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Safety of vaccines used for routine immunization of U.S. children: a systematic review
Margaret A Maglione1, Lopamudra Das2, Laura Raaen2
1RAND Corporation, Santa Monica, California; maglione@rand.org.
Insights
This systematic review confirms that while rare serious adverse events can occur with routine childhood vaccines, their benefits significantly outweigh the risks. Evidence supports the safety of the measles, mumps, and rubella (MMR) vaccine, including no association with autism.
Area of Science:
- Pediatric medicine
- Immunology
- Public health
Background:
- Parental vaccine safety concerns contribute to declining vaccination rates and disease resurgence.
- Ensuring vaccine safety is crucial for maintaining population health.
- This study systematically reviewed the safety of routine childhood vaccines in the US.
Purpose of the Study:
- To systematically review and assess the scientific literature on the safety of routine vaccines recommended for children in the United States.
- To provide evidence-based information to address concerns about vaccine safety.
Main Methods:
- Conducted a systematic literature review using multiple databases and sources, including PubMed and the Institute of Medicine report.
- Included studies with active surveillance and control mechanisms, focusing on US-formulated vaccines.
- Evaluated adverse event reporting using the McHarm scale and rated the strength of evidence.
Main Results:
- High strength of evidence supports the measles/mumps/rubella (MMR) vaccine's safety, with no association with autism.
- Moderate evidence links rotavirus vaccines to intussusception; varicella vaccine associated with complications in immunocompromised individuals.
- Identified limitations include inconsistent reporting of adverse event risk factors and severity.
Conclusions:
- Routine childhood vaccines are associated with rare serious adverse events.
- The protective benefits of vaccination significantly outweigh the risks of these rare events.
- Evidence supports the overall safety profile of recommended childhood vaccines.
Background:
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.
Methods:
Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient.
Results:
Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported.
Conclusions:
We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide.
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