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Immunization update: A 2011 retrospective on product changes and new recommendations


Vaccines are one of the greatest achievements of biomedical science and public health. Proper vaccination plays a critical role in the reduction of vaccine-preventable disease and related morbidity and mortality. Despite levels of vaccine-preventable diseases being at or near record lows, many still persist due to numerous underimmunized children, adolescents, and adults. In addition to morbidity and premature deaths, vaccine-preventable diseases impose a high societal and economic burden, including decreased school and work productivity, increased doctor's visits, and hospitalizations. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention releases updated immunization schedules annually. In the 12 months that span schedule updates, new evidence becomes available and product changes occur. New products are approved by FDA and existing products may obtain approval for additional formulations or further indications. This article reviews certain recommendations and product changes that have occurred during 2011 since publication of the immunization schedules in January/February 2011. The covered vaccines include influenza intradermal and high-dose, herpes zoster, human papillomavirus, quadrivalent meningococcal conjugate, and tetanus toxoid. ACIP guidance affects vaccine practices; pharmacists' knowledge of the most current recommendations can enhance patient education, improve patient care, and potentially result in increased vaccination rates. (Formulary. 2012;47:58–74.)

Table 1 Immunization formulation summary
Vaccines are one of the greatest achievements of biomedical science and public health.1 The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) releases updated immunization schedules annually.2 ACIP also provides updated recommendations on the proper administration of vaccines every 1 to 3 years.2,3 The recommendations include appropriate age for administration; frequency, interval, and number of doses to be administered; as well as precautions and contraindications. ACIP aims to reduce vaccine-preventable disease and promote the safe use of vaccines and biologics in the United States.2,3 It is estimated that vaccination with 7 of the 12 routinely recommended childhood immunizations prevents 33,000 deaths, 14 million cases of disease, and saves $10 billion in direct costs in every birth cohort, saving society an additional $33 billion in costs that include disability and lost productivity.4 This article reviews certain vaccine recommendations and product changes that occurred during 2011. For a summary of vaccines discussed in this article, see Table 1


Table 2 Immune system functional branches
Our immune system is a complex defense mechanism whose main function is to protect us from invading pathogens.5 The immune system eliminates antigens from the body by producing antibodies; it also inactivates viruses, microbes, and bacteria.6 The immune system is divided into 2 functional branches—innate and adaptive. Innate or nonspecific immunity involves neutrophils, monocytes, macrophages, natural killer cells, and eosinophils and provides a rapid response to nonmammalian targets (eg, viruses, bacteria).5,7 Adaptive or specific immunity is further divided into the humoral and cell-mediated branches.5 The humoral branch comprises B lymphocytes, which can produce antibodies, or memory B cells that are antigen specific. B lymphocytes eliminate pathogens prior to host cell entry. The cell-mediated branch, comprising T lymphocytes, defends against intracellular infections (eg, viruses).5,7 The innate system responds rapidly and does not retain memory, whereas the adaptive immune system responds more slowly but develops memory (Table 2). Memory allows for a more rapid response with future exposures to the same pathogen.6 Despite the appearance of a clear delineation between the functional branches, they interact extensively.5

Immunity involves the body's ability to discriminate "self" from "non-self," allowing the immune system to attack foreign antigens and pathogens in order to protect us from disease, while sparing our own tissues.5,7 Immunity is typically very specific to a particular organism or group of similar organisms and is generally noted by the presence of antibodies.6 Immunity can be acquired by 1 of 2 methods, passive or active. Both can be obtained by either natural or artificial means. Passive immunity is acquired by the transfer of preformed antibodies to unimmunized individuals. This method can occur naturally, as in the transplacental passage of maternal antibodies to a fetus. Artificial passive immunity is achieved by the administration of human immune gamma globulin or antitoxin. Due to lack of memory, this passive immunity will dissipate if not accompanied by active production of antibodies. Active immunity requires exposing an unimmunized person to a pathogenic agent either naturally by exposure to the disease or artificially through vaccination. The largest benefit of vaccination is avoidance of the disease and related complications. Whether obtained naturally or artificially, active immunity confers the additional benefit of immunologic memory, which persists for years and may be permanent. This memory allows B cells to replicate and reestablish protection upon future exposure to the same pathogen.6–8

Cardiovascular agents

Hospital-acquired Clostridium difficile significantly prolongs the duration of a patient's stay in the hospital by at least 6 days, according to the findings of a study published online December 5, for the Canadian Medical Association Journal.

Prompted by the 2009 H1N1 influenza outbreak, FDA has announced plans to create a mobile app that will help it gather information and send out alerts about adverse reactions to experimental medications prescribed during public health crises.

Recent FDA Approvals (through January 2012) related to (BTG International, Biogen Idec, Elan, Pfizer, Gilead, INSYS Therapeutics, Takeda, CSL Behring)

New indication: FDA approved Zolpidem tartrate sublingual tablets or the treatment of insomnia characterized by middle-of-the-night (MOTN) wakening followed by difficulty returning to sleep.