Saturday, December 5, 2020

Corona Daily 246: China’s Efficient Vaccine Approval Process


The media is currently buzzing with talk of approvals for Pfizer, Moderna and AstraZeneca vaccines. But much before that, in July, “Coronavac”, a vaccine by the Chinese company “Sinovac Biotech” was approved for limited use in China.

Beijing based Sinovac was the first company to conduct SARS vaccine clinical trials (2003). it was also the first to develop a swine flu vaccine (2009). Yin Weidong (in picture), 56, its founder and chairman, started his career in the early 1980s at a public health unit. On his first day, he was assigned to a group investigating hepatitis outbreaks. After spending two decades in working on preventing liver disease in rural China, he founded Sinovac in 2001. Sinovac prefers the traditional method of using an inactivated virus. Not fancy like the Pfizer vaccine, it can be mass produced, easily stored and distributed. In September 2020, Yin Weidong stated his ambition of applying to the US FDA for approval, and supplying coronavac around the world, including the USA and Europe.

Will he succeed in that ambition?

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To answer this question, two written judgments issued by Beijing’s no.1 Intermediate People’s Court may help. The criminal case judgments are called “Hongzhang Yin’s Acceptance of Bribes” and “Guo’s Acceptance of Bribes”. Yin Hongzhang was in charge of approving drugs and vaccines. Guo is his wife.

That story begins in 2002, a year after the founding of Sinovac. Yin Hongzhang told Yin Weidong he wanted a car. Sinovac made a $15,200 cash gift to enable him buy a car. A few months later, Healive hepatitis A vaccine, Sinovac’s first flagship product, was approved for sale.

In 2006, Hongzhang’s wife Guo wished to furnish their new apartment. Yin Weidong gifted $7600 to sponsor the furnishing. When Weidong visited the furnished house, he gave the couple another $15,200 in cash for housewarming. During that period, Sinovac gained approvals to sell influenza, avian flu and swine flu vaccines in China. Swine flu vaccine was the fastest, launched six months after the virus was first detected in Mexico.

In 2011, Yin Hongzhang asked Yin Weidong for a “loan” of $45,600 to buy a villa in Beijing’s northern outskirts. This time Weidong used a middleman who handed over the cash to the couple in a hotel lobby. Guo admitted the thought of returning the loan never occurred to them.

Yin Hongzhang was sentenced to 10 years in prison and fined 500,000 yuan ($72,000). His wife and son were also sent to prison. Hongzhang admitted to receiving cash bribes as well as ivory products to speed up vaccine approvals.

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Yin Hongzhang was fortunate. Earlier in 2007, China had executed Zheng Xiaoyu, the Head of China’s Food and Drug Administration. During Zheng’s tenure from 1998 to 2005, he had approved six drugs that turned out to be fake. One approved antibiotic was contaminated and killed at least ten people.

It is possible the Sinovac vaccines are good, thereby sparing Hongzhang a death sentence.

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Yin Weidong, the head of Sinovac who had bribed his way to speed up the vaccine approvals was not charged by the courts. “How could I refuse demands for money from a regulatory official?” he said in his testimony. The impeccable logic of the question and his cooperation in divulging the precise amounts and dates of bribing meant he was adjudged an innocent man. He continues to head Sinovac.

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In a boardroom scandal, minority shareholders of Sinovac tried a coup to overthrow Yin Weidong. The coup was unsuccessful. However, following that attempt, Nasdaq, the US stock exchange, has frozen Sinovac shares since February 2019. Even if Sinovac were to become a roaring success, the price of its frozen shares will not alter.

Coronavac has been actively marketed in poor countries. When there are no options and a pandemic is raging, you take what you get. In any case, Sinovac is unlikely to face hurdles in getting speedy approvals.

Ravi 

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