FDA Approves IM Administration of Merck’s MMRV Family of Vaccines
The FDA approved the inclusion of intramuscular (IM) administration to the U.S. package insert for Merck’s measles-mumps-rubella-varicella (MMRV) family of vaccines, increasing the options for administering routinely recommended injectable pediatric vaccinations, according to a company release.
The MMRV vaccine family includes M-M-R II, Varivax and ProQuad. These vaccines have long been used in the United States. However, until now, they have only been given subcutaneously. Healthcare providers now have the choice to administer all routinely recommended injectable pediatric vaccinations included in the CDC immunization schedule through the same IM route.
The three vaccines included in the MMRV family—M-M-R II, Varivax and ProQuad—are the only vaccines for measles, mumps, rubella and varicella approved to be administered intramuscularly in the United States.
ProQuad was approved by the FDA in 2005, and is indicated for active immunization to prevent measles, mumps, rubella and varicella in children (12 months through 12 years of age). Varivax is the only available varicella vaccine in the United States and is indicated for use in children and adults who are at least 12 months of age. It was approved in 1995.
M-M-R II was approved in 1978, and is used for the prevention of measles, mumps and rubella in children and adults at least 12 months of age or older.
Adverse events for the three vaccines include fever, injection site reactions (pain/tenderness/soreness, erythema and swelling) and rash. Irritability was also reported following subcutaneous injections.
“As a pediatrician who routinely vaccinates children, I am excited to now have the option to administer these vaccines intramuscularly,” said Todd Wolynn, MD, MMM, a pediatrician and the co-founder of Kids Plus Pediatrics, in Pittsburgh. “This approval provides our practice with an additional route of administration.”
These vaccines also have been licensed in the European Union for IM administration.
MARCH 8, 2023
