Saturday, June 15, 2013

Japan Health Ministry Withdraws its Recommendation for HPV Vaccines for Women/ Japan Times



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)
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 Japan Times refers to halting both Gardasil and Cervarix vaccines. In the US, attention has focused on neurological abnormalities.  In Japan, these have occurred, but the expert panel focused on 38 recipients who developed chronic pain syndromes. I have seen a large number of chronic pain disorders (usually associated with fatigue, cognitive and sometimes personality changes) occur following anthrax vaccinations, so it seems logical that other vaccines may cause similar disorders.  Note that Gardasil was approved by FDA under a "fast-track" designation, without definitive evidence of either safety or efficacy at the time of licensure, and many studies are still in process that were required by FDA to issue the license.

Note also that two years after giving its approval, FDA required Merck to add warnings to the Gardasil label for muscle pains, joint pains and fatigue.   

FDA's MO is to warn in the label and continue to allow product sales without restriction, and continue to allow this and other vaccines to be promoted, and in some cases mandated, by federal and state authorities..           
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...
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...

According to the Japanese newspaper 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 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.

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