Japans Decade-old Vaccine Scandal Leaves Infants At Risk Today
The worlds second-largest economy only began vaccinating infants in December against haemophilus influenzae type b, or Hib, one of the most common causes of meningitis. The shot, made by a unit of Sanofi-Aventis SA, didnt get Japanese approval until 2007. Vaccines against other deadly bacteria, including meningococcal and pneumococcal infections, are still not approved for infants in the country.
“I only learned that there are vaccines available elsewhere after Kenta fell into a coma,” said the boys father, Daishi Morioka, 40. “The memory of my son will never fade away. I had my daughter inoculated as soon as the vaccine became available.”
Japans reluctance to approve new vaccines stems from the introduction of a shot for measles, mumps and rubella in 1989 that sickened 1,040 people, three of whom died, sparking a scandal about lax drug manufacturing. Since Japan stopped using the MMR vaccine in 1993, approvals have slowed — Japan has certified about half as many vaccines in the past two decades as the U.S.
Sanofis ActHib, which went on sale on Dec. 19, was the first vaccine in Japan against one of the main causes of meningitis, an inflammation of the membrane that covers the brain and spinal cord. Without a Hib shot, the rate of meningitis in Japan rose 36 percent to 11.7 children per 100,000 in 2005, from 8.6 per 100,000 in 1996, according to a study by Naruhiko Ishiwada at Chiba University.
Catching Up
“Japan is finally catching up with developing nations with coverage against Hib and measles,” Kouichi Morita, professor of virology at Nagasaki University, said in an interview. “Its extremely behind with the vaccination policy because lawsuits and accidents have traumatized the government.”
Immunization averts more than 2 million deaths a year worldwide, according to the World Health Organization. Hib causes 3 million serious illnesses and 386,000 deaths every year, mostly in developing countries, the WHO says.
In the U.S., cases of meningitis caused by Hib dropped 94 percent to 0.2 per 100,000 in 1995, from 2.9 in 1986, because of vaccines, according to research led by Anne Schuchat, published in the New England Journal of Medicine.
Slow Approval
ActHib, first approved in 1992 in France, dropped the incidence rate of the disease among children younger than three years old to 3.1 cases per 100,000 in 1994, from 19.1 in 1992, Sanofi said. It took four years to get the drug approved in Japan and then another two to meet quality and manufacturing controls. Its introduction in December led to articles in newspapers including the Yomiuri, Asahi and Nikkei, interviewing meningitis victims and questioning why approval took so long.
Spokespeople for Sanofi Pasteur MSD, the joint venture of Sanofi and Merck & Co. that makes the vaccine, didnt respond to repeated requests for comment.
“We hope Prevnar will win approval soon,” said Ken Takashima, a spokesman at Wyeths Japan unit. “The vaccine has been used widely outside of Japan.”
Baby Shots
In the U.K., babies complete a routine of four shots for Hib and three for pneumococcal by the age of 13 months. In the U.S. four shots are given of each before 15 months. They are routinely inoculated for polio, diphtheria, tetanus, whooping cough, mumps, measles and rubella, often using combined shots.
Even with approval, drugs may not receive the state subsidies needed to get them widely accepted. Immunization for Hib, influenza, mumps, chickenpox and hepatitis A and B dont get a full state subsidy in Japan. A course of ActHib costs about 32,000 yen ($352). In the U.S. and U.K. its subsidized.
Without state funding, the immunization rate falls to as low as 20 percent, from above 90 percent, according to doctors including Chiba Universitys Ishiwada.
“From the public health perspective, its desirable that a country has vaccines available,” said Hideo Kusayanagi, a Japanese health ministry official. “However, before giving full funding, we must evaluate whether its worthwhile.”
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