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Sinovac’s late-stage COVID-19 vaccine trial paused in Brazil

Health regulator Anvisa reports that pause is due to severe adverse event

A late-stage clinical trial for Sinovac’s COVID-19 vaccine trial has been paused in Brazil due to a severe adverse event (SAE), according to the country’s health regulator Anvisa.

The Chinese biotech company had been evaluating its vaccine in three large phase 3 clinical trials in Brazil, Indonesia and Turkey. At this point, neither Indonesia nor Turkey have announced a trial pause.

On Monday, Anvisa said that it had decided to pause the clinical trial after an SAE occurred on 29 October, although it did not specify whether it occurred in Brazil or another location. Anvisa also did not clarify the length of the trial suspension.

In a statement, Sinovac said that it had communicated with its Brazilian partner, the Butantan Institute, that is conducting the vaccine trial.

“We learned the head of Butantan Institute believed that this serious adverse event (SAE) is not related to the vaccine. Sinovac will continue to communicate with Brazil on this matter,” the company said.

Sinovac added that it is “confident in the safety of the vaccine”.

According to the BBC, Sinovac has previously said most of its employees, as well as their families, have received the company’s investigational vaccine.

The head of the Butantan Institute, Dimas Covas, told local media that the trial pause is related to a participant's death, although he maintained that this was not related to the vaccine, according to Reuters.

Previously, Sinovac released positive results from a phase 2 study of its COVID-19 vaccine candidate, CoronaVac, in which the vaccine induced detectable antibody-based immune responses in participants and also appeared to be safe to use.

This is not the first COVID-19 vaccine trial to face a suspension – AstraZeneca (AZ) paused a phase 3 study of its vaccine candidate, AZD1222, in September after a participant experienced an SAE.

Johnson & Johnson (J&J) also halted a late-stage trial of its investigational COVID-19 vaccine on 12 October after a participant in the trial developed an unexplained illness.

The AZ trials have since restarted at all global sites, while J&J announced on 23 October that it is preparing to resume recruitment in the pivotal phase 3 trial.

Article by
Lucy Parsons

10th November 2020

From: Research



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