Saturday, June 15, 2013

Breaking: Japan Halts Cervical Cancer Vaccine Over Health Issues

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

NATIONAL

Cervix vaccine issues trigger health notice

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.

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Health ministry withdraws recommendation for cervical cancer vaccine
June 15, 2013
THE ASAHI SHIMBUN
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.
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