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Sinovac Biotech has seen a phase 3 trial of its pandemic vaccine in hopes that Coronavac would be stopped in Brazil after reports of a serious safety issue, with one report stating that there is a death involved, but that it was not on the vaccine arm.
Details are still a bit vague, but Bloomberg and CNN say that the Brazilian Health Surveillance Agency halted the trial due to the “occurrence of a serious adverse event in one of the volunteers in Brazil.”
No further information has been shared, although director Dimas Covas said in a television interview via Bloomberg that a volunteer in the trial died, but that the death was not due to the vaccine.
This comes less than a day after Pfizer released an interim front-line look through a COVID vaccine press release from partner BioNTech, which showed 90% efficacy, creating a solid rebound in its shares, the biotech industry in general and global stocks.
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But it also comes amid several similar safety shutdowns that have hit AstraZeneca / Oxford University and Johnson & Johnson. These are quite common in large trials and are part of the course, and usually do not stop a trial or drug / vaccine in its tracks. Since then, both companies have resumed their testing.
Even if the safety issue is not related to the vaccine, a study has yet to be stopped and investigated to see what happened. However, this remains a setback for one of China’s leading vaccine candidates, coming as China has, in fact, already begun to inoculate large swaths of people across the country with the vaccine.
There is a political element to the story: Brazilian President Jair Bolsonaro has been critical of the vaccine in the past, saying that Brazilians will not feel safe using it “because of its origin.”
In a brief statement, Sinovac said: “After communicating with the Brazilian partner Butantan Institute [which is helping with the trial], we learned that the director of the 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 clinical study in Brazil is carried out strictly in accordance with the requirements of GCP and we are confident in the safety of the vaccine ”.
