Rotavirus Vaccine Live Oral (Monograph)

Rotavirus Vaccine Live Oral (Monograph)

Rotavirus Vaccine Live Oral (Monograph)

introduction

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).

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

Before the widespread use of the rotavirus vaccine, rotavirus was the most common cause of severe gastroenteritis in infants and young children. Worldwide, rotavirus gastroenteritis causes approximately 500,000 deaths in children under 5 years of age each year. Rotavirus gastroenteritis is estimated to cause up to 70,000 hospitalizations and up to 60-70 deaths in children under 5 years of age each year.

Following approval of the rotavirus vaccine (RotaTeq) in the United States in 2006, there was a significant decrease in the incidence of rotavirus disease and significant changes in the epidemiology of the disease. A second rotavirus vaccine (Rotarix) was approved in the United States in 2008. Surveillance data collected by the CDC National Respiratory and Enteric Virus Surveillance System (NREVSS) showed that the 2007-2008 and 2008-2009 rotavirus seasons were shorter, had a later onset, and there were significantly fewer reports of positive rotavirus test results compared to the 2000-2006 seasons. Additional NREVSS data showed that the national decline in rotavirus detection ranged from 58 to 90% in each of the seven years postvaccination (2007-2014) compared to all seven years prevaccination (2000-2006) combined, and that there was a biennial pattern of rotavirus activity with alternating years of less or greater activity. Some evidence suggests that rotavirus vaccination may provide clinical benefits to both vaccinated and unvaccinated individuals by reducing overall transmission of rotavirus (i.e., herd immunity).

The USPHS Advisory Committee on Immunization Practices (ACIP) and AAP recommend that all infants be vaccinated against rotavirus gastroenteritis starting at 6 weeks of age unless there is a contraindication. (See “Contraindications” under “Precautions.”) These experts indicate to administer the first dose at 6 to 14 weeks of age (at the latest at 14 weeks and 6 days of age) and to complete the vaccination series at 8 months and 0 days of age.

ACIP and AAP do not indicate a preference for the Rotarix or RotaTeq vaccine for primary infant immunization. The effectiveness and safety of the vaccines are similar; However, dosage and dosing schedule (i.e. number and timing of doses) differ depending on the vaccine used. (See dosage under Dosage and Administration.)

There are no data on the efficacy and safety of the rotavirus vaccine for post-exposure prophylaxis after exposure to natural rotavirus.

Oral dosage and administration of rotavirus vaccine

Administration

Oral administration

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

Do not administer by IM, IV, or Sub-Q injection.

Do not mix with other vaccines or solutions.

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

May be administered concurrently with other age-appropriate vaccines during the same visit. (See Interactions.)

Rotarix (RV1)

Reconstitute the lyophilized vaccine using the diluent and transfer adapter provided by the manufacturer. For complete reconstitution instructions, see the manufacturer's information. Reconstituted Rotarix is ​​a white, cloudy suspension.

After reconstitution, administer orally directly using the oral applicator provided by the manufacturer. Administer the entire contents of the oral applicator into the infant's mouth on the inside of the cheek.

If an incomplete dose is administered (e.g., if the infant spits up or vomits during or after the vaccination dose), the manufacturer states that a single replacement dose may be considered at the same vaccination visit. ACIP and AAP do not recommend a replacement dose if an incomplete dose is administered because there are no data on the benefits and risks of re-administration. Administer the remaining dose of the 2-dose vaccination series at the typically recommended intervals (minimum interval of 4 weeks between doses).

RotaTeq (RV5)

Administer orally directly from the single-dose tube provided by the manufacturer. Do not dilute.

Should appear as a pale yellow, clear liquid that may have a pinkish tinge.

Administer the dose by gently squeezing the entire contents of the tube into the infant's mouth toward the inside of the cheek. A residual drop may remain in the tip of the dosing tube.

If an incomplete dose is administered (e.g., the infant spits up or vomits the vaccine during or after the vaccine dose), a replacement dose is not recommended because there are no data on the benefits and risks of re-administration. Administer the remaining doses of the 3-dose vaccination series at the typically recommended intervals (minimum interval of 4 weeks between doses).

dosage

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

There are no data on the interchangeability of rotavirus vaccines. The specific rotavirus vaccine (Rotarix or RotaTeq) used for the initial dose should, if possible, be used to complete the vaccination series. If a specific rotavirus vaccine was used for previous doses that is not known or unavailable, continue or complete the vaccination series with the currently available rotavirus vaccine. Do not postpone vaccination.

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

ACIP and AAP state that the first dose of rotavirus vaccine should be administered between 6 weeks and 14 weeks and 6 days of age and should not be started in infants ≥ 15 weeks of age. If the first dose is accidentally administered at ≥ 15 weeks of age, complete the remainder of the vaccination series according to the recommended schedule.

For premature infants who are medically stable, administer the rotavirus vaccine at the usual chronological age at the usual dosage, provided the vaccine is administered to the age-appropriate infant after or at the time of discharge from the hospital's neonatal intensive care unit (NICU) or nursery. The theoretical risks of transmitting rotavirus vaccine virus to other hospitalized infants outweigh the benefits of vaccination in age-appropriate infants who remain in the NICU or nursery following dosing. (See “Use in Children” under “Precautions.”)

Because natural rotavirus infection often provides only partial immunity, ACIP and AAP recommend starting or completing a rotavirus vaccination series in infants with rotavirus gastroenteritis before administering the full vaccination series. (See “People with Gastrointestinal Disorders” under “Precautions.”)

Pediatric patients

Prevention of rotavirus gastroenteritis

Infants 6 to 24 weeks old (Rotarix; RV1)

Orally

The primary vaccination consists of a series of 2 doses. Each dose consists of the entire contents of a reconstituted single-dose vial.

The manufacturer recommends that the first dose be given at 6 weeks of age and the second dose at least 4 weeks after the first dose. The manufacturer also recommends completing the 2-dose series at 6 months of age (24 weeks).

ACIP and AAP recommend administration of Rotarix at ages 2 and 4 months with a minimum interval of 4 weeks between doses. These experts state that the maximum age for the last dose is 8 months and 0 days.

Infants 6 to 32 weeks old (RotaTeq; RV5)

Orally

The primary vaccination consists of a series of 3 doses. Each dose consists of the entire contents of the commercially available single-dose tube.

The manufacturer recommends that the initial dose be given at 6 to 12 weeks of age and the remaining 2 doses given 4 to 10 weeks apart. The manufacturer states that the third dose should not be given after week 32.

ACIP and AAP recommend administration of RotaTeq at 2, 4, and 6 months of age with a minimum interval of 4 weeks between doses. These experts state that the maximum age for the last dose is 8 months and 0 days.

Special populations

Liver dysfunction

No specific dosage recommendations.

Renal dysfunction

No specific dosage recommendations.

Geriatric patients

Not indicated in adults, including geriatric adults.

Precautions for Rotavirus Vaccine Live Oral

Contraindications

Rotarix(RV1)

• Known hypersensitivity to Rotarix or any of the vaccine components (e.g. latex). (See “Latex Sensitivity” under “Precautions.”)

• History of intussusception (a type of intestinal obstruction that occurs when the intestine folds) or history of an uncorrected congenital malformation of the gastrointestinal tract (e.g. Meckel's diverticulum) that would predispose the child to intussusception. (See “Intussusception” under “Precautions.”)

• Severe combined immunodeficiency disease (SCID). (See “Individuals with Altered Immunocompetence” under “Precautions.”)

RotaTeq(RV5)

• Known hypersensitivity to RotaTeq or any of the vaccine components.

• History of intussusception. (See “Intussusception” under “Precautions.”)

• SCID. (See “Individuals with Altered Immunocompetence” under “Precautions.”)

Warnings/Precautions

Sensitivity reactions

Hypersensitivity reactions

Anaphylactic reactions reported (RotaTeq). Urticaria and angioedema have also been reported.

Review infant vaccination history to determine whether there is a history of hypersensitivity or other reactions to vaccine components.

Do not administer additional doses of rotavirus vaccine if the infant develops symptoms suggestive of hypersensitivity after receiving one dose.

Provide appropriate medical treatment and monitoring to manage possible anaphylactic reactions.

Latex sensitivity

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

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

Consider using RotaTeq (which is latex-free) as an alternative to Rotarix. in infants with severe latex allergy. Some experts prefer that infants with spina bifida or bladder exstrophy who are at high risk of latex allergy receive RotaTeq as an alternative to Rotarix to minimize latex exposure. ACIP and AAP administer Rotarix when it is the only rotavirus vaccine available because the benefit of rotavirus vaccination is considered to outweigh the risk of latex sensitization.

People with altered immune competence

Safety and effectiveness in immunocompromised or potentially immunocompromised infants have not been established. Examples include infants with blood dyscrasias, leukemia, lymphoma, or other malignancies affecting the bone marrow or lymphatic system; those receiving immunosuppressive therapy (see Interactions); Persons with primary and acquired immunodeficiency conditions such as HIV/AIDS or other clinical manifestations of HIV infection, cellular immunodeficiencies or hypogammaglobulinemic and dysgammaglobulinemic conditions; and those with undetermined HIV status born to HIV-infected (HIV-exposed) mothers.

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

Consider the potential risks and benefits of rotavirus vaccination in infants with known or suspected altered immunocompetence. It is recommended to consult an immunologist or infectious disease specialist.

ACIP, AAP, CDC, National Institutes of Health (NIH), HIV Medicine Association of IDSA, and Pediatric Infectious Diseases Society state that the use of rotavirus vaccines in HIV-infected or HIV-exposed infants is supported since HIV diagnosis in infants born with HIV-infected mothers may not be identified before the recommended age for the first dose of vaccine. Only 1.5-3% of HIV-exposed infants in the United States are ultimately found to be HIV-infected, and the rotavirus strains used in the vaccines are also significantly attenuated. Limited data to date suggest that the safety profiles of rotavirus vaccine reported in clinically asymptomatic or mildly symptomatic HIV-infected infants are similar to the safety profiles in infants without HIV infection.

Intussusception

Rare cases of intussusception, including some deaths, have been reported in infants receiving Rotarix or RotaTeq. Although data from initial clinical trials with these vaccines did not suggest an increased risk of intussusception compared to placebo, there is postmarketing evidence that rotavirus vaccines are associated with an increased risk of intussusception, particularly in the first week after the first vaccine dose. During the first year of life, the background rate of intussusception hospitalizations in the United States is estimated to be approximately 34 per 100,000 infants.

In a postmarketing observational study in Mexico, cases of intussusception were observed temporally (within 31 days) after the first dose of Rotarix, with cases occurring more frequently in the first 7 days. This study did not consider all medical conditions that could predispose infants to intussusception, and the results may not be generalizable to U.S. infants, who have lower background rates of intussusception than Mexican infants. However, if a temporal increase in the risk of intussusception following Rotarix occurs in U.S. infants similar to that observed in the Mexico study, it is estimated that approximately one to three additional cases of hospitalization for intussusception per 100,000 vaccinated infants in the U.S. would occur within 7 days of the first dose of Rotarix. Other post-marketing observational studies in Brazil and Australia also suggest an increased risk of intussusception within the first 7 days after the second dose of Rotarix.

In a postmarketing observational study in the United States, cases of intussusception were observed temporally (within 21 days) after the first dose of RotaTeq, with cases occurring more frequently in the first 7 days. This study evaluated more than 1.2 million RotaTeq vaccinations (507,000 first doses) given to infants 5 to 36 weeks of age. From 2004 to 2011, potential cases of intussusception in inpatient or emergency department settings and vaccine exposures were identified and confirmed through electronic procedure and diagnosis codes. Intussusceptions have been reported within 21 days of the first dose of RotaTeq, with a cluster of cases occurring in the first 7 days. Based on these results, approximately 1-1.5 additional cases of intussusception per 100,000 U.S. infants vaccinated occur within 21 days of the first dose of RotaTeq. Cases of intussusception temporally related to RotaTeq have also been reported in global passive postmarketing experience.

A previously available live oral rotavirus vaccine (RotaShield; Wyeth) was voluntarily withdrawn from the U.S. market in 1999 following postmarketing reports of intussusception in infants receiving the vaccine. The data showed that the period with the highest risk of intussusception associated with RotaShield was the first 42 days after the initial dose.

Careful monitoring for intussusception should be performed following administration of the rotavirus vaccine, particularly during the first week after administration. Report all cases of intussusception or other serious events potentially related to the vaccine to VAERS at 800-822-7967 or [Web].

Rotarix and RotaTeq are contraindicated in infants with a history of intussusception. Intussusception has been reported to result in death when a second dose of Rotarix was given to an infant who had already had an intussusception after the first dose.

Other gastrointestinal disorders or diseases

Rotarix: Safety and efficacy not established in infants with chronic gastrointestinal disorders; Delay administration of the vaccine to infants with acute diarrhea or vomiting.

RotaTeq: Use with caution in infants with a history of gastrointestinal disease (e.g., active acute gastrointestinal disease, chronic diarrhea and failure to thrive, history of congenital abdominal disease, abdominal surgery). There are no safety and effectiveness data in these infants. The manufacturer states that the vaccine can be used in infants with controlled gastroesophageal reflux disease (GERD).

Although the safety and effectiveness of the rotavirus vaccine have not been studied in infants with pre-existing chronic gastrointestinal diseases, ACIP and AAP state that the benefits of the vaccine outweigh the theoretical risks in infants with pre-existing gastrointestinal diseases (e.g., congenital malabsorption syndrome, Hirschsprung disease, short bowel syndrome) if they do not receive immunosuppressive therapy.

There are no data on the use of rotavirus vaccine in infants with concurrent acute gastroenteritis. Immunogenicity and efficacy may be compromised in these infants. ACIP and AAP state that the rotavirus vaccine can be given to infants with mild acute gastroenteritis (particularly when a delay in vaccination may render the child ineligible for the vaccine due to age at the first dose), but should not be given to infants with acute, moderate to severe gastroenteritis until improvement in the condition is noted.

Hematochezia has been rarely reported within 42 days of a RotaTeq dose; The incidence was similar to that in patients receiving placebo during clinical trials. Hematochezia has been reported following postmarketing use of Rotarix or RotaTeq. Causal relationship between administration of rotavirus vaccine and the occurrence of hematochezia not established.

Transmission of the vaccine virus

Rotarix contains live, attenuated rotaviruses and RotaTeq contains live, reassorted rotaviruses.

Virus shedding may occur in vaccine recipients and the vaccine virus was transmitted between vaccinated people and susceptible contacts.

Following a dose of Rotarix, peak excretion occurs approximately 7 days after the dose. In a study of healthy twins aged 6-14 weeks, one twin in each household was randomized to receive Rotarix and the other twin received placebo. In 19% of couples there was transmission of the vaccine virus from the vaccinated twin to the twin who received the placebo; Gastrointestinal symptoms associated with transmitted viruses have not been reported. The 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 contracted the vaccine virus.

Up to 9% of infants who received RotaTeq passed the vaccine virus in their stool after the first dose (as early as the first day and as late as the 15th day after the dose). Viral shedding rarely occurs after subsequent doses of RotaTeq.

Caution should be exercised when considering whether to administer rotavirus vaccination to infants with close contacts who are immunocompromised (e.g., those with malignancies or primary immunodeficiencies, or those receiving immunosuppressive therapy). The manufacturers say they are weighing the risk of possible transmission of the vaccine virus against the risk of infants developing a natural rotavirus infection that could be transmitted to susceptible contacts.

ACIP and AAP state that infants living in households with immunocompromised individuals should receive a rotavirus vaccine if necessary. The protection of immunocompromised household contacts by rotavirus vaccination of infants in the household and the prevention of wild-type rotavirus disease outweighs the small risk of transmission of the vaccine virus to the susceptible individual and any resulting theoretical risk of disease associated with the vaccine virus.

To minimize potential transmission of the vaccine virus from the vaccinee, advise all household contacts to practice hygiene measures (e.g., thorough hand washing) after contact with a vaccinated infant's feces (e.g., changing diapers) at least one week after each dose of vaccine.

If an infant who has recently been vaccinated with the rotavirus vaccine is hospitalized for any reason, take standard precautions to prevent the spread of the vaccine virus in the hospital. Due to the possible risk of transmission of the rotavirus vaccine virus to other hospitalized infants, contact precautions must be taken if a premature infant previously vaccinated with the rotavirus vaccine needs to be readmitted to the hospital's neonatal intensive care unit or day care center within 2 weeks of a dose of the vaccine. Maintain these precautions for 2-3 weeks after dosing. (See “Pediatric Use” under “Warnings/Precautions: Specific Populations” under “Precautions.”)

Kawasaki disease

During Phase 3 clinical trials of RotaTeq, Kawasaki disease was reported in 5 of 36,150 infants who received the vaccine and 1 of 35,536 infants who received placebo. An additional 3 cases in vaccinated infants were reported to VAERS and 1 unconfirmed case was reported through the CDC Vaccine Safety Datalink (VSD) Project.

Kawasaki disease was also observed in 18 infants who received Rotarix in clinical trials. The time of onset of Kawasaki disease after the Rotarix dose ranged from 3 days to 19 months.

Causal relationship between rotavirus vaccine or any other vaccine and the occurrence of Kawasaki disease not established. To date, the number of reported cases of Kawasaki disease associated with the use of RotaTeq does not exceed the number of expected cases occurring by chance in this population. Post-marketing surveillance data to date do not indicate that RotaTeq is associated with an increased risk of Kawasaki disease.

Report any case of Kawasaki disease that occurs following administration of a rotavirus vaccine (or other vaccine) to VAERS at 800-822-7967 or [Web].

Concomitant disease

The decision to administer or delay rotavirus vaccine to an infant with current or recent febrile illness depends on the severity of symptoms and the etiology of the illness. The manufacturer of RotaTeq states that a low-grade fever (<38.1°C) or a mild upper respiratory tract infection does not preclude vaccination.

ACIP and AAP state that the rotavirus vaccine can be administered to infants with transient, mild illness (with or without low-grade fever), but postpone vaccination for those with moderate or severe acute illness until after recovery from the acute phase of illness.

Risk of random agents

Pork materials are used in the production of Rotarix and Rotateq; The vaccines contain DNA from porcine circoviruses.

After it was revealed in March 2010 that porcine circovirus type 1 (PCV1) DNA was present in Rotarix, the FDA recommended temporarily suspending use of the vaccine for safety reasons pending further investigation. In May 2010, the FDA provided additional information that DNA fragments of PCV1 and porcine circovirus type 2 (PCV2) were detected in RotaTeq. After careful evaluation, the FDA determined that it was appropriate to restart the use of Rotarix and continue the use of RotaTeq to prevent rotavirus infection in infants.

The 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. Because the available evidence supports the safety of Rotarix and RotaTeq in infants, the FDA states that the clinical benefit of vaccination against rotavirus infection outweighs any theoretical risks from the presence of PCV1 or PCV2 in rotavirus vaccines. The FDA and manufacturers will continue to investigate the presence of swine viruses in Rotarix and RotaTeq and evaluate safety data from ongoing studies.

Limitations on vaccine effectiveness

May not protect all vaccine recipients from rotavirus infection.

There are no data to determine the level of protection against rotavirus infection in infants who have not received the full series of vaccinations (i.e. only received a single dose of Rotarix or only 1 or 2 doses of RotaTeq).

Duration of immunity

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

Some evidence from clinical trials shows that a full course of both vaccines generally provides protection against rotavirus infection in the second rotavirus season after vaccination or up to 2 years of age.

The effectiveness beyond the second rotavirus season after vaccination has not yet been fully investigated.

Improper storage and handling

Improper storage or handling of vaccines may reduce the effectiveness of the vaccine and lead to a reduced or inadequate immune response in vaccinated people.

Inspect all vaccines upon delivery and monitor storage to ensure proper temperature is maintained.

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

If there is concern about mishandling, contact the manufacturer or state or local immunization or health authorities for guidance on whether the vaccine is usable.

Specific populations

pregnancy

Not suitable for use in adults, including pregnant women.

ACIP and AAP state that infants living in households with pregnant women may receive rotavirus vaccine. The risk of rotavirus infection from potential exposure to the vaccine virus is considered to be very low because most women of childbearing age are expected to already have immunity to rotavirus.

To date, there is no evidence that rotavirus infection during pregnancy poses a risk to the fetus. Vaccination of infants against rotavirus avoids potential exposure of pregnant women to natural rotavirus from unvaccinated infants with rotavirus gastroenteritis.

lactation

Not suitable for use in adults, including breastfeeding women.

ACIP and AAP state that nursing infants may receive the rotavirus vaccine because effectiveness in nursing infants appears to be similar to that in infants who are not breastfeeding.

Pediatric use

Rotarix: Safety and efficacy not established in infants <6 weeks or >24 weeks of age. The manufacturer states that effectiveness in premature babies has not been proven. Safety data to date in preterm infants suggest serious adverse events in 5.2% of vaccine recipients compared to 5% of placebo recipients; To date, no deaths or cases of intussusception have been reported in this patient group.

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

Until more data is available, ACIP and AAP state that the benefits of routine vaccination with rotavirus vaccine outweigh the theoretical risks in medically stable premature infants. These experts state that clinically stable premature infants who meet the age requirements (at least 6 weeks and not older than 14 weeks and 6 days old) can receive the first dose of rotavirus vaccine after or at the time of discharge from the hospital's neonatal intensive care unit or nursery. However, the potential risk of transmission of rotavirus vaccine virus to other hospitalized infants outweighs the benefits of vaccination in age-appropriate infants who remain in the NICU or nursery following dosing. If a premature infant who has previously received a rotavirus vaccine needs to be readmitted to the NICU or hospital day care center within 2 weeks of a vaccine dose, initiate contact precautions for the premature infant and maintain these precautions for 2-3 weeks after the vaccine dose.

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

Geriatric use

Not indicated in adults, including geriatric adults.

Common side effects

Fever, diarrhea, vomiting, loss of appetite, restlessness/irritability, middle ear infection, cough/runny nose, nasopharyngitis, bronchospasm.

Interactions with other medications

Other vaccines

Coadministration with other age-appropriate vaccines or toxoids (e.g., hemophilus B conjugate). [Hib]Poliovirus vaccine inactivated [IPV]Hepatitis B [HepB]inactivated influenza virus vaccines, measles, mumps and rubella virus live vaccines [MMR]Pneumococcal conjugate vaccine, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed [DTaP]) during the same health visit, which is not expected to that it influences the immunological reactions or adverse reactions to one of the vaccines.

Specific medications

stability

storage

Orally

For hanging

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

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

Does not contain thimerosal or other preservatives.

Solution

RotaTeq (RV5): 2-8°C. Protect from light. Administer as soon as possible after removing from the refrigerator.

Does not contain thimerosal or other preservatives.

Actions

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

• RotaTeq (RV5): Oral solution containing live, reassortant rotaviruses corresponding to 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]).

• Rotarix and RotaTeq use porcine-derived materials; DNA from porcine circoviruses was detected in the vaccines. (See “Accidental Agent Risk” under “Precautions.”)

• After vaccination, the live, attenuated virus (Rotarix) or the live, reassorted rotaviruses (RotaTeq) multiply in the small intestine and induce active immunity against the rotavirus types contained in the vaccine.

• The exact immunological mechanism by which Rotarix or RotaTeq protects against rotavirus gastroenteritis is not known.

• The connection between the antibody response to the rotavirus vaccine and protection against rotavirus gastroenteritis has not yet been established.

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

• Studies with Rotarix show that 76.8-86.5% of vaccine recipients seroconvert after 2 doses. Seroconversion in these studies was defined as the appearance of anti-rotavirus IgA antibodies in infants previously negative for rotavirus.

• Studies with RotaTeq indicate a 3-fold or greater increase in serum anti-rotavirus IgA concentrations in 93-100% of infants who received a three-dose vaccination series compared to 12-20% of infants who received placebo.

• Because Rotarix contains live, attenuated rotaviruses and RotaTeq contains live, reassorted rotaviruses, vaccine viruses can be excreted in the stool of vaccinated individuals and transmitted between vaccinated individuals and susceptible contacts. (See “Vaccine Virus Transmission” under “Precautions.”)

Advice for patients

• Before administering each dose of vaccine, provide the patient's parent or guardian with a copy of the manufacturer's Patient Information Information. Also provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient's parent or legal guardian (VIS available at [Web]).

• Inform the patient's parents or guardians of the risks and benefits of vaccination.

• Inform the patient's parents or guardians 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 or pose a safety risk in humans. (See “Accidental Agent Risk” under “Precautions.”)

• Advise the patient's parents or guardians that the rotavirus vaccine may not provide complete protection in all vaccinated individuals. In addition, the vaccine does not protect against diseases caused by rotavirus strains not found in the vaccine.

• Inform the patient's parents or guardians of the possible risk of transmission of vaccine virus to rotavirus-susceptible individuals, including close or household contacts with weakened immune systems or pregnant women who have not had rotavirus infection.

• It is important to inform doctors if a child has an illness that includes fever, diarrhea, or vomiting. is not gaining weight or growing as expected; has a blood disorder, any type of cancer, a weakened immune system (e.g., HIV infection, SCID), or a history of gastrointestinal problems (e.g., intussusception, blockage, abdominal surgery); or is receiving treatment that may weaken the immune system (e.g. high-dose corticosteroids).

• For infants receiving Rotarix (2-dose series) or RotaTeq (3-dose series), inform the patient's parents or guardians of the importance of completing the vaccination series by the infant's age of 8 months and 0 days, unless a contraindication is present.

• It is important to inform doctors if side effects (including allergic reactions) occur. Physicians or individuals can report any post-vaccination adverse reactions to VAERS at 800-822-7967 or [Web].

• Advise the patient's parents or guardians that the vaccine should not be given to children who have had an allergic reaction after a previous dose of vaccine or to children who are allergic to any of the vaccine components.

• It is important to notify doctors immediately if a child experiences signs and/or symptoms of intussusception, including vomiting, diarrhea, severe stomach pain, blood in the stool, or high fever. Contact the doctor if the child experiences any of these symptoms after vaccination, especially if the symptoms appear within 7 days of the first dose of the vaccine, but also if they occur several weeks after the last dose of the vaccine.

• It is important to inform physicians about any existing or planned concomitant therapies, including prescription and over-the-counter medications, as well as any comorbidities.

• It is important to inform patients of other important precautionary information. (See Precautions.)

Preparations

Excipients in commercial drug preparations may have clinically significant effects in some individuals; Details can be found on the respective product labeling.

For information about shortages of one or more of these drugs, visit the ASHP Drug Shortages Resource Center.

Rotavirus vaccine live vaccine oral

Rotavirus Vaccine Live Oral Pentavalent

AHFS DI Essentials™. © Copyright 2024, Selected changes December 4, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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