Kenta Morioka, 4, died last year from suffocation caused by a bacterial infection. But the vaccine that could have saved his life, in use for 16 years and offered in 120 countries, wasn’t available in Japan.
The world’s second-largest economy only began vaccinating infants against haemophilus influenzae type b, or Hib — one of the most common causes of meningitis — in December. The shot, made by a unit of Sanofi-Aventis SA, didn’t get Japanese approval until 2007. And vaccines against other deadly bacteria, including meningococcal and pneumococcal infections, have still not been approved for infants here.
“I only learned that there are vaccines available elsewhere after Kenta fell into a coma,” said the boy’s 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.”
The government’s 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 United States has.
Sanofi’s ActHib, which went on sale Dec. 19, was the first vaccine in Japan to combat Hib. Without the shot, meningitis infections in Japan rose 36 percent to 11.7 children per 100,000 in 2005, compared with 8.6 per 100,000 in 1996, according to a study by Naruhiko Ishiwada at Chiba University.
Meningitis is an inflammation of the membrane that covers the brain and spinal cord.
“Japan is finally catching up with developing nations with coverage against Hib and measles,” said Kouichi Morita, professor of virology at Nagasaki University. “It’s extremely behind with the vaccination policy because lawsuits and accidents have traumatized the government.”
Immunization helps avert 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.
ActHib, first approved in 1992 in France, dropped the incidence rate among children younger than 3 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, which interviewed meningitis victims and questioned why approval took so long.
Representatives for Sanofi Pasteur MSD, the joint venture of Sanofi and Merck & Co. that makes the vaccine, didn’t respond to repeated requests for comment.
Japan was the last country among the Group of Seven to allow an Hib inoculation. Wyeth’s Prevnar shot against pneumococcus, a cause of pneumonia and meningitis, is still awaiting regulatory approval. The vaccine was first approved in the U.S. in 2000 and had $2.72 billion in global sales last year.
“We hope Prevnar will win approval soon,” said Ken Takashima, a spokesman at Wyeth’s Japan unit. “The vaccine has been used widely outside of Japan.”
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 don’t get a full state subsidy in Japan. A course of ActHib costs about ¥32,000 ($352). In the U.S. and U.K. it’s subsidized.
Without state funding, the immunization rate falls to as low as 20 percent, from above 90 percent, according to doctors, including Chiba University’s Ishiwada.
“From the public health perspective, it’s desirable that a country has vaccines available,” said Hideo Kusayanagi, a health ministry official. “However, before giving full funding, we must evaluate whether it’s worthwhile.”
Japan’s vaccine market held steady at about 1 percent of the total drug market of ¥6 trillion for 10 years to 2004, government data show. With an increasing acceptance of the need for new vaccines, the market is becoming more attractive to drugmakers such as GlaxoSmithKline PLC and Sanofi.
Approval for Glaxo’s cervical cancer vaccine Cervarix and other shots may boost Japan’s vaccine market 44 percent to ¥78 billion by 2016, according to marketing research firm Fuji Keizai Co.
Concern about the safety of vaccinations and lack of public information led to a measles epidemic of 2,511 reported cases in 2007 that shut down classes at 363 schools and universities nationwide.
“There’s a lack of knowledge about the importance of vaccinations,” said Morioka.
Miki Tanaka, 36, whose 5-year-old boy, Sei, can’t talk or walk after getting meningitis from pneumococcus, travels across Japan to educate parents, because she says there’s little information available to the public.
“I cried when I learned my child could have been saved by vaccines available elsewhere,” Tanaka said. “I had to speak out when I thought there are other families whose children hover between life and death.”