China Investigates Deaths After Swine Flu Shot

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High school students receive the H1N1 vaccine in Shenyang, northeast China, on Nov. 12, 2009

Chinese health officials reported on Nov. 13 the first deaths in people who received the H1N1 vaccine. The Ministry of Health announced that the two people, including a teacher from Hunan province, died hours after receiving their inoculations. Since September, when the ministry began its H1N1 immunization program, 12 million Chinese have received the pandemic flu shot.

A preliminary autopsy revealed that the teacher died of an apparent heart attack while playing basketball, and a ministry spokesperson told the China Daily newspaper that the death was a "coincidental medical incident" and not related to the vaccine. No details on the second victim have been released thus far.

As they conduct an autopsy investigation into the second death, Chinese health officials have pulled all vaccines that were manufactured in the same batch used to inoculate the teacher. Although the H1N1 vaccine has been rigorously tested and vetted for safety, no inoculation can be considered 100% safe, and some may cause adverse events, including death, in some people.

Taking an aggressive approach to the pandemic flu, the Chinese government in June asked 11 biotech companies to develop a pandemic H1N1 vaccine. Beijing-based Sinovac succeeded in developing the world's first approved swine flu shot. The company raced to conduct clinical trials and was the first to report that a single dose of vaccine, instead of the two doses that most flu experts believed would be necessary, was sufficient to protect against 2009 H1N1. In early September, China became the first country to begin swine flu inoculations.

But by the end of October, 54% of Chinese residents reported in a China Daily survey that they would not get the H1N1 vaccine because of concerns about the shot's safety. That prompted the director of the World Health Organization's Beijing office, Dr. Michael O'Leary, to tell the newspaper, "The H1N1 vaccine is one of the safest vaccines being used. When it's available to me, I would not hesitate to get the vaccine developed and produced by China."

Three vaccine manufacturers in China, including Sinovac, have received orders from the government for more than 34 million doses. Among the 12 million people inoculated so far, 1,235 have complained of side effects, ranging from sore arms, rashes and headaches to anaphylactic shock and sudden drops in blood pressure.

While the Chinese government has been criticized for its draconian public-health response to swine flu — using quarantines, canceling school and detaining entire planeloads of people when a single passenger appears to have flulike symptoms — the country's officials say the strict measures helped stem the spread of flu. So far, China reports about 36 deaths and 62,800 H1N1 cases — compared with U.S. government estimates of 4,000 American deaths and 22 million infections. China plans to immunize 65 million citizens, or 5% of the country's population, by the end of the year. As in the U.S., health officials are targeting high-priority groups first, including the military, police, health care workers, teachers, students and those with chronic diseases.