstraZeneca has posted no public comment, but the trial has not been paused.

WHY THIS MATTERS
 
The race for a vaccine continues because it is seen as the best answer to stemming the pandemic.

It has also become politicized around the presidential election in the United States as President Trump has taken criticism over his handling of the COVID-19 pandemic and challenger Joe Biden has said he could do better.

Pfizer has announced plans to submit an application next month to the U.S. Food and Drug Administration seeking approval for its Covid-19 vaccine.

The European Commission has signed a contract on behalf of European Union states with Johnson & Johnson for the supply of 400 million doses of its COVID-19 vaccine candidate, according to Pharmaceutical Technology. The vaccine was developed by J&J subsidiary Janssen Pharmaceutical and is currently in Phase III of clinical trials.
 
J&J plans to make available the first batch for emergency use authorization early next year.

THE LARGER TREND

Two COVID-19 trials have been paused after volunteers got sick. This is the first reported death.

AstraZeneca put its clinical drug trial temporarily on hold in September after a volunteer became ill.

A late-stage study by Johnson & Johnson was paused while the company investigated whether a trial participant's illness was related to the vaccine.

While these temporary setbacks in clinical trials are reportedly common, there is pressure to develop a vaccine, both for health and economic reasons.

The effectiveness of a new vaccine matters. New research has shown that the American public is wary of COVID-19 vaccine that is less than 50% effective, but that confidence grows if a vaccine is shown to be 90% effective.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com