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Thursday, Jan. 12, 2012

Polio shot sheds light on vaccine lag

System, bureaucratic cowardice work against new drug approvals


Staff writer

When she gave birth five months ago, Tokyo resident Yumiko Sakai was determined to have her baby vaccinated to protect him from preventable diseases.

News photo
Shot in the arm: A baby receives an inactivated polio vaccination in Chigasaki, Kanagawa Prefecture, on Dec. 15. KYODO

Among the several different vaccinations recommended for babies is the one for polio. Unlike the inactivated polio vaccine commonly used in developed countries, alive-attenuated vaccine, taken orally, is common in Japan, where the inactivated vaccine hasn't been approved.

On learning that the inactivated polio vaccine is considered safer because it holds fewer risks of paralytic poliomyelitis, and is commonly used in industrialized nations, Sakai took her son to a clinic in Tokyo that individually imports the inactivated type even though it would cost her more.

"I've watched news stories about the side effects of oral polio vaccines, so I wanted to choose a vaccine that was as safe as possible," the young mother said.

In the inactivated polio vaccine, the polio virus has been inactivated, or killed. In the alive-attenuated vaccine, the virus is alive but has been weakened, or "attenuated."

While Sakai is one of many mothers who have pushed for the approval and introduction of the inactivated polio vaccine in Japan, the government has been slow to act.

But having received strong criticism from the public, the Health, Labor and Welfare Ministry is finally preparing to approve and introduce the inactivated polio vaccine as soon as this autumn.

Still, that will be more than a decade since the United States shifted completely to the inactivated vaccine in 2000. According to the World Health Organization, the inactivated polio vaccine was already being used exclusively in 22 countries and regions, including the U.S. and Europe, by 2002.

Medical experts promoting vaccination to protect more children from preventable diseases say the polio vaccine is an example of how Japan lags in terms of its vaccination program despite being one of the world's most medically advanced nations.

Critics blame the government.

"Japan has been ignoring the importance of vaccination, and the government has no political will to protect children from vaccine-preventable diseases," said Tomoyoshi Sonobe, a pediatrician and adviser to the pediatrics department at the Japanese Red Cross Medical Center.

The announcement in October by Kanagawa Gov. Yuji Kuroiwa that the prefecture would initiate the introduction of the inactivated polio vaccine in December — far ahead of the central government — heightened public attention.

Health minister Yoko Komiyama, appearing before the Upper House Budget Committee, admitted Dec. 8 that Japan was late in deciding to switch from the oral polio vaccine. Eight days later, Komiyama told a news conference she had directed the ministry to prepare the vaccine in time for the next inoculation period, which is this fall, moving it up from the initially planned March 2013.

The licensing of other vaccines has also been slow. For instance the Hib vaccine, which is one of those for infants that the WHO recommends for national immunization programs, was only approved in Japan in 2007, while children in other industrialized countries have been receiving it since the 1990s.

The WHO also recommends routine pneumococcal and rotavirus vaccinations, which prevent meningitis, pneumonia and severe acute gastroenteritis. Japan didn't approve them until 2010 and 2011, six to 10 years later than the U.S.

The reason behind the delays, according to Sonobe, was that health ministry bureaucrats have been reluctant to introduce new vaccines out of fear of having to take responsibility for any side effects.

"They don't want to get into trouble. By not introducing vaccines, they don't have to deal with troubles caused by them," said Sonobe, who with other pediatricians established an organization in 2008 called Know Vaccine Preventable Diseases to provide information on vaccinations to parents.

The ministry's desire to avoid trouble has its roots in a court case. In 1993, the government stopped using the MMR vaccine for measles, mumps and rubella because the mumps component caused side effects in some 1,800 children nationwide. Families of the victims sued the government and a research center affiliated with Osaka University. In 2003 the defendants were slapped with a court order to pay a total of ¥155 million to the plaintiffs.

Sonobe also blames the media, because since the MMR incident news reports have focused on the side effects of vaccines without bothering to compare them with the risks of contracting the diseases if children aren't immunized. This has led both the health ministry and the public to become less enthusiastic about immunization, he said.

Sonobe notes that the country's fault-based compensation system is another problem because doctors are likely to lose in the courts, where legal precedence takes priority over scientific evidence.

This has also discouraged doctors and the ministry from promoting vaccinations, Sonobe said.

He believes the U.S. compensation system is preferable because it allows people who develop serious diseases after getting vaccinated to win compensation without accusing anyone.

In addition to the lack of enthusiasm by the health ministry, experts point out that Japanese pharmaceutical companies are also not very eager to develop new vaccines.

Masahiro Kami, a professor in the Institute of Medical Science at the University of Tokyo, pointed out that Japanese pharmaceutical companies lack financial incentives to create new vaccines.

"Many Japanese pharmaceutical companies have not developed new medicines for the past 10 years, but they can still survive thanks to the medicine prices set by the health ministry," Kami said.

In Japan, off-patent drugs remain profitable even after generic drugs make it to the market because their prices don't take a big hit, nor do the generic drugs take over market share like in other countries, including the U.S., he explained.

Japan is also not attractive to foreign firms because drug approval takes such a long time and clinical testing costs are high, usually two to four times more than abroad when it comes to late-stage trials, according to the U.S. Department of Commerce.

But Kanagawa Prefecture's bold decision to move ahead of the central government and begin immunizing children with the inactivated polio vaccines may trigger change.

The prefecture individually imported the inactivated polio vaccine and began administering it last month. Although the cost, ¥6,000 per dose, isn't covered by the prefectural government, many parents signed up their children.

The governor said in a recent interview with The Japan Times that the decision was simple.

"I'm looking at this from patients' point of view," Kuroiwa said. "If there's a vaccine proved safer overseas, why not import it?"

Kami of the University of Tokyo said he hopes public opinion will have an impact on Japan's "vaccine lag."

"Gov. Kuroiwa's case is influencing the central government. Now the public knows what is going on and they're concerned. That may change the delay of introducing new vaccines to Japan," he said.



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