Japan withdraws recommendation of Merck and GSK HPV jabs

Japan takes a particularly reactive approach to vaccine adverse events. In 2011 Pfizer's ($PFE) Prevnar and Sanofi's ($SNY) ActHIB vaccines were both suspended following the deaths of four children. This week the spotlight is on GlaxoSmithKline ($GSK) and Merck ($MRK).

The Japanese health ministry has told local governments to suspend promotion of Gardasil and Cervarix while it investigates adverse events linked to the human papillomavirus (HPV) shots. As of this week, the vaccines are still freely available, but physicians will stop recommending use of the jabs, at least temporarily. The health ministry decision follows reports of people experiencing severe prolonged pain after receiving the vaccines.

An estimated 3.3 million people have received the HPV vaccines in Japan, almost 2,000 of whom have then reported possible side effects, The Asahi Shimbun reports. A ministry task force took a closer look at 43 cases but was unable to establish a causal relationship between HPV shots and symptoms of pain or numbness. HPV vaccines have been linked to more side effect reports than other shots approved at the same time, though. For every million vaccinations with Cervarix, Japanese people have reported 241 side effect cases. In contrast, there have been 67 cases per million Japanese encephalitis vaccinations.

The prevalence of side effects--coupled with high-profile cases, such as a girl who lost the ability to walk after receiving Cervarix--prompted the task force to call for further studies. In the meantime, the ministry is withdrawing its recommendation of the vaccine.

"The decision does not mean that the vaccine itself is problematic from the viewpoint of safety. By implementing investigations, we want to offer information that can make the people feel more at ease," task force head Mariko Momoi said. A ministry official told The Japan Times the HPV vaccination rate is certain to drop sharply while the issue is being resolved.

- here's the Asahi Shimbun article
- read the Japan Times item