The European Medicines Agency has said two of Sanofi Pasteur MSD’s hepatitis B vaccines seem to be effective, despite using the same antigen as suspended product Hexavac.
Last September, the EMEA suspended sales of Sanofi Pasteur's vaccine Hexavac, as a precautionary measure on concerns that the six-in-one shot may not provide adequate protection against hepatitis B. But in a statement released yesterday, the agency said a review of two other hepatitis vaccines - HBvaxPRO and Procomvax - continue to offer effective protection against the virus.
Hexavax was estimated to account for around 10% of vaccine sales at Sanofi-Aventis, which shares ownership of Sanofi Pasteur MSD with Merck & Co, with analysts predicting that the suspension would cost the firm around 100 million euros in annual turnover. The JV’s total hepatitis vaccine sales came in at around $81 million in 2005, largely flat compared to 2004.
Although it has allowed the vaccines to remain on the market, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) has asked the company to conduct a range of studies in different age and risk groups to further ensure that the vaccines provide a sufficient level of long-term protection against hepatitis B.
Hexavac’s suspension was a lift for the vaccines business at GlaxoSmithKline, which has been stepping up production of its rival to the vaccine - Infanrix Hexa - in order to meet an anticipated hike in demand.