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Neurovirulence safety testing of mumps vaccines--historical perspective and current status

S A Rubin1, M A Afzal

  • 1Center for Biologics Evaluation and Research, United States Food and Drug Administration, Bethesda, MD 20892, USA. steven.rubin@fda.hhs.gov

Vaccine
|February 22, 2011
PubMed

Insights

Live viral vaccines require safety testing for neurotoxicity. Current monkey-based tests for mumps vaccines are unreliable, prompting development of alternative methods to ensure human safety.

Area of Science:

  • Virology
  • Vaccinology
  • Neuroscience

Background:

  • Live, attenuated viral vaccines are derived from wild-type viruses, necessitating pre-clinical neurovirulence safety testing to ensure the absence of residual neurotoxicity.
  • Mumps virus, being highly neurotropic, undergoes neurovirulence safety testing in monkeys.

Observation:

  • Laboratory studies indicate that current monkey-based neurovirulence testing may not accurately differentiate between mumps virus strains with varying neurovirulence potential in humans.
  • Some mumps vaccines deemed neuroattenuated in monkeys later exhibited neurovirulence in humans when administered in large quantities.

Findings:

  • Over the last decade, significant efforts have focused on replacing monkey-based neurovirulence safety testing with more informative alternative methods.
  • This review examines the current state of mumps vaccine neurovirulence safety testing and evaluates approved and emerging alternative models.

Implications:

  • Developing reliable alternative methods for mumps vaccine neurovirulence testing is crucial for enhancing vaccine safety and efficacy.
  • Advancements in alternative testing models promise more accurate prediction of vaccine neurovirulence in humans, improving public health outcomes.

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