STN: BL 125546
Proper Name: Meningococcal Group B Vaccine
Trade Name: BEXSERO
Manufacture: Novartis Vaccines and Diagnostics, Inc
Indication:
- Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Product Information
Supporting Documents
- May 31, 2018 Approval Letter – BEXSERO
- October 12, 2017 Approval Letter – BEXSERO
To update the package insert to include additional adverse events of extensive limb swelling and injection nodule in Section 6.3 Postmarketing Experience. - January 23, 2015 Approval Letter – BEXSERO
- January 23, 2015 Summary Basis for Regulatory Action – BEXSERO
- Clinical Review, January 23, 2015 – BEXSERO
- Statistical Review – BEXSERO
- Approval History, Letters, Reviews, and Related Documents – BEXSERO
January 2016 – Severe Upper Extremity Dysfunction After 4CMenB Vaccination in a Young Infant. “We report the case of a 5 month old infant who developed prolonged upper extremity dysfunction after the 2nd injection of the 4CMenB vaccine in the left deltoid muscle along with two concomitantly applied routine vaccinations. Myositis, periostitis, (peri-) vasculitis and axillar inflammation was confirmed by magnetic resonance imaging. Two months after initial initiation of anti-inflammatory and antibiotic treatment symptoms resolved completely. Administration of three vaccines requires clear recommendations for the preferred injection site in infants since increased reactogenicity of 4CMenB might lead to local severe adverse events.
September 30, 2015 – The introduction of the meningococcal B (MenB) vaccine (Bexsero®) into the national infant immunisation programme – New challenges for public health “Because of high rates of fever post-vaccination, parents were advised to give their infants three doses of prophylactic paracetamol, with the first dose given as soon as possible after the primary MenB vaccination dose. Since the vaccine only protects against 73–88% of circulating MenB strains in England, clinical isolates and PCR-positive samples will require extensive characterisation by the Meningococcal Reference Unit (MRU) at Public Health England (PHE) in order to monitor vaccine effectiveness and identify potential vaccine failures.
March 27, 2015 – Waning antibody levels seen in children who received meningococcal B vaccine as infants (full text) “The Novartis vaccine (Bexsero) and Pfizer’s meningococcal group B vaccine, Trumenba, which are approved in Europe and other countries, were recently approved in the United States. At a meeting in February, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended serogroup B meningococcal vaccination for several groups at increased risk for serogroup B disease, including students during outbreaks at college campuses. Broader use of these vaccines in adolescents and college students is on the agenda of the next ACIP meeting in June 2015.”
December 26, 2014 – Progressive Decrease in the Potential Usefulness of Meningococcal Serogroup B Vaccine (4CMenB, Bexsero®) in Gipuzkoa, Northern Spain (full text) “The incidence of meningococcal disease in our region has substantially declined in the last decade, and most recent circulating isolates lacked antigens against which vaccinated people would have been protected. In the current situation, and considering the high incidence of fever from the vaccine, the introduction of the 4CMenB vaccine in our community does not seem to achieve the necessary priority to be recommended. If an outbreak caused by a hypervirulent clone were to occur, especially if the clone was the ST11 clone, the vaccine would be extremely useful.”
November 7, 2013 – Immunisation against meningococcus B: the case of Spain “Alongside France and the UK, Spain has been added to the list of countries adopting a wait-and-see approach to this vaccine. In Spain, not even a rigorous cost-benefit assessment was deemed necessary to support the decision; hasty calculations of disability-adjusted life-years have been considered sufficient. As in other European countries, the incidence of meningococcal B disease in Spain is at its lowest level in decades. NOTE: The author has received funding for research and consultancy from Novartis and manufacturers of other meningococcal vaccines.
Comment: France, United Kingdom, and now Spain have refused to adopt the new meningitis B vaccine. The 8 confirmed cases of meningitis B at Princeton has lead to more than 5800 students volunteering to be vaccinated. There is no proof that this vaccine will be effective.
In addition, there is NO research into the interaction with the other vaccines, including meningitis vaccines Menactra or Menomune, which many freshman students may have received prior to entering college. The “voluntary” vaccination program has frightened students into “volunteering” for an unofficial – and free – clinical trial for Novartis. Will adverse events be reported? Will the public be informed if any students have side effects? Is this experimental vaccine covered by the National Vaccine Injury Compensation Program (NVICP)? There are just too many unanswered questions on Bexsero.