Meningococcal Vaccines

In 2000, the CDC recommended that all college freshman get a dose of meningococcal vaccine containing four strains (A, C, W-35, Y) and, in 2005, that policy was expanded to include all 11 year olds. 

The meningococcal vaccine does not contain strain B, which is the strain associated with more than 50 percent of meningococcal cases and deaths, especially in children under five years old. 

The meningococcal vaccine has been found to be about 58 percent effective within two to five years after adolescents have gotten the shot and, in 2011, CDC recommended that all 16 year olds get a booster dose of meningococcal vaccine.

By August 2012, the federal Vaccine Adverse Events Reporting System (VAERS), which includes only a small fraction of the health problems that occur after vaccination in the U.S., had recorded more than 2,300 serious health problems, hospitalizations and injuries following meningococcal shots, including 39 deaths with about 40% of the deaths occurring in children under age six.  

http://www.nvic.org/Vaccines-and-Diseases/Meningitis.aspx

MENVEO

 MENVEO Package Insert – Novartis  http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM201349.pdf

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.  MENVEO is approved for use in persons 2 through 55 years of age.  MENVEO does not prevent N. meningitidis serogroup B infections.  (Page 3)

Syncope, sometimes resulting in falling injury associated with seizure-like movements, has been reported following vaccination with MENVEO.   (Page 4)

Safety and effectiveness of MENVEO have not been evaluated in immunocompromised persons.  If MENVEO is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained. (Page 4)

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. (Page 5)

Apnea following intramuscular vaccination has been observed in some infants born prematurely.  (Page 5)

In the safety studies in children 2 months through 23 months of age MENVEO was given along with the routine vaccine schedule with no control group. (Page 5)

In the safety studies in children 2 through 10 years of age children who received MENVEO were compared to children who received comparator vaccines (either Menomune or Menactra).  No placebo was used. (Page 6)

In the safety study in individuals 11 through 55 years of age participants received either MENVEO alone, MENVEO concomitant with other vaccines, or a comparator vaccine (either Menomune or Menactra).  No placebo was used.  (Page 6)

In infants initiating vaccination at 2 months of age and receiving the four-dose series, common solicited adverse reactions (> 10%) were tenderness (24-41%) and erythema at injection site (11-15%), irritability (42-57%), sleepiness (29-50%), persistent crying (21-41%), change in eating habits (17-23%), vomiting (5-11%) and diarrhea (8-16%). (Page 7)

Common solicited adverse reactions (≥ 10%) among children initiating vaccination at 7 months through 23 months of age and receiving the two-dose series were tenderness (10-16%) and erythema at injection site (12-15%), irritability (27- 40%), sleepiness (17-29%), persistent crying (12-21%), change in eating habits (12- 20%) and diarrhea (10-16%). (Page 9)

Common solicited adverse reactions (> 10%) among children 2 through 10 years of age who received MENVEO were:  injection site pain (31%), erythema (23%), irritability (18%), induration (16%), sleepiness (14%), malaise (12%), and headache (11%). (Page 10)

Common solicited adverse reactions among adolescents and adults who received MENVEO were pain at the injection site (41%), headache (30%), myalgia (18%), malaise (16%) and nausea (10%).  (Page 10)

The following events have been reported in postmarketing experience which are serious events or events that have a plausible causal connection to MENVEO:  hearing impairment, ear pain, vertigo, vestibular disorder, eyelid ptosis, injection site pruritus, pain, erythema, inflammation and swelling, fatigue, malaise, pyrexia, hypersensitivity, vaccination site cellulitis, fall, head injury, alanine aminotransferase increased, body temperature increased, arthralgia, bone pain, dizziness, syncope, tonic convulsion, headache, facial paresis, balance disorder, oropharyngeal pain, skin exfoliation.  (Page 15)

Neisseria meningitidis is a gram-negative diplococcus that causes life-threatening invasive disease such a meningitis and sepsis.  Globally, 5 serogroups, A, B, C, Y and W-135 cause almost all invasive meningococcal infections.  (Page 18)

MENVEO has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility.  (Page 18)

MENVEO Ingredients: Formaldehyde, amino acids, yeast extract, Franz complete medium              http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

MENACTRA

Menactra – Sanofi Pasteur – Package Insert            http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM131170.pdf

Menactra vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.  Menactra is approved for use in individuals 9 months through 55 years of age.  Menactra does not prevent N. meningitidis serogroup B disease.  (Page 2)

Children 9 through 23 months of age receive two doses, three months apart.  Individuals 2 through 55 years of age receive a single dose.  (Page 2)

Common (>10%) solicited events in infants and toddlers 9 and 12 months of age were injection site tenderness, erythema and swelling, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever.  (Page 1)

Common (>10%) solicited events in individuals 2 through 55 years of age were injection site pain, redness, induration and swelling, anorexia and diarrhea.  Other common solicited events were irritability and drowsiness (2-10 years of age), headache, fatigue, malaise, and arthralgia (11-55 years of age). (Page 1)

Guillain-Barre syndrome (GBS) has been reported in temporal relationship following administration of Menactra vaccine.  (Page 4)

Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur after the administration of Menactra.  (Page 4)

Syncope (fainting) has been reported following vaccination with Menactra vaccine. Procedures should be in place to prevent falling injury and manage syncopal reactions. (Page 4)

Adverse reactions in post-marketing experience are as follows: Hypersensitivity reactions such as anaphylaxis/anaphylactic reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, Guillain-Barré syndrome, paresthesia, vasovagal syncope, dizziness, convulsion, facial palsy, acute disseminated encephalomyelitis, transverse myelitis and myalgia.  (Page 19)

Menactra ingredients: Watson Scherp media containing casamino acid, modified culture medium containing hydrolyzed casein, ammonium sulfate, sodium phospate, formadehyde, sodium chloride  http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

 

 
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