Japan Health Ministry: Cervical Cancer Vaccinations No Longer Recommended Because Of Several Adverse Reactions

Cervix vaccine issues trigger health notice (Japan Times/Kyodo News, June 15, 2013):

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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