China vaccine trial suspended after serious adverse event by Bloomberg

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© Bloomberg. BEIJING, CHINA - SEPTEMBER 24: A worker checks syringes of the potential CoronaVac vaccine on the production line of Sinovac Biotech where the company produces its potential COVID-19 vaccine CoronaVac during a media tour on September 24, 2020 in Beijing, China China. The Sinovacs inactivated vaccine candidate, called CoronaVac, is one of a number of companies in the global race to control the coronavirus pandemic. The company is conducting Phase 3 human trials in four countries and is ramping up production to 300 million doses per year at a new plant 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 collect the volume of data needed to gain regulatory approvals. When the Chinese government launched an emergency use program in July to vaccinate groups of essential workers, the chief executive of Sinovacs said the company had provided tens of thousands of doses, even as trials were ongoing. About 90% of Sinovacs employees opted to receive injections of CoronaVac, one of eight Chinese vaccine candidates in human trials. The company is also seeking approval to begin clinical trials with adolescents and children as young as 3 years old. (Photo by Kevin Frayer / Getty Images)

© Bloomberg. BEIJING, CHINA – SEPTEMBER 24: A worker checks syringes for the potential CoronaVac vaccine on the production line of Sinovac Biotech where the company produces its potential COVID-19 vaccine CoronaVac during a media tour on September 24, 2020 in Beijing, China . Sinovacs’ inactivated vaccine candidate, called CoronaVac, is one of a number of companies in the global race to control the coronavirus pandemic. The company is conducting phase 3 human trials in four countries and increasing production to 300 million doses per year at a new plant south of Beijing. A lack of domestic coronavirus cases in China has meant companies developing vaccines have shifted their focus overseas to conduct trials in order to collect the volume of data needed to gain regulatory approvals. When the Chinese government launched an emergency use program in July to vaccinate groups of essential workers, the chief executive of Sinovacs said the company had provided tens of thousands of doses, even as trials were ongoing. About 90% of Sinovacs employees opted to receive injections of CoronaVac, one of eight Chinese vaccine candidates in human trials. The company is also seeking approval to begin clinical trials with adolescents and children as young as 3 years old. (Photo by Kevin Frayer / Getty Images)

(Bloomberg) – Final testing of a favorite Chinese vaccine candidate has been halted in Brazil due to a serious adverse event, the first time any of the Asian nation’s rapidly developed Covid-19 vaccines have experienced a such setback.

Testing of Sinovac Biotech Ltd.’s vaccine, called Coronavac, was halted in Brazil after an event on October 29, the Brazilian Health Agency said on Tuesday, without further details on the disease. The study is being halted according to regulations while the agency analyzes whether the study should continue, he said.

Serious adverse events that occur in drug trials include death, immediate risk of death, long-term or severe disability, and hospitalization.

Such breaks are not uncommon in large-scale drug trials and two Western developers – AstraZeneca (NYSE 🙂 Plc and Johnson & Johnson – have suspended their vaccine trials in recent months due to serious adverse events, for them. restart after investigation.

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

China defends giving experimental vaccines to thousands of people

Last month, China’s science ministry said its companies had inoculated about 60,000 volunteers in end-stage trials, but no serious adverse events were reported. The representative of the Sinovac company did not immediately respond to a request for comment on the stay of the trial in Brazil.

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

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

Chinese reverse comes as Pfizer Inc. (NYSE 🙂 and BioNTech SE (NASDAQ 🙂 published the first results showing that a vaccine they were developing prevented more than 90% of symptomatic infections in the trial of tens of thousands of volunteers, bolstering the hope for a rapid neutralization of Covid-19.

(Updates with Sinovac Company’s response to the sixth paragraph. An earlier version corrected the date of the serious adverse event in Brazil to October 29)

© 2020 Bloomberg LP

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