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Other Vaccines (other + vaccine)
Selected AbstractsSafety and efficacy of vaccinesDERMATOLOGIC THERAPY, Issue 2 2009Brenda L. Bartlett ABSTRACT For the past two centuries, vaccines have provided a safe and effective means of preventing a number of infectious diseases. Although the safety of some vaccines has been questioned in recent years, the currently available vaccines are more than a millionfold safer than the diseases they are designed to prevent. Vaccines, however, should always be used in conjunction with other public health interventions. One important intervention is education because the general public can be led to believe that vaccines are unsafe and not needed by misinformation readily available electronically and in print. Not only are some vaccines available via injection but other vaccines are also given orally or intranasally. New vaccines are being studied for topical and intravaginal use. In addition, new systems are being developed for more efficient production of vaccines, especially for influenza. Vaccines are currently available for only a limited number of viral and bacterial diseases. In the future, it is anticipated that safe and effective vaccines will be developed against a number of other viral and bacterial infections as well as fungal and protozoan diseases. [source] Potential population-based electronic data sources for rapid pandemic influenza vaccine adverse event detection: a survey of health plans,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 12 2008Kristen M. Moore MPH Abstract Purpose A vaccine against pandemic influenza may be rapidly and widely distributed, and could be used in populations with little prior exposure to influenza vaccines. Under such conditions, it will be important to gain timely information about the rates of vaccine adverse events, ideally by using electronic data from large populations. Many public and private health plans and payers have such information. Methods Between May and September 2007, we conducted a decision maker interview and technical assessment with several health plans in the United States. The interview and survey evaluated technical capability, organizational capacity, and willingness to participate in a coordinated program of rapid safety research targeting pandemic and other influenza vaccines. Results Eleven health plans (eight private, three public) participated in the decision maker interview. Most interviewees were medical directors or held similar positions within their organizations. Participating plans provided coverage and/or care for approximately 150 million members in the U.S. Nine health plans completed a technical assessment survey. Most decision makers indicated interest and willingness to participate in a coordinated rapid safety surveillance program, and all reported the necessary claims data analysis experience. Respondents noted legal, procedural, budgetary, and technical barriers to participation. Conclusions Senior decision makers representing private and public health plans were willing and asserted the ability of their organizations to participate in pandemic influenza vaccine safety monitoring. Developing working relationships, negotiating contracts, and obtaining necessary regulatory and legal approvals were identified as key barriers. These findings may be generalizable to other vaccines and pharmaceutical products. Copyright © 2008 John Wiley & Sons, Ltd. [source] Short-term reactogenicity and gender effect of anthrax vaccine: analysis of a 1967,1972 study and review of the 1955,2005 medical literature,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2007Michael M. McNeil MD Abstract Purpose In the 1960s, the Centers for Disease Control and Prevention (CDC) held the investigational new drug (IND) application for the anthrax vaccine and collected short-term safety data from approximately 16,000 doses administered to almost 7000 individuals. While some recent anthrax vaccine safety studies have suggested that women experience more injection site reactions (ISRs), to our knowledge the IND safety data were not previously examined for a gender-specific difference. Methods We identified and analyzed a subset of the IND study data representing a total of 1749 persons who received 3592 doses from 1967 to 1972. Original data collection forms were located and information extracted, including: vaccine recipient's name, age at vaccination, gender, dose number, date of vaccination, lot number, grading of ISR, presence and type of systemic reactions. Overall and gender-specific rates for adverse reactions to anthrax vaccine were calculated and we performed a multivariable analysis. Results We found an ISR was associated with 28% of anthrax vaccine doses; however, 87% of these were considered mild. Systemic reactions were uncommon (<1%) and most (70%) accompanied an ISR. Our dose-specific analysis by gender found women had at least twice the risk of having a vaccine reaction compared to men. Our age-adjusted relative risk for ISR in women compared to men was 2.78 (95%CI: 2.29, 3.38). Conclusions Our results for both overall and gender-specific reactogenicity are consistent with other anthrax safety studies. To date, possible implications of these gender differences observed for anthrax and other vaccines are unknown and deserve further study. Copyright © 2007 John Wiley & Sons, Ltd. [source] Comparing data mining methods on the VAERS database,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 9 2005David Banks PhD Abstract Purpose Data mining may enhance traditional surveillance of vaccine adverse events by identifying events that are reported more commonly after administering one vaccine than other vaccines. Data mining methods find signals as the proportion of times a condition or group of conditions is reported soon after the administration of a vaccine; thus it is a relative proportion compared across vaccines, and not an absolute rate for the condition. The Vaccine Adverse Event Reporting System (VAERS) contains approximately 150,000 reports of adverse events that are possibly associated with vaccine administration. Methods We studied four data mining techniques: empirical Bayes geometric mean (EBGM), lower-bound of the EBGM's 90% confidence interval (EB05), proportional reporting ratio (PRR), and screened PRR (SPRR). We applied these to the VAERS database and compared the agreement among methods and other performance properties, particularly focusing on the vaccine,event combinations with the highest numerical scores in the various methods. Results The vaccine,event combinations with the highest numerical scores varied substantially among the methods. Not all combinations representing known associations appeared in the top 100 vaccine,event pairs for all methods. Conclusions The four methods differ in their ranking of vaccine,COSTART pairs. A given method may be superior in certain situations but inferior in others. This paper examines the statistical relationships among the four estimators. Determining which method is best for public health will require additional analysis that focuses on the true alarm and false alarm rates using known vaccine,event associations. Evaluating the properties of these data mining methods will help determine the value of such methods in vaccine safety surveillance. Copyright © 2005 John Wiley & Sons, Ltd. [source] Safety of anthrax vaccine: an expanded review and evaluation of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS),,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 12 2004John L. Sever Abstract Purpose To assess the safety of a licensed anthrax vaccine (AVA) given to more than 500,000 US military personnel, through review and medical evaluation of adverse events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS). Methods AEs were summarized by person, vaccine lot, type, frequency and impact. A Delphic approach was used to tentatively assess causality in an effort to detect serious AEs (SAEs) or other medically important AEs (OMIAEs) possibly attributable to AVA. Results The Anthrax Vaccine Expert Committee (AVEC) reviewed 1841 reports describing 3991 AEs (9.4 reports/10,000 doses of AVA) that were submitted to VAERS from 1Q1998 through 4Q2001. One hundred forty-seven reports described an SAE or OMIAE, of which 26 were tentatively rated as possible, probable or certain consequences of vaccination (injection-site reaction [12], ,anaphylactic-like reaction' [5] and eight other systemic AEs [1,2 each]). Conclusions This review produced no evidence for an unusual rate of any SAE or OMIAE attributable to AVA. It supported an earlier impression that AVA may cause significant local inflammation and should be administered over the deltoid rather than the triceps to avoid direct or compression injury to the ulnar nerve. The subjects of VAERS reports tended to be older than all recipients of AVA. Females generally had and/or reported AEs more often than males, but transient articular reactions were surprisingly more common in males. Variations in the frequency or severity (as judged by hospitalization and/or loss of duty) of reported AEs did not suggest a significant problem with (1) a particular lot of AVA, (2) recurrent AEs after multiple doses or (3) vaccination of persons with a concomitant illness or those given other vaccines or medications. Copyright © 2004 John Wiley & Sons, Ltd. [source] Challenges, lessons learned and results following the implementation of a human papilloma virus school vaccination program in South AustraliaAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 4 2009Maureen Watson Abstract Objective: To describe the process and challenges in the roll out of a large cervical cancer vaccination program to protect against human papilloma virus (HPV) infection. Methods: This article describes the process of planning and implementing a HPV vaccination program using the existing state-wide framework that supports vaccine delivery to all 219 high schools in South Australia. The decision was made to offer three doses of HPV vaccine to 50,191 female students in Years 8-12 during the 2007 school year. Results: By November 2007, despite many challenges, the school vaccination program had delivered 107,541 doses of HPV vaccine. Coverage of dose 1 was highest in Years 8 (83%) and 10 (70%), but was reduced for doses 2 and 3 in all year levels, with dose 3 coverage ranging from 55% (Year 11) to 77% (Year 8). Conclusions: The introduction of a large school-based vaccination program at short notice posed new challenges for the co-ordination and implementation. Not all schools supported the introduction of HPV vaccine, resulting in reduced access for some students. Negative media messages provided a strong platform for individuals who opposed vaccination. These factors may have contributed to the less-than-expected uptake of HPV vaccine. Implications: Historically, there has been high uptake of other vaccines given to adolescents. However, the introduction of HPV vaccine may have adversely affected the uptake of Hepatitis B vaccine, given concurrently in the school program. Further studies are needed to determine if this is likely to have a negative effect on the public perception of the value of vaccine programs in general. [source] | ||||||||||