Initial US Approval: 2010
In children 6 weeks through 5 years of age… Prevnar 13 is indicated for:
– Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae…
– Active immunization for the prevention of otitis media [ear infection]…
– Active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae…
Prevnar 13 does not protect against disease caused by S.pneumoniae serotypes that are not in the vaccine.
Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients…
Reactions occurring in less than 1% of infants and toddlers: crying, hypersensitivity reaction (including face edema, dyspnea, and bronchospasm), seizures (including febrile seizures), and urticaria or urticaria-like rash.
Two of 12 deaths occurred within 30 days of vaccination and both deaths were in subjects >65 years of age. One death due to cardiac failure occurred 3 days after receiving placebo [see comments below regarding “placebo” – placebo contained aluminum]. This subject had received Prevnar 13 and IIV3 [trivalent inactivated influenza vaccine] one month earlier. The other death was due to peritonitis 20 days after receiving Prevnar 13.
(7%) Prevnar 13 vaccinated subjects… reported serious adverse events [in a subset of subjects monitored for 6 months]…
(7.1%) [of test subjects 65 years and older, died within 4 years after receiving] Prevnar 13…
Post-marketing Experience With Prevnar 13 in Infants and Toddlers
– Vaccination-site dermatitis, vaccination-site pruritus, vaccination-site urticaria
– Lymphadenopathy localized to the region of the injection site
– Cyanosis
– Anaphylactic/anaphylactoid reaction including shock
– Hypotonia
– Angioneurotic edema, erythema multiforme
– Apnea
– Pallor
Each 0.5 mL dose of the vaccine is formulated to contain… 100 μg polysorbate 80… and 125 μg aluminum as aluminum phosphate adjuvant.
Prevnar 13 has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.
[C]hildren who received Prevnar appeared to be at increased risk of otitis media [ear infection] due to pneumococcal serotypes not represented in the vaccine.