What should be done if a “one-vial” Menveo brand of meningococcal ACWY vaccine is administered to an infant at high risk? The person giving the vaccine didn’t notice that this new formulation is only licensed for use beginning at age 10 years.

The “two-vial” formulation of Menveo (MenACWY-CRM, GSK) requires reconstitution of a lyophilized powder with a diluent: it is FDA-licensed for administration to individuals age 2 months through 55 years. The “one-vial” liquid formulation of Menveo licensed in 2022 is essentially the same vaccine, but does not require reconstitution before administration; however, this formulation is currently licensed only for administration to people age 10 through 55 years.

If the “one-vial” formulation is inadvertently administered to a child younger than age 10 years, this incident should be reported to the Vaccine Adverse Event Reporting System (VAERS, https://vaers.hhs.gov) as a vaccine administration error; however, the dose may be counted as valid and should not be repeated. If your facility stocks both one-vial and two-vial Menveo formulations, review practices and protocols and ensure clear labeling of vaccines in storage units to minimize the risk of administering the one-vial formulation to a child younger than age 10 years.

Note that administration of a dose of either Menveo formulation to a patient who is older than the FDA-licensed upper age limit of 55 years should not be reported to VAERS and is not considered an error. This is because ACIP recommendations state that Menveo may be administered to adults age 56 or older when MenACWY vaccination is indicated and MenQuadfi (MenACWY-TT, Sanofi, licensed with no upper age limit) is not available.