Death of Infant after Vaccination Causes Confusion, Concern


A father in Shenzhen displays packaging from the vaccine his baby received shorty after birth. The child later died and the hospital says the death could be related to the shot

(Hengshan, Hunan) – It was pouring rain on December 16 in Hengshan, in the central province of Hunan, when 70-year-old Li Nanxiu prostrated herself before photos of her husband's ancestors to make an incense offering. Near her was a picture of her long-deceased husband.
Li held incense sticks, wet from the rain, in her trembling hands, lighting them over and over. Once they finally caught fire, she abandoned herself to a deep sob, which continued until her voice was gone.
Meanwhile her daughter-in-law, Zhao Dan, mentally disabled since youth, sat in the front room watching television, unable to experience the sadness of a mother for a dead child.
It would be another two months before autopsy reports of the newest member of the rural family could be released. Li's grandson was one of two Hunan infants who died shortly after receiving hepatitis B vaccinations, casting doubt over the safety of China's hepatitis shots.
In early December, Li's month-old grandson died shortly after receiving a hepatitis B vaccination in a city hospital. After his death, residents of Li's village converged on the hospital, where in an altercation with authorities, Li was thrown to the ground and lost consciousness.
Li's son, Liao Zhonghai, a migrant worker who had rushed home from Foshan, in the southern province of Guangdong, upon receiving the news, had no choice but to return to work when he heard the autopsy results would not be available for months. For their debt-ridden family, survival is more important than mourning.
A little over 100 kilometers away, in Changning, also in Hunan, another family grieves. On December 8, an 8-month-old boy died after receiving the third of three hepatitis B vaccine shots and a flu vaccine shot. The bodies of both babies were sent to medical authorities in the provincial capital Changsha for autopsies.
Not long before the two deaths, at the end of November, a two-month-old in Hanshou, Hunan, went purple in the face after being inoculated with hepatitis B vaccine and a vitamin shot. He went into shock, but survived and is receiving treatment.
A total of six infant deaths have been linked to hepatitis B vaccines made by Biokangtai Pharmaceuticals Inc., based in the southern city of Shenzhen. And one death occurred after an infant received a vaccine made by a Beijing pharmaceutical company.
The China Food and Drug Administration (CFDA) and the Hunan Provincial Center for Disease Control and Prevention (CDCP) called for use of all vaccines from the same Biokangtai batch as those linked to the deaths to be suspended. The CFDA announced in mid-December that an investigation had been launched into Biokangtai and the results are expected to be released in 20 days.
On December 16, the Hunan CDPC announced said it had not discovered any relationship between the vaccines and "the infants whose bodies experienced abnormalities." After the first two deaths, Biokangtai also released a statement denying any problems with the company's products, and saying that "the infant deaths are suspected to be coincidental."
The vaccines involved in the deaths were offered to families for free. Later, some health centers began offering a different type of vaccine to families for a fee in order to ensure planned vaccination work was completed.
But none of that has eased the fears of parents. Reports of the deaths and the ill baby were quickly picked up by major media outlets, causing a national uproar. Although autopsy reports are still not available, parents are expressing doubts about the quality of government vaccines. Some are even refusing to have their children inoculated.
A Long Trip
It was still cold and foggy in Li's mountain village at 9 a.m. on December 4, the morning she took her grandson to be vaccinated.
Holding the child, she walked 2 kilometers along muddy mountain roads to the Wangzhou Village Center, where she waited for a bus. The bus took her to Jiangdong Township, where, after crossing a cable suspension bridge, she took another bus to Baiguo Town and the No. 2 People's Hospital of Hengshan County. There, her son received his second round of a hepatitis B vaccination.
Hepatitis B is widespread in China, where it is widely believed that vaccinations are the safest and most effective means of preventing the disease. In 1992, hepatitis B vaccinations were included in the National Immunization Program. The government began providing immunization drugs for free in 2005. As of 2013, vaccination rates for newborns exceeded 95 percent.
Hepatitis vaccines are administered in three shots; the first is delivered within 24 hours of birth, another follows a month later and the final shot is given six months later.
It was almost noon when Li and her grandson arrived at the hospital, where doctors quickly flipped through a booklet she brought called Hunan Province Children's Vaccination Certificate before giving the boy a shot. "Don't bathe him today," was the only advice they gave Li before stamping a line in the booklet labeled "hepatitis B vaccine (6 months)."
Li could have had the same vaccine administered in her village clinic, but since the boy was born in the County No. 2 People's Hospital, she figured that "a big hospital is better at giving shots."
Hengshan No. 2 People's Hospital is the second-largest comprehensive hospital in the county of more than 412,000 people, and serves the regular medical and emergency medical needs of ten surrounding towns and townships.
Fellow Wangzhou Village resident Wang Huifang said there is an old run-down clinic in the village, but it lacks the most basic personnel and medical equipment. "They can't even treat the simplest fever or external injury," Wang said.
A medical worker who lives in the village keeps records of all local children and reminds parents when to take them for immunizations.
The Hengshan hospital pales in comparison with more sophisticated facilities in large cities, but it is still deemed a big hospital by rural residents like Li and Wang. In its immunization office sit a refrigerator for storing drugs, an old desk and two chairs. On the walls are various health-related posters.

"They don't perform any tests before administering the vaccines," said one local resident, whose summary was echoed by many others in the area. "They don't ask anything either. You show up, and they give you the shot."
"Don't bathe your baby today," is the only advice most receive after their children are vaccinated.
Hengshan is but one county of the Hengyang City administrative area. In the Hengyang Community Health Service Center, doctors all perform tests and ask questions before administering the hepatitis B vaccine. The usual questions include: Does your baby have a fever? Is your baby suffering from any acute diseases? Does your baby have a history of reactions to vaccines? Before issuing shots, the center also requires guardians to sign an Informed Consent for Inoculation with Hepatitis B Vaccine form, containing information about potential side effects and risks.
The vaccination procedure in Hengshan No. 2 People's Hospital, however, is much simpler.
"The hepatitis B vaccine is extremely safe, and the probability of negative reaction is only 1 percent," said the hospital's deputy director, who declined to provide his full name. "We've administered these shots for so many years and to so many people, and there was never a problem before."
Declared Dead
Li and her grandson returned home on the afternoon of December 4. On the bumpy ride, all Li remembered about her grandson was that he was particularly calm, with no fussing or crying. Around the time of his midnight feeding, she realized something was wrong.
"He didn't drink much milk," she said. "He had no energy and hardly opened his eyes."
Around 3 a.m., he stopped feeding altogether. Flustered, Li cradled the child in her arms the rest of the night. The next morning, Li rushed back to the hospital.
"The child had no blood in his face," Li said. "His mouth had gone white."
A doctor examined the boy and listened to his heartbeat with a stethoscope before concluding it was nothing more than a normal reaction to the vaccine, Li said. He sent them home with instructions to continue observing the child.
The hospital deputy director tells a different version of events, saying that "after their examination, our doctor suggested she take the child to a higher-level hospital because we're a grass-roots hospital here with limited capabilities."
Li returned home with the child. On the morning of December 6, she again returned to the hospital, where "doctors wouldn't see us. They told me to take him to a big hospital, but what do I know about big hospitals?" (The deputy director says the hospital director received Li and her grandson on the morning of December 6.)
In any case, at 8 p.m. that night, Li took her grandson to a village doctor, who pronounced him dead. Li then found her daughter-in-law's uncles, who brought her and her dead grandson to the hospital on motorcycles.
"They made us wait there," Li said. "They said that everybody was off duty."
 Li sat at the hospital entrance all night with the uncles and her grandson's body.
A Death in Fujian
On the morning of December 7, Li and her relatives asked the hospital for an explanation and especially wanted to know if the vaccination killed the child. Hospital officials put her grandson's body in the emergency room and started talks on a settlement.
That afternoon, the boy's father, Liao, arrived from Guangdong and began negotiating with the hospital for compensation.
"The hospital said they wanted to settle the matter in private," Liao said. "We asked for 40,000 yuan, but they said they could give us only 4,000 at most. No hospital leadership ever showed up."
The next morning Liao carried his son's body out of the hospital. "I asked for them to conduct tests to see if it was the hospital's fault, to see if it was the vaccine that killed him."
In the afternoon, the conflict escalated. "Seven or eight police officers came," Liao said. "They tried to grab the child from me."
He said the police eventually succeeded in taking the body from him after a serious physical confrontation.
"They threw the grandmother to the ground and started kicking her," Liao said. "My wife's uncle was picked up and thrown to the street curb. Now he has back pains."
The hospital's deputy director tells a different version of events. "The public security bureau became involved with making peace and had the child's body transported to the funeral parlor of Hengdong County. The child's family members were extremely reasonable and exhibited restraint. All they wanted was to proceed through legal channels. That was also the result we wanted."
What everybody did agree on is that the chief of Wangzhou Village and both the township chief and Communist Party secretary all showed up to mediate.
"The child's grandmother was so angry she fainted, and before that she was beaten by the police," Liao said. "Deputy township chief Zhou Wei had the village chief lend the child's grandmother 500 yuan to receive medical treatment."
On the night of December 9, the child's body was taken to one of the province's best hospitals, the Third Xiangya Hospital of Central South University in Changsha, for an autopsy.
"The forensic pathologist looked at the child and said he had cyanosis (blue or purple discoloring) of the skin and that his lungs were purple, which probably meant death by suffocation," the deputy director of the Hengshan No. 2 People's Hospital said. "But that was just an initial observation.
"This is not one of the adverse reactions to hepatitis B vaccine, so there should be no direct relationship to the hepatitis B vaccine."
Caixin reporters have learned that on September 14, 2003, an infant boy in the eastern province of Fujian also suffered adverse reactions from the second round of hepatitis B vaccination and died the next day. His primary reactions were similar to the Hunan baby, including discoloring of the lips.
In 2006, the Chinese Journal of Modern Applied Pharmacy published a paper co-authored by the Tianjin Haihe Hospital and Tianjin Medical University's Department of Pharmacology entitled Adverse Reactions to Hepatitis B Vaccine, which listed such reactions as difficulty breathing, discoloring of the lips and anaphylactic shock. The two infants that died in Hunan both displayed these symptoms.
In fact, the number of adverse reactions is rising along with the expansion of free immunization. Following advice form the World Health Organization, China set up a system called Adverse Events Following Immunization in 2005. In 2012 alone, its recorded 100,000 such event.    
Still, health experts consider state-sponsored immunization a great achievement for China. "Free immunization is the biggest contribution to China's public health, whose importance to contain hepatitis B can hardly be overestimated," said Zhang Jiankang, the national program leader for the non-profit international health organization PATH.
'Coincidental Disease'
Four days after Li's grandson died, officials from the Hunan Province Department of Health went to Hengshan. "The Hunan Department of Health and Hunan CDPC sent three groups of experts to investigate," a source at the Hunan CDPC said.
The scope of the investigation included such information as the boy's vaccination history and his symptoms and treatment, as well as the source of the vaccine, its storage and transportation, the temperatures of its cold storage, warehouse logs, qualifications of both the vaccinating organization and personnel who administer vaccinations and vaccination procedures.
"Through our investigation, we have discovered that there were no problems with the storage, transportation or inoculation procedures of the vaccine in question," said Gao Lidong, the Hunan CDCP deputy director.
The Hunan Department of Health said the two batches totaled 310,000 individual doses, of which 110,000 had already been used since mid-September. To make up for the shortfall, the Hunan government had 168,000 doses from Dalian, in the northeastern province of Liaoning.
"We're still using Shenzhen Biotaikang vaccines, but from different batches. Inoculations are proceeding as usual," the deputy director of the hospital said.
The deaths of the infants in Hunan caught the nation's attention after news spread in the media and on weibo, the country's version of Twitter. On December 13, the CFDA issued a notice suspending vaccines from the batches in question that were delivered to Hunan, Guangdong and Guizhou, provinces. 
That night, the Drug Administration of Shenzhen Municipality (DASM) launched an inquiry to determine if manufacturing inspections and sterility assurances for the vaccines in question had been performed in accordance with pharmaceutical standards, and whether the vaccines met quality standards. Shenzhen officials later announced they "had not discovered any non-compliant behavior" and that the two batches of vaccine in question had been issued certificates by the Chinese Academy of Food and Drug Testing.
A week later, the Hunan CDCP announced that "we have not discovered any direct causal relationship between hepatitis B vaccines and the infants whose bodies experienced abnormalities."
(Caixin reporters asked officials in Hunan for more detailed information, but they declined.)
On December 17, Biotaikang also issued a notice claiming "the infant deaths are suspected to be coincidental" and that there were no problems with their company's products.
Biotaikang, founded in August 1988, was one of Shenzhen's first high-tech companies. Its primary business is the research and development, manufacturing, and sales of biological products. Its website says it is the nation's largest producer of hepatitis B vaccines, and that its products are sold all over China. The company says it holds more than 50 percent of domestic market share.
It also quoted from material issued by the former Ministry of Health, which says "coincidental diseases" occur easily and lead to misunderstandings.
The term "coincidental disease" means that at the time of an inoculation a patient might be in the incubation period of a disease or may have some underlying disease not yet discovered. After being vaccinated, the patient may then begin experiencing symptoms of the disease, but this is not caused by the vaccine. More vaccines and more varieties of vaccine mean higher rates of incidence of coincidental disease, the company said.

The Family Line
Villagers in Wanggzhou are now fearful of vaccines. "Nobody in our village dares to have vaccines administered anymore," one said. "We're afraid it'll kill our children. If it wasn't caused by the vaccine, then why was that child just fine before he got the shot and dead after?"
An employee of the Hengyang City CDCP Immunization Program Department said that hepatitis B shots are "inherently safe" but added that "there's widespread public panic, so the work of popularization and promotion has become difficult."
The director of a vaccination center in Hengyang, Cao Liqun, said his center has stopped providing free type 1 hepatitis B vaccines. Parents may now choose to delay their children's inoculations or they may pay for imported type 2 vaccines. The charge for that service is 108 yuan.
Cao said he has never seen a single adverse reaction to hepatitis B vaccine during his 20-year medical career. "But some parents who have seen the reports are afraid that domestic vaccines aren't good. They're more willing to choose imported vaccines, which aren't really all that expensive."
Experts say that the technology behind hepatitis B vaccines is mature, that the vaccine has a solid safety record and it carries one of the lowest rates of adverse reactions.
Gao, the deputy director of the Hunan CDCP, said vaccines are all subjected to rigorous animal testing and clinical research phases before being approved for sale, and that each batch is rigorously tested before being approved for release. There are complete, scientific, normalized demands for vaccinations before, during and after individual inoculations, Gao said.
For the family of Li Nanxiu, however, the worries now go beyond whether there were problems with the vaccine.
After the death of her husband in 1989, the family started going into debt for medical expenses and a new house, a must for a rural family before a son can marry. They borrowed from every relative in the village and took out a mortgage.
In 2006, Li, fearing the family line would end without an heir, again borrowed money and sold family property to arrange a marriage between her 33-year-old son and an 18-year-old mentally handicapped woman. The woman gave birth to their first son in 2008. (She had a second son in October, and then was sterilized.)
"I feel so sorry for the child," Li said. "First he died, and now they want to cut him open (for an autopsy)!"
Li said her greatest wish now is that the body of her grandson be returned to her for burial in the family graveyard. 

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