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© Bloomberg. BEIJING, CHINA – SEPTEMBER 24: A worker checks syringes of the potential CoronaVac vaccine on the Sinovac Biotech production line, where the company is producing its potential COVID-19 CoronaVac vaccine during a press tour on September 24, 2020 in Beijing, China. Sinovacs’ inactivated candidate vaccine, called CoronaVac, is among several companies in the global race to control the coronavirus pandemic. The company is running phase 3 human trials in four countries and is increasing production to 300 million doses per year at a new manufacturing facility south of Beijing. The lack of domestic coronavirus cases in China has meant that companies developing vaccines have shifted their focus abroad to conducting 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 Sinovacs chief executive says the company supplied tens of thousands of doses, even as testing is still ongoing. About 90% of Sinovacs employees have chosen to receive injections of CoronaVac, which is one of eight Chinese candidate vaccines in human trials. The company is also seeking approval to begin clinical trials with adolescents and children as young as 3 years of age (Photo by Kevin Frayer / Getty Images).(Bloomberg) – The end-stage trial of a leading vaccine candidate in China has been halted in Brazil due to a serious adverse event, the first time that any of the rapidly developed Covid-19 injections in the Asian nation have run into such a reverse.
Testing of Sinovac Biotech Ltd.’s vaccine, called Coronavac, was halted in Brazil after an event that occurred on Oct. 29, the Brazilian Health Agency said Tuesday, without further details on the disease. The study is halted in accordance with 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, severe or prolonged disability, and hospitalization.
These pauses are not uncommon in large-scale drug trials and two Western developers, AstraZeneca (NYSE 🙂 Plc and Johnson & Johnson, have halted their vaccine trials in recent months due to serious adverse events, only to restart them after an investigation. .
But China has already started administering its vaccines, including Coronavac, to hundreds of thousands of people under broad approval for emergency use, making the possibility of a safety issue being detected at this stage all the more concerning.
China defends the application of experimental vaccines to thousands of people
Last month, China’s Ministry of Science said its companies have inoculated about 60,000 volunteers in end-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 lull in the trial in Brazil.
Chinese vaccine developers have been at the forefront of the global race to create effective immunization against the virus. The momentum has become vitally important as countries seek to move beyond Covid-19 and permanently reopen their economies.
The vaccine development processes, which generally take years, have been squeezed into months by global players, encouraged by politicians who want a quick solution to the pandemic that has sickened more than 50 million.
The Chinese reverse comes as Pfizer Inc. (NYSE 🙂 and BioNTech SE (NASDAQ 🙂 published the first findings showing that a vaccine they are developing prevented more than 90% of symptomatic infections in the trial of tens of thousands of volunteers, raising hopes of a rapid neutralization of Covid-19.
(Updates with the response of the Sinovac company in the sixth paragraph. An earlier version corrected the date of the serious adverse event in Brazil to October 29)
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