Most nations require newborns to be vaccinated in first 24 hours

The hepatitis B vaccination program for newborns should stay in place despite the recent deaths of eight babies, medical experts said.

But expectant mothers are worried about the quality of vaccines as authorities investigate the cause of the deaths.

Jia Jidong, who leads the Liver Research Center at the Beijing Friendship Hospital, cited China's relatively high prevalence of the viral infection as a major reason for keeping the immunization program.

China reported a hepatitis B prevalence of more than 7 percent.

"We would have seen a relapse of the epidemic if the program was not well implemented," he warned.

"Vaccination is the most effective way to prevent newborns from hepatitis B even if it, like all other medical procedures, is never risk free," he said.

Industrialized countries in Europe and the US include hepatitis B vaccination in their national immunization programs.

In China, three doses are given to babies, the first within 24 hours of birth.

"The hepatitis B vaccine is safe. A few individuals may experience pain or lumps where the vaccine is injected, but they will fade. The incidence of very severe abnormal reactions is one in every 100,000, one in every 1 million or even lower," Jia said.

Since 2000, there have been 188 deaths after hepatitis B inoculation in China, Wang Huaqing, a public health official with the National Immunization Program under the Chinese Center for Disease Control and Prevention, said at a news conference on Tuesday.

Of these cases, 18 were confirmed as abnormal reactions, meaning that special individual health conditions triggered the deaths, though the vaccine quality and inoculation procedures met standards.

A newborn died on Monday morning in Meishan, Sichuan province, after a hepatitis B vaccination, bringing the number of suspected vaccine-related baby deaths to eight since November.

The vaccine was manufactured by Beijing Tiantan Biological Products, a major supplier of free hepatitis B vaccine.

The seven other deaths were of infants who had received vaccines made by Biokangtai, a drug manufacturer in Shenzhen, Guangdong province.

A circular on Friday issued by China's top health, drug and food administration authorities ordered suspension of the Biokangtai vaccine.

The top drug authority has sent experts to Biokangtai to investigate and results will be released in 20 days, said Li Guoqing, director of the department of drug and cosmetics inspection and management under the China Food and Drug Administration.

But early immunization for newborns is necessary to keep away the virus, said Zhuang Hui, a professor with Peking University Health Science Center.

"According to the World Health Organization, by 2013 hepatitis B vaccines have been included into the expanded immunization programs in 181 countries, of which 127 require babies to be vaccinated in the first 24 hours," he said.

Lance Rodewald, team leader of the WHO China Office Expanded Program on Immunization, said China's program keeps children healthy.

However, expectant mothers are worried.

Zhang Dan, who is due in March, said she is worried about vaccines and will ask her doctor for suggestions soon.

"I'll ask my doctor if it's necessary to have the baby inoculated and whether I could use an imported vaccine," she said.

"From baby formula to vaccine, I have been worried all through the pregnancy," she said.

Liu Min, director of the gynecology and obstetrics department of Beijing Ditan Hospital, said they administer the first dose of the vaccine immediately after birth.

The parents sign a consent form before the vaccination, she said.

Information like the producer and batch number of the vaccine and potential adverse reactions are included in the consent paper.

"So far we've heard no reports of side effects after vaccination from the women who gave birth at our hospital," she said.

Also, no one has rejected the vaccination given a rising awareness of hepatitis B, she added.

At Ditan, only domestically produced hepatitis B vaccines under the national program are provided, she said.

Contact the writer at shanjuan@chinadaily.com.cn

Li Wenfang in Guangzhou contributed to this story.

(China Daily USA 12/25/2013 page5)