Sanofi's Novel Six-In-One Vaccine Receives Approval
BMI View: Mexico's relatively low-cost business environment, growing domestic pharmaceutical market and hospitable regulatory environment have made it an attractive market to multinationals. Sanofi's vaccine portfolio is well-positioned in Mexico's pharmaceutical market. The company has partnered with state-own vaccine developer and distributor, BIRMEX, to gain advantages in market penetration and winning national tenders. Its innovative, high-price vaccines have benefited from Mexico's acceleration of market approval timelines.
Mexico's Federal Commission for Sanitary Risk Protection (COFEPRIS) has approved Sanofi's six-in-one paediatric vaccine, Hexyon/Hexacima (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age. Hexyon/Hexacima is the only fully liquid, ready-to-use, six-in-one vaccine to protect infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. We note that the market approval for Hexyon/Hexacima has been granted within two months after its first approval by the European Medicines Agency (EMA) in April 2013.
Mexico's comparable low immunization rates, large population and birth cohorts as well as increasing demand on healthcare coverage from both public and private sector have generated significant opportunities for drugmakers in the vaccine sector. A survey from local pharmaceutical industry reported that Mexicans have been unable to enjoy the full benefit from the potential of immunisation, and suggested that the government should increase public awareness of vaccination. The Ministry of health has planned to introduce a law that will guarantee an allocation in the budget to purchase vaccines. The surety of the funding allocation would encourage immunisation programmes in the country.
In comparison with Brazil, which is striving to achieve self-sufficiency in vaccine supply through strengthening its domestic industry to partner with multinationals, Mexico has heavily relied on vaccine imports. According to reports from Laboratorio de Biológicos y Reactivos de México (BIRMEX), a state-own vaccine producer in Mexico, the country only produces two of the twelve vaccines included in the Basic Vaccine Programme (Esquema Básico de Vacunación). Imports of basic vaccinations cost around MXN5bn (US$371mn) annually. The government has started to ease Secretaria de Salud (SSA) registration requirements for low-risk products and introduce new guidelines to speed up the release of imported vaccines.