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General Vaccine Safety Studies


Infant Hospitalizations and Mortality After Maternal Vaccination

Source: Sukumaran et al. Pediatrics | February 21, 2018

No association was found between vaccination during pregnancy and risk of infant hospitalization or death in the first 6 months of life. These findings support the safety of current recommendations for influenza and Tdap vaccination during pregnancy.



Demographic characteristics of members of the Vaccine Safety Datalink (VSD): A comparison with the United States population.

August 26, 2015

Sukumaran et al. Vaccine

The Vaccine Safety Datalink (VSD) is a collaboration between CDC and nine integrated health care systems that serves as a cornerstone of US post-licensure vaccine safety monitoring. Given concerns that potential differences between the insured VSD population and the US population could limit the generalizability of VSD study findings, this paper performed a comparison of the demographic characteristics between the two populations.



More General Vaccine


Studies about Pertussis and Tdap/DTap


Association of Tdap Vaccination With Acute Events and Adverse Birth Outcomes Among Pregnant Women With Prior Tetanus-Containing Immunizations

October 20, 2015

Sukumaran et al. JAMA

Pertussis is poorly controlled, with the highest rates of morbidity and mortality among infants. Although the source of infant pertussis is often unknown, when identified, mothers have historically been the most common reservoir of transmission. Despite high vaccination coverage, disease incidence has been increasing. The authors examined whether infant source of infection (SOI) has changed in the United States in light of the changing epidemiology.



Sources of Infant Pertussis Infection in the United States

September 1, 2015

Skoff et al. Pediatrics

Pertussis is poorly controlled, with the highest rates of morbidity and mortality among infants. Although the source of infant pertussis is often unknown, when identified, mothers have historically been the most common reservoir of transmission. Despite high vaccination coverage, disease incidence has been increasing. The authors examined whether infant source of infection (SOI) has changed in the United States in light of the changing epidemiology.



More Pertussis & Tdap/DTap


Studies Examining the Reduction of Disease Burden


Seasonal Trivalent Influenza Vaccination During Pregnancy and the Incidence of Stillbirth: Population-Based Retrospective Cohort Study

April 1, 2016

Regan et. al Clinical Infectious Diseases

Mothers who received seasonal TIV during pregnancy were significantly less likely to experience stillbirth compared with unvaccinated mothers. These results support the safety of seasonal influenza immunization during pregnancy and suggest a protective effect.



The Benefit of Early Influenza Treatment of Pregnant Women Hospitalized with Laboratory Confirmed Influenza

February 4, 2016

Oboho et al. The Journal of Infectious Diseases

Pregnant women are at higher risk for serious illness and complications, including death, from influenza. For expectant mothers hospitalized with flu, early treatment with the influenza antiviral drug oseltamivir may shorten their time in the hospital, especially in severe cases, suggests a study published in The Journal of Infectious Diseases. The findings also underscore the importance of flu vaccination for this risk group.



More on Disease Burden


Measles-Mumps-Rubella (MMR) Vaccine and Autism Studies


Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism

May 21, 2015

Jain et al. JAMA

To report ASD occurrence by MMR vaccine status in a large sample of US children who have older siblings with and without ASD the authors did a retrospective cohort study using an administrative claims database associated with a large commercial health plan. Participants included children continuously enrolled in the health plan from birth to at least 5 years of age during 2001-2012 who also had an older sibling continuously enrolled for at least 6 months between 1997 and 2012.



Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review.

August 1, 2014

Maglione et al. Pediatrics

Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States.



More MMR & Autism


Thimerosal and Autism Studies


Administration of thimerosal-containing vaccines to infant rhesus macaques does not result in autism-like behavior or neuropathology

October 6, 2015

Gdad et al. PNAS

Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder. Some anecdotal reports suggest that ASD is related to exposure to ethyl mercury, in the form of the vaccine preservative, thimerosal, and/or receiving the measles, mumps, rubella (MMR) vaccine. Using infant rhesus macaques receiving thimerosalcontaining vaccines (TCVs) following the recommended pediatric vaccine schedules from the 1990s and 2008, we examined behavior, and neuropathology in three brain regions found to exhibit neuropathology in postmortem ASD brains. No neuronal cellular or protein changes in the cerebellum, hippocampus, or amygdala were observed in animals following the 1990s or 2008 vaccine schedules. Analysis of social behavior in juvenile animals indicated that there were no significant differences in negative behaviors between animals in the control and experimental groups. These data indicate that administration of TCVs and/or the MMR vaccine to rhesus macaques does not result in neuropathological abnormalities, or aberrant behaviors, like those observed in ASD.



Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism

September 13, 2010

Price et al. Pediatrics

Exposure to thimerosal, a mercury-containing preservative that is used in vaccines and immunoglobulin preparations, has been hypothesized to be associated with increased risk of autism spectrum disorder (ASD). This study was designed to examine relationships between prenatal and infant ethylmercury exposure from thimerosal-containing vaccines and/or immunoglobulin preparations and ASD and 2 ASD subcategories: autistic disorder (AD) and ASD with regression.



More Thimerosal/Autism


Institute of Medicine (IOM) Reports


Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies

January 16, 2013

The Institute of Medicine (IOM) of the National Academies

This report is the most comprehensive examination of the immunization schedule to date. The IOM committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule. Should signals arise that there may be need for investigation, however, the report offers a framework for conducting safety research using existing or new data collection systems.



Adverse Effects of Vaccines: Evidence and Causality

August 25, 2011

The Institute of Medicine (IOM) of the National Academies

Using epidemiologic and mechanistic evidence, the committee developed 158 causality conclusions and assigned each relationship between a vaccine and an adverse health problem to one of four categories of causation:

  • Evidence convincingly supports a causal relationship
  • Evidence favors acceptance of a causal relationship
  • Evidence favors rejection of a causal relationship
  • Evidence is inadequate to accept or reject a causal relationship

The committee finds that evidence convincingly supports a causal relationship between some vaccines and some adverse events—such as MMR, varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines linked to anaphylaxis. Additionally, evidence favors rejection of five vaccine-adverse event relationships, including MMR vaccine and autism and inactivated influenza vaccine and asthma episodes. However, for the majority of cases (135 vaccine-adverse event pairs), the evidence was inadequate to accept or reject a causal relationship. Overall, the committee concludes that few health problems are caused by or clearly associated with vaccines.



More IOM Reports


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