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How safe are vaccines really? Is it safe for them to get so many shots at the same time?

How safe are vaccines really? Is it safe for them to get so many shots at the same time?. Frequently Asked Questions in Pediatrics. Research Synthesis for Practitioners. Multiple and Combined Vaccination Safety

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How safe are vaccines really? Is it safe for them to get so many shots at the same time?

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  1. How safe are vaccines really? Is it safe for them to get so many shots at the same time? Frequently Asked Questions in Pediatrics

  2. Research Synthesis for Practitioners • Multiple and Combined Vaccination Safety • Bar-On ES, Goldberg E, Fraser A, Vidal L, Hellmann S, Leibovici L. Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilusinfluenzae B (HIB). Cochrane Database of Systematic Reviews2009, Issue 3. Art. No.: CD005530. DOI: 10.1002/14651858.CD005530.pub2 2009 Cochrane meta-analysis of the most common combined vaccine DTP/HBV/HIB revealed that combined vaccines provided the advantage of fewer patient visits, increased compliance, and fewer injections with a minor and statistically insignificant increase in adverse reactions. There is no difference in immunity between combined vaccination and separated vaccination (even when a staggered schedule for separated vaccinations is used). Pros and cons from meta-analysis reveal no significant or safety differences between combined versus separated vaccination.

  3. Research Synthesis for Practitioners • MMR Safety Profile • Demicheli V, Jefferson T, Rivetti A, Price D. Vaccines for measles, mumps and rubella in children. Cochrane Database of Systematic Reviews2008, Issue 4. Art. No.: CD004407. DOI: 10.1002/14651858.CD004407.pub2. International media coverage correlating MMR vaccine with ASD and other adverse events has led to significant breaks in herd immunity. Meta-analysis reiterates the safety profile of this vaccine as comparable to other scheduled vaccines, as well as total non-association with ASD as adverse event. However, breaks in herd immunity have resulted in statistically significant increases in deaths from, particularly, measles.

  4. Research Synthesis for Practitioners • Researchers from Nationwide Children’s Hospital forward risk-assessment approaches to evaluating vaccine safety for the American Academy of Pediatrics • Ball, R., Horne, D., Izurieta, H., Sutherland, A., Walderhaug, M., , & Hsu, H. (2011). Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration. Pediatrics, 127 Suppl 1, S31-8. doi:10.1542/peds.2010-1722F Responding to demands from the public health and general community to standardize processes for evaluating vaccine safety, NCH forwards methodology for the FDA. This new methodology includes genomics data and provides better end-product safety profiles for vaccines, their additives, and their routes of administration.

  5. Research Synthesis for Practitioners • There is increased recognition that protecting the public health requires increased vigilance to vaccine safety monitoring. Superb monitoring reassures the media and the public and diminishes breaks in herd immunity. • Kanesa-thasan, N., Shaw, A., Stoddard, J., , & Vernon, T. (2011). Ensuring the optimal safety of licensed vaccines: a perspective of the vaccine research, development, and manufacturing companies. Pediatrics, 127 Suppl 1, S16-22. doi:10.1542/peds.2010-1722D The reality is that part of vaccine compliance is vaccine safety perception by the public. This research group evaluate both vaccine safety monitoring and the perspective by the public of this monitoring, in order to demonstrate overall safety of childhood vaccination.

  6. Childhood Immunization Practice Guidelines • Advisory Committee on Immunization Practices (ACIP)directs CDC guidelines for the protection of public health • (2011). General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports / Centers for Disease Control, 60(2), 1-64. The ACIP evaluates meta-analysis and reports of adverse reactions, as well as conjugated mortality and morbidity reports, in order to develop immunization guidelines adapted and recommended by the CDC and AAP.

  7. Childhood Immunization Practice Guidelines • Vaccine-concerned families may be interested in information readily available from mainstream media that alternative, or more ‘spread out’ vaccination schedules are safer for their children. • R, ümke, H., Loch, H., Hoppenbrouwers, K., Vandermeulen, C., Malfroot, A., ,…Willems, P. (2011). Immunogenicity and safety of a measles-mumps-rubella-varicella vaccine following a 4-week or a 12-month interval between two doses. Vaccine, 29(22), 3842-9. doi:10.1016/j.vaccine.2011.02.067 As demonstrated previously, combined versus separated immunization does not reveal a safety or immunity difference, and this 2011 study that looks specifically at longer-interval vaccination reveals that immunity is the same for the CDC guidelines and for longer interval schedules. It should be noted that the safety is no better for CDC versus alternative schedules, but if family compliance relies on alternative scheduling, the practitioner can be assured of immunity.

  8. Childhood Immunization Practice Guidelines • Caring for families who choose not to vaccinate for religious, personal belief, and personal practice reasons. • Parker Fiebelkorn, A., Redd, S., Gallagher, K., Rota, P., Rota, J., Bellini, W., , & Seward, J. (2010). Measles in the United States during the postelimination era. The Journal of infectious diseases, 202(10), 1520-8. doi:10.1086/656914 In the ‘post-elmination era’ of infectious childhood diseases like measles, many family and pediatric practitioners are choosing to drop unvaccinated families from their caseload as preventive move against litigation and to make practice policy statements about vaccination. This study reveals that dropping unvaccinated clients is not best practice for a number of reasons. 1) Unvaccinated families will turn to providers who tolerate or encourage non-vaccination, widening breaks in herd immunity 2) Unvaccinated families have less access to care due to these policies and may have increased morbidity and mortality if they cannot retain a practitioner 3) These families cannot benefit from ‘third-wave’ vaccination in the event of an outbreak 4) These families lose a connection to increased education regarding vaccines and chances to vaccinate.

  9. Common Mainstream Sources of Vaccination Education for Families • Pro-Vaccination sources evaluated for popularity by Google Analytics vaccinateyourbaby.org (Amanda Peet celebrity endorsed) cdc.gov askdrsears.com (extended schedule vaccination. Note: this schedule has been promoted by Oprah) aap.org pbskids.org Parenting Magazine Parents Ready, Set, Grow

  10. Common Mainstream Sources of Vaccination Education for Families • Anit-Vaccination sources evaluated for popularity by Google Analytics thinktwice.com Jennymcarthybodycount.com (Jenny McCarthy has also authored books and made media appearances, including Oprah, about the topic of vaccinations and their link to ASD) NVIC.org (National Vaccine Information Center—this site creates a legislative and political action platform connecting anti-vaccination to the political idea of ‘choice.’ Provides a lot of information on school policies, state laws, community requirements) Mothering (The official stance of this magazine is that vaccines must be family choice, and does provide pro-vaccine information alongside anti-vaccine information. The magazine’s online community has anti-vaccination forums with a lot of information and discussion)

  11. So what’s the answer to the question? Vaccine safety is carefully monitored with a variety of methodologies and has been established for combined and non-combined vaccines and for CDC and alternative schedules in terms of mortality, morbidity, and immunity status. While the research and professional guidelines take a number of different approaches to establishing safety profiles for vaccines and their routes, the overall conclusions are shared. There are currently no reliable meta-analyses demonstrating a casual relationship between vaccinations and long-term disabilities. While adverse reactions may occur, they are exceedingly rare. Morbidity and mortality associated with natural immunity, however, is statistically significant.

  12. References (2011). General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports / Centers for Disease Control, 60(2), 1-64. Ball, R., Horne, D., Izurieta, H., Sutherland, A., Walderhaug, M., , & Hsu, H. (2011). Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration. Pediatrics, 127 Suppl 1, S31-8. doi:10.1542/peds.2010-1722F Bar-On ES, Goldberg E, Fraser A, Vidal L, Hellmann S, Leibovici L. Combined DTP-HBV-HIB vaccine versus separately administered DTP-HBV and HIB vaccines for primary prevention of diphtheria, tetanus, pertussis, hepatitis B and Haemophilusinfluenzae B (HIB). Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD005530. DOI: 10.1002/14651858.CD005530.pub2 Demicheli V, Jefferson T, Rivetti A, Price D. Vaccines for measles, mumps and rubella in children. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD004407. DOI: 10.1002/14651858.CD004407.pub2. Kanesa-thasan, N., Shaw, A., Stoddard, J., , & Vernon, T. (2011). Ensuring the optimal safety of licensed vaccines: a perspective of the vaccine research, development, and manufacturing companies. Pediatrics, 127 Suppl 1, S16-22. doi:10.1542/peds.2010-1722D Parker Fiebelkorn, A., Redd, S., Gallagher, K., Rota, P., Rota, J., Bellini, W., , & Seward, J. (2010). Measles in the United States during theposteliminationera. The Journal of infectious diseases, 202(10), 1520-8. doi:10.1086/656914 Umke, H., Loch, H., Hoppenbrouwers, K., Vandermeulen, C., Malfroot, A., ,…Willems, P. (2011). Immunogenicity and safety of a measles-mumps-rubella-varicella vaccine following a 4-week or a 12-month interval between two doses. Vaccine, 29(22), 3842-9. doi:10.1016/j.vaccine.2011.02.067

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