China COVID-19 Vaccine Trial Halted In Brazil After Reports Of Patient's Death

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by Tyler Durden
Tuesday, Nov 10, 2020 - 07:11 AM

We haven't heard too many negative reports about China's full-court press for a COVID-19 vaccine, which involves at least half a dozen standalone projects that have reached the latest stages of testing. But just as trials for the AstraZeneca-Oxford vaccine project, and other western projects, have been halted, sometimes for weeks at a time, so now too are some Chinese projects hitting a wall.

It just goes to show that while Beijing has grown adept at using its economic muscle to browbeat its geopolitical rivals/partners into acquiescence, dealing with foreign regulators who must inevitably scrutinize Chinese vaccines (as trials of Chinese-developed vaccines are underway around the world) can have its limits, as Brazil has showed us today.

On Tuesday morning in Asia (late Monday in Brazil), Bloomberg reported that a final-stage trial of one of the Chinese "frontrunners" had been halted by Brazilian regulators due to a "serious adverse event". The incident marks, as Bloomberg points out, "the first time that any of the Asian nation's rapidaly developed COVID-19 shots have met with such a setback."

The order impacts Sinovac's vaccine candidate, "Coronavac". The halt began on Oct. 29, nearly two weeks ago, after a subject became ill. Like in the west, details about the decision were scant, and Brazilian officials provided little insight into the nature of the problem.

Testing of Sinovac Biotech Ltd.’s vaccine, called Coronavac, has been halted in Brazil after an event that occurred on Oct. 29, said the Brazil Health Agency on Tuesday, without any further detail on the illness. The study is interrupted in accordance with regulations while the agency analyzes if the study should continue, it said. Serious adverse events that occur in drug trials include death, immediate risk of death, long term or serious incapacitation, and hospitalization. Such pauses are not uncommon in large-scale drug trials and two western developers - AstraZeneca (NYSE:AZN) Plc and Johnson & Johnson -- have paused their vaccine trials in recent months due to serious adverse events, only to re-start them after investigation.

According to the NYT and its virus tracker, the Sinovac program is one of 11 experimental vaccines currently in Phase 3 testing. Heaping further embarrassment on Sinovac and Beijing, news of the suspension comes just after data from the Pfizer-BioNTech trial purported to show that the vaccine was sufficiently effective.

Beijing has already allowed tens of thousands of Chinese to receive the Sinovac candidate, along with several other experimental vaccines, as Chine has aggressively stretched the definition of "emergency" use.

While Brazil was mum, Sinovac put out a statement vouching for the safety of its vaccine.

In a statement issued on Tuesday, Sinovac said Instituto Butantan, the medical center coordinating the Brazilian trials, had deemed the “serious event” not related to the vaccine. The company said it was “confident in the safety” of its vaccine.

To be sure, the halt follows reports published late last month that a coronavirus study vaccine volunteer had died in Brazil, but it's not clear whether the "serious adverse effect" reported by the Brazilian government was indeed the death of a study participant. Phase 3 trials employ tens of thousands of patients, and it's certainly possible that deaths are unrelated to the virus, or the vaccine.

But it certainly raises some uncomfortable questions.

Perhaps Beijing needs to invest more resources and energy into promoting the vaccine safety narrative in Brazil, Pakistan and other 'partner' nations?