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 Package Insert – BEXSERO Supporting Documents May 31, 2018 Approval Letter – BEXSERO October
August 28, 2018 – Emerging clinical experience with vaccines against group B meningococcal disease “While recent data from the United Kingdom supports the potential for protein-based vaccines to provide direct protection against MenB disease in immunised children, further research is required to understand the breadth and duration of this protection. A more detailed
Meningitis is inflammation of the meninges, the lining which surrounds the brain. The disease should not be confused with encephalitis which is inflammation of the brain itself. Essentially, there are two distinct types of meningitis; aseptic (usually caused by viral infections) and bacterial. Bacterial meningitis, while it is comparatively rare, is
Human papillomavirus (HPV) is a viral infection that passes between people through skin-to-skin contact. There are more than 140 varieties of HPV. The infection is so common that most sexually active people will be infected at some point. In fact, the CDC states that HPV is the most common sexually
Cervarix HPV Vaccine Bivalent Recombinant Types 16 and 18 “The adjuvant system, AS04, is composed of 3-O-desacyl-4’-monophosphoryl lipid A (MPL) adsorbed on to aluminum (as hydroxide salt). Found 4459 cases where Vaccine is HPV2 and Manufacturer is GLAXOSMITHKLINE BIOLOGICALS Cervarix here October 26, 2017 – Adjuvants and the vaccine response to the DS-Cav1-stabilized fusion glycoprotein of
Gardasil 4vHPV Vaccine Package Insert Found 45001 cases where Vaccine is HPV4 and Manufacturer is MERCK & CO. INC. March 20, 2018 – Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009–2015 “We identified 92 reports of death. Sixty-one were hearsay
Prejudicial Distribution of the HPV Vaccine (thorough overview) Gardasil is a vaccine designed to prevent infections caused by certain types of human papillomavirus (HPV), specifically HPV types 6, 11, 16 and 18. HPV types 16 and 18 have been associated with cervical cancers and strains HPV types 6 and 11
Menveo, manufactured by Novartis, received approval for use in 2010 to vaccinate against Neisseria meningitidis serogroups A, C, Y and W-135. It is approved for use in people 11 to 55 years of age. Menveo Vaccine Package Insert Approval History, Letters, Reviews, and Related Documents – Menveo March 27, 2017
Menomune (MPSV4) is a polysaccharide vaccine for serogroups A, C, Y and W-135 that has been available since 1970. The vaccine is approved for use in persons 2 years of age and older. The duration of immunity mediated by Menomune is three years or less in children aged under 5
Neisseria meningitidis, the bacteria that causes meningitis, has 13 clinically significant serogroups. These are classified according to the structure on the surface of their capsule. Six serogroups, A, B, C, Y, W135, and X are responsible for virtually all cases of the disease in humans. The most common cause of