The 74-minute life and death of a newborn baby has stirred up heated debate about the Chinese mainland's free inoculation program.

Born in Longgang district, Shenzhen,Guangdong Province on December 17, the baby suffered respiratory difficulties two minutes after his inoculation and died within an hour, Nanwan People's Hospital office director Yang Jinmin told the Global Times. The names of the boy and his parents have not been released.

China's top health, drug and food watchdog on December 20 suspended the free hepatitis B vaccine supplied by BioKangtai Company. The Shenzhen-based company owns about 60 percent of the domestic market.

The suspension came not only in response to the Shenzhen death, but also to the deaths of six more infants since November in Guangdong, Hunan and Sichuan provinces after receiving BioKangtai hepatitis B vaccinations.

Launched in 1992, the immunization program's efficacy and safety have seldom been questioned. The hepatitis B vaccine was widely regarded as safe and necessary to address China's relatively high prevalence of the killer liver virus.

Although autopsy results have not been released and the causes of deaths cannot be confirmed while authorities investigate, questions have inevitably arisen about the quality controls in the whole industry.

Since 2005, the hepatitis B vaccine has been given to children free as part of the government's immunization programme, with local governments responsible for procurement. Each province usually has one or two suppliers.

"The vaccine industry is one of the high-tech industries that require innovative technologies," a staff member at Dalian Hissen Biochemical Company, one of the country's major vaccine producers, told the Global Times on Wednesday.

Out of stock

Hepatitis B vaccine suppliers included BioKangtai, Beijing Tiantan and Dalian Hissen companies, said the staff member, who refused to be named.

Since suspension of the BioKangtai vaccine, shortfalls have emerged in several provinces.

The Guangdong disease control center switched to Beijing Tiantan Biological Products, buying 1.45 million hepatitis B vaccines or enough to meet demand for two or three months.

Meanwhile in Hainan, the province has sealed away 240,000 Biokangtai vaccines while procuring 120,000 from Beijing Tiantan Biological Products, hinews.cn reported.

Another newborn died on December 23 in Southwest China's Sichuan Province after a Beijing Tiantan hepatitis B vaccination. Yet another died after being inoculated with a Dalian Hissen vaccine on December 20.

The cause of death can only be confirmed after an autopsy, according to local health bureaus.

Investigations into vaccine production will take about 20 days and results will be made public in a timely manner, Li Guoqing, head of inspections at the China Food and Drug Administration, said on Tuesday.

Sixteen babies have died after inoculation as of press time. Two deaths have been confirmed as unconnected to the vaccine.

Shortages have led some observers to speculate if it is safe and reasonable to have such a limited number of hepatitis B vaccine suppliers, each occupying  significant swathes of the market.

Monopoly powers

Vaccine production is a highly planned operation due to limited demand, Capital Medical University Professor Cui Xiaobo told the Global Times.

"The current number of suppliers is reasonable," Cui said, "and they are in regular competition."

Liu Yuanli, director of the school of public health at Peking Union Medical College, echoed Cui's opinion, saying more suppliers do not equal a better quality vaccine.

"The most important thing is to improve research and development of biological products and strengthen quality supervision," he told the Global Times.

As a biological, not simply a pharmaceutical product, there is no generic version, according to the WHO website, and new manufacturers face high costs of market entry.

In contrast with the pharmaceutical industry, the global vaccine market is therefore limited to relatively few manufacturers and suppliers.

For the majority of vaccines, there are less than five manufacturers for each specific product, with new vaccines often resulting in monopolies.

The hepatitis B vaccine is free to all Chinese people and the National Development and Reform Commission has fixed the factory price of a typical 10-gram single dose at 3.1 yuan ($0.51). The vaccines are purchased by provincial government.

As a result, hepatitis B vaccine manufacturers have suffered reduced profits, said Hu Yinglian, a professor at the National School of Administration.

"The companies can only benefit from a bigger share of the market," Hu was quoted as saying in China Business News.

"Government procurement in the US provides a reasonable profit margin for the companies and encourages them to improve quality, not lower cost," he said.

The government in China should let the market work this out better in future, Hu argued.

The bio companies still make a massive profit, said Chen Tao'an, former information chief at the Shanxi Center for Disease Control and Prevention.

Take the Biokangtai hepatitis B vaccination for example, Chen was quoted as saying on cb.com.cn. The cost of each dose is less than $0.16 with low costs and large sales.

Over-reaction

As vaccine horror stories fill front pages, expectant and new mothers grow increasingly concerned.

"I certainly felt worried at first," a new mother in Beijing told the Global Times on Thursday. She refused to be named, but believed such cases were still of a low probability and a vaccination still made sense.

She had considered using an imported vaccine, she said, but since they are in less use on the Chinese mainland, there aren't many reference materials about adverse reactions.

"After all, the free ones are nationwide and have a larger base," she said.

Some experts believe these cases are isolated and the quality of domestic hepatitis B vaccines is still trustworthy.

The highly developed media and increasing public concern may have caused some unnecessary panic, Professor Cui believed.

From 2000 to December 20, 2013, China has suffered 188 deaths after hepatitis B inoculations, according to data from Chinese Center for Disease Control and Prevention.

Some 18 of the 188 cases were confirmed as adverse reactions, meaning special individual health conditions triggered the deaths, although the vaccine quality and inoculation procedures met standards.