Health scares in China put extra scrutiny on efficacy of Chinese-made coronavirus vaccines

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Startling pictures of a baby’s badly swollen face have drawn new attention in China to the safety of locally-made medical products, at a time when the country is racing to inject tens of millions of people with domestic vaccines whose efficacy has been drawn into question.

The parents of a four month-old baby nicknamed “Pomelo” had applied Love Baby Tree, an infant antibacterial cream, when their daughter’s face engorged to nearly twice its normal size.

Suspecting that that the makers of Love Baby Tree had adulterated their product with hormones, they posted pictures of Pomelo online, provoking a panicked response from worried parents and an investigation by regulators. The Zhangzhou Municipal Health Commission and Market Supervision Bureau ordered Love Baby Tree, made by Fujian Ouai Yingtong Health Care Products Co., Ltd., pulled from shelves and off production lines. They also mandated third-party testing.

What happened to Pomelo is “horrifying. It’s crazy,” said Zhang Wen, a sales clerk at the Aiqin Muying Products Store, whose customers warned her about the suspected problems with Love Baby Tree. Local health authorities told The Globe and Mail they continue to investigate. The company did not answer phone calls. Pomelo’s parents did not respond to requests for comment.

“I’ve been in this business for three years, and I can already see the negative impact this scandal will have on us,” Ms. Zhang said. Medical scares only serve to heighten fears over product quality, “not to mention that the pandemic isn’t over,” she said.

Health scares are not new in China, where a series of contaminated drug scandals led to the 2007 execution of Zheng Xiaoyu, the former head of the Chinese State Food and Drug Administration. Since then, other scandals have involved patients paralyzed by contaminated leukemia drugs; a blood pressure medication laced with a probable carcinogen and the fabrication of production and inspection records for a rabies vaccine administered to infants. The 2018 recall of a substandard vaccine for diphtheria, tetanus and whooping cough prompted some parents to swear off Chinese-made vaccines.

The scandals must be set against the scale of an enormous industry that has won considerable trust overseas. Chinese companies supply more than 90 per cent of the antibiotics used in the U.S., and a large majority of the vitamins and acetaminophen used there.

But questions about the trustworthiness of the country’s health regulators have been magnified in the midst of the pandemic, as local companies pump out huge quantities of vaccine doses in a race to inoculate 50 million people ahead of Chinese New Year festivities in mid-February.

This week, however, Brazilian authorities raised pointed new questions about those vaccines when they said Sinovac’s Coronavac vaccine had achieved an efficacy rate of 50.38 per cent, the lowest such rate disclosed among global coronavirus vaccines. Tests in other countries showed much different efficacy rates for Coronavac, with 65.3 per cent in Indonesia and 91.25 per cent in Turkey.

Another Chinese vaccine, made by state-owned Sinopharm, has been found to be 79.34 per cent effective.

Medical authorities in the country have gone to great lengths to assure people that the domestic vaccines are safe and effective. Earlier this month, state media circulated video of Zhang Wenhong, a nationally renowned infectious disease specialist in Shanghai, receiving a Chinese-made COVID-19 vaccine. “Really not painful at all,” he says in the video as he is being jabbed.

He called vaccination “a common rational choice for all countries around the globe.”

International surveys have shown broad support for vaccination in China, although that has been tempered by rising reticence. Last summer, 87 per cent of respondents said they would get the vaccine if available, according to polling by the World Economic Forum and Ipsos. By December, that number had fallen to 80 per cent.

Over that same period, the poll has shown a slight decrease in vaccine unwillingness in the U.S., and a five-point increase in Canada.

Though all COVID-19 vaccines have been brought to market with extraordinary speed, the Chinese products are based on standard techniques, compared to the more novel approach used by the Pfizer and Moderna vaccines. The western formulations are based on mRNA, a technology never before given vaccine approval by the Food and Drug Administration in the U.S.

“There is certainly more uncertainty generated with those vaccines than from those in mainland China,” said Aimin Xu, director of the State Key Laboratory of Pharmaceutical Biotechnology at the University of Hong Kong.

The vaccines developed by both Sinovac and Sinopharm use an inactivated virus, a technique that dates back to polio vaccines.

“It’s been used for many, many years and there is no safety concern,” Prof. Xu said.

There is no reason to doubt the capacity of Chinese pharmaceutical certification, he said. “Many people outside China do not know how rigorous the regulatory approval inside mainland China is,” he said.

China has been the world’s largest manufacturer of active pharmaceutical ingredients for more than a decade, making roughly 40 per cent of the global total. Among consumers, however, some skepticism remains about the quality of domestically-made drugs.

The broad range in efficacy estimates for the Sinovac vaccine only heightened those qualms, some of them expressed on the country’s Twitter-like Weibo service. One person wrote that barely 10 per cent of people at their workplace agreed to a vaccine.

“Domestic medical manufacturers should work harder,” another person wrote. “When it comes to the vaccine, I have two principles,” wrote a third. “Pick the foreign one when it’s available, and choose the more expensive one when there’s a cheaper option.”

With reporting by Alexandra Li

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