Fake vaccines hinder avian flu prevention

Lu Honggang thought he could weather the avian flu storm by vaccinating his poultry against the virus. But the vaccines he used turned out to be fake, and every last chicken died despite his efforts.

Many farmers, especially in the affected area of Liaoning Province’s Heishan County, purchased thousands of vaccines that failed to protect their chicken populations. Experts are calling the failed vaccines a factor that helped the deadly influenza spread quickly through the province’s major poultry-raising region. Since the government quarantined the county on November 5th, six million birds have been destroyed.

While some vaccines may have failed to protect poultry stocks because they require 14 days after injection to build immunity, it was the fake vaccines circulating throughout the local market that caught farmers off guard. On November 9th, the Ministry of Agriculture (MOA) website reported that the Inner Mongolia Bio-Pharmaceuticals Factory (IBF) was a primary producer of fake vaccines, and that “some vaccines used by Heishan farmers failed to take effect.” The factory was closed for investigation the next day.

Just three days before, on November 6th, the MOA had identified 13 manufacturers known to have produced fake vaccines and published a list of qualified vaccine producers. IBF was not included in either group. The ministry reminded the public of the danger of using fake vaccines, which can not only fail to prevent disease but can actually spread different, live viruses used in their production.

It is not clear what tipped off regulators about fake vaccine production. Xu Shijun, vice president of Inner Mongolia’s Jinyu Group, which owns IBF, told that the head of the IBF factory, Wang Jiafu, had been detained by police three days before the MOA’s announcement and was later arrested.

IBF was once one of China’s best-known bio-pharmaceutical factories. Established in the early 1990s, it was incorporated into Jinyu Group, a domestically listed company, in 1998. Last April, the MOA included it on a list of highly qualified avian influenza vaccine producers that had met requirements for good manufacturing practices (GMP) certification. Last October, the Ministry named IBF one of only seven producers eligible to manufacture H5N2 vaccines, giving Jinyu Group an edge as flu season approached this year.

According to ’s investigations, IBF had an overstock of bird flu vaccines earlier this year, when the bird flu epidemic did not unfold as some had predicted.  The company then decided to manufacture vaccines against foot-and-mouth disease to meet increased market demand, revamping its facilities to produce those vaccines instead. MOA approved the shift, and IBF indicated it would no longer produce bird flu vaccines.

But the change in production was not made public, and IBF still held its certificate for H5N2 vaccine production. When bird flu outbreaks grew serious this fall, IBF returned to flu vaccine production to take advantage of soaring demand. One IBF manager told that that shift was clearly illegal, since IBF no longer had qualified production facilities.

Despite its illegal operation status, IBF even went so far as to launch a new product that, it claimed, vaccinates against four strains of the virus, which would make it the most powerful vaccine on the market to date. Meanwhile, the Jinyu Group has benefited enormously from the “bird flu effect” in the stock market, with stock prices rising rapidly even as the market took a slight downturn in late October.

Analysts say although the factory itself has been punished, the incident has exposed regulatory loopholes of considerable concern, especially since the MOA had previously certified the factory involved. China is among the world’s leaders in poultry vaccination research. But the practice of vaccination, not just the theory, must conform to strict procedures; at a most basic level, it must ensure that the vaccines being distributed are genuine. 

One bird flu expert at the China Agricultural University, Gan Menghou, warned that if other viruses were mixed with sub-par vaccines, the combination could actually cause flu outbreaks. In 2001, the H5N1 strain was accidentally mixed with live avian pox vaccines manufactured in Guizhou Province, triggering bird flu outbreaks on some poultry farms in northern China.

Producing inactivated vaccines requires even stricter safety precautions, experts say. If the viruses used are not fully inactivated, vaccination can spread new viruses, said Guan Pingyuan, a professor at Inner Mongolia’s Agricultural University.

Given the potential danger of vaccine research and production, the MOA designated a single national avian flu research laboratory in 1992 at the Harbin Veterinary Research Institute, under the supervision of the Chinese Academy of Agricultural Sciences. Samples from all possible flu cases are tested at the laboratory, which is also China’s only approved manufacturer of H5N1 vaccines. However, during the Hong Kong flu outbreaks in 2003, when bordering Guangdong Province was in dire need of the vaccines to protect its local poultry, the MOA agreed to let the Harbin Institute share its flu vaccine production techniques with nine other producers to satisfy market demand.

Analysts say although that disclosure was necessary, it has helped give rise to the production of fakes, which in recent years have been widely circulated in some local markets. That poses new challenges for the government, the agricultural community, and the public health community alike. To address the problem, the MOA has drafted new regulations for the sale of bio-pharmaceutical products for animals, which are expected to be released by the end of this year.

Staff reporters Li Jing and Ye Doudou contributed to the story
English version by Xin Zhiming and Lauren Keane