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Rotavirus Vaccine Live Oral

Class: Vaccines
VA Class: IM100
Brands: Rotarix, RotaTeq

Introduction

Live, attenuated virus vaccine.1 11 12 22 Commercially available in the US as a monovalent vaccine derived from a human rotavirus strain (Rotarix; RV1)11 12 22 105 166 and as a pentavalent vaccine containing 5 reassortant rotaviruses derived from human and bovine hosts (RotaTeq; RV5).1 2 3 9 11 12 105 166 Some other rotavirus vaccines (e.g., other monovalent or multivalent human-animal reassortant vaccines) are being investigated or may be available in other countries.3 4 9

Uses for Rotavirus Vaccine Live Oral

Prevention of Rotavirus Gastroenteritis

Rotarix (RV1): Prevention of gastroenteritis caused by rotavirus type G1 and non-G1 types (G3, G4, G9).11 12 22 23 24 25

RotaTeq (RV5): Prevention of gastroenteritis caused by rotavirus types G1, G2, G3, G4, and G9.1 2 11 12 19

Prior to widespread use of rotavirus vaccine, rotavirus was the most common cause of severe gastroenteritis in infants and young children.9 11 12 29 105 166 Worldwide, rotavirus gastroenteritis caused approximately 500,000 deaths each year in children <5 years of age.11 166 In the US, rotavirus gastroenteritis was estimated to cause up to 70,000 hospitalizations11 12 29 38 and up to 60–70 deaths each year in children <5 years of age.11 12 29 166

After rotavirus vaccine (RotaTeq) was licensed in the US in 2006, a marked decrease in incidence of rotavirus disease and substantial changes in epidemiology of the disease occurred.29 38 39 105 166 A second rotavirus vaccine (Rotarix) was licensed in the US in 2008.166 Surveillance data collected by the CDC National Respiratory and Enteric Virus Surveillance System (NREVSS) indicated that the 2007–2008 and 2008–2009 rotavirus seasons were shorter, had later onset, and had substantially fewer reports of positive rotavirus test results compared with the 2000–2006 seasons.29 Additional NREVSS data indicated that the national decline in rotavirus detection ranged from 58–90% in each of the 7 postvaccine years (2007–2014) compared with all 7 prevaccine years (2000–2006) combined and there was a biennial pattern of rotavirus activity with alternating years of lower or greater activity.38 Some evidence indicates that rotavirus vaccination may provide clinical benefits to both vaccinated and unvaccinated individuals29 166 by reducing overall rotavirus transmission (i.e., herd immunity).29 38

USPHS Advisory Committee on Immunization Practices (ACIP) and AAP recommend that all infants be vaccinated against rotavirus gastroenteritis beginning at 6 weeks of age, unless contraindicated.11 12 199 (See Contraindications under Cautions.) These experts state give first dose at 6 through 14 weeks of age (no later than 14 weeks 6 days of age) and complete vaccination series by 8 months 0 days of age.11 12 199

ACIP and AAP do not state a preference for Rotarix or RotaTeq vaccine for primary immunization in infants.11 12 105 Efficacy and safety of the vaccines are similar;39 166 however, dosage and dosing schedule (i.e., number and timing of doses) differ depending on which vaccine is used.1 22 (See Dosage under Dosage and Administration.)

Data not available regarding efficacy and safety of rotavirus vaccine for postexposure prophylaxis after exposure to natural rotavirus.1 22

Rotavirus Vaccine Live Oral Dosage and Administration

Administration

Oral Administration

Administer Rotarix (RV1) and RotaTeq (RV5) orally.1 22

Do not administer by IM, IV, or sub-Q injection.1 22

Do not mix with any other vaccine or solution.1 22

Food or liquid intake (including breast milk) does not need to be restricted before or after administration of rotavirus vaccine.1 11 12 22

May be given simultaneously with other age-appropriate vaccines during the same health-care visit.1 11 12 22 105 134 (See Interactions.)

Rotarix (RV1)

Reconstitute lyophilized vaccine using diluent and transfer adapter provided by the manufacturer.22 Consult manufacturer’s information for complete reconstitution instructions.22 Reconstituted Rotarix is a white, turbid suspension.22

Following reconstitution, administer orally directly from oral applicator provided by manufacturer.22 Administer entire contents of the oral applicator into infant’s mouth on inside of the cheek.22

If an incomplete dose is given (e.g., infant spits or regurgitates during or after vaccine dose), the manufacturer states that a single replacement dose may be considered at the same vaccination visit.22 ACIP and AAP do not recommend a replacement dose if an incomplete dose is given11 12 105 134 since data not available on benefits or risks associated with re-administration.11 12 Administer remaining dose of the 2-dose vaccination series at usually recommended interval (minimum interval 4 weeks between doses).11 12 105 134

RotaTeq (RV5)

Administer orally directly from the single-dose tubing supplied by the manufacturer.1 Do not dilute.1

Should appear as a pale yellow, clear liquid that may have a pink tint.1

Administer dose by gently squeezing entire contents of tubing into infant’s mouth toward inner cheek.1 A residual drop may remain in tip of dosing tube.1

If an incomplete dose is given (e.g., infant spits or regurgitates vaccine during or after vaccine dose), a replacement dose is not recommended since data not available on benefits or risks associated with readministration.1 11 12 Administer remaining doses of the 3-dose vaccination series at usually recommended intervals (minimum interval 4 weeks between doses).1 11 12 105 134

Dosage

Dosage and dosing schedule (i.e., number and timing of doses) differ between Rotarix and RotaTeq.1 22 Follow dosage recommendations for specific vaccine used.1 22

Data not available regarding interchangeability of rotavirus vaccines.11 12 The specific rotavirus vaccine (Rotarix or RotaTeq) used for initial dose should be used to complete the vaccination series, whenever possible.11 12 22 105 134 If specific rotavirus vaccine used for previous doses unknown or unavailable, continue or complete the vaccination series with the currently available rotavirus vaccine;11 12 105 134 do not defer vaccination.11 12 105

If RotaTeq or an unknown rotavirus vaccine was administered for any dose in the vaccination series, administer a total of 3 doses to complete the primary vaccination series.11 12 105 134 199

ACIP and AAP state that first dose of rotavirus vaccine should be given at 6 weeks through 14 weeks 6 days of age and should not be initiated in infants ≥15 weeks of age.11 12 199 If first dose is inadvertently administered at ≥15 weeks of age, complete the remainder of the vaccination series according to the recommended schedule.11 12 199

In preterm infants who are medically stable, administer rotavirus vaccine at usual chronologic age using usual dosage, provided the vaccine is administered to the age-eligible infant after or at the time of discharge from the neonatal intensive care unit (NICU) or hospital nursery.1 11 12 105 Theoretical risks of transmission of rotavirus vaccine virus to other hospitalized infants outweigh benefits of vaccination in age-eligible infants who will remain in the NICU or nursery after the dose.12 (See Pediatric Use under Cautions.)

Because natural rotavirus infection frequently provides only partial immunity, ACIP and AAP recommend that rotavirus vaccination series be initiated or completed in infants who had rotavirus gastroenteritis before receiving the complete series.11 12 (See Individuals with GI Disorders under Cautions.)

Pediatric Patients

Prevention of Rotavirus Gastroenteritis
Infants 6–24 Weeks of Age (Rotarix; RV1)
Oral

Primary immunization consists of a series of 2 doses.11 12 22 Each dose consists of entire contents of reconstituted single-dose vial.22

Manufacturer recommends giving initial dose at 6 weeks of age and second dose at least 4 weeks after first dose.11 12 22 Manufacturer also recommends completing the 2-dose series by 6 months (24 weeks) of age.22

ACIP and AAP recommend giving Rotarix at 2 and 4 months of age with a minimum interval of 4 weeks between doses.11 12 199 These experts state maximum age for final dose is 8 months 0 days of age.11 12 199

Infants 6–32 Weeks of Age (RotaTeq; RV5)
Oral

Primary immunization consists of a series of 3 doses.1 11 12 Each dose consists of entire contents of the commercially available single-dose tubing.1 11

Manufacturer recommends giving initial dose at 6–12 weeks of age and remaining 2 doses at 4- to 10-week intervals.1 11 12 199 Manufacturer states third dose should not be given after 32 weeks of age.1 11 12 199

ACIP and AAP recommend giving RotaTeq at 2, 4, and 6 months of age with a minimum interval of 4 weeks between doses.11 12 199 These experts state maximum age for final dose is 8 months 0 days of age.11 12 199

Special Populations

Hepatic Impairment

No specific dosage recommendations.1 22

Renal Impairment

No specific dosage recommendations.1 22

Geriatric Patients

Not indicated in adults, including geriatric adults.1 22

Cautions for Rotavirus Vaccine Live Oral

Contraindications

    Rotarix(RV1)
  • Known hypersensitivity to Rotarix or any vaccine component (e.g., latex).22 (See Latex Sensitivity under Cautions.)

  • History of intussusception (a type of bowel obstruction occurring when bowel folds in on itself) or history of uncorrected congenital malformation of the GI tract (e.g., Meckel’s diverticulum) that would predispose infant to intussusception.22 (See Intussusception under Cautions.)

  • Severe combined immunodeficiency disease (SCID).22 (See Individuals with Altered Immunocompetence under Cautions.)

    RotaTeq(RV5)
  • Known hypersensitivity to RotaTeq or any vaccine component.1

  • History of intussusception.1 (See Intussusception under Cautions.)

  • SCID.1 (See Individuals with Altered Immunocompetence under Cautions.)

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylactic reactions reported (RotaTeq).1 Urticaria and angioedema also reported.1

Review infant immunization history to determine whether there is a history of hypersensitivity or other reactions to any vaccine components.1 22

Do not give any further doses of rotavirus vaccine if infant develops symptoms suggestive of hypersensitivity after receiving a dose.1 22

Have appropriate medical treatment and supervision available to manage possible anaphylactic reactions.1

Latex Sensitivity

Rotarix: Packaging component (tip cap of oral applicator containing diluent) contains natural rubber latex,22 which may cause hypersensitivity reactions in susceptible individuals.22 134 Vial stoppers are not made with natural rubber latex.22

ACIP states that vaccines supplied in vials or syringes containing dry natural rubber or natural rubber latex may be administered to individuals with latex allergies other than anaphylactic allergies (e.g., history of contact allergy to latex gloves), but should not be used in those with a history of severe (anaphylactic) allergy to latex, unless the benefits of vaccination outweigh the risk of a potential allergic reaction.11 134

Consider use of RotaTeq (which is latex-free) as an alternative to Rotarix. in infants with severe allergy to latex.11 Some experts prefer that infants with spina bifida or bladder exstrophy, who are at high risk for acquiring latex allergy, receive RotaTeq as an alternative to Rotarix to minimize latex exposure.11 12 ACIP and AAP state administer Rotarix if it is the only rotavirus vaccine available since the benefit of rotavirus vaccination is considered to be greater than the risk for latex sensitization.11 12

Individuals with Altered Immunocompetence

Safety and efficacy not established in immunocompromised or potentially immunocompromised infants.1 11 12 22 Examples include infants with blood dyscrasias, leukemia, lymphoma, or other malignant neoplasms affecting bone marrow or the lymphatic system; those receiving immunosuppressive therapy (see Interactions); those with primary and acquired immunodeficiency states such as HIV/AIDS or other clinical manifestations of HIV infection, cellular immune deficiencies, or hypogammaglobulinemic and dysgammaglobulinemic states; and those of indeterminate HIV status born to HIV-infected mothers (HIV-exposed).1 11 12 22

There have been postmarketing reports of vaccine-acquired rotavirus gastroenteritis, with severe diarrhea and prolonged vaccine virus shedding, in infants who received Rotarix or RotaTeq and were subsequently diagnosed with SCID.1 22 33 34 Some of these infants continued to shed vaccine virus for 5–12 months.33 Rotarix and RotaTeq are contraindicated in infants with SCID.1 22 33 34

Consider potential risks and benefits of rotavirus vaccine in infants with known or suspected altered immunocompetence.11 12 156 Consultation with an immunologist or infectious diseases specialist is advised.11 12 156

ACIP, AAP, CDC, National Institutes of Health (NIH), HIV Medicine Association of IDSA, and Pediatric Infectious Diseases Society state that use of rotavirus vaccine in HIV-infected or HIV-exposed infants is supported since HIV diagnosis in infants born to HIV-infected mothers may not be established before the recommended age for the first dose of the vaccine, only 1.5–3% of HIV-exposed infants in the US will eventually be determined to be HIV infected, and the rotavirus strains used in the vaccines are considerably attenuated.11 12 156 Limited data to date indicate that safety profiles of rotavirus vaccine reported in clinically asymptomatic or mildly symptomatic HIV-infected infants are similar to safety profiles in infants without HIV infection.156

Intussusception

Cases of intussusception, including some fatalities, reported rarely in infants who received Rotarix or RotaTeq.1 11 12 13 14 22 24 27 Although data from initial clinical trials of these vaccines did not suggest an increased risk of intussusception relative to placebo,1 22 there is postmarketing evidence that rotavirus vaccines are associated with increased risk of intussusception, particularly during first week after first vaccine dose.1 40 166 In first year of life, the US background rate of intussusception hospitalizations is estimated to be approximately 34 per 100,000 infants.22

In a postmarketing observational study in Mexico, cases of intussusception were observed in temporal association (within 31 days) following first dose of Rotarix, with a clustering of cases in first 7 days.22 This study did not take into account all medical conditions that may predispose infants to intussusception and results may not be generalizable to US infants who have a lower background rate of intussusception than Mexican infants.22 However, if a temporal increase in risk for intussusception following Rotarix similar in magnitude to that observed in the Mexico study does exist in US infants, it is estimated that approximately 1–3 additional cases of intussusception hospitalizations would occur per 100,000 vaccinated infants in the US within 7 days following first dose of Rotarix.22 Other postmarketing observational studies in Brazil and Australia also suggest increased risk of intussusception within first 7 days following second dose of Rotarix.22

In a US postmarketing observational study, cases of intussusception were observed in temporal association (within 21 days) following first dose of RotaTeq, with a clustering of cases in first 7 days.1 This study evaluated more than 1.2 million RotaTeq1 vaccinations (507,000 first doses) administered to infants 5 through 36 weeks of age.1 From 2004 through 2011, potential cases of intussusception in either inpatient or emergency department settings and vaccine exposures were identified and confirmed through electronic procedure and diagnosis codes.1 Intussusception was observed in temporal association within 21 days following first dose of RotaTeq, with a clustering of cases in first 7 days.1 Based on these results, approximately 1–1.5 excess cases of intussusception occur per 100,000 vaccinated US infants within 21 days following first dose of RotaTeq.1 Cases of intussusception in temporal association with RotaTeq also reported in worldwide passive postmarketing experience.1

A previously available rotavirus vaccine live oral (RotaShield; Wyeth) was voluntarily withdrawn from US market in 1999 following postmarketing reports of intussusception in infants receiving the vaccine.1 2 6 7 9 11 12 13 14 27 Data indicated period of highest risk of intussusception associated with RotaShield was first 42 days following initial dose.1 2 6

Closely monitor for intussusception after administration of rotavirus vaccine, particularly during first week following dose.10 36 Report any cases of intussusception or other serious events possibly associated with the vaccine to VAERS at 800-822-7967 or .1 13 14 36 22

Rotarix and RotaTeq are contraindicated in infants with a history of intussusception.1 22 Intussusception resulting in death reported when a second dose of Rotarix was given to an infant with a history of intussusception after first dose.22

Other GI Disorders or Illnesses

Rotarix: Safety and efficacy not evaluated in infants with chronic GI disorders;22 delay administration of the vaccine in infants with acute diarrhea or vomiting.22

RotaTeq: Use with caution in infants with a history of GI disorders (e.g., active acute GI illness, chronic diarrhea and failure to thrive, history of congenital abdominal disorders, abdominal surgery);1 safety and efficacy data not available in these infants.1 Manufacturer states the vaccine may be used in infants with controlled gastroesophageal reflux disease (GERD).1

Although safety and efficacy of rotavirus vaccine not evaluated in infants with preexisting chronic GI disorders, ACIP and AAP state that the benefits of the vaccine outweigh theoretical risks in those with preexisting GI tract conditions (e.g., congenital malabsorption syndrome, Hirschsprung disease, short-gut syndrome) if they are not receiving immunosuppressive therapy.11 12

Data not available regarding use of rotavirus vaccine in infants with concurrent acute gastroenteritis;11 12 immunogenicity and efficacy may be compromised in these infants.11 12 ACIP and AAP state that rotavirus vaccine may be administered to infants with mild acute gastroenteritis (particularly if a delay in vaccination may result in the child becoming ineligible to receive the vaccine based on age at first dose), but should not be administered to infants with acute, moderate-to-severe gastroenteritis until improvement of the condition is noted.11 12

Hematochezia reported rarely within 42 days after a dose of RotaTeq;1 incidence was similar to that observed in those receiving placebo during clinical trials.1 11 12 Hematochezia following use of Rotarix or RotaTeq reported during postmarketing experience.1 22 Causal relationship between administration of rotavirus vaccine and occurrence of hematochezia not established.1

Transmission of Vaccine Virus

Rotarix contains live, attenuated rotavirus22 and RotaTeq contains live, reassortant rotaviruses.1

Viral shedding can occur in vaccine recipients and the vaccine virus has been transmitted between vaccinees and susceptible contacts.1 11 12 22

After a dose of Rotarix, peak shedding occurs approximately 7 days after the dose.22 In a study in healthy twins 6–14 weeks of age, 1 twin in each household was randomized to receive Rotarix and the other twin received placebo.22 Transmission of vaccine virus from vaccinated twin to the twin who received placebo occurred in 19% of the pairs;22 GI symptoms related to transmitted virus not reported.22 Median duration of vaccine virus shedding was 10 days in twins who received Rotarix compared with 4 days in twin siblings who received placebo, but acquired the vaccine virus.22

Up to 9% of infants receiving RotaTeq shed vaccine virus in their stools after first dose (as early as day 1 and as late as day 15 following the dose);1 viral shedding occurs rarely after subsequent doses of RotaTeq.1

Caution advised when considering whether to administer rotavirus vaccine to infants with close contacts who are immunocompromised (e.g., individuals who have malignancies, primary immunodeficiencies, or are receiving immunosuppressive therapy).1 Manufacturers state weigh risk of possible vaccine virus transmission against risk of infant developing natural rotavirus infection that could be transmitted to susceptible contacts.1 22

ACIP and AAP state that infants living in households with individuals who are immunocompromised should receive rotavirus vaccine when indicated.11 12 134 Protection of immunocompromised household contacts afforded by rotavirus vaccination of infants in the household and prevention of wild-type rotavirus disease outweighs the small risk of transmitting vaccine virus to the susceptible individual and any subsequent theoretical risk of vaccine virus-associated disease.11 12

To minimize potential vaccine virus transmission from the vaccinee, advise all household contacts to use hygienic measures (e.g., good hand washing) following contact with feces from a vaccinated infant (e.g., diaper changing) for at least 1 week after each vaccine dose.11 12

If an infant recently vaccinated with rotavirus vaccine is hospitalized for any reason, use standard precautions to prevent spread of vaccine virus in the hospital setting.11 12 Because of possible risk of transmission of rotavirus vaccine virus to other hospitalized infants, if a preterm infant previously vaccinated with rotavirus vaccine requires readmission to the NICU or hospital nursery within 2 weeks following a dose of the vaccine, initiate contact precautions for the preterm infant and maintain these precautions for 2–3 weeks following the dose.12 (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

Kawasaki Disease

Kawasaki disease reported during phase 3 clinical trials of RotaTeq in 5 out of 36,150 infants who received the vaccine and in 1 out of 35,536 infants who received placebo.1 15 Additional 3 cases in vaccinated infants reported to VAERS and 1 unconfirmed case reported through the CDC Vaccine Safety Datalink (VSD) Project.15

Kawasaki disease also reported in 18 infants who received Rotarix during clinical trials.22 Time of onset of Kawasaki disease after Rotarix dose ranged from 3 days to 19 months.22

Causal relationship between rotavirus vaccine or any vaccine and the occurrence of Kawasaki disease not established.15 To date, number of reported cases of Kawasaki disease occurring in association with use of RotaTeq does not exceed the number of expected cases occurring randomly in this population.15 Postmarketing surveillance data to date do not indicate that RotaTeq is associated with an increased risk of Kawasaki disease.11

Report any case of Kawasaki disease occurring following administration of rotavirus vaccine (or any other vaccine) to VAERS at 800-822-7967 or .15

Concomitant Illness

A decision to administer or delay administration of rotavirus vaccine in an infant with current or recent febrile illness depends on the severity of symptoms and etiology of the illness.1 Manufacturer of RotaTeq states presence of low-grade fever (<38.1°C) or mild upper respiratory infection does not preclude vaccination.1

ACIP and AAP state that rotavirus vaccine may be administered to infants with transient, mild illnesses (with or without low-grade fever),11 12 134 but defer vaccination of individuals with moderate or severe acute illness until after recovery from the acute phase of illness.11 12 134

Risk of Adventitious Agents

Porcine-derived materials are used in the manufacture of Rotarix and Rotateq; DNA from porcine circoviruses is present in the vaccines.1 22 31

In March 2010, after becoming aware that DNA from porcine circovirus type 1 (PCV1) was present in Rotarix, FDA advised that use of the vaccine be temporarily suspended as a safety precaution pending further investigation.31 In May 2010, FDA provided additional information that DNA fragments from PCV1 and porcine circovirus type 2 (PCV2) were detected in RotaTeq.31 After careful evaluation, FDA decided that it was appropriate to resume use of Rotarix and continue use of RotaTeqfor prevention of rotavirus infection in infants.31

FDA states that there is no evidence to date that PCV1 or PCV2 can cause clinical infection or disease in humans or that either virus poses a safety risk in humans.31 Because available evidence supports the safety of Rotarix and RotaTeq in infants, FDA states that clinical benefits of vaccination against rotavirus infection outweigh any theoretical risks from the presence of PCV1 or PCV2 in rotavirus vaccines.31 FDA and the manufacturers will continue to investigate the presence of porcine virus in Rotarix and RotaTeq and evaluate safety data from ongoing studies.31

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against rotavirus infection.1

Data not available to determine the level of protection provided against rotavirus infection in infants who have not received the complete vaccination series (i.e., have received only a single dose of Rotarix or only 1 or 2 doses of RotaTeq).1 22

Duration of Immunity

Duration of protection against rotavirus gastroenteritis following the 2-dose vaccination series of Rotarix or 3-dose vaccination series of RotaTeq not fully determined.1 22 166

Some evidence from clinical trials that complete vaccination series of either vaccine generally provides protection against rotavirus infection through second rotavirus season after vaccination or up to 2 years of age.1 22 166

Efficacy beyond second rotavirus season after vaccination not fully evaluated to date.1 22

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune response in vaccinees.134

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.134

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.134 (See Storage under Stability.)

If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.134

Specific Populations

Pregnancy

Not indicated for use in adults, including pregnant women.1 22

ACIP and AAP state that infants living in households with pregnant women may receive rotavirus vaccine.11 12 105 Risk of acquiring rotavirus infection from potential exposure to vaccine virus considered very low since most women of childbearing age would be expected to have preexisting immunity to rotavirus.11 12

No evidence to date that rotavirus infection during pregnancy poses any fetal risk.11 Vaccination of infants against rotavirus avoids potential exposure of pregnant women to natural rotavirus from unvaccinated infants with rotavirus gastroenteritis.11 12

Lactation

Not indicated for use in adults, including nursing women.1 22

ACIP and AAP state that breast-feeding infants may receive the rotavirus vaccine since efficacy in breast-feeding infants appears to be similar to that in infants not breast-feeding.11 12

Pediatric Use

Rotarix: Safety and efficacy not established in infants <6 weeks or >24 weeks of age.22 Manufacturer states efficacy in preterm infants not established.22 Safety data to date in preterm infants indicate serious adverse events in 5.2% of vaccine recipients compared with 5% of placebo recipients;22 no deaths or cases of intussusception reported in this patient population to date.22

RotaTeq: Safety and efficacy not established in infants <6 weeks or >32 weeks of age.1 Manufacturer states data support use of RotaTeq in preterm infants (i.e., gestational age 25–36 weeks) according to age in weeks since birth.1 Safety data in preterm infants indicate serious adverse events in 5.5% of vaccine recipients compared with 5.8% of placebo recipients;1 2 deaths reported among vaccine recipients, but no cases of intussusception.1

Pending additional data, ACIP and AAP state that the benefits of routine vaccination with rotavirus vaccine outweigh theoretical risks in medically stable preterm infants.11 12 These experts state that clinically stable preterm infants who meet age requirements (at least 6 weeks and not greater than 14 weeks 6 days of age) may receive the first dose of rotavirus vaccine after or at the time of discharge from the NICU or hospital nursery.11 12 However, possible risk of transmission of rotavirus vaccine virus to other hospitalized infants outweigh benefits of vaccination in age-eligible infants who will remain in the NICU or nursery after the dose.12 If a preterm infant who previously received rotavirus vaccine requires readmission to the NICU or hospital nursery within 2 weeks following a dose of the vaccine, initiate contact precautions for the preterm infant and maintain such precautions for 2–3 weeks following the vaccine dose.12

ACIP and AAP state that a replacement dose of rotavirus vaccine is not recommended if an infant receives an incomplete vaccine dose (e.g., infant spits or regurgitates the dose).105 134 (See Administration under Dosage and Administration.) In limited postmarketing experience of reported overdosage of RotaTeq (e.g., resulting from >1 dose or a replacement dose after regurgitation), adverse events reported after incorrect administration of higher than recommended doses were similar to adverse events reported with recommended dosage and dosing schedule.1

Geriatric Use

Not indicated in adults, including geriatric adults.1 22

Common Adverse Effects

Fever,1 22 diarrhea,1 22 vomiting,1 22 loss of appetite,22 fussiness/irritability,1 22 otitis media,1 cough/runny nose,22 nasopharyngitis,1 bronchospasm.1

Interactions for Rotavirus Vaccine Live Oral

Other Vaccines

Simultaneous administration with other age-appropriate vaccines or toxoids (e.g., haemophilus b conjugate [Hib], poliovirus vaccine inactivated [IPV], hepatitis B [HepB], inactivated influenza virus vaccines, measles, mumps, and rubella virus vaccine live [MMR], pneumococcal conjugate vaccine, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed [DTaP]) during same health-care visit not expected to affect immunologic responses or adverse reactions to any of the vaccines.1 11 12 22 28 134

Specific Drugs

Drug

Interaction

Comments

Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV], immune globulin sub-Q) or specific immune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])

Safety and efficacy data not available regarding use of rotavirus vaccine in infants who received blood transfusions or blood products, including immunoglobulins1 11 12

ACIP and AAP state rotavirus vaccine may be given concurrently with or at any time before or after blood or antibody-containing products11 12 105 134

Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, cytotoxic agents, radiation)

Potential for decreased antibody response to rotavirus vaccine;1 22 safety and efficacy data not available regarding use in patients receiving immunosuppressive therapy (including greater than physiologic dosages of systemic corticosteroids)1 11 12

Rotarix: Manufacturer states safety and efficacy not established in infants receiving immunosuppressive therapy22

RotaTeq: Manufacturer states may be administered to infants receiving topical or inhaled corticosteroids1

Tetanus and diphtheria toxoids and acellular pertussis vaccine adsorbed (DTaP)

No evidence of reduced antibody response to any of the antigens if administered concomitantly with DTaP1 11 22 28

May be administered concomitantly with or at any interval before or after toxoids routinely used in infants11 12 134

Vaccines, inactivated

No evidence to date of reduced antibody responses if administered concomitantly with inactivated vaccines (e.g., Hib, IPV, HepB, inactivated influenza vaccine, pneumococcal conjugate vaccine)1 11 12 22 28 134

May be administered concomitantly with or at any interval before or after inactivated vaccines routinely used in infants11 12 134

Vaccines, live virus

No evidence to date of reduced antibody responses if administered concomitantly with other live vaccines administered parenterally or intranasally (e.g., MMR)11 12 134

Poliovirus vaccine live oral (OPV) (not commercially available in the US): Concomitant use not permitted during clinical studies of rotavirus vaccine1 2 22

May be administered concomitantly with or at any interval before or after other live vaccines routinely used in infants11 12 134

Stability

Storage

Oral

For Suspension

Rotarix (RV1): 2–8°C.22 Store diluent at 2–8°C or at room temperature (≤25°C).22 Do not freeze; if freezing occurs, discard.22 Protect from light.22

After reconstitution, store for up to 24 hours at 2–8°C or at room temperature (≤25°C).22 Discard reconstituted vaccine if not used within 24 hours.22 Do not freeze reconstituted vaccine; discard if frozen.22

Does not contain thimerosal or any other preservatives.22

Solution

RotaTeq (RV5): 2–8°C.1 Protect from light.1 Administer as soon as possible after removal from refrigeration.1

Does not contain thimerosal or any other preservatives.1

Actions

  • Rotarix (RV1): Lyophilized vaccine containing live, attenuated rotavirus derived from a human strain (89–12) belonging to type G1P[8] for administration as an oral suspension.22

  • RotaTeq (RV5): Oral solution containing live, reassortant rotaviruses that represent the G types responsible for most cases of rotavirus gastroenteritis worldwide (G1, G2, G3, G4, G9) and the most common P type associated with these strains (P1A; genotype P[8]).1 3 5 9

  • Porcine-derived materials are used during the manufacture of Rotarix and RotaTeq;1 22 DNA from porcine circoviruses has been detected in the vaccines.1 22 31 (See Risk of Adventitious Agents under Cautions.)

  • Following vaccination, the live, attenuated virus (Rotarix) or live, reassortant rotaviruses (RotaTeq) replicate in the small intestine and induce active immunity to rotavirus types represented in the vaccine.1 2 3 9 22

  • Exact immunologic mechanism by which Rotarix or RotaTeq protects against rotavirus gastroenteritis not known.1 2 9 22

  • Correlation between antibody response to rotavirus vaccine and protection against rotavirus gastroenteritis not established to date.5 22

  • Data suggest that serum neutralizing antibodies, fecal anti-rotavirus IgA, and serum anti-rotavirus IgA may correlate with protection against rotavirus gastroenteritis.5

  • Studies using Rotarix indicate that 76.8–86.5% of vaccine recipients seroconvert after 2 doses.22 Seroconversion in these studies was defined as appearance of anti-rotavirus IgA antibody in infants previously negative for rotavirus.22

  • Studies using RotaTeq indicate a threefold or greater increase in serum anti-rotavirus IgA concentrations in 93–100% of infants who received a 3-dose vaccination series compared with 12–20% of infants who received placebo.1 2 11 19

  • Because Rotarix contains live, attenuated rotavirus and RotaTeq contains live, reassortant rotaviruses, vaccine virus can be shed in the stools of vaccinees and transmitted between vaccinees and susceptible contacts.1 11 12 22 (See Transmission of Vaccine Virus under Cautions.)

Advice to Patients

  • Prior to administration of each vaccine dose, provide copy of manufacturer’s patient information to the patient’s parent or guardian.1 22 Also provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient’s parent or legal representative (VISs are available at ).1 21 22

  • Advise patient’s parent or guardian of the risks and benefits of vaccination.1 22

  • Advise patient’s parent or guardian that porcine circoviruses (or fragments of the viruses) have been found in rotavirus vaccines, and that there is no evidence to date that these viruses cause infection or disease in humans or pose a safety risk. (See Risk of Adventitious Agents under Cautions.)1 22

  • Advise patient’s parent or guardian that rotavirus vaccine may not provide complete protection in all vaccinees.1 22 In addition, the vaccine will not protect against disease due to rotavirus strains not represented in the vaccine.1 22

  • Advise patient’s parent or guardian of the possible risk of vaccine virus transmission to rotavirus-susceptible individuals, including close or household contacts with a weakened immune system or pregnant women who have not had rotavirus infection.1 22

  • Importance of informing clinicians if a child has any illness with fever, diarrhea, or vomiting; has failure to gain weight or is not growing as expected; has a blood disorder, any type of cancer, a weakened immune system (e.g., HIV infection, SCID), or a history of GI problems (e.g., intussusception, blockage, abdominal surgery); or receives treatment that may weaken the immune system (e.g., high-dose corticosteroids).1 22

  • For infants receiving Rotarix (2-dose vaccination series) or RotaTeq (3-dose vaccination series), advise the patient’s parent or guardian of the importance of completing the vaccination series by the time the infant is 8 months 0 days of age, unless contraindicated.11 12

  • Importance of informing clinicians if any adverse reactions (including allergic reactions) occur.1 14 22 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or .1 14 22

  • Advise patient’s parent or guardian that the vaccine should not be administered to children who had an allergic reaction following a prior vaccine dose or in those allergic to any vaccine component.1 22

  • Importance of informing clinicians immediately if a child develops any signs and/or symptoms of intussusception, including vomiting, diarrhea, severe stomach pain, blood in stools, or high fever.1 14 22 Contact clinician if child has any of these symptoms following vaccination, especially if symptoms occur within 7 days following first vaccine dose, but even if they occur several weeks following last vaccine dose.1 14 36

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 22

  • Importance of informing patients of other important precautionary information.1 22 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Rotavirus Vaccine Live Oral

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For Suspension

Live attenuated rotavirus content: ≥1 x 106 median cell culture infective dose of G1P[8] per 1 mL

Rotarix

GlaxoSmithKline

Rotavirus Vaccine Live Oral Pentavalent

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

Live human-bovine reassortant rotavirus content: ≥ 2.2 x 106 infectious units of G1, 2.8 x 106 infectious units of G2, 2.2 x 106 infectious units of G3, 2 x 106 infectious units of G4, and 2.3 x 106 infectious units of P1A (P[8]) per 2 mL

RotaTeq

Merck

AHFS DI Essentials. © Copyright 2018, Selected Revisions December 4, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

References

1. Merck & Co. RotaTeq (rotavirus vaccine, live, oral, pentavalent) oral solution prescribing information. Whitehouse Station, NJ; 2017 Feb.

2. Vesikari T, Matson DO, Dennehy P et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006; 354:23-33. [PubMed 16394299]

3. Bresee KS, Parashar UD, Widdowson MA et al. Update on rotavirus vaccines. Pediatr Infect Dis J. 2005; 24: 947-52.

4. Glass RI, Parashar UD. The promise of new rotavirus vaccines. N Engl J Med. 2006; 354:75-7. [PubMed 16394305]

5. Heaton PM, Goveia MG, Miller JM et al. Development of a pentavalent rotavirus vaccine against prevalent serotypes of rotavirus gastroenteritis. J Infect Dis. 2005; 192 (Suppl 1): S17-21. [PubMed 16088800]

6. Wyeth-Lederle. Dear health care professional letter regarding withdrawal of RotaShield rotavirus vaccine. Philadelphia, PA: 1999 October 14. From FDA website.

7. Centers for Disease Control and Prevention. Withdrawal of rotavirus vaccine recommendations. MMWR Morb Mortal Wkly Rep. 1999; 48:1007. [PubMed 10577495]

9. Cunliffe NA, Nakagomi O. A critical time for rotavirus vaccines: a review. Expert Rev Vaccines. 2005; 4:521-32. [PubMed 16117709]

10. Merck & Co. Personal communication. North Wales, PA. 2007 Oct 12.

11. Cortese MM, Parashar UD, Centers for Disease Control and Prevention (CDC). Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2009; 58(RR-2):1-25.

12. Committee on Infectious Diseases, American Academy of Pediatrics. Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics. 2009; 123:1412-20. [PubMed 19332437]

13. Centers for Disease Control and Prevention. Postmarketing monitoring of intussusception after RotaTeq vaccination—United States, February 1, 2006–February 15, 2007. MMWR Morb Mortal Wkly Rep. 2007; 56:218-22. [PubMed 17363890]

14. Food and Drug Administration. Information on RotaTeq and intussusception. 2007 Feb 13. Public health notification. From FDA website.

15. Food and Drug Administration. Information pertaining to labeling revision for RotaTeq. 2007 Jun 15. MedWatch alert and information page. From FDA website.

19. Block SL, Vesikari T, Goveia MG et al. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007; 119:11-8. [PubMed 17200266]

21. Centers for Disease Control and Prevention. Rotavirus vaccine information statement. 2015 Apr 15. From CDC website.

22. GlaxoSmithKline. Rotarix (rotavirus vaccine, live, oral) oral suspension prescribing information. Research Triangle Park, NC; 2016 Apr.

23. Vesikari T, Karvonen A, Prymula R et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007; 370:1757-63. [PubMed 18037080]

24. Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006; 354:11-22. [PubMed 16394298]

25. Linhares AC, Velázquez FR, Pérez-Schael I et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet. 2008; 371:1181-9. [PubMed 18395579]

27. Haber P, Patel M, Izurieta HS et al. Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics. 2008; 121:1206-12. [PubMed 18519491]

28. Dennehy PH, Bertrand HR, Silas PE et al. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008; 122:e1062-6. [PubMed 18977955]

29. Centers for Disease Control and Prevention (CDC). Reduction in rotavirus after vaccine introduction--United States, 2000-2009. MMWR Morb Mortal Wkly Rep. 2009; 58:1146-9. [PubMed 19847149]

31. Food and Drug Administration. Update on recommendations for the use of rotavirus vaccines. 2010 May 14. Available at FDA website. Accessed 2010 Oct 4.

33. Patel NC, Hertel PM, Estes MK et al. Vaccine-acquired rotavirus in infants with severe combined immunodeficiency. N Engl J Med. 2010; 362:314-9. [PubMed 20107217]

34. Centers for Disease Control and Prevention (CDC). Addition of severe combined immunodeficiency as a contraindication for administration of rotavirus vaccine. MMWR Morb Mortal Wkly Rep. 2010; 59:687-8. [PubMed 20535093]

36. Food and Drug Administration. Information on Rotarix: labeling revision pertaining to intussusception. 2010 Sep 22. Available at FDA website. Accessed 2010 Sep 22.

37. Tate JE, Simonsen L, Viboud C et al. Trends in intussusception hospitalizations among US infants, 1993-2004: implications for monitoring the safety of the new rotavirus vaccination program. Pediatrics. 2008; 121:e1125-32. [PubMed 18450856]

38. Aliabadi N, Tate JE, Haynes AK et al. Sustained decrease in laboratory detection of rotavirus after implementation of routine vaccination—United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2015; 64:337-42. [PubMed 25856253]

39. Payne DC, Selvarangan R, Azimi PH et al. Long-term Consistency in Rotavirus Vaccine Protection: RV5 and RV1 Vaccine Effectiveness in US Children, 2012-2013. Clin Infect Dis. 2015; 61:1792-9. [PubMed 26449565]

40. Kassim P, Eslick GD. Risk of intussusception following rotavirus vaccination: An evidence based meta-analysis of cohort and case-control studies. Vaccine. 2017; 35:4276-4286. [PubMed 28648544]

105. American Academy of Pediatrics. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.

134. National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011; 60:1-64.

156. Panel on Opportunistic Infection in HIV-exposed and HIV-infected children, US Department of Health and Human Services (HHS). Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics (December 15, 2016). Updates may be available at HHS AIDS Information (AIDSinfo) website.

166. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 13th ed. Washington DC: Public Health Foundation; 2015. Available at CDC website.

199. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules forchildren and adolescents aged 18 years or younger, United States, 2017. Updates may be available at CDC website.

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