HPV vaccines regulatory update

Japan's MHLW last week withdrew its recommendation of HPV vaccination pending further review of safety data related to systemic pain, according to GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.). MHLW-approved HPV vaccines include Cervarix from GSK and Gardasil from Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.).

GSK told BioCentury that there is "no evidence" that systemic pain is related to Cervarix administration, but that the company is providing information to MHLW. The pharma added that despite the recommendation, the Japanese government is continuing to pay for HPV vaccinations. Merck did not provide comment in time for publication, and MHLW could not be reached for details. ...