Written by: Silvia Eash
Analysis of: WHO Suspends Sanofi Vaccine
SUMMARY
In March 2010, the WHO suspended the distribution of sanofi-aventis' Shan5 vaccine based on quality issues. As a result, short-term gains are expected for Novartis/Crucell's equivalent pentavalent vaccine, Quinvaxem, but limits on local manufacturing capacity will ultimately cap the benefit. Instead the overall effect is expected to be minor as the shortfall will be addressed with similar paediatric combination vaccines from GSK as well as sanofi/Shantha’s other WHO-pre-qualified vaccines.
ANALYSISSHAN5 (DPT-HebB-Hib) is a pentavalent paediatric combination vaccine that includes Diphtheria, Pertussis, Tetanus, Haemophilus influenza B, and Hepatitis B. The vaccine is developed and manufactured by Shantha Bioethics in Hyderabad, India. Sanofi-aventis acquired an 80% stake in Shantha in August 2009, and the company positions Shantha, with its range of affordable paediatric vaccines and established relationships with a number of supranational organizations for vaccine supply to Asia-Pacific, Africa and Latin America, as one of its main drivers of growth for its vaccine portfolio in the emerging markets.
SHAN5 is pre-qualified by the WHO for supplying to U.N. agencies around the world. In September 2009 the U.N. agency awarded Shantha a $340-million contract to supply SHAN5 for the period 2010-2012. The contract covers supply of SHAN5 to countries in Africa, Asia, and Latin America. However, in March 2010 the WHO suspended SHAN5 because of complaints that white sediment was found in some of the vials. No safety concerns have been associated with the vaccine but in the countries where the vaccine is available, immunisation with SHAN5 has been suspended pending the findings from an ongoing quality investigation.
Despite the suspension of SHAN5, the WHO has advised that immunisation should continue using pentavalent vaccines from different manufacturers or using different vaccines that also offer protection against DTP. This will provide benefit only to a small subset of the global vaccine companies, as the likes of Merck and Pfizer have a limited presence in the paediatric vaccine market in the regions covered by SHAN5. The companies that are likely to benefit the most are Novartis / Crucell who produce an equivalent paediatric combination vaccine, Quinvaxem, which offers coverage against the same five childhood disease as SHAN5. Quinvaxem is also a WHO pre-qualified vaccine and is sold to developing countries through supranational organizations for large vaccination programs. In August 2009 Crucell was awarded a new $300-million contract by
a large supranational organization to supply Quinvaxem during the 2010-2012 period.
While the suspension SHAN5 is expected to be temporary, a prolonged absence from the market would clearly leave a void in the paediatric combination vaccine market in developing countries. However, given its own contractual obligations it is unlikely that Novartis/Crucell will be able to take on additional sizeable orders at this time. Instead we expect that if SHAN5 is suspended following the quality investigation, the gap will be filled with other similar, but not identical, paediatric combination vaccines including Shantha’s other WHO-pre-qualified vaccines that offer similar coverage such as SHANTETRA (DTP-HepB), SHANVC-B (rHepB), and SHANTT (tetanus toxoid), meaning the overall impact on sanofi-aventis will likely be minimal.