Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine.
ABSTRACT Clinical trials evaluate a vaccine's safety before approval, but some risks may escape detection or adequate characterization until larger population exposures occur after licensure.
To summarize reports of events occurring after vaccination with 7-valent pneumococcal conjugate vaccine (PCV), including those that may warrant further investigation to assess possible causation by PCV.
Descriptive epidemiology of reports submitted to the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance database.
United States during first 2 years after licensure of PCV (February 2000 through February 2002). Reports studied were for children younger than 18 years and vaccinated with PCV.
Numbers and proportional distributions of reports.
A total of 4154 reports of events following PCV were submitted to VAERS, for a rate of 13.2 reports per 100,000 doses distributed. Multiple vaccines were given in 74.3% of reports. The most frequently reported symptoms and signs included fever, injection site reactions, fussiness, rashes, and urticaria. Serious events were described in 14.6% of reports. There were 117 deaths, 23 reports of positive rechallenges, and 34 cases of invasive pneumococcal infections possibly representing vaccine failure. Immune-mediated events occurred in 31.3% of reports. All 14 patients with anaphylactic or anaphylactoid reactions survived. Thrombocytopenia developed in 14 patients and serum sickness in 6 others. Neurologic symptoms occurred in 38% of reports. Seizures described in 393 reports included 94 febrile seizures.
The majority of reports to VAERS in the first 2 years after licensure of PCV described generally minor adverse events previously identified in clinical trials. The proportion of reports portraying serious events was similar to that for other vaccines. Although there are important limitations in passive surveillance data, and caution in their interpretation is necessary, symptoms experienced by a few children more than once after successive PCV doses, including allergic reactions, prolonged or abnormal crying, fussiness, dyspnea, and gastrointestinal distress, warrant continued surveillance, as do reports of rare but potentially serious events, such as seizures, anaphylactic or anaphylactoid reactions, serum sickness, and thrombocytopenia.
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ABSTRACT: To evaluate the economic impact of the 2009 routine US childhood immunization schedule, including diphtheria and tetanus toxoids and acellular pertussis, Haemophilus influenzae type b conjugate, inactivated poliovirus, measles/mumps/rubella, hepatitis B, varicella, 7-valent pneumococcal conjugate, hepatitis A, and rotavirus vaccines; influenza vaccine was not included. Decision analysis was conducted using population-based vaccination coverage, published vaccine efficacies, historical data on disease incidence before vaccination, and disease incidence reported during 2005 to 2009. Costs were estimated using the direct cost and societal (direct and indirect costs) perspectives. Program costs included vaccine, administration, vaccine-associated adverse events, and parent travel and work time lost. All costs were inflated to 2009 dollars, and all costs and benefits in the future were discounted at a 3% annual rate. A hypothetical 2009 US birth cohort of 4 261 494 infants over their lifetime was followed up from birth through death. Net present value (net savings) and benefit-cost ratios of routine childhood immunization were calculated. Analyses showed that routine childhood immunization among members of the 2009 US birth cohort will prevent ∼42 000 early deaths and 20 million cases of disease, with net savings of $13.5 billion in direct costs and $68.8 billion in total societal costs, respectively. The direct and societal benefit-cost ratios for routine childhood vaccination with these 9 vaccines were 3.0 and 10.1. From both direct cost and societal perspectives, vaccinating children as recommended with these vaccines results in substantial cost savings.PEDIATRICS 03/2014; · 5.30 Impact Factor
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ABSTRACT: Parneet, Sukhsaihaj, and Imaan were born at 30 weeks gestation via cesarean section and their weights were 1.31, 1.38, and 1.46 Kg, respectively. They suffered from respiratory acidosis, hypoglycemia, respiratory distress syndrome, sepsis, jaundice, gastroesophageal reflex, and anemia. They were discharged from the hospital at 42 days of age. The triplets were vaccinated with DTaP, IPV, Hib, and PCV vaccines at the age of 61 days in Imaan's case and 75 days in Parneet and Sukhsaihaj's case. At 15 days following vaccination, Parneet suffered from apnea, metabolic acidosis, sei-zures, infections, intracranial and retinal bleeding, and a skull fracture. Sukhsaihaj developed respiratory tract and eye infections, severe anemia, bleeding, and skull fracture. Imaan had severe anemia and a skull fracture. It was alleged that the babies' injuries were caused by blunt trauma to the head. The parents were accused of causing the triplet's injuries. The clinical data described in this report reveal that the triplet's health problems were caused by vaccines. The severity of their injuries correlates with their hemoglobin levels at the time of vaccination. The subcutaneous and the intracranial bleeding resulted from protein and vitamin K deficien-cies and infections. Severe anemia, vitamin K deficiency, and systemic infections are the likely causes of Parneet's retinal bleeding. The skull frac-tures resulted from protein and vitamin K deficiencies. The severity of the fractures correlates with the severity of the protein and vitamin K deficien-cies, the degree of the infection, and the level of the intracranial pressure.
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ABSTRACT: Immune thrombocytopenic purpura (ITP) is an autoimmune condition characterized by low platelet count with mucocutaneous and other bleedings. Clinical manifestations may range from spontaneous formation of purpura and petechiae, especially on the extremities, to epistaxis, bleeding at the gums or menorrhagia, any of which occur usually if the platelet count is below 20,000 per μl. A very low count may result in the spontaneous formation of hematomas in the mouth or on other mucous membranes. Fatal complications, including subarachnoid or intracerebral, lower gastrointestinal or other internal bleeding can arise due to an extremely low count. Vaccines may induce ITP by several mechanisms. Vaccine-associated autoimmunity may stem not only from the antigen-mediated responses but also from other constituents of the vaccine, such as yeast proteins, adjuvants, and preservatives diluents. The most likely is through virally induced molecular mimicry. The binding of pathogenic autoantibodies to platelet and megakaryocytes may cause thrombocytopenia by different mechanisms, such as opsonization, direct activation of complement, or apoptotic pathways. The autoantibodies hypothesis is not sufficient to explain all ITP cases: In the anti-platelet antibody-negative cases, a complementary mechanism based on T cell immune-mediated mechanism has been suggested. In particular, T cell subsets seem dysregulated with an increased production of pro-inflammatory cytokines, as IFN-γ and TNF, and chemokines, as CXCL10. Vaccines are one of the most striking discoveries in human history that changed dramatically life expectancy. Nonetheless, the occurrence of adverse events and autoimmune phenomena has been described following vaccination, and ITP may represent one of this.Immunologic Research 11/2014; · 3.53 Impact Factor