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RamnandanKumar
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Chinese companies have made a seemingly unstoppable push to the front of the race for a coronavirus vaccine. Yet their speedy ascent has been unhindered by common scientific setbacks being reported by Western rivals, raising questions about how stringently they are vetting and reporting potential safety issues.
The lack of clarity over the standards and safeguards used by Chinese developers is drawing concern because some of their vaccines are being distributed in China under an emergency use program before full regulatory approval. In the US, President Donald Trump repeatedly claimed a working shot would be available there ahead of the Nov. 3 election.
That hasn’t panned out as the most optimistic timelines for US emergency use authorization now go into late November and December, well behind China on this front. There are potentially far-reaching implications for the way China goes about its vaccines. The Asian country has the largest number of candidates in late-stage trials, and Chinese shots could be used by millions worldwide because President Xi Jinping has pledged to share successful ones overseas.
The UK’s AstraZeneca Plc and US-based Johnson & Johnson temporarily halted testing earlier this year after a single participant in each trial got sick, in order to examine the cause. In contrast, China’s science ministry has said its companies have inoculated about 60,000 volunteers in final-stage trials, but there have been no reports of serious adverse events.
One front-runner, China National Biotec Group Co., says it’s vaccinated hundreds of thousands of people under the emergency use program, a sign of how widely Chinese shots are being administered without reports of serious adverse events. Yet scientists say the discovery of health problems are inevitable when tens of thousands of people across ages and with varying conditions are tested -- even if the vaccine isn’t causing the illness.
“Biology is fundamentally messy and you will always get heart attacks, neurological events and other toxicities by pure random chance," said Michael Kinch, a vaccine specialist at Washington University in St. Louis. “In a large enough population you’re going to see that and so it seems odd, maybe even suspicious, that nothing has been reported at all."
The author of a 2018 book ‘Between Hope and Fear: A History of Vaccines and Human Immunity,’ Kinch said he’d be concerned about data that are “really, really clean." He pointed to research published in 2015 in the journal BMC Medicine that examined 202 late-stage trials, and found that only about 10% didn’t mention serious adverse effects. Even this number likely under-represents the pervasiveness of major adverse effects in testing, Kinch said.
Globally, worries about the safety of coronavirus vaccines are rising as researchers across nations work at an unprecedented pace, buffeted by political pressures and an urgency to end a pandemic that’s killed more than 1 million.
China’s companies and officials say their vaccines have been found safe in the research that’s being conducted. The companies have so far said they’ve seen only mild effects, such as low fevers, pain at the injection sites, itchiness, fatigue and dizziness, symptoms consistent with a regular flu vaccine.