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 have said. 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.
