Scientific Evidence

 

VACCINE CONCERNS


Safety – Autism


Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Taylor B, Miller E, Farrington CP, Petropoulos MC, Favot-Mayaud I, Li J, Waight PA. – Lancet. 1999 Jun 12;353(9169):1987-8.

INTERPRETATION: Our analyses do not support a causal association between MMR vaccine and autism. If such an association occurs, it is so rare that it could not be identified in   this large regional sample.

On-time Vaccine Receipt in the First Year Does Not Adversely Affect Neuropsychological Outcomes. Michael J. Smith, MD, MSCE, Charles R. Woods, MD, MS

CONCLUSIONS:  Timely vaccination during infancy has no adverse effect on neuropsychological outcomes 7 to 10 years later. These data may reassure parents who are concerned that children receive too many vaccines too soon.

Epidemiology of Autism Spectrum Disorders in Adults in the Community in England.  Traolach S. Brugha, MD(NUI), FRCPsych; Sally McManus, MSc; John Bankart, MSc, PhD; Fiona Scott, PhD, CPsychol; Susan Purdon, MSc, PhD; Jane Smith, BSc; Paul Bebbington, PhD, FRCPsych; Rachel Jenkins, MD, FRCPsych; Howard Meltzer, PhD.  Arch Gen Psychiatry. 2011;68(5):459-465. doi:10.1001/archgenpsychiatry.2011.38

Conclusions:  Conducting epidemiologic research on ASD in adults is feasible. The prevalence of ASD in this population is similar to that found in children. The lack of an association with age is consistent with there having been no increase in prevalence and with its causes being temporally constant. Adults with ASD living in the community are socially disadvantaged and tend to be unrecognized.

Safety – Side Effects


Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study. Englund JA, Walter E, Black S, Blatter M, Nyberg J, Ruben FL, Decker MD; GRC28 Study Team.

CONCLUSION: TIV administered to young infants beginning at 6 to 12 weeks of age is safe and immunogenic.

Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures Nicola P. Klein, Bruce Fireman, W. Katherine Yih, Edwin Lewis, Martin Kulldorff, Paula Ray, Roger Baxter, Simon Hambidge, James Nordin, Allison Naleway, Edward A. Belongia, Tracy Lieu, James Baggs, and Eric Weintraub for the Vaccine Safety Datalink 2010;126;e1-e8; originally published online Jun 29, 2010; Pediatrics DOI: 10.1542/peds.2010-0665

CONCLUSION: Among 12- to 23-month-olds who received their first dose of measles-containing vaccine, fever and seizure were elevated 7 to 10 days after vaccination. Vaccination with MMRV results in 1 additional febrile seizure for every 2300 doses given instead of separate MMR + varicella vaccines. Providers who recommend MMRV should communicate to parents that it increases the risk of fever and seizure over that already associated with measles-containing vaccines.

Pneumococcal Conjugate Vaccination and Nasopharyngeal Acquisition of Pneumococcal Serotype 19A Strains. Elske J. M. van Gils, MD; Reinier H. Veenhoven, MD, PhD; Eelko Hak, PhD; Gerwin D. Rodenburg, MD; Wendy C. M. Keijzers; Debby Bogaert, MD, PhD; Krzysztof Trzcinski, DVM, PhD; Jacob P. Bruin; Loek van Alphen, PhD; Arie van der Ende, PhD; Elisabeth A. M. Sanders, MD, PhD.  JAMA. 2010;304(10):1099-1106. doi:10.1001/jama.2010.1290

Conclusion - A 2 + 1-dose PCV-7 schedule was associated with an increase in serotype 19A nasopharyngeal acquisition compared with unvaccinated controls.

Safety of influenza vaccination during pregnancy. Munoz FM, Greisinger AJ, Wehmanen OA, Mouzoon ME, Hoyle JC, Smith FA, Glezen WP. Am J Obstet Gynecol. 2005 Apr;192(4):1098-106.

CONCLUSION: Influenza vaccine that was administered in the second or third trimester of gestation was safe in this study population.

Pentavalent Rotavirus Vaccine in Developing Countries: Safety and Health Care Resource Utilization. Celia D. C. Christie, MBBS, DMPeds, MPH, FAAP, FRCPa, Newton D. Duncan, MBBS, DMSurg, FACSb, Kirk A. Thame, MBBS, DMPeds, FAAPa, Matthew T. Onorato, BScc, Hyacinth D. Smith, RN, RM, MPHa, Lavern G. Malcolm, BSc, RN, MPHa, Robbin F. Itzler, PhDd, Mark J. DiNubile, MDe, Penny M. Heaton, MD, MPHc

CONCLUSIONS In this posthoc subgroup analysis, the vaccine reduced health care resource utilization attributable to rotavirus gastroenteritis, without increased risk of intussusception or other serious adverse events, among infants in a resource-limited country.

Safety of Influenza A (H1N1) Vaccine in Postmarketing Surveillance in China Xiao-Feng Liang, M.D., Li Li, M.D., Ph.D., Da-Wei Liu, M.D., Ke-Li Li, M.D.,Wen-Di Wu, M.D., Bao-Ping Zhu, M.D., Hua-Qing Wang, M.D., Ph.D.,Hui-Ming Luo, M.D., Ling-Sheng Cao, M.D., Jing-Shan Zheng, M.D.,Da-Peng Yin, M.D., Lei Cao, M.P.H., Bing-Bing Wu, M.D., Hong-Hong Bao, M.D.,Di-Sha Xu, M.D., Wei-Zhong Yang, M.D., and Yu Wang, M.D., Ph.D.

Conclusion: In conclusion, these findings suggest that the H1N1 vaccine has a reasonable safety profile, and there is no evidence that the vaccine is associated with an increased risk of the Guillain–Barré syndrome.

Vaccination status and health in children and adolescents—findings of the German health interview and examination survey for children and adolescents (KiGGS). Schmitz R, Poethko-Müller C, Reiter S, Schlaud M: Dtsch Arztebl Int 2011; 108(7): 99–104.DOI: 10.3238/arztebl.2011.0099

Conclusion: Conclusion: The prevalence of allergic diseases and non-specific infections in children and adolescents was not found to depend on vaccination status.

Efficacy


Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trial.  Maruyama T, Taguchi O, Niederman MS, Morser J, Kobayashi H, Kobayashi T, D’Alessandro-Gabazza C, Nakayama S, Nishikubo K, Noguchi T, Takei Y, Gabazza EC.  Department of Pulmonary and Critical Care Medicine, Mie University Graduate School of Medicine, Tsu City, Mie Prefecture, Japan. BMJ. 2010 Mar 8;340:c1004. doi: 10.1136/bmj.c1004.

CONCLUSION: The 23-valent pneumococcal polysaccharide vaccine prevented pneumococcal pneumonia and reduced mortality from pneumococcal pneumonia in nursing home residents.

Reduction in Acute Gastroenteritis Hospitalizations among US Children After Introduction of Rotavirus Vaccine: Analysis of Hospital Discharge Data from 18 US States. Aaron T. Curns, Claudia A. Steiner, Marguerite Barrett, Katherine Hunter, Emily Wilson, and Umesh D. Parashar.  The Journal of Infectious Diseases 2010;201:1617–1624 © 2010 by the Infectious Diseases Society of America. All rights reserved.

CONCLUSION: The introduction of the RV5 vaccine was associated with a dramatic reduction in hospitalizations for acute gastroenteritis among US children during the 2008 rotavirus season.

Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. K Zaman, Dang Duc Anh, John C Victor, Sunheang Shin, Md Yunus, Michael J Dallas, Goutam Podder, Vu Dinh Thiem, Le Thi Phuong Mai,Stephen P Luby, Le Huu Tho, Michele L Coia, Kristen Lewis, Stephen B Rivers, David A Sack, Florian Schödel, A Duncan Steele, Kathleen M Neuzil,Max Ciarlet

CONCLUSION: In infants in developing countries in Asia, pentavalent rotavirus vaccine is safe and efficacious against severe rotavirus gastroenteritis, and our results support expanded WHO recommendations to promote its global use.

Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. George E Armah, Samba O Sow, Robert F Breiman, Michael J Dallas, Milagritos D Tapia, Daniel R Feikin, Fred N Binka, A Duncan Steele, Kayla F Laserson, Nana A Ansah, Myron M Levine, Kristen Lewis, Michele L Coia, Margaret Attah-Poku, Joel Ojwando, Stephen B Rivers, John C Victor, Geoff rey Nyambane, Abraham Hodgson, Florian Schödel, Max Ciarlet, Kathleen M Neuzil

CONCLUSION: Pentavalent rotavirus vaccine is effective against severe rotavirus gastroenteritis in the first 2 years of life in African countries with high mortality in infants younger than 5 years. We support WHO’s recommendation for adoption of rotavirus vaccine into national expanded programmes on immunisation in Africa.

Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study. Englund JA, Walter E, Black S, Blatter M, Nyberg J, Ruben FL, Decker MD; GRC28 Study Team.

CONCLUSION: TIV administered to young infants beginning at 6 to 12 weeks of age is safe and immunogenic.

Reduction in Gastroenteritis With the Use of Pentavalent Rotavirus Vaccine in a Primary Practice. Rodolfo E. Bégué, MDa, Keith Perrin, MDb

CONCLUSION: Increased use of RV5 in a pediatric practice was associated with fewer AGE office visits and hospitalizations. The reduction was specific for RV-positive AGE and seen among children who were targeted for immunization as well as older groups, suggesting a herd-immunity effect.

Maternal Influenza Vaccination and Effect on Influenza Virus Infection in Young Infants. Angelia A. Eick, PhD; Timothy M. Uyeki, MD, MPH, MPP; Alexander Klimov, PhD; Henrietta Hall, MS; Raymond Reid, MD; Mathuram Santosham, MD; Katherine L. O’Brien, MD, MPH. Arch Pediatr Adolesc Med. Published online October 4, 2010. doi:10.1001/archpediatrics.2010.192

Conclusions: Maternal influenza vaccination was significantly associated with reduced risk of influenza virus infection and hospitalization for an ILI up to 6 months of age and increased influenza antibody titers in infants through 2 to 3 months of age.

Immunogenicity of bivalent types 1 and 3 oral poliovirus vaccine: a randomised, double-blind, controlled trial. Dr Roland W Sutter MD a , Prof T Jacob John FRCP[E] b, Prof Hemant Jain MD c, Prof Sharad Agarkhedkar MD d, Prof Padmasini Venkat Ramanan MD e, Harish Verma MB f, Jagadish Deshpande PhD g, Ajit Pal Singh MB h, Meghana Sreevatsava MPH a, Pradeep Malankar MD a, Anthony Burton a, Arani Chatterjee MB h, Hamid Jafari MD f, R Bruce Aylward MD a

Interpretation: The findings show the superiority of bOPV compared with tOPV, and the non-inferiority of bOPV compared with mOPV1 and mOPV3.

Effectiveness of inactivated influenza vaccine in children aged 9 months to 3 years: an observational cohort study. Santtu Heinonen MD a, Heli Silvennoinen MD a, Pasi Lehtinen MD a, Raija Vainionpää PhD b, Thedi Ziegler PhD c, Dr Terho Heikkinen MD

Interpretation – Trivalent inactivated influenza vaccine was effective in preventing influenza in young children, including those younger than 2 years. Our findings suggest that influenza vaccine recommendations should be reassessed in most countries.

Impact of the seven-valent pneumococcal conjugate vaccination (PCV7) programme on childhood hospital admissions for bacterial pneumonia and empyema in England: national time-trends study, 1997–2008.  Elizabeth Koshy, Joanna Murray, Alex Bottle, Mike Sharland, Sonia Saxena

Conclusion Childhood bacterial pneumonia and empyema admission rates were increasing prior to 2006 and decreased by 19% and 22% respectively between 2006 and 2008, following the introduction of the PCV7 pneumococcal conjugate vaccination to the national childhood immunisation programme.

Pentavalent Rotavirus Vaccine in Developing Countries: Safety and Health Care Resource Utilization. Celia D. C. Christie, MBBS, DMPeds, MPH, FAAP, FRCPa, Newton D. Duncan, MBBS, DMSurg, FACSb, Kirk A. Thame, MBBS, DMPeds, FAAPa, Matthew T. Onorato, BScc, Hyacinth D. Smith, RN, RM, MPHa, Lavern G. Malcolm, BSc, RN, MPHa, Robbin F. Itzler, PhDd, Mark J. DiNubile, MDe, Penny M. Heaton, MD, MPHc

CONCLUSIONS In this posthoc subgroup analysis, the vaccine reduced health care resource utilization attributable to rotavirus gastroenteritis, without increased risk of intussusception or other serious adverse events, among infants in a resource-limited country.

 

THE VACCINES

MMR


Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Taylor B, Miller E, Farrington CP, Petropoulos MC, Favot-Mayaud I, Li J, Waight PA. – Lancet. 1999 Jun 12;353(9169):1987-8.

INTERPRETATION: Our analyses do not support a causal association between MMR vaccine and autism. If such an association occurs, it is so rare that it could not be identified in   this large regional sample.

MMRV


Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures Nicola P. Klein, Bruce Fireman, W. Katherine Yih, Edwin Lewis, Martin Kulldorff, Paula Ray, Roger Baxter, Simon Hambidge, James Nordin, Allison Naleway, Edward A. Belongia, Tracy Lieu, James Baggs, and Eric Weintraub for the Vaccine Safety Datalink 2010;126;e1-e8; originally published online Jun 29, 2010; Pediatrics DOI: 10.1542/peds.2010-0665

CONCLUSION: Among 12- to 23-month-olds who received their first dose of measles-containing vaccine, fever and seizure were elevated 7 to 10 days after vaccination. Vaccination with MMRV results in 1 additional febrile seizure for every 2300 doses given instead of separate MMR + varicella vaccines. Providers who recommend MMRV should communicate to parents that it increases the risk of fever and seizure over that already associated with measles-containing vaccines.

Pneumococcal


Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trial. Maruyama T, Taguchi O, Niederman MS, Morser J, Kobayashi H, Kobayashi T, D’Alessandro-Gabazza C, Nakayama S, Nishikubo K, Noguchi T, Takei Y, Gabazza EC. Department of Pulmonary and Critical Care Medicine, Mie University Graduate School of Medicine, Tsu City, Mie Prefecture, Japan. BMJ. 2010 Mar 8;340:c1004. doi: 10.1136/bmj.c1004.

CONCLUSION: The 23-valent pneumococcal polysaccharide vaccine prevented pneumococcal pneumonia and reduced mortality from pneumococcal pneumonia in nursing home residents.

Pneumococcal Conjugate Vaccination and Nasopharyngeal Acquisition of Pneumococcal Serotype 19A Strains. Elske J. M. van Gils, MD; Reinier H. Veenhoven, MD, PhD; Eelko Hak, PhD; Gerwin D. Rodenburg, MD; Wendy C. M. Keijzers; Debby Bogaert, MD, PhD; Krzysztof Trzcinski, DVM, PhD; Jacob P. Bruin; Loek van Alphen, PhD; Arie van der Ende, PhD; Elisabeth A. M. Sanders, MD, PhD.  JAMA. 2010;304(10):1099-1106. doi:10.1001/jama.2010.1290

Conclusion - A 2 + 1-dose PCV-7 schedule was associated with an increase in serotype 19A nasopharyngeal acquisition compared with unvaccinated controls.

Impact of the seven-valent pneumococcal conjugate vaccination (PCV7) programme on childhood hospital admissions for bacterial pneumonia and empyema in England: national time-trends study, 1997–2008.  Elizabeth Koshy, Joanna Murray, Alex Bottle, Mike Sharland, Sonia Saxena

Conclusion Childhood bacterial pneumonia and empyema admission rates were increasing prior to 2006 and decreased by 19% and 22% respectively between 2006 and 2008, following the introduction of the PCV7 pneumococcal conjugate vaccination to the national childhood immunisation programme.

Rotavirus


Reduction in Acute Gastroenteritis Hospitalizations among US Children After Introduction of Rotavirus Vaccine: Analysis of Hospital Discharge Data from 18 US States. Aaron T. Curns, Claudia A. Steiner, Marguerite Barrett, Katherine Hunter, Emily Wilson, and Umesh D. Parashar.  The Journal of Infectious Diseases 2010;201:1617–1624 © 2010 by the Infectious Diseases Society of America. All rights reserved.

CONCLUSION: The introduction of the RV5 vaccine was associated with a dramatic reduction in hospitalizations for acute gastroenteritis among US children during the 2008 rotavirus season.

Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. K Zaman, Dang Duc Anh, John C Victor, Sunheang Shin, Md Yunus, Michael J Dallas, Goutam Podder, Vu Dinh Thiem, Le Thi Phuong Mai,Stephen P Luby, Le Huu Tho, Michele L Coia, Kristen Lewis, Stephen B Rivers, David A Sack, Florian Schödel, A Duncan Steele, Kathleen M Neuzil,Max Ciarlet

CONCLUSION: In infants in developing countries in Asia, pentavalent rotavirus vaccine is safe and efficacious against severe rotavirus gastroenteritis, and our results support expanded WHO recommendations to promote its global use.

Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. George E Armah, Samba O Sow, Robert F Breiman, Michael J Dallas, Milagritos D Tapia, Daniel R Feikin, Fred N Binka, A Duncan Steele, Kayla F Laserson, Nana A Ansah, Myron M Levine, Kristen Lewis, Michele L Coia, Margaret Attah-Poku, Joel Ojwando, Stephen B Rivers, John C Victor, Geoff rey Nyambane, Abraham Hodgson, Florian Schödel, Max Ciarlet, Kathleen M Neuzil

CONCLUSION: Pentavalent rotavirus vaccine is effective against severe rotavirus gastroenteritis in the first 2 years of life in African countries with high mortality in infants younger than 5 years. We support WHO’s recommendation for adoption of rotavirus vaccine into national expanded programmes on immunisation in Africa.

Reduction in Gastroenteritis With the Use of Pentavalent Rotavirus Vaccine in a Primary Practice. Rodolfo E. Bégué, MDa, Keith Perrin, MDb

CONCLUSION: Increased use of RV5 in a pediatric practice was associated with fewer AGE office visits and hospitalizations. The reduction was specific for RV-positive AGE and seen among children who were targeted for immunization as well as older groups, suggesting a herd-immunity effect.

Pentavalent Rotavirus Vaccine in Developing Countries: Safety and Health Care Resource Utilization. Celia D. C. Christie, MBBS, DMPeds, MPH, FAAP, FRCPa, Newton D. Duncan, MBBS, DMSurg, FACSb, Kirk A. Thame, MBBS, DMPeds, FAAPa, Matthew T. Onorato, BScc, Hyacinth D. Smith, RN, RM, MPHa, Lavern G. Malcolm, BSc, RN, MPHa, Robbin F. Itzler, PhDd, Mark J. DiNubile, MDe, Penny M. Heaton, MD, MPHc

CONCLUSIONS In this posthoc subgroup analysis, the vaccine reduced health care resource utilization attributable to rotavirus gastroenteritis, without increased risk of intussusception or other serious adverse events, among infants in a resource-limited country.

Influenza


Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study. Englund JA, Walter E, Black S, Blatter M, Nyberg J, Ruben FL, Decker MD; GRC28 Study Team.

CONCLUSION: TIV administered to young infants beginning at 6 to 12 weeks of age is safe and immunogenic.

Safety of influenza vaccination during pregnancy. Munoz FM, Greisinger AJ, Wehmanen OA, Mouzoon ME, Hoyle JC, Smith FA, Glezen WP. Am J Obstet Gynecol. 2005 Apr;192(4):1098-106.

CONCLUSION: Influenza vaccine that was administered in the second or third trimester of gestation was safe in this study population.

Maternal Influenza Vaccination and Effect on Influenza Virus Infection in Young Infants. Angelia A. Eick, PhD; Timothy M. Uyeki, MD, MPH, MPP; Alexander Klimov, PhD; Henrietta Hall, MS; Raymond Reid, MD; Mathuram Santosham, MD; Katherine L. O’Brien, MD, MPH. Arch Pediatr Adolesc Med. Published online October 4, 2010. doi:10.1001/archpediatrics.2010.192

Conclusions: Maternal influenza vaccination was significantly associated with reduced risk of influenza virus infection and hospitalization for an ILI up to 6 months of age and increased influenza antibody titers in infants through 2 to 3 months of age.

Effectiveness of inactivated influenza vaccine in children aged 9 months to 3 years: an observational cohort study. Santtu Heinonen MD a, Heli Silvennoinen MD a, Pasi Lehtinen MD a, Raija Vainionpää PhD b, Thedi Ziegler PhD c, Dr Terho Heikkinen MD

Interpretation – Trivalent inactivated influenza vaccine was effective in preventing influenza in young children, including those younger than 2 years. Our findings suggest that influenza vaccine recommendations should be reassessed in most countries.

Safety of Influenza A (H1N1) Vaccine in Postmarketing Surveillance in China Xiao-Feng Liang, M.D., Li Li, M.D., Ph.D., Da-Wei Liu, M.D., Ke-Li Li, M.D.,Wen-Di Wu, M.D., Bao-Ping Zhu, M.D., Hua-Qing Wang, M.D., Ph.D.,Hui-Ming Luo, M.D., Ling-Sheng Cao, M.D., Jing-Shan Zheng, M.D.,Da-Peng Yin, M.D., Lei Cao, M.P.H., Bing-Bing Wu, M.D., Hong-Hong Bao, M.D.,Di-Sha Xu, M.D., Wei-Zhong Yang, M.D., and Yu Wang, M.D., Ph.D.

Conclusion: In conclusion, these findings suggest that the H1N1 vaccine has a reasonable safety profile, and there is no evidence that the vaccine is associated with an increased risk of the Guillain–Barré syndrome.

Polio


Immunogenicity of bivalent types 1 and 3 oral poliovirus vaccine: a randomised, double-blind, controlled trial. Dr Roland W Sutter MD a , Prof T Jacob John FRCP[E] b, Prof Hemant Jain MD c, Prof Sharad Agarkhedkar MD d, Prof Padmasini Venkat Ramanan MD e, Harish Verma MB f, Jagadish Deshpande PhD g, Ajit Pal Singh MB h, Meghana Sreevatsava MPH a, Pradeep Malankar MD a, Anthony Burton a, Arani Chatterjee MB h, Hamid Jafari MD f, R Bruce Aylward MD a

Interpretation: The findings show the superiority of bOPV compared with tOPV, and the non-inferiority of bOPV compared with mOPV1 and mOPV3.

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  3 Responses to “Scientific Evidence”

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    • Not at all, there seems to be plenty of important information in your site. I’ll definitely use it as a source, especially since you seem to have done some investigative leg work in some areas I may be interested in. Thanks for pointing it to my attention.

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