MMRV Vaccines Gain Intramuscular Administration Authorization

A global leader in children's vaccines today announced an additional administration route approved by the U.S. Food and Drug Administration (FDA).

Merck confirmed on March 6, 2023, the FDA had approved the addition of the intramuscular (IM) route of administration to the United States Product Insert for Merck's M-M-R®II, VARIVAX®, and ProQuad® vaccines.

Merck says these are the only measles, mumps, rubella, and varicella vaccines that can be administered IM.

These vaccines have already been licensed for IM administration in the European Union.

While these vaccines have a long history in the U.S., until today, they have only been administered via subcutaneous 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 U.S.," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release.

With these approvals, healthcare professionals now have the option to choose to administer all routinely recommended injectable pediatric vaccinations included in the CDC immunization schedule via the same IM route.

"As a pediatrician who routinely vaccinates children, I am excited to now have the option to administer these vaccines intramuscularly," said Dr. Todd Wolynn, co-founding pediatrician of Kids Plus Pediatrics.

"This approval provides our practice with an additional route of administration."

• ProQuad® is a vaccine indicated for active immunization to prevent measles, mumps, rubella, and varicella in children 12 months through 12 years of age. The FDA approved it in 2005.
• VARIVAX® is a vaccine indicated for active immunization to prevent varicella in individuals 12 months or older. It received FDA approval in 1995 and remains the only varicella vaccine available in the U.S.
• M-M-R®II is indicated for active immunization to prevent measles, mumps, and rubella in individuals 12 months of age or older and received FDA approval in 1978.

These approvals are timely as active measles outbreaks exist in the U.S. (Kentucky) and globally.

The U.S. CDC Global Measles Outbreaks list was updated in February 2023, indicating India had confirmed about 32,000 measles cases last year.