China Vaccine Trial Halted After Serious Adverse Event

  • Bloomberg
China Vaccine Trial Halted After Serious Adverse Event
Credit: © Reuters.

(Bloomberg) -- The final-stage trial of a Chinese frontrunner vaccine candidate has been halted in Brazil due to a serious adverse event, the first time that any of the Asian nation’s rapidly developed Covid-19 shots have met with such a setback.

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.

But China has already started administering its vaccines, including Coronavac, to hundreds of thousands of people under an expansive emergency use approval, making the prospect of a safety issue being detected at this stage more concerning.

China Defends Giving Experimental Vaccines to Thousands

Last month, China’s science ministry said its companies have inoculated about 60,000 volunteers in final-stage trials, but there have been no reports of serious adverse events. Sinovac’s company representative did not immediately respond to a request for comment on the Brazil trial pause.

Chinese vaccine developers have been at the forefront of the global race to create an effective immunization against the virus. The push has taken on vital importance as countries look to move beyond Covid-19 and more definitively re-open their economies.

Vaccine development processes that usually take years have been compressed into months by global players, encouraged by politicians wanting a quick fix to the pandemic that has sickened more than 50 million.

The Chinese setback comes as Pfizer Inc. (NYSE: PFE ) and BioNTech SE (NASDAQ: BNTX ) released early findings showing that a vaccine they are developing prevented more than 90% of symptomatic infections in the trial of tens of thousands of volunteers, boosting hope for a quick neutralization of Covid-19.

(Updates with Sinovac company response in sixth paragraph. An earlier version corrected the date of the serious adverse event in Brazil to Oct. 29)

©2020 Bloomberg L.P.

© Bloomberg. BEIJING, CHINA - SEPTEMBER 24: A worker checks syringes of the potential vaccine CoronaVac on the production line at Sinovac Biotech where the company is producing their potential COVID-19 vaccine CoronaVac during a media tour on September 24, 2020 in Beijing, China. Sinovacs inactivated vaccine candidate, called CoronaVac, is among a number of companies in the global race to control the coronavirus pandemic. The company is running Phase 3 human trials in four countries and ramping up production to 300 million doses per year at a new manufacturing facility south of Beijing. A lack of domestic coronavirus cases in China has meant that companies developing vaccines have shifted their focus overseas to conduct trials to gather the volume of data necessary to win regulatory approvals. When Chinas government launched an emergency use program in July to vaccinate groups of essential workers, Sinovacs chief executive says the company supplied tens of thousands of doses, even as trials are still underway. About 90% of Sinovacs employees have chosen to receive injections of CoronaVac, which is one of eight Chinese vaccine candidates in human trials. The company is also seeking approval to begin clinical trials with teenagers and children as young as age 3.(Photo by Kevin Frayer/Getty Images)

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  • James Vijayakumar @James Vijayakumar
    You can not believe China in any way. This is my conclusion.
    Like 2

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