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Pre-pandemic bird flu shots eyed / Health ministry to urge study of potential early vaccination recipients
04-26-2009, 03:09 PM,
#1
Pre-pandemic bird flu shots eyed / Health ministry to urge study of potential early vaccination recipients
Pre-pandemic bird flu shots eyed / Health ministry to urge study of potential early vaccination recipients

Masayuki Takata / Yomiuri Shimbun Staff Writer

Despite the recent announcement by a Health, Labor and Welfare Ministry research group that vaccines planned for use ahead of a pandemic of a new type of influenza are effective and safe, the ministry will ask experts to carefully study the occupations of people to be given the vaccines and the timing for the vaccinations.

The pre-pandemic vaccines are produced based on the H5N1 type of highly pathogenic avian influenza virus, commonly known as bird flu, which experts regard as highly likely to become transmissible among humans.

The ministry believes vaccines planned for development based on a new type of human-transmittable influenza virus after a flu outbreak will be the key to tackling a flu pandemic.

However, experts believe it will take at least 1-1/2 years to prepare appropriate pandemic vaccines for everyone in the country, given current manufacturing capacities.

Therefore, the ministry believes pre-pandemic vaccines are necessary to fill the time gap before the pandemic vaccines become available.

After NHK aired a TV program early last year warning of the potential for a pandemic of a new type of influenza, public interest in and hope for such pre-pandemic vaccines have increased.

The program depicted widespread deaths among humans from the flu and mentioned the vaccines as one way to avoid infection.

Many books discussing the flu and a potential pandemic also have been released.

Committees of the House of Representatives and the House of Councillors adopted resolutions to urge the government to discuss prescribing the pre-pandemic vaccines for members of the public who make such a request.

The moves prompted clinical studies of the pre-pandemic vaccines to be carried out between August and November.

During a 2007 study that preceded official approval for the vaccines, they were administered to 380 people. But in a bid to check safety and effectiveness as part of the latest study, inoculations were given to a much wider group of about 6,000 people.

According to the latest study, eight subjects, or 0.14 percent, were hospitalized after being given the vaccines. However, of the eight, it was concluded that only two recipients suffered side effects--in their cases, high fever and numbness of the extremities--directly resulting from the vaccines.

The group also found that prescribing two types of the vaccines would help a person acquire immunity to different types of influenza.

The group successfully confirmed the vaccines' effectiveness and safety.

However, doctors are not willing to prescribe the pre-pandemic vaccines to a wide variety of people based solely on the group's findings.

Norio Sugaya, head of the Keiyu Hospital pediatric department, said: "There's no guarantee that the H5N1 virus will develop as a new type of flu that will cause a pandemic. So I don't think the latest clinical study proved that pre-pandemic vaccines really are effective against new types of influenza."

In September, the government released a draft on how the pandemic vaccines will be prescribed. It classifies into three categories 10 million to 15 million people involved in 97 occupations regarded as having priority for receiving the vaccines ahead of others. The top-priority Category I includes medical practitioners, police officers, Self-Defense Forces personnel and others Category II lists the prime minister and other ministers, while Category III comprises those in the power, gas and transport industries and others.

One of the Health, Labor and Welfare Ministry's concerns about prescribing pre-pandemic vaccines is side effects.

In 1976, the United States prescribed a vaccine in preparation for a pandemic of a human-transmittable influenza virus developed from a swine flu virus. However, the pandemic did not occur, and instead, many who received the vaccine suffered serious side effects.

Based on the findings of the latest clinical study, about 3,000 per 10 million vaccine recipients are expected to be hospitalized due to pre-pandemic vaccine side effects.

A senior health ministry official said, "It's impossible [for the government] to take responsibility for suffering from pre-pandemic vaccine side effects if no pandemic breaks out."

The problems of determining pre-pandemic vaccine recipients and who would bear the prescription costs will be discussed at a ministry committee of experts tasked with combatting a potential new type of influenza and by a separate council comprising experts in the fields of law and ethics.

Some members of the ministry experts' committee also have taken a cautious stance toward prescribing pre-pandemic vaccines to a wider population.

The problem is how to find an appropriate balance between the risk of a pandemic and the risk of side effects.

Japan is the only country planning to prescribe vaccines before a pandemic as a way of dealing with a potential new type of influenza. So how Japan strikes an appropriate balance is attracting attention from other countries.
(Apr. 25, 2009)

http://www.yomiuri.co.jp/dy/national/20090425TDY03103.htm
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