What is the Meningococcus vaccine?
IMPORTANT NOTE: Corvelva invites you to get in-depth information by reading all the sections and links, as well as the manufacturer's product leaflets and technical data sheets, and to speak with one or more trusted professionals before deciding to vaccinate yourself or your child. This information is for informational purposes only and is not intended as medical advice.
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Bexero - GlaxoSmithKline - Meningococcal group B vaccine
Bexsero is indicated for the active immunization of individuals 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.
Dosage declared by the manufacturer
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Italian National Vaccination Prevention Plan (PNPV).
Three or four doses depending on the type of vaccine and the month of administration of the first dose.
Adverse events declared by the manufacturer
- fever (temperature equal to or greater than 38°C and even equal to or greater than 40°C)
- loss of appetite
- injection site tenderness (including severe tenderness that causes crying when the injected limb is moved)
- joint pain
- rash
- drowsiness
- irritability
- unusual cry
- vomiting (uncommon after booster dose)
- Diarrhea
- headache
- rash (children ages 2 to 10)
- seizures (including febrile seizures)
- dry skin
- pallor (rarely after booster dose)
- Kawasaki disease
- itchy rash, rash
- pain at the injection site causing inability to carry out normal daily activities
- aching muscles and joints
- nausea
- general feeling of being unwell
- Enlarged lymph nodes.
- Allergic reactions which may include severe swelling of the lips, mouth, throat (with possible difficulty swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness and very low blood pressure.
- Collapse (sudden muscle floppiness), less responsive than usual or loss of consciousness, paleness or bluish discolouration of the skin in young children.
- Feeling faint or faint.
- Neck stiffness or discomfort in light (photophobia), indicating irritation of the meninges
Excipients declared by the manufacturer
- Neisseria meningitidis group B recombinant NHBA fusion protein
- Neisseria meningitidis group B recombinant NadA protein
- Neisseria meningitidis group B recombinant fHbp fusion protein
- Outer membrane vesicles (OMV) of Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing PorA P1.4
- E. coli cells by recombinant DNA technology
- adsorbed on aluminum hydroxide (0,5 mg Al3+)
- NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A),
- fHbp (factor H binding protein)
- Sodium chloride
- Histidine
- Sucrose
- Water for injections
Curiosity
BEXSERO, a second meningococcal serogroup B vaccine, manufactured by Novartis Vaccines and Diagnostics (GlaxoSmithKline), received FDA approval for use on January 23, 2015.45 However, between late 2013 and early In 2014, prior to FDA approval, the unlicensed vaccine was cleared by the CDC and FDA for use at both Princeton University and the University of California Santa Barbara (UCSB), where they were reported outbreaks of meningococcal serogroup B disease. At UCSB, where 51% of students received a single dose of vaccine and only 37% completed the recommended two-dose series,46 no additional cases of meningococcal serogroup B disease were reported.47 Princeton, where 90% of students opted to receive two doses of the unlicensed vaccine, no additional cases of meningococcal serogroup B disease were reported among vaccinated Princeton students, but one additional case was reported in a student at another local university who had been in close contact with several Princeton University students.4849 The researchers therefore concluded that although the vaccine appeared effective in protecting vaccinated individuals, it likely had no impact on nasopharyngeal transport and vaccinated individuals still had the potential to spread the disease to others. 50
BEXSERO also received Breakthrough Therapy designation from the FDA and, with the Accelerated Approval designation, was cleared within 10 months. At the time of FDA approval, no clinical studies had examined the safety or immunogenicity of BEXSERO when given concomitantly with other vaccines.51
TRUMENBA
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Dosage declared by the manufacturer
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Italian National Vaccination Prevention Plan (PNPV).
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Adverse events declared by the manufacturer
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Excipients declared by the manufacturer
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Curiosity
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MENJUGATE
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Dosage declared by the manufacturer
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Italian National Vaccination Prevention Plan (PNPV).
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Adverse events declared by the manufacturer
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Excipients declared by the manufacturer
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Curiosity
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NEISVAC-C
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Dosage declared by the manufacturer
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Italian National Vaccination Prevention Plan (PNPV).
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Adverse events declared by the manufacturer
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Excipients declared by the manufacturer
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Curiosity
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MENVEO (MENINGOCOCCAL CONJUGATE A, C, W135, Y) - intramuscular use
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Dosage declared by the manufacturer
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Italian National Vaccination Prevention Plan (PNPV).
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Adverse events declared by the manufacturer
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Excipients declared by the manufacturer
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Curiosity
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NIMENRIX (MENINGOCOCHA CONJUGATE A, C, W135, Y) - intramuscular use
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Dosage declared by the manufacturer
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Italian National Vaccination Prevention Plan (PNPV).
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Adverse events declared by the manufacturer
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Excipients declared by the manufacturer
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Curiosity
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What is the history of Rotavirus vaccines?
Development of rotavirus vaccines began soon after the virus was discovered in 1973, and in August 1998, the FDA approved RotaShield, a live-virus oral vaccine containing four components (tetravalent) derived from a rhesus monkey strain of rotavirus(1) produced by Wyeth-Lederle. In August 1999, the US Committee on Government Reform initiated an investigation into federal vaccine policy as it related to possible conflicts of interest between federal policymakers and the manufacturer of the RotaShield. The committee focused its investigations on the CDC's Advisory Committee on Immunization Practices (ACIP) and members of the Vaccines and Related Biologics Advisory Committee (VRBPAC). Heavy conflicts of interest emerged.(2)
On March 22, 2010, the US Food and Drug Administration (FDA) announced that an independent US academic research group had found porcine circovirus 1 (PCV1) DNA in the ROTARIX vaccine. The FDA has recommended that healthcare professionals suspend use of the ROTARIX vaccine in the United States, pending further information on PCV1. However, he said this finding did not pose a safety concern and said PCV1 was not known to cause disease in humans or other animals.(3)
On May 7, 2010, the FDA announced that the RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2. Although PCV1 has not been associated with clinical disease in pigs, PCV2 was known to be a lethal porcine virus causing immunosuppression and severe wasting disease in pig pups affecting lung, kidney, reproductive system and brain and ultimately analysis, causes death. On March 22, 2010, the FDA recommended temporary suspension of use of the ROTARIX vaccine after PCV1 DNA was identified in ROTARIX, but did not request suspension of use of the RotaTeq vaccine after PCV2 was found in RotaTeq.(4)
However, a week later, on May 14, 2010, the FDA announced that it had reviewed the scientific evidence and determined that the vaccine was safe and that use of the product should continue.(5) PCV1 remains a contaminant of the ROTARIX vaccine, and PCV1 and PCV2 continue to contaminate RotaTeq vaccines.(6)
On June 11, 2010, the CDC issued a revised recommendation and added severe combined immunodeficiency (SCID) as a contraindication to the administration of rotavirus vaccines. SCID is a group of rare disorders caused by mutations in various genes involved in T- and B-lymphocyte function and development. The addition of this contraindication occurred following reports of vaccine-acquired rotavirus infections and prolonged shedding of the vaccine strain in this specific population.(7)
In October 2011, the CDC updated the rotavirus vaccine recommendations again, adding a prior history of intussusception as a contraindication to rotavirus vaccine. In this updated recommendation, the CDC reported that infants with a history of intussusception are at higher risk for a repeat case; however, no data were available to determine the risk of a subsequent case of intussusception after rotavirus vaccination in infants with a prior history of intussusception.(8) Intussusception between days 23 and 2015 after the first and second doses of rotavirus vaccine was recognized as a vaccine injury and added to the National Vaccine Injury Compensation Program's vaccine injury table on July XNUMX, XNUMX.(9)
References:
- Matson DO. RotaShield: the ill-fated rhesus-human reassortant rotavirus vaccine. Pediatrician Ann Jan. 2006;35(1):44-50.
- US Congress. House of Representatives. Committee on Government Reform. 2000. Conflicts of Interest in Vaccine Policy Making. Majority Staff Report. National Vaccine Information Center June 15, 2000
- Schrinning L. FDA urges clinicians to suspend use of GSK rotavirus vaccine CIDRAP News Mar. 22, 2010.
- Schnirring L. Second rotavirus vaccine found to contain porcine centovirus. CIDRAP News. May 7, 2010.
- US Food and Drug Administration. Information for Parents and Caregivers. In: Vaccines, Blood, and Biologics. May 14, 2010.
- Communication and Education Branch, National Center for Immunization and Respiratory Diseases (NCIRD) and the Centers for Disease Control (CDC). Appendix B: Vaccine Excipient Summary - Excipients included in US Vaccines, by Vaccine In: Epidemiology and Prevention of Vaccine-Preventable Diseases. February 2020.
- US Centers for Disease Control and Prevention. Addition of Severe Combined Immunodeficiency as a Contraindication for Administration of Rotavirus Vaccine. MMWR June 11, 2010; 59(22):687-688 .
- US Centers for Disease Control and Prevention. Addition of History of Intussusception as a Contraindication for Rotavirus Vaccination. MMWR Oct. 21, 2011; 60(41):1427-1427 .
- National Archives. National Vaccine Injury Compensation Program: Addition of Intussusception as Injury for Rotavirus Vaccines to the Vaccine Injury Table. Federal Register June 23, 2015