The European Commission has granted a marketing authorisation for Zostavax, a vaccine for the prevention of shingles in individuals aged 60 years or older. It is the first and only vaccine registered in Europe for this indication.
The agent was developed by US drug major Merck & Co, which has just won US Food and Drug Administration approval for the product, and Sanofi Pasteur MSD, a joint venture that it set up with Sanofi-Aventis. Zostavax will be marketed in Europe by the JV.
Sanofi Pasteur MSD noted that the licences granted as part of the EC's decision are for a frozen formulation of the vaccine but the firm will shortly file a variation with the European Medicines Agency (EMEA) for a refrigerated formulation.
Shingles is caused by latent varicella zoster virus, the same virus that causes chickenpox, and can result in a blistering rash that can last for months or even years. In trials reported last year, Zostavax was able to reduce pain and discomfort in more than 60% of patients, cutting the incidence of persistent pain by two thirds.
Sanofi Pasteur MSD pointed particularly to Zostavax’ ability to tackle post-herpetic neuralgia, a complication of shingles that can leave patients saddled with pain long after the visible symptoms clear up. Many patients are refractory to current existing treatments for PHN, so a preventive vaccine would be of great benefit. In trials, Zostavax reduced the incidence of PHN by 67% compared to placebo.
The prevalence of the disease is similar to the USA, so that the estimated size of the market in the European Union is approximately 1.5 million cases each year, a figure which can be expected to increase as the population ages. Analysts have suggested that Zostavax could achieve sales in excess of $500 million a year at its peak.