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			Agency for Healthcare Research and Quality (AHRQ)The National Academy of Medicine (NAM)
		
CDC’s vaccine safety systems help ensure vaccines are as safe as possible. These monitoring systems help scientists conduct high-quality vaccine safety research. This research is then peer-reviewed and published in reputable scientific outlets.
CDC also closely partners with other federal, state, and local agencies, as well as private entities, to monitor and communicate about the safety of vaccines.
Agency for Healthcare Research and Quality (AHRQ)
AHRQ is the lead federal agency charged with improving the safety and quality of America’s healthcare system. AHRQ’s mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to make sure that the evidence is understood and used.
In 2014, AHRQ developed a report based on a systematic review of vaccine safety that builds upon the 2011 Institute of Medicine (IOM) report: *Adverse Effects of Vaccines: Evidence and Causality.*  Since the first report came out, the vaccination schedule evolved to include newly approved vaccines and changes to several existing vaccines.
Safety of Vaccines Used for Routine Immunization in the United States: An Update – 2021Agency for Healthcare Research and Quality. *Safety of Vaccines Used for Routine Immunization in the United States: An Update.*external icon AHRQ Publication No. 21-EHC024 May 2021.In May 2021, AHRQ released an updated report of the *Safety of Vaccines Used for Routine Immunization in the United States.* Researchers conducted a systematic review of the published scientific research (literature) on the following vaccines, which are recommended for routine immunization in adults, pregnant people and children and adolescents:AHRQ 2021 Report, Safety of Vaccines Used for Routine Immunization in the US: An UpdateDiphtheria, Tetanus and Acellular Pertussis (DTaP)Haemophilus influenzae type b (Hib)Hepatitis AHepatitis BHuman Papillomavirus (Gardasil)Influenza (inactivated, recombinant and live)Inactivated PolioMeasles, Mumps, and Rubella (MMR)Meningococcal ACWYMeningococcal BPneumococcal (13- and 23-valent)RotavirusTetanus, diphtheria (Td)Tetanus, diphtheria and acellular pertussis (Tdap)Shingles (Shingrix)Varicella (chickenpox)
For this update, researchers reviewed nearly 57,000 citations and found 189 studies that addressed key questions evaluating the vaccines above and in the specific populations, adding to data in the prior 2014 report, for a total of 338 included studies reported in 518 publications.
Safety signals from the prior report remain unchanged for adverse events, including:
Anaphylaxis in adults and children
Febrile seizures in children
Idiopathic Thrombocytopenia Purpura in childrenThis report did not find any new evidence of increased risk for key adverse events following administration of vaccines that are routinely recommended for adults, children, and pregnant people. There remains insufficient evidence to make conclusions about some rare potential adverse events.
Top of PageThe National Academy of Medicine (NAM) – formerly Institute of Medicine (IOM)
Founded in 1970 as IOM, NAM is one of three academies that make up the National Academies of Sciences, Engineering, and Medicineexternal icon (the National Academies) in the United States. As part of a restructuring of the National Academies in 2015, IOM became NAM. The National Academies are private, nonprofit institutions that work outside of government to provide objective advice on matters of science, technology, and health.
Occasionally, the U.S. Department of Health and Human Services (HHS) asks NAM to examine all of the current medical and scientific evidence on a particular topic. Below are summaries of historical IOM reports relating to vaccine safety.
The Childhood Immunization Schedule and Safety – 2013Institute of Medicine. 2013. *The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studiesexternal icon*. Washington, DC: The National Academies Press. https://doi.org/10.17226/13563.The IOM convened the Committee on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule to conduct an independent evaluation of the safety of the childhood immunization schedule.
The IOM issued their report on January 16, 2013. In it, **the Committee expressed support for the****recommended childhood immunization schedule as a tool to protect against vaccine-preventable diseases**. The Committee recommended using healthcare records data to continue studying the safety of vaccines. The Committee also reconfirmed a finding of the National Vaccine Advisory Committee (NVAC)pdf iconexternal icon white paper  that said conducting a study requiring some children to receive fewer vaccines than recommended, as would be needed for a randomized controlled trial, would be unethical. However, the committee concluded that the Vaccine Safety Datalink (VSD) is the best available system for studying the safety of the immunization schedule in the United States.The Childhood Imminuzation Schedule and Safety Reportcalendar alt light iconChild and Adult Immunization Schedules
Get CDC’s official recommended immunization schedules for children, adolescents, and adults.Top of PageAdverse Effects of Vaccines: Evidence and Causality – 2012Institute of Medicine. 2012. *Adverse Effects of Vaccines: Evidence and Causalityexternal icon*. Washington, DC: The National Academies Press. https://doi.org/10.17226/13164.HHS charged the IOM with providing a thorough review of the current medical and scientific evidence on vaccines and vaccine adverse events.
The IOM Committee on Vaccines and Adverse Events released its report on August 25, 2011. This analysis was used to update the Vaccine Injury Table pdf icon[PDF – 12 Pages]external iconfor the National Vaccine Injury Compensation Program (VICP)external icon. The report provides a scientific basis for future review and decisions on VICP claims. The IOM Committee used peer-reviewed literature to review eight vaccines given to children or adults:Adverse Effects of Vaccines - Evidence and CausalityMeasles, Mumps, and Rubella (MMR)
Varicella
Influenza
Hepatitis A
Hepatitis B
Human papillomavirus (HPV)
Meningococcal
Diphtheria-toxoid-, tetanus toxoid-, and acellular pertussis-containing vaccines**The findings indicate that these vaccines are safe and that serious adverse events are quite rare.** The IOM has conducted two similar extensive reviews in the past. The last one was published in 1994.
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						Page last reviewed:  November 8, 2021					Content source: 	Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP) homeVaccine Safety
Safety Information by Vaccineplus icon
Chickenpox (Varicella) Vaccines
COVID-19 Vaccines
Diphtheria, Tetanus, and Pertussis Vaccines
Haemophilus influenzae type b (Hib) Vaccines
Hepatitis A Vaccines
Hepatitis B Vaccines
Human Papillomavirus (HPV) Vaccineplus icon
Questions about HPV Vaccine Safety
Influenza (Flu) Vaccines
Measles, Mumps, Rubella (MMR) Vaccinesplus icon
MMR Safety Studies
Measles, Mumps, Rubella, Varicella (MMRV) Vaccinesplus icon
VSD MMRV Safety Study
MMRV Safety Studies
MMRV and Febrile Seizures
Meningococcal Vaccines
Mpox Vaccines
Pneumococcal Vaccines
Polio Vaccine
Respiratory Syncytial Virus (RSV) Vaccine
Rotavirus Vaccine
Shingles (Herpes Zoster) Vaccines
Smallpox Vaccines
Questions and Concernsplus icon
Adjuvants
Autismplus icon
CDC Statement: 2004 Pediatrics Paper on MMR and Autism
Fainting after Vaccination
Febrile Seizures
Guillain-Barre Syndrome
Multiple Vaccinations at Once
Sudden Infant Death Syndrome (SIDS)
Thimerosalplus icon
CDC Study (2010 ) on Thimerosal and Risk of Autism
Thimerosal FAQs
Related Scientific Articles
Infant and Environmental Exposures to Thimerosal 2007 Study
Timeline: Thimerosal in Vaccines
Vaccines During Pregnancy FAQs
FAQs about Vaccine Recalls
Historical Vaccine Safety Concernsplus icon
GBS and Menactra Vaccine FAQs
Gardasil Vaccine Recall (2013) FAQs
Hep B and Multiple Sclerosis FAQs
Hib Vaccine Recall (2007) Summary
Narcolepsy Following Pandemrix Influenza Vaccination in Europe
Information for Healthcare Providersplus icon
Talking to Patients About Vaccine Safety
Reporting Adverse Events
Resources for Healthcare Providers
Information for Parents and Caregiversplus icon
Vaccine Safety FAQs
Researchplus icon
Publications
Partner Reports on Vaccine Safety
ISO Scientific Agenda
Ensuring Safetyplus icon
Overview, History, and How It Works
Side Effects and Adverse Events
Vaccine Safety Monitoringplus icon
Vaccine Adverse Event Reporting System (VAERS)
CISAplus icon
CISA Resources for Healthcare Professionals
Evaluation
Clinical Research Studies
Historical Background 2001-12
Publications
Technical Reports
Vaccine Safety Datalink (VSD)plus icon
Accessing Data from Vaccine Safety Datalink
Data Sharing Guidelines
Vaccine Safety Datalink Publications
V-safe
V-safe Publications
Emergency Preparedness
Vaccine Safety Partners
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