ID :
79688
Sun, 09/13/2009 - 00:53
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http://m.oananews.org//node/79688
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Novartis to begin clinical test with new-flu vaccine in Japan
TOKYO, Sept. 12 Kyodo -
Swiss drug maker Novartis will begin conducting a clinical test Wednesday in
Japan's Kagoshima Prefecture to ensure the safety and effectiveness of its
vaccine for the H1N1 strain of influenza, sources familiar with the matter said
Saturday.
The clinical test, involving some 200 healthy adults at first and around 100
children later, will be made so the company can export the vaccine to Japan,
the sources said.
Japan's Health, Labor and Welfare Ministry has said it will allow overseas
drugmakers to sell their vaccines for the new influenza in Japan without
conducting a clinical test in Japan based on the Pharmaceutical Affairs Act and
obtaining its approval, if the drugs have already been approved by drug
authorities overseas.
The ministry has said drugmakers planning to export their vaccines to Japan
need to somehow confirm their safety in the country, even if they do not need
to undertake a formal clinical test based on the Japanese law.
Novartis' planned clinical test is in response to this, the sources said.
To make up for a shortfall in domestically produced vaccines for the flu, the
government has been negotiating with the Swiss company and Britain's Glaxo
Smith Kline to import their vaccines, with an eye to using them on priority
targets such as schoolchildren and the elderly beginning in late December.
Health minister Yoichi Masuzoe has said Japan would be able to secure new-flu
vaccines for at least 42 million people by importing them.
According to Novartis, the virus used to produce its vaccine is cultivated with
the so-called MDCK cell, derived from canine kidneys, while domestically
produced vaccines are made from viruses incubated with chicken eggs.
A substance called vaccine adjuvant is added to the Swiss company's vaccine to
enhance immunity.
But some experts have expressed concern about the company's vaccine, saying its
vaccine adjuvant has never been used in Japan and that the MDCK cell may cause
tumors.
Novartis has already conducted clinical tests with its new-flu vaccine in four
European countries.
A study in Britain allegedly showed that more than 90 percent of people who had
been vaccinated twice with the company's vaccine obtained a type of immunity
expected to prevent them from catching the new influenza.
Of people who had been vaccinated once, some 80 percent reportedly obtained
such immunity.
Influenza vaccines are said to be effective to a certain degree in preventing
those who have caught flu from developing serious symptoms or dying.
But it is not proven whether vaccines can prevent people from catching the flu.
Although it is rare, vaccination can produce serious side-effects.
==Kyodo
Swiss drug maker Novartis will begin conducting a clinical test Wednesday in
Japan's Kagoshima Prefecture to ensure the safety and effectiveness of its
vaccine for the H1N1 strain of influenza, sources familiar with the matter said
Saturday.
The clinical test, involving some 200 healthy adults at first and around 100
children later, will be made so the company can export the vaccine to Japan,
the sources said.
Japan's Health, Labor and Welfare Ministry has said it will allow overseas
drugmakers to sell their vaccines for the new influenza in Japan without
conducting a clinical test in Japan based on the Pharmaceutical Affairs Act and
obtaining its approval, if the drugs have already been approved by drug
authorities overseas.
The ministry has said drugmakers planning to export their vaccines to Japan
need to somehow confirm their safety in the country, even if they do not need
to undertake a formal clinical test based on the Japanese law.
Novartis' planned clinical test is in response to this, the sources said.
To make up for a shortfall in domestically produced vaccines for the flu, the
government has been negotiating with the Swiss company and Britain's Glaxo
Smith Kline to import their vaccines, with an eye to using them on priority
targets such as schoolchildren and the elderly beginning in late December.
Health minister Yoichi Masuzoe has said Japan would be able to secure new-flu
vaccines for at least 42 million people by importing them.
According to Novartis, the virus used to produce its vaccine is cultivated with
the so-called MDCK cell, derived from canine kidneys, while domestically
produced vaccines are made from viruses incubated with chicken eggs.
A substance called vaccine adjuvant is added to the Swiss company's vaccine to
enhance immunity.
But some experts have expressed concern about the company's vaccine, saying its
vaccine adjuvant has never been used in Japan and that the MDCK cell may cause
tumors.
Novartis has already conducted clinical tests with its new-flu vaccine in four
European countries.
A study in Britain allegedly showed that more than 90 percent of people who had
been vaccinated twice with the company's vaccine obtained a type of immunity
expected to prevent them from catching the new influenza.
Of people who had been vaccinated once, some 80 percent reportedly obtained
such immunity.
Influenza vaccines are said to be effective to a certain degree in preventing
those who have caught flu from developing serious symptoms or dying.
But it is not proven whether vaccines can prevent people from catching the flu.
Although it is rare, vaccination can produce serious side-effects.
==Kyodo
