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Merck, known as MSD outside of the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved the addition of the intramuscular (IM) route of administration to the United States Product Insert (USPI) for Merck’s MMRV family of vaccines: M-M-R II, VARIVAX, and ProQuad.
While these vaccines have a long history in the US, until now they have only been administered via subcutaneous (SC) injection.
“Building on our history of innovation in the world of vaccines, we’re proud to introduce another method of administration for M-M-R II, VARIVAX, and ProQuad vaccines, which have been important in the fight against measles, mumps, rubella, and varicella in the US,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.
With these approvals, healthcare professionals now have the option to choose to administer all routinely recommended injectable paediatric vaccinations included in the CDC immunization schedule, via the same IM route. In the US, the only measles, mumps, rubella, and varicella vaccines that can be administered IM are M-M-R II, VARIVAX, and ProQuad. Additionally, the MMRV family of vaccines has already been licensed for IM administration in the European Union.
“As a paediatrician who routinely vaccinates children, I am excited to now have the option to administer these vaccines intramuscularly,” said Dr. Todd Wolynn, co-founding paediatrician of Kids Plus Paediatrics. “This approval provides our practice with an additional route of administration.”
ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age. It was approved by the FDA in 2005. VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age or older. It received FDA approval in 1995 and remains the only varicella vaccine available for use in the US M-M-R II is indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older and received FDA approval in 1978.
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