pected to reach 290 million people by 2017.
Another ripe target for Chinese vaccinemakers was HFMD, which can trigger
dangerous complications like encephalitis.
Enterovirus 71 has hammered the country:
From 2008 to 2015, China reported 14 million cases and 3391 deaths, primarily in children under 5. Teams here at Sinovac Biotech
and the Institute of Medical Biology raced
to develop vaccines. China’s drug regulator
recently approved products from both. Officials are looking to export them to countries
struggling with enterovirus 71 outbreaks.
China also made a bold foray into a
crowded field with a vaccine against the
Ebola virus. In The Lancet in March 2015, researchers led by Zhu Fengcai of the Jiangsu
Provincial Center for Disease Control and
Prevention in Nanjing reported promising
early clinical trial results for a vaccine based
on the 2014 Ebola strain that sparked the
epidemic in West Africa. But China’s export
prospects dimmed when Gavi, The Vaccine
Alliance, struck a deal with Merck in January to stockpile 300,000 doses of its effective
Ebola vaccine, also based on the 2014 strain.
Gambling on future demand for a Chinese
alternative, the vaccine’s developers have
started work on a facility in Tianjin to mass-produce Ebola vaccine by 2017–18.
At home, however, vaccines face growing wariness. The police sting targeting a
syndicate based in Shandong province has
eroded shaky confidence in China’s ability to safeguard public health. “Of course
we know children must be vaccinated, but
how can we know the vaccines are safe or
even real?” says Pan Zhiyang, a mother of an
18-month-old girl. Such sentiments worry
Rodewald, who fears that parents may
opt out of China’s national vaccine program, which covers 14 diseases, including
smallpox, polio, and tetanus. When confidence wanes, he says, “some parents will
withhold vaccines from their children in
the mistaken belief that it is safer not to
vaccinate.” Hong Kong, which has limited
vaccine stocks, is bracing for an influx of
Without a major overhaul, China’s vaccine system might not recover quickly.
“Unless they have seamless regulation of
all vaccines that are available, I think we’re
probably going to see more of these cases”
like the Shandong affair, says Yanzhong
Huang, global health fellow at the Council
on Foreign Relations in New York City. “As
long as vaccines are sold for a profit, there
will be room for bad practices.” j
Kathleen McLaughlin is a writer in Beijing.
Hoping to quell public concern, safety officials
inspect vaccine doses in Southwest China.
Scandal clouds China’s
global vaccine ambitions
Porous regulation of private preparations threatens to
undermine vaccinemakers’ bid to boost exports
Last month, a 3-year-old toddler in the southwestern Chinese city of Kunming was the first person in the world inoc- ulated against hand, foot, and mouth disease (HFMD). Health experts hailed the vaccine—one of two new Chinese-made preparations against enterovirus 71—
as a milestone against a malady that has run
rampant in China. But that triumph was
overshadowed by a safety crisis involving
other homegrown vaccines.
In recent weeks, police have arrested
more than 200 people in connection with
the nationwide distribution of 2 million
doses of mishandled Chinese-made vaccines
against scourges such as hepatitis B and rabies. Even as government officials pledged
to shore up oversight, censors worked to
quell news of the scandal. No adverse reactions have been confirmed. But the crisis
laid bare weak regulation of China’s private
vaccine market, which handles billions of
doses of vaccines that the government does
not distribute under its national free inoculation program.
China’s vaccine developers hope the safety
debacle won’t derail efforts to make inroads
into the global $33 billion vaccine market.
“A major challenge for China’s vaccine in-
dustry is to overcome concerns about prod-
uct safety,” says Melvin Sanicas, a program
officer in Seattle, Washington, with the Bill
& Melinda Gates Foundation. The manufac-
turing system here is not at fault, says Lance
Rodewald, China team lead based here for
the World Health Organization’s (WHO’s)
Expanded Program on Immunization. “All
vaccines made and used in China start their
life as safe, pure, and effective,” he says. But
the less-regulated private vaccine market is
plagued with supply-chain problems, from
woeful management to improper storage,
according to watchdogs. Critics say the
system is too vast to watch every step. And
if the Chinese public stops trusting home-
grown vaccines, the country’s bid to become
a global producer could be in jeopardy.
China’s first big splash in global vaccines came in 2013, when WHO approved
a vaccine against Japanese encephalitis.
Developed in Chengdu, the vaccine targets
a regional threat ignored by Western drug
companies. The mosquito-borne virus is endemic in Southeast Asia and the Western Pacific, with an estimated 70,000 annual cases
and up to 15,000 deaths. WHO endorsement
qualifies a vaccine for inclusion in United
Nations aid programs, and with the help
of partnerships to fund vaccines in poor
countries, China’s encephalitis vaccine is ex-
By Kathleen McLaughlin, in Beijing