In 1993, Japan stopped using the combination vaccine for mumps, measles and rubella (MMR) in routine immunisations. The Health Ministry said the triple vaccine was linked to side effects, notably non-viral meningitis.
Of the 1.8 million children who were administered it, some had adverse reactions and three children reportedly died. Japan, as a result, remains the only developed country to have banned the MMR combination vaccine, and use separate jabs for measles and rubella.
The ban is controversial. In 2002, then-British Prime Minister Tony Blair cited Japan as an example of the dangers in scrapping the combination vaccine. He said the result was outbreaks of occasionally fatal measles. The vaccine has been the subject of scare stories linked to autism, but studies have failed to uncover any such connection. Indeed, the Japan ban has helped to disprove it — a 2005 study of 30,000 children found cases of autism rose despite the ban.
The MMR ban is not the only problem cited in regards to routine immunisation programs in Japan against potentially fatal diseases. While noting that the country is “catching up with” the European Union and the United States in the number of vaccines available to children, the 2014 European Business Council white paper warns: “Protection by vaccines remains insufficient.”
The report’s lead author is Dr Shunjiro Sugimoto, who chaired the Vaccine Subcommittee of the European Federation of Pharmaceutical Industries and Associations (EFPIA) Japan. He said the combination vaccine for diphtheria, tetanus and pertussis (inactivated polio vaccine) had only just been approved in Japan, “15 years behind Europe”. Dr Sugimoto said that the 5-in-1 or 6-in-1 combination vaccines, produced by adding hepatitis B and/or polio vaccines, though widely used elsewhere, are still unavailable here.
In addition, some vaccines, such as for mumps and hepatitis B, are not part of the national immunisation programs. Regular vaccinations cover diphtheria, acute poliomyelitis, measles, rubella, Japanese encephalitis, tetanus and influenza.
“Some experts say the mumps vaccine in Japan may not be as safe as that from abroad,” explains Jun Honda, current chairman of the Vaccine Subcommittee at the EFPIA. “The lack of combinations is an inconvenience, but the ones that are not available are a public health issue.”
The result is that Japanese mothers have to make multiple trips to the doctor for shots. They must ask for vaccines that are not available on the public program and pay out of their own pockets. Perhaps most worrying of all is that stocks may run out during an emergency.
“There have been a number of occasions where there were shortages due to sporadic outbreaks,” points out Simon Collier of the EFPIA.
The most prominent, says Collier, was the swine flu (H1N1) epidemic in 2009, which forced the Ministry of Health, Labor and Welfare to import “a huge amount of flu vaccines from outside Japan.”
About 15 million Japanese had been vaccinated against the disease by the end of 2009. A string of side effects, and over 100 reported deaths, prompted the Health Ministry to launch a probe into the vaccines. In 2013, a rubella outbreak caused another temporary vaccine shortage.
All this underscores the enormous difficulties of keeping millions of people healthy using public programs. But Honda is among many experts who say Japan’s sluggish bureaucracy is needlessly putting lives at risk.
“The Health Ministry takes a lot of time to make decisions and to put these vaccines into national vaccine programs,” he laments. One reason, Honda says, is that Japan lacks vaccine expertise. The difference in the number of Health Ministry experts compared to the National Institute of Infectious Diseases in the United States is in the order of 1 to 10, he estimates.
Japan’s Health Ministry says it “cannot deny” that its decisions take time, but counters that public safety comes first.
“In the case of MMR, we decided that we needed a newer, safer vaccine, and have asked the Japanese Association of Vaccine Industries to develop one,” says Yoshihisa Ota, an industry spokesman. “Measles and rubella vaccines are currently given individually. Mumps is still voluntary.”
While developing new drugs can take years, the Japanese government, in the meantime, sometimes shuns imports from Europe or elsewhere. Collier cites the case of the combination vaccines of diphtheria, tetanus and pertussis (DTP), which required the addition of the inactivated polio vaccine.
“It took time for the Japanese manufacturers to develop the polio vaccine,” Collier continues, “and the ministry chose to wait for the local development, rather than rely on imported combination vaccines.”
Furthermore, experts are worried by government decisions to withdraw approval for certain drugs, most recently the papillomavirus (HPV) vaccines for cervical cancer in girls. Over 8 million Japanese had received the drug by the time it was pulled in 2013. The Health Ministry reported about 106 cases of serious adverse effects, including convulsions. According to Medscape.com, the decision was “in stark contrast” to an announcement in the United States in the same week that vaccination rates in teenage girls “should be increased” because the effectiveness of the vaccine is “high.”
Honda accepts the outlook that the problems in Japan’s public immunisation programs have eased.
“There are more vaccines than ever before,” Honda says. But there is still some way to go, he adds. “We have to make some noise that we need to have these vaccines approved. The HPV vaccine has been suspended for nearly three years. That implies that more girls in Japan are susceptible to cervical cancer.”
In his report, Dr Sugimoto says that the bottom line is that many pediatric combination vaccines necessary to protect Japanese infants from infections remain unapproved and are not in use, “even though infants represent the future of Japan.” Congested immunisation schedules in other parts of the world have been eased thanks to the approval of a variety of combination vaccines that have now been in use for more than 10 years.
“Japan is undisputedly lagging behind in this area,” the 2014 EBC report says.© Japan Today