FDA and CDC Recommendations for Vaccination

Pneumococcus and Prevnar®

The 7-valent pneumococcal conjugate vaccine (PCV) Prevnar® is recommended for all children.

• Studies in the US and Europe have demonstrated its safety and efficacy in children.
• The American Academy of Pediatrics and the American Academy of Family Physicians recommend the 7-valent pneumococcal conjugate vaccine (PCV) for universal use in children 23 months and younger.
• Prevnar® covers pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F.
• Vaccination with Prevnar® is believed to generate some immunity against vaccine-related serogroups (specifically other serotypes in the serogroups 6, 9, 18, 19, and 23), but the extent of this cross-protection is unknown. (Cross-protection for serotype 6A by vaccination for serotype 6B has been reported.)

Prevnar® covers 80% to 85% of pneumococcal meningitis (and other invasive pneumococcal diseases) in the United States and 50% to 80% in Europe.

• In a review of most of the relevant literature existing up to the year 2000, the authors determined that the serogroups related to the Prevnar® vaccine are responsible for 86% of meningitis cases in young children in the United States/Canada and 79% in Europe.
• According to the review mentioned previously, the specific serotypes in the 7-valent Prevnar® vaccine are responsible for approximately 80% of the invasive pneumococcal disease (IPD, primarily bacteremia, meningitis, and pneumonia) in young children in the United States and Canada and for approximately 60% of the invasive pneumococcal disease in young children in Europe.
• Two other US studies determined that the serogroups related to the Prevnar® vaccine are responsible for 84.6% to 85.7% of IPD cases in young children in the United States.
• Another US study found that the specific serotypes in the 7-valent Prevnar® vaccine are responsible for approximately 78% of the IPD in young children in the United States.
• A German study determined that the serogroups related to the Prevnar® vaccine are responsible for 62.5% of IPD cases in young children in Germany and that the specific serotypes in the 7-valent Prevnar® vaccine are responsible for approximately 52% of IPD in young children.
• Additional studies in Europe find that the serogroups related to the Prevnar® vaccine are responsible for 55% to 80% of meningitis cases in young children in Europe and that the specific serotypes in the 7-valent Prevnar® vaccine are responsible for approximately 47% to 53% of meningitis in young children.
• Additional studies in Europe find that the serogroups related to the Prevnar® vaccine are responsible for 60% to 78% of IPD cases in young children in Europe.
• In the northern California Kaiser trial of Prevnar®, the incidence of meningitis in children due to the specific serotypes in the vaccine was reduced by 97% and the incidence of meningitis in children due to the serogroups related to the Prevnar® vaccine was reduced by 89%

Prevnar® covers 67% to 93% of pneumococcal otitis media in the United States and approximately 73% in Europe.

• In a review of most of the relevant literature existing up to the year 2000, the authors determined that the serogroups related to the Prevnar® vaccine are responsible for 71.2% of otitis media cases in young children in the United States/Canada and 72.8% in Europe.
• Another recent study finds that the serogroups related to the Prevnar® vaccine are responsible for 93% of otitis media cases in young children in the United States/Canada. Additionally, the specific serotypes in the Prevnar® vaccine are responsible for 67% of otitis media cases in young children in the United States/Canada.
• In the northern California Kaiser trial of Prevnar®, the incidence of otitis media in children due to the specific serotypes in the vaccine was reduced by 67%.
• In a trial of Prevnar® in Finland, the incidence of otitis media due to the specific serotypes in the vaccine was reduced by 57%, and the incidence of otitis media due to all of the serogroups related to the Prevnar® vaccine was reduced by 51%.

Prevnar® covers 56% to 73% of pneumococcus detected in surveys of nasopharyngeal carriage in young children in Europe. The most common nasopharyngeal carriage serotypes are the same as the invasive isolates.

• The middle ear is normally a sterile environment.
• Pneumococcus is normally carried in the nasopharynx at rates from 10% to 60%, and it may spread to the middle ear via the Eustachian tube or to the meninges via the blood.
• According to US and Canadian studies, the most common nasopharyngeal carriage serotypes are the same as the invasive isolates, although the rank order of specific serotypes is different.
• A recent study in Israel found that the rate of nasopharyngeal carriage of vaccine-type pneumococci was lower among subjects who received a 9-valent pneumococcal vaccine (similar to the 7-valent vaccine) than among control subjects, and the effect was most pronounced among children less than 36 months of age.
• Several studies show that the serogroups related to the Prevnar® vaccine constitute 56% to 73% of pneumococcal nasopharyngeal carriage in young children in Europe.

Prevnar® does not cover all serotypes of pneumococcus.

• Prevnar® covers the most common serotypes of pneumococcus. While as yet unproven, these common serotypes may represent pneumococcal strains of higher virulence than others.
• In several clinical trials, those vaccinated with Prevnar® or with similar vaccines have shown increased carriage of non-vaccine serotypes of pneumococcus.
• These increases of non-vaccine serotypes may be due to serotype replacement, if vaccine-induced protection against carriage of vaccine serotypes increases susceptibility to carriage of non-vaccine serotypes.
• Alternatively, observed increases of non-vaccine serotypes may be an artifact of “unmasking”, in which non-vaccine serotypes are more readily detected among those vaccinated than among controls because vaccine serotypes are not present.

Some additional measures may be considered to decrease the likelihood of pneumococcal carriage and disease.

• Pneumococcal vaccination (with Prevnar® and, in those older than 2 years, with the 23-valent pneumococcal vaccine) of all family members and caretakers may reduce the likelihood of pneumococcal carriage and disease in children.
  • Living with more than three persons in the same household is a risk factor statistically associated with nasopharyngeal pneumococcal carriage.
  • Among children older than 6 months of age, the strongest predictor of nasopharyngeal pneumococcal carriage was simultaneous carriage of the same serogroup by another family member
  • Having siblings under the age of 2 years is a risk factor for the carriage of pneumococcus.
  • Children attending day-care centers compared with non-day-care center children are at increased risk for nasopharyngeal colonization.
• Influenza vaccination may decrease the possibility of pneumococcal otitis media.
  • Pneumococcus carried in the nasopharynx is more likely to spread to the middle ear following an influenza infection.
  • In a study in Finland, administration of the influenza vaccine prior to the 1988-1989 influenza epidemic reduced the rate of associated otitis media by as much as 83% in children 1 to 3 years of age and by 36% in all children.
  • Children in a North American study given a new intranasal, live attenuated influenza virus vaccine were shown to have a 35% reduction in the incidence of acute otitis media.
  • The influenza vaccine may be administered to children as young as 6 months of age.
• Prophylactic antibiotics (e.g., penicillin) may be considered, but the risk of side effects is likely to be greater than the risk of developing pneumococcal meningitis.
  • A short course of antimicrobial agents is likely only to replace susceptible bacteria with resistant bacteria.
  • The American Academy of Pediatrics recommends chronic antibiotic prophylaxis for pneumococcus only in those children at very high risk, i.e., children with sickle cell disease and functional or anatomic asplenia.

Anatomical abnormalities or defects of the inner ear, specifically those in which an abnormal connection exists between the cochlea or the vestibular system and the central nervous system, predispose a patient to recurrent meningitis.

• Patients with malformations of the cochlea may be subject to recurrent otogenic meningitis due to a fistulous communication between the middle ear cavity and the subarachnoid space.
• Pneumococcus is commonly implicated in otogenic meningitis.
• Patients with congenital dysplasias of the labyrinth of the inner ear and other malformations of the cochlea may also be subject to varying degrees of hearing loss, and as a result these patients may be implanted with a cochlear implant.
• Cochlear implantation in children with such malformations requires special attention before, during, and after surgery.

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