Japan vaccines briefs: Gardasil and Cervarix; Daiichi Sankyo files NDA

The Japanese Ministry of Health, Labor and Welfare has decided 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, according to the Japanese Asahi Shimbun. This applies to Merck & Co’s (NYSE: MRK) Gardasil and GlaxoSmithKline’s (LSE: GSK) Cervarix.

The Ministry 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. Girls can still receive the vaccination for free, although medical institutions must now inform them beforehand that the ministry does not recommend it.

“The decision (not to recommend the vaccination) does not mean that the vaccine itself is problematic from the viewpoint of safety,” said Mariko Momoi, vice president of the International University of Health and Welfare, who headed a ministry task force looking into the matter quoted by the newspaper, adding: “By implementing investigations, we want to offer information that can make the people feel more at ease.”