Vaccine Academy › Vaccine School › Childhood and adolescent
Content current as of October 11, 2026. AI-assisted draft; not yet reviewed by a licensed pharmacist. Current CDC schedules: immunization schedules.
- The disease and why it matters
- Video and figures
- Get CE credit
- Products available
- Who should get it
- Dosing and schedule, including catch-up
- Administration
- Storage and handling
- Contraindications and precautions
- Safety and adverse events
- Special populations
- Counseling pearls for the pharmacy counter
- Common patient questions
- References
The disease and why it matters
Rotavirus spreads through direct contact between people; disease is characterized by vomiting and watery diarrhea for three to eight days, with fever and abdominal pain also common, and infants and young children are most at risk. [1]
Before vaccine introduction almost all U.S. children were infected with rotavirus before their 5th birthday, leading each year to more than 400,000 doctor visits, more than 200,000 emergency room visits, 55,000 to 70,000 hospitalizations and 20 to 60 deaths; the most severe disease occurs primarily among unvaccinated children aged 3 months to 3 years. [1]
Rotavirus is primarily transmitted through the fecal-oral route, usually by direct contact between people; the virus is stable in the environment, so transmission can also occur through contaminated water, food or surfaces, and the incubation period is approximately 2 days. [1]
CDC says rotavirus vaccine prevents an estimated 40,000 to 50,000 hospitalizations among U.S. infants and young children each year, and during an infant's first year provides 85% to 98% protection against severe rotavirus illness and hospitalization and 74% to 87% protection against rotavirus illness of any severity. [2]
Video and figures
Video
Get CE credit
- CDC You Call the Shots: Rotavirus module (CDC TRAIN course WB4760) — CDC · Free (CDC states no fees for its CE activities) · accredited by CDC, jointly accredited by ACCME, ACPE and ANCC; pharmacy UAN JA4008229-0000-24-020-H06-P. CDC's listing shows credit expiring 3/19/2026, so confirm on CDC TRAIN that credit is still available · link confirmed October 11, 2026
RxEvidence is not an accredited continuing education provider and does not award CE credit. These are links to activities offered by others.
Products available
CDC says there are two rotavirus vaccines approved for use in infants in the United States, both given orally by putting drops in the child's mouth: RotaTeq (licensed in 2006; 3 doses at 2, 4 and 6 months) and Rotarix (licensed in 2008; 2 doses at 2 and 4 months). [2]
| Vaccine | Manufacturer (FDA page) | Types covered | FDA-approved ages | Dose volume | Initial U.S. approval |
|---|---|---|---|---|---|
| Rotarix (RV1) | GlaxoSmithKline Biologicals SA [3] | G1 and non-G1 types (G3, G4 and G9) [4] | Infants 6 weeks and up to 24 weeks of age [4] | 1.5 mL oral applicator [4] | 2008 [4] |
| RotaTeq (RV5) | Merck Sharp & Dohme LLC. [5] | Types G1, G2, G3, G4 and G9 [6] | Infants 6 weeks to 32 weeks of age [6] | 2 mL oral dose [6] | 2006 [6] |
Label currency as posted by FDA: the Rotarix page is marked content current as of 09/28/2026 (label 9/2026) and the RotaTeq page 05/18/2026 (label 5/2026). The Rotarix label notes that the reconstituted lyophilized formulation used in clinical trials has been discontinued and is no longer marketed. [3] [4] [5] [6]
Another virus called porcine circovirus can be found in one brand of rotavirus vaccine (Rotarix); according to CDC's VIS this virus does not infect people and there is no known safety risk. [7]
Who should get it
CDC / ACIP (rotavirus vaccine recommendations page, July 15, 2024)
As of July 15, 2024
CDC recommends routine vaccination of infants with either of the two available rotavirus vaccines; the first dose of either vaccine should be given before a child is 15 weeks of age and all doses should be received before the child turns 8 months old. [2]
FDA labels (Rotarix 9/2026; RotaTeq 5/2026)
As of September 28, 2026
The Rotarix label gives the first dose beginning at 6 weeks of age with a second dose after an interval of at least 4 weeks and up to 24 weeks of age; the RotaTeq label gives 3 doses starting at 6 to 12 weeks of age, with subsequent doses at 4 to 10 week intervals and the third dose not given after 32 weeks of age. [4] [6]
CDC's schedule notes (July 2, 2025) say the minimum age is 6 weeks, that the series should not be started on or after age 15 weeks 0 days, and that the maximum age for the final dose is 8 months 0 days. [8]
CDC: January 2026 schedule revision and its legal status (rotavirus)
As of June 11, 2026
On January 5, 2026 the CDC Acting Director approved a revised childhood and adolescent schedule that changed the recommendation type for rotavirus and influenza vaccines from a full recommendation for all children to a shared clinical decision-making recommendation; the schedule's first category (recommended for all children) lists measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Hib, pneumococcal disease, HPV and varicella. A federal district court stayed that schedule on March 16, 2026 and reverted it to the version as of May 2025, and CDC's schedule page continues to show the July 2, 2025 addendum edition. [9] [10] [11]
American Academy of Pediatrics 2026 schedule (endorsed by AAFP, ACOG, AMA, IDSA, APhA and others)
As of January 26, 2026
The AAP published its own 2026 schedule on January 26, 2026, which continues to recommend routine immunization for protection against 18 diseases, including RSV, hepatitis A, hepatitis B, rotavirus, influenza and meningococcal disease, and differs from the schedule recently issued by CDC; the AAP schedule is formally endorsed by 12 organizations, including AAFP, ACOG, AMA, IDSA and the American Pharmacists Association. [12]
Dosing and schedule, including catch-up
| Product | Series |
|---|---|
| Rotarix | 2-dose series at age 2 and 4 months. [8] |
| RotaTeq | 3-dose series at age 2, 4 and 6 months. [8] |
| Mixed or unknown product | If any dose in the series is either RotaTeq or unknown, default to a 3-dose series. [8] |
The VIS summarizes the limits as: the first dose must be given before 15 weeks of age and the last dose by 8 months of age; babies should get 2 or 3 doses depending on the brand. [7]
The Rotarix label says the 2-dose series should be completed by 24 weeks of age with an interval of at least 4 weeks between doses, and that safety and effectiveness have not been evaluated if Rotarix is given for the first dose and another rotavirus vaccine for the second dose or vice versa. [4]
The RotaTeq label states there are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination. [6]
Administration
- Both vaccines are for oral use only and must never be injected; Rotarix is supplied as a single 1.5-mL ready-to-use prefilled oral dosing applicator (a liquid formulation). [4] [6]
- Rotarix: remove the protective tip cap from the applicator without pulling the plunger out of the barrel (if it comes out, do not administer the vaccine); seat the infant in a reclining position, place the applicator toward the inner cheek and administer the entire contents into the infant's mouth. [4]
- RotaTeq is supplied in two presentations (a single-dose ampule supplied in a strip of 5, and a single-dose tube individually wrapped in a pouch); verify the presentation before following the instructions, and return remaining ampules to the carton to protect from light and store refrigerated. [6]
- Rotavirus vaccine may be given at the same time as other vaccines, and babies with a mild illness can get the vaccine. [7] [2]
Storage and handling
- Rotarix: store refrigerated at 2 to 8 °C (36 to 46 °F); do not freeze; discard if the vaccine has been frozen; keep in the original package to protect from light. [4]
- RotaTeq: store and transport refrigerated at 2 to 8 °C (36 to 46 °F); administer as soon as possible after removal from refrigeration; protect from light; discard in approved biological waste containers according to local regulations. [6]
- The Rotarix oral dosing applicator tip cap and plunger stopper are not made with natural rubber latex. [4]
Contraindications and precautions
| Source | Contraindications | Precautions |
|---|---|---|
| CDC appendix (July 2, 2025 edition) | Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a vaccine component; severe combined immunodeficiency (SCID); history of intussusception. [13] | Altered immunocompetence other than SCID; chronic gastrointestinal disease; for RV1 (Rotarix) only, spina bifida or bladder exstrophy; moderate or severe acute illness with or without fever. [13] |
| CDC recommendations page | Do not give rotavirus vaccine to babies with a severe allergic reaction to a previous dose or to any component, severe combined immunodeficiency, or a previous episode of intussusception. [2] | Babies who are moderately or severely ill should wait until they recover, including babies with moderate or severe diarrhea or vomiting; vaccination may be considered for babies with weakened immune systems due to HIV/AIDS, steroids or cancer treatment. [2] |
| Rotarix label | Hypersensitivity to any component of the vaccine; history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception; history of intussusception; history of Severe Combined Immunodeficiency Disease (SCID). [4] | Administration to infants with acute diarrhea or vomiting should be delayed; safety and effectiveness in infants with chronic gastrointestinal disorders or known primary or secondary immunodeficiencies have not been established. [4] |
| RotaTeq label | Hypersensitivity to the vaccine or any component; history of SCID; history of intussusception. [6] | No safety or efficacy data are available for infants who are potentially immunocompromised (for example HIV/AIDS) or who have a history of gastrointestinal disorders; vaccine virus transmission to non-vaccinated contacts has been reported, so caution is advised with immunodeficient contacts. [6] |
CDC lists conditions commonly misperceived as contraindications for rotavirus vaccine: prematurity, immunosuppressed household members, and pregnant household members. [2]
Safety and adverse events
Intussusception: CDC's VIS says there is a small risk of intussusception from rotavirus vaccination, usually within a week after the first or second dose, estimated to range from about 1 in 20,000 to 1 in 100,000 U.S. infants who get rotavirus vaccine; intussusception also happens naturally in some infants every year. [7]
The Rotarix label says that in a postmarketing observational study in Mexico cases of intussusception were observed in temporal association within 31 days following the first dose, with a clustering of cases in the first 7 days, and other studies in Brazil and Australia suggest an increased risk within the first 7 days following the second dose; the RotaTeq label describes cases within 21 days following the first dose in a U.S. postmarketing study, clustered in the first 7 days. [4] [6]
No increased risk of intussusception was observed with Rotarix compared with placebo in a pre-licensure randomized, placebo-controlled safety study including 63,225 infants conducted in Latin America and Finland. [4]
Common (5% or more) solicited adverse reactions with Rotarix included fussiness/irritability, cough/runny nose, fever, loss of appetite and vomiting; the most common adverse events with RotaTeq included diarrhea, vomiting, irritability, otitis media, nasopharyngitis and bronchospasm. [4] [6]
CDC's VIS says irritability or mild, temporary diarrhea or vomiting can happen after rotavirus vaccine. [7]
Special populations
Infants with weakened immune systems: CDC says vaccination may be considered for babies with weakened immune systems due to HIV/AIDS or another disease that affects the immune system, steroids, or cancer or cancer treatment, while SCID is a contraindication; CDC's appendix lists altered immunocompetence other than SCID as a precaution. [2] [13]
Premature infants: prematurity is listed by CDC as a condition commonly misperceived as a contraindication; Rotarix is approved for infants 6 weeks up to 24 weeks and RotaTeq 6 weeks to 32 weeks of age. [2] [4] [6]
Household contacts: immunosuppressed or pregnant household members are not a contraindication to vaccinating the infant (CDC), while the RotaTeq label advises caution when considering whether to administer RotaTeq to individuals with immunodeficient contacts because vaccine virus transmission to non-vaccinated contacts has been reported. [2] [6]
Counseling pearls for the pharmacy counter
- Rotavirus vaccine is given as drops in the baby's mouth, in 2 or 3 doses depending on the brand; the first dose must be given before 15 weeks of age and the last by 8 months of age. [7]
- For intussusception, look for stomach pain along with severe crying, with episodes that may last a few minutes and come and go several times in an hour; babies might pull their legs up to their chest, vomit several times, have blood in the stool, or appear weak or very irritable; signs would usually happen during the first week after the first or second dose, and if suspected, contact a health care provider right away. [7]
- Tell the vaccination provider about an allergic reaction after a previous dose, a weakened immune system, severe combined immunodeficiency (SCID), or a history of intussusception; infants with minor illnesses may be vaccinated while moderately or severely ill infants should usually wait. [7]
- Report suspected adverse reactions to VAERS; the labels ask parents or guardians to report any signs of intussusception immediately. [7] [4]
Common patient questions
A baby is 16 weeks old and has never had rotavirus vaccine. Can it be started?
No. CDC says the series should not be started on or after age 15 weeks 0 days. [8]
What is the maximum age for the final dose?
CDC's schedule notes give 8 months 0 days as the maximum age for the final dose. [8]
The first dose was Rotarix, the second record says "rotavirus vaccine, unknown brand". How many doses?
CDC says if any dose in the series is either RotaTeq or unknown, default to a 3-dose series. [8]
The baby spit up part of the dose. Should it be repeated?
The two labels differ. The Rotarix label says that if the infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be considered at the same vaccination visit; the RotaTeq label says that if for any reason an incomplete dose is administered (for example the infant spits or regurgitates the vaccine), a replacement dose is not recommended and the infant should continue to receive any remaining doses. [4] [6]
A mother is pregnant. Can her baby still get the vaccine?
Yes. CDC lists pregnant household members as a condition commonly misperceived as a contraindication. [2]
References
- Centers for Disease Control and Prevention. Clinical overview of rotavirus. Accessed October 11, 2026. https://www.cdc.gov/rotavirus/hcp/clinical-overview/index.html. Accessed October 11, 2026.
- Centers for Disease Control and Prevention. Rotavirus vaccine recommendations (information for healthcare professionals). Page dated July 15, 2024. Accessed October 11, 2026. https://www.cdc.gov/rotavirus/hcp/vaccine-considerations/index.html. Accessed October 11, 2026.
- U.S. Food and Drug Administration. ROTARIX product page (content current as of 09/28/2026). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/rotarix. Accessed October 11, 2026.
- ROTARIX (rotavirus vaccine, live, oral): prescribing information, revised 9/2026. GlaxoSmithKline Biologicals SA. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/163009/download?attachment. Accessed October 11, 2026.
- U.S. Food and Drug Administration. RotaTeq product page (content current as of 05/18/2026). Accessed October 11, 2026. https://www.fda.gov/vaccines-blood-biologics/vaccines/rotateq. Accessed October 11, 2026.
- RotaTeq (rotavirus vaccine, live, oral, pentavalent): prescribing information, revised 5/2026. Merck Sharp & Dohme LLC. U.S. Food and Drug Administration. Accessed October 11, 2026. https://www.fda.gov/media/75718/download?attachment. Accessed October 11, 2026.
- Centers for Disease Control and Prevention. Rotavirus vaccine: what you need to know. Vaccine Information Statement, October 15, 2021. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/current-vis/rotavirus.html. Accessed October 11, 2026.
- Centers for Disease Control and Prevention. Child and adolescent immunization schedule notes: recommendations for ages 18 years or younger, United States, 2025. July 2, 2025. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-notes.html. Accessed October 11, 2026.
- Congressional Research Service. The 2026 Childhood Immunization Schedule (R48982). June 11, 2026. Accessed October 11, 2026. https://www.congress.gov/crs_external_products/R/PDF/R48982/R48982.1.pdf. Accessed October 11, 2026.
- Centers for Disease Control and Prevention. CDC acts on Presidential Memorandum to update childhood immunization schedule. News release, January 5, 2026. Accessed October 11, 2026. https://www.cdc.gov/media/releases/2026/2026-cdc-acts-on-presidential-memorandum-to-update-childhood-immunization-schedule.html. Accessed October 11, 2026.
- Centers for Disease Control and Prevention. Healthcare professionals: immunization schedules. Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/index.html. Accessed October 11, 2026.
- American Academy of Pediatrics. AAP releases recommended childhood and adolescent immunization schedule for 2026. HealthyChildren.org news. Accessed October 11, 2026. https://healthychildren.org/English/news/Pages/AAPs-recommended-childhood-and-adolescent-immunization-schedule-for-2026.aspx. Accessed October 11, 2026.
- Centers for Disease Control and Prevention. Child and adolescent immunization schedule appendix: guide to contraindications and precautions (July 2, 2025 edition). Accessed October 11, 2026. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-appendix.html. Accessed October 11, 2026.
For professional education. Check current labeling and guidance before acting. Not medical advice.
