The Food and Drug Administration (FDA) has expanded the approval for Merck’s M-M-R II® (measles, mumps, and rubella virus vaccine live), Varivax® (varicella virus vaccine live), and ProQuad® (measles, mumps, rubella and varicella virus vaccine live) vaccines to include an intramuscular (IM) route of administration.

Health care professionals now have the option to administer these vaccines via IM or subcutaneous (SC) injection. M-M-R II is indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. Varivax is indicated for active immunization for the prevention of varicella in individuals 12 months of age and older. ProQuad is indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months to 12 years of age. 

The approvals were based on data from randomized, open-label clinical trials (ClinicalTrials.gov Identifier: NCT00432523, NCT00402831) that evaluated the efficacy and safety of M-M-R II, Varivax, and ProQuad administered either intramuscularly or subcutaneously in children 12 through 18 months of age. Seroresponse rates were generally found to be noninferior in the IM group compared with the SC group. The safety profile was similar between groups.

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M-M-R II, Varivax, and ProQuad are supplied in single-dose vials as a lyophilized vaccine for SC or IM injection after reconstitution.

References

  1. US FDA approves intramuscular administration for Merck’s MMRV family of vaccines: M-M-R II (measles, mumps, and rubella virus vaccine live), Varivax (varicella virus vaccine live), and ProQuad (measles, mumps, rubella and varicella virus vaccine live). News release. Merck. Accessed March 6, 2023. https://www.merck.com/news/us-fda-approves-intramuscular-administration-for-mercks-mmrv-family-of-vaccines-m-m-rii-measles-mumps-and-rubella-virus-vaccine-live-varivax-varicella-virus-vaccine-live-and-proquad/.
  2. M-M-R II. Package insert. Merck; 2023. Accessed March 6, 2023. https://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf.
  3. Varivax. Package insert. Merck; 2023. Accessed March 6, 2023. https://www.merck.com/product/usa/pi_circulars/v/varivax/varivax_pi.pdf.
  4. ProQuad. Package insert. Merck; 2023. Accessed March 6, 2023. https://www.merck.com/product/usa/pi_circulars/p/proquad/proquad_pi_4171.pdf.

This article originally appeared on MPR

Topics:

Immunization Pediatrics Vaccines