Potential Questions and Answers for the New Liquid Formulation ROTARIX Licensure

Two, a vial and oral dosing applicator presentation (the current lyophilized formulation) and an oral dosing applicator only presentation (the new liquid formulation). Note that both formulations/preparations are subsumed in one package insert. The link to the package insert is entitled “Oral Dosing Applicator Only Presentation” and is found at ROTARIX – FDA. One formulation/preparation requires the reconstitution of lyophilized vaccine with a diluent (the vial and oral dosing applicator presentation). The other formulation/preparation does NOT require reconstitution (oral dosing applicator only presentation). Also be aware that there is a third preparation that is licensed in the U.S. but is NOT available in the U.S.; this third preparation is used in other countries. This third preparation is listed as a discrete link to a different package insert. The link is entitled: “Squeezable Tube Presentation” and is found at ROTARIX – FDA. The ONLY two products available in the U.S. are described in the one package insert entitled “Oral Dosing Applicator Only Presentation.”

Yes, the current lyophilized formulation will be eventually retired. The last lot of the current lyophilized formulation was manufactured in March 2022, the last lot shipment to U.S. customers will be no later than November 2023, and the last expiry date, i.e., the last day the vaccine is NOT expired, is March 3, 2025 (last lot produced in March 2022, 3-year shelf-life).

Yes. The number of doses and the intervals are the same for the new liquid formulation as they are for the current lyophilized formulation. The vaccination series consists of two doses administered orally at ages 2 and 4 months. The minimum and maximum ages for the first dose are 6 weeks and 14 weeks and 6 days of age, respectively. The minimum interval between the first and second dose is 4 weeks. The maximum age for the last dose is 8 months and 0 days. Please note that a single dose of the current lyophilized vaccine is 1 mL after reconstitution, while a single dose of the new liquid vaccine is 1.5 mL.

Rotavirus vaccination should not be initiated for infants aged 15 weeks and 0 days or older. For infants to whom dose 1 of rotavirus vaccine is administered inadvertently at age 15 weeks and 0 days or older, the rest of the rotavirus vaccination series should be completed according to the schedule and by age 8 months and 0 days.

Although it is preferable for doses in a vaccine series to come from the same formulation and product, interchangeability between the current lyophilized formulation and new liquid formulation is acceptable if the same formulation is not available or if the formulation or product of doses given previously is unknown.

No. Do not re-administer the dose if the provider inadvertently mixed the current lyophilized formulation with the new liquid formulation.

No. Do not re-administer the dose if the provider inadvertently mixed the diluent (from the current lyophilized formulation) with the new liquid formulation.

The new liquid formulation should be stored refrigerated at 2° to 8°C (36° to 46°F) and protected from light (kept in original package). The vaccine should not be frozen and should be discarded if the vaccine has been frozen.

No. As with the current lyophilized formulation, do not re-administer the dose if the infant spits it out or vomits immediately after administration of the new liquid formulation.

Yes. As with the current lyophilized formulation, infants can breast feed or drink formula or water immediately after being immunized with the new liquid vaccine.

An injected dose is not considered a valid dose, and a properly administered oral replacement dose should be given within the appropriate age and dosing schedule. As with other injectable vaccines, common and rare adverse reactions should be monitored for, including pain, swelling, redness at the injection site, general reactions such as a fever or irritability, and severe allergic reactions including anaphylaxis.

Yes, administration of rotavirus vaccine via a gastrostomy tube or nasogastric tube is acceptable. However, note that infants with a history of uncorrected gastrointestinal malformation (such as Meckel’s diverticulum) that predisposes them to intussusception should not receive ROTARIX, so the reason for the gastrostomy tube or nasogastric tube should be taken into consideration.

The new liquid formulation comes as an oral dosing applicator only presentation, which already contains ROTARIX, and does NOT require reconstitution or dilution before use (the vial or transfer adapter components found in the current lyophilized formulation are not included). The oral dosing applicator used for the new liquid formulation is similar to the one used for the current lyophilized formulation. The preparation and administration steps of the new liquid formulation are simpler: the protective tip cap of the oral dosing applicator is removed, and the vaccine is administered.

Yes. Preterm infants can be vaccinated according to the same schedule and precautions as full-term infants and under the following conditions: the infant’s chronological age meets the age requirements for rotavirus vaccine (e.g., age 6 weeks–14 weeks and 6 days for dose 1), the infant is clinically stable, and the vaccine is administered at the time of discharge from the neonatal intensive care unit [NICU] or nursery, or after discharge from the NICU or nursery. This same NICU or nursery exemption also applies to the current lyophilized formulation.

It is recommended that the vaccine be administered at the time of discharge from the neonatal intensive care unit [NICU] or nursery, or after discharge from the NICU or nursery.