European Commission Approves Pfizer's Trumenba Vaccine
31 May 2017
CoMO is delighted by the news that another vaccine to protect against Meningococcal Group B has been approved for use in Europe.
Following its positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in March of this year, the European Commission (EC) yesterday approved the use of Pfizer’s Trumenba® vaccine in individuals over the age of 10. The vaccine can now be made available for purchase in all EU member states, as well as Norway, Liechtenstein and Iceland.
The vaccine comes to Europe almost three years after its FDA approval in the US in October 2014, where it is recommend for use in individuals aged 10-25 years of age. In 2015, Trumenba was granted a Category B recommendation by the US Advisory Committee on Immunisation Practices (ACIP), meaning the costs of the vaccine for this age group can be claimed back through most insurance companies.
Trumenba is now the second vaccine licensed for use in Europe to protect against group B meningococcal infection. The first was GSK’s Bexsero, which was approved in January 2013 for use in individuals two months of age and older. Bexsero was introduced into the National Immunisation Programme for babies in the UK in September 2015 and other countries are due to follow suit.
Group B Meningococcal infection is the most common cause of meningococcal disease in Europe, so the introduction of another protective intervention is a great success for CoMO and its members. More applications for authorisation are under way in other countries so it is hoped that the vaccine will soon become more widely available.
Chris Head, CoMO’s President commented, “The increased availability of vaccines against meningitis in recent years is great news for CoMO members. There is still much work to be done however to ensure these vaccines are taken up widely and that there is good awareness of the disease globally”.