The role of the Vaccine Adverse Event Reporting system (VAERS) in monitoring vaccine safety.
ABSTRACT The role of the health professional in supporting the national passive surveillance system is essential, as the first hint of a potential problem usually originates with the astute clinician who reports a case to the appropriate source. The investigation that resulted in the voluntary withdrawal of rotavirus vaccine was triggered by nine reports to VAERS of intussuception, eight of which had occurred within 1 week of the first dose of this vaccine. Health professionals have access to the most complete information related to adverse events experienced by their patients. Any index of suspicion that a serious event or death may be related to vaccination is reason for the health professional to submit a VAERS report. Determination of whether an event was caused by the vaccine is not a prerequisite for filing a VAERS report. When in doubt, providers should report to VAERS. VAERS solicits reports for all events temporally related to vaccination, some of which may be coincidental and some of which may merely indicate a change in the frequency of expected events. Post-marketing surveillance relies on health professionals to report suspicious events, thus improving the quality of reported data and contributing significantly to safeguarding public health. Recommendations for healthcare professionals to report to VAERS recently have been incorporated into the Standards for Pediatric Immunization Practices, which are endorsed by multiple professional organizations. Despite the limitations of spontaneous reports, VAERS provides vital information of clinical importance. The identification of signals in adverse event surveillance may initiate further investigation of potential problems in vaccine safety or efficacy, and facilitate subsequent dissemination of safety-related information to the scientific community and the public. This process begins with voluntary submission of reports of possible vaccine-associated events to VAERS by the informed and conscientious health professional.
SourceAvailable from: Elizabeth R Unger
Article: Human Papillomavirus Vaccination.[Show abstract] [Hide abstract]
ABSTRACT: This report summarizes the epidemiology of human papillomavirus (HPV) and associated diseases, describes the licensed HPV vaccines, provides updated data from clinical trials and postlicensure safety studies, and compiles recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for use of HPV vaccines. Persistent infection with oncogenic HPV types can cause cervical cancer in women as well as other anogenital and oropharyngeal cancers in women and men. HPV also causes genital warts. Two HPV vaccines are licensed in the United States. Both are composed of type-specific HPV L1 protein, the major capsid protein of HPV. Expression of the L1 protein using recombinant DNA technology produces noninfectious virus-like particles (VLPs). Quadrivalent HPV vaccine (HPV4) contains four HPV type-specific VLPs prepared from the L1 proteins of HPV 6, 11, 16, and 18. Bivalent HPV vaccine (HPV2) contains two HPV type-specific VLPs prepared from the L1 proteins of HPV 16 and 18. Both vaccines are administered in a 3-dose series. ACIP recommends routine vaccination with HPV4 or HPV2 for females aged 11 or 12 years and with HPV4 for males aged 11 or 12 years. Vaccination also is recommended for females aged 13 through 26 years and for males aged 13 through 21 years who were not vaccinated previously. Males aged 22 through 26 years may be vaccinated. ACIP recommends vaccination of men who have sex with men and immunocompromised persons (including those with HIV infection) through age 26 years if not previously vaccinated. As a compendium of all current recommendations for use of HPV vaccines, information in this report is intended for use by clinicians, vaccination providers, public health officials, and immunization program personnel as a resource. ACIP recommendations are reviewed periodically and are revised as indicated when new information and data become available.
[Show abstract] [Hide abstract]
ABSTRACT: Generally benefits and risks of vaccines can be determined from studies carried out as part of regulatory compliance, followed by surveillance of routine data; however there are some rarer and more long term events that require new methods. Big data generated by increasingly affordable personalised computing, and from pervasive computing devices is rapidly growing and low cost, high volume, cloud computing makes the processing of these data inexpensive.Yearbook of medical informatics 01/2014; 9(1):27-35. DOI:10.15265/IY-2014-0016
[Show abstract] [Hide abstract]
ABSTRACT: Human papillomaviruses are the primary etiological agents of cervical cancer. Thus, cervical cancer and other Human papillomavirus associated malignancies might be prevented by Human papillomavirus vaccines. Currently, two Human papillomavirus L1 Virus -Like Particle vaccines namely Gardasil® (HPV4) - quadrivalent (Merck) and Cervarix™ (HPV2) - bivalent (GlaxoSmithKline) are marketed internationally. Food and Drug Administration (FDA) licensed the quadrivalent HPV vaccine in 2006 while Food and Drug Administration (FDA) licensed bivalent human papillomavirus vaccine on October 16, 2009, for use in females aged 10 through 25 years. We searched and analyzed reports of adverse events associated with HPV 2 and HPV4 vaccines from Vaccine Adverse Event Reporting System (VAERS). In United States, between the year 2006-2013, total 24,719 adverse events were reported after taking HPV2 and HPV4 vaccines. For HPV2 vaccine, we searched for reports from October 2009 to December 2013 and for HPV4 vaccine, we searched for reports from October 2006 to December 2013. For HPV4 vaccine during 2006-2013, total 24,460 adverse events and 84 deaths were reported while for HPV2 vaccine during 2009-2013, total 259 adverse events and 3 deaths were reported. Even after proper route of HPV vaccines administration i.e. intramuscular 13,287 adverse events have been reported for HPV4 while 259 adverse events have been reported for HPV2 vaccine. The most frequently recorded adverse events due to HPV4 vaccine were found to be within the year 2006-2013 which included rash (2306 cases) followed by injection site erythrema (2245 cases) and pyrexia (2142 cases). However, adverse events recorded for HPV2 vaccine were within the period 2009-2013 which included dizziness (37 cases) followed by headache (34 cases) and malaise (19 cases). In future ongoing HPV vaccines safety surveillance and further studies may shed light on some of the hypothesized associations.International Journal of Pharmacy and Pharmaceutical Sciences 01/2014; · 1.59 Impact Factor