Japan: Due to adverse effects, recommendation of HPV vaccination of 12-16 yr-old girls suspended Print E-mail

  Kyodo ~ Saturday June 15 2013

Cervix vaccine issues trigger health notice

Speaking out: Mika Matsufuji (center), who represents a parents' association of cervical cancer vaccination victims, answers reporters' questions Friday at the health ministry in Tokyo. | KYODO

Kyodo: The health ministry has issued a nationwide notice that cervical cancer vaccinations should no longer be recommended for girls aged 12 to 16 because several adverse reactions to the medicines have been reported.

“It is necessary to gather information immediately to accurately grasp how often (the side effects) are occurring,” said Mariko Momoi, who chairs the panel at the Health, Labor and Welfare Ministry that decided to suspend the recommendation. Momoi is vice president of the International University of Health and Welfare.

Cervical cancer vaccines are a recent addition to the regular vaccination list and were added after a revision to the Preventive Vaccination Law took effect in April. In Japan, cervical cancer is second only to breast cancer among those aged 20 to 39 and is estimated to strike nearly 9,000 women each year.

Despite the notice, issued Friday, most local governments will likely keep the vaccinations in question on their lists of free vaccines. But a ministry official said the vaccination rate is certain to drop sharply.

The two vaccines sold in Japan are Cervarix, made by GlaxoSmithKlein PLC of Britain, and Gardasil, made by Merck Sharp & Dohme, known as Merck & Co. in the United States.

Mika Matsufuji, 46, who represents an association of cervical cancer vaccination victims’ parents, said the health panel’s decision was a “big step forward.” Her daughter, who was vaccinated with Cervarix in 2011, lost the ability to walk and is now in a wheelchair, she said.

The group is calling for the vaccinations to be halted.

The panel said there was a strong possibility that severe prolonged pain was caused by some of the vaccinations. It concluded that active recommendation of cervical cancer vaccinations should thus be halted until a more complete picture of their side effects can be attained.

The ministry said this is the second time it has suspended a recommendation related to the regular vaccine program since problems cropped up with the Japanese encephalitis vaccine in 2005.

In 2011, however, Pfizer Inc.’s Prevnar and Sanofi SA’s ActHIB vaccines were suspended for about a month following the deaths of four children.

The panel focused on 38 cervical vaccine recipients who reported widespread pain. Given the timing of their symptoms, the panel concluded that a causal link to the vaccines could not be ruled out in many of the cases.

There were 245.1 reports of side effects per million vaccinations for Cervarix, and 155.7 reports per million for Gardasil ­ more than two other, separate vaccines that affect both sexes and were added to the regular list at around the same time.

Reports of side effects from the other two medicines came to 89.1 per million for a set of pneumococcus vaccines and 67.4 per million for Japanese encephalitis vaccines.


Tokyo ~ June 15, 2013

Health ministry withdraws recommendation for cervical cancer vaccine


 Mika Matsufuji, second from right, and other members of the “Zenkoku Shikyukeigan Vaccine Higaisha Renrakukai” hold a news conference to explain possible side effects of a vaccination against cervical cancer in Tokyo on March 25. (Asahi Shimbun file photo)

The health ministry decided June 14 to withdraw its recommendation for a vaccination to protect girls against cervical cancer after hundreds complained about possible side effects, including long-term pain and numbness.

The Ministry of Health, Labor and Welfare is not suspending the use of the vaccination, but it has instructed local governments not to promote the use of the medicine while studies are conducted on the matter.

“The decision (not to recommend the vaccination) does not mean that the vaccine itself is problematic from the viewpoint of safety,” said Mariko Momoi, vice president of the International University of Health and Welfare, who headed a ministry task force looking into the matter. “By implementing investigations, we want to offer information that can make the people feel more at ease.”

It is rare for the ministry to withdraw a recommendation for a vaccine that is used regularly by local governments and is spelled out in a law.

Girls can still receive the vaccination for free, although medical institutions must now inform them beforehand that the ministry does not recommend it.

The government’s subsidy program for vaccination against cervical cancer started in 2010. The vaccination became regularly used in April this year under revisions to the Preventive Vaccination Law.

Those subject to the vaccination range from six-graders of elementary schools to first-year students of senior high schools.

So far, an estimated 3.28 million people have received the vaccination. However, 1,968 cases of possible side effects, including body pain, have been reported.

The ministry’s task force discussed 43 of those cases. However, a cause-and-effect relationship between the vaccination and the pain and numbness could not be established, so the task force members called for further studies by the ministry.

On June 14, the task force concluded that the ministry should withdraw its recommendation until it can offer appropriate information about what caused the pain and numbness.

The ministry’s investigation is expected to take several months. It will then decide whether to reinstate or continue to withhold its recommendation for the vaccination.

“We welcome the decision not to recommend the vaccination even though it is a small step,” said Mika Matsufuji, head of a group of parents who say their children have suffered side effects from the vaccination. “Parents can decide whether their children should receive the vaccination or not.”

The risk of cervical cancer increases in women in their 20s or 30s. About 9,000 people contract the disease every year in Japan, and about 2,700 die annually.

The World Health Organization recommends the vaccination, which is used in various countries.

 Friday June 14 2013


HPV vaccine raises questions

On April 1, vaccinations against cervical cancer began being administered on a regular basis free of charge. But a series of reports have surfaced suggesting that the vaccinations have caused side effects.

Parents of children who are said to have suffered serious health damage have formed an association and called on the government to immediately stop the vaccinations. Usually junior high school first-grade girl students receive the vaccinations; they have to go through three rounds of vaccinations.

The health and welfare ministry should immediately carry out a thorough study of the health damage allegations. If the health risks from the vaccinations appear to exceed the benefits promised, the government should stop the vaccinations. Otherwise, it should fully explain both the benefits and any possible damage from the vaccinations to help people make decisions.

The government should extend sufficient relief if it is ascertained that the vaccinations have caused health damage.

Every year, about 20,000 women in Japan are diagnosed with cervical cancer and about 3,500 of them die. Cervical cancer cases are on the rise among women in their 20s and 30s. The cancer is caused by the commonplace human papillomavirus (HPV), which is transmitted usually through sexual intercourse.

There are more than 100 types of HPV; some 15 types have a high risk of causing cervical cancer. HPV types 16 and 18 are responsible for about 70 percent of all cervical cancers. It is thought that 80 percent of Japanese women become infected with HPV during their lifetime.

Two types of vaccines that are effective against HPV types 16 and 18 are used in Japan. Although they do not cover all of the high-risk types of HPV, combining the vaccinations and medical examinations is considered an effective preventive.

The regular vaccinations cover girls in the sixth year of elementary school through the first year of junior high school. The vaccinations against cervical cancer began in December 2009. A total of 8.29 million people had received them as of December 2012. According to a health and welfare ministry panel, 1,968 cases of side effects were reported through the end of March 2013. Of these, 106 were rated serious cases of pains or body convulsions, pains in joints or difficulty in walking.

This means about 12.3 serious cases of side effects per 1 million inoculations ­ higher than the 0.9 serious cases per million inoculations of influenza vaccine and the 2.1 serious cases per million inoculations of inactivated polio vaccine. The side-effect rate for the HPV vaccine is still lower than the 26.0 serious cases per million inoculations of Japanese encephalitis vaccine.

The panel’s view is that the side-effect danger from cervical cancer vaccinations is not particularly high compared with that from other vaccinations. If the vaccinations are stopped, many more women may fall victim to cervical cancer.

The health and welfare ministry has the duty to show convincingly that the benefit from the vaccinations is greater than the risks from the vaccinations. Hospitals and doctors need to provide sufficient information to people about the vaccinations so that they can make a rational decision.