Adverse Events After MMR or MMRV Vaccine in Infants Under Nine Months Old

Emily Jane Woo1, Scott K Winiecki, Deepa Arya

  • 1From the *Office of Biostatistics and Epidemiology and †Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

Abstract

Insights

Infants under nine months receiving measles vaccines experienced no major safety concerns. Most reports involved vaccination errors or mild side effects like fever, with few serious events noted.

Area of Science:

  • Pediatrics
  • Vaccinology
  • Public Health

Background:

  • Measles outbreaks are resurging in the U.S., with over 700 cases reported since January 2014.
  • Infants at risk during outbreaks may receive measles vaccination as early as six months of age.

Purpose of the Study:

  • To assess the safety of measles, mumps, and rubella (MMR) or measles, mumps, rubella, and varicella (MMRV) vaccines in infants under nine months old.
  • To evaluate adverse events reported following vaccination in this age group.

Main Methods:

  • Searched the Vaccine Adverse Event Reporting System (VAERS) for vaccination reports in children younger than nine months.
  • Conducted clinical assessments of retained reports, summarizing adverse event frequency, range, onset, and severity.

Main Results:

  • 204 reports were analyzed after exclusions; 35 (17%) were serious.
  • Most nonserious reports (52%) were vaccination errors. Other nonserious events included fever and injection site reactions.
  • Serious events included developmental disorders and fever; only 4 fever cases occurred within the peak risk window post-immunization.

Conclusions:

  • No significant safety concerns were identified with measles-containing vaccines in infants under nine months.
  • Findings support informed discussions on the risks and benefits of early vaccination for infants exposed to measles.

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