Rotavirus vaccine

Rotavirus Vaccine is a prescription medication belonging to the vaccine class.

Rotavirus Vaccine is approved to protect infants and young children from severe gastroenteritis (inflammation of the stomach and intestines) leading to diarrhoea or dehydration and potentially against life-threatening complications caused by rotavirus infection.

Rotavirus vaccines are administered orally, absorbed in the gastrointestinal tract, circulated to immune-mediated sites but do not go through regular metabolism, and are eliminated after triggering an immune response, providing long-term protection.

The common side effects of the Rotavirus vaccine are ear infection, fussiness or crying, diarrhoea, vomiting and loss of appetite.

Rotavirus vaccine is available in the form of suspension oral solutions.

Rotavirus Vaccine is available in the United States, the United Kingdom, India, Canada and Australia.

The Rotavirus vaccine, belonging to the vaccine class, acts as a live attenuated virus.

The rotavirus vaccination is essential to fight against severe diarrhoea, especially in young children and newborns, where the condition can be fatal. It functions through a carefully thought-out process to boost the immune system without spreading illness.

The rotavirus vaccine is administered orally and simulates the rotavirus's natural method of infection, in which it enters the body through the mouth. Since rotavirus predominantly affects the digestive system, this oral route is highly beneficial in the case of rotavirus.

Live attenuated virus is at the core of the rotavirus vaccine's mechanism. Rotarix and RotaTeq are two widespread vaccinations that contain attenuated rotavirus strains.

The weakened virus interacts with the immune system as it multiplies in the intestines. The interaction triggers the immune system to produce specific anti-rotavirus antibodies, principally IgA. These antibodies are essential for fighting against potential diseases.

Thus, the rotavirus vaccine is a crucial tool in paediatric healthcare because it offers a high degree of defence without resulting in severe illness linked to untreated rotavirus infection.

It was found that viral shedding lasted 10 days on average.

Rotavirus vaccine is available in the form of suspension oral solutions.

Suspension oral solutions: Shake the plastic tube and, if necessary, squeeze all of its contents into the mouth. The Rotavirus vaccine is not administered parenterally but is given orally to infants in multiple doses for each vaccination as scheduled.

A health care professional should administer the first dose of the rotavirus vaccine before a child becomes 15 weeks old, usually in 2 or 3 separate doses (depending on the brand). All amounts of rotavirus vaccine should be given to the children before they turn 8 months of age. Both vaccines are given by putting drops in the infant's mouth.

Rotavirus Vaccine can be used as follows:

• The rotavirus vaccine's primary purpose is to protect infants and young children from rotavirus infections and significantly reduce the risk of severe diarrhoea, vomiting, and dehydration caused by rotavirus.
• In case of severe rotavirus infections, the vaccine lowers the incidence of hospitalizations of young children due to rotavirus-induced dehydration and other related complications.
• Vaccination can help prevent rotavirus-related deaths among young children, especially in areas with poor access to medical treatment.
• Widespread vaccination contributes to generating community immunity, which lowers the prevalence of rotavirus in the population. Infants who are too young to get vaccinations or have specific contraindications are indirectly immunised.

The rotavirus vaccine can help support the following health benefits:

• Severe Gastroenteritis: The rotavirus vaccination significantly decreases the chance of developing severe gastroenteritis for infants and young children. This illness can lead to significant effects such as dehydration, hospitalization, and even death, but vaccination can help prevent this severe outcome.
• Community Immunity: Mass vaccination boosts herd immunity, protecting others who might not receive the vaccine, including children too young for the shot, and lowering the overall frequency of rotavirus in the community.
• Reduces Dehydration: In children, dehydration may be harmful and is frequently a result of severe diarrhoea. The risk of dehydration caused by rotavirus infection is significantly lowered by rotavirus vaccination.
• Mortality: Rotavirus is a major global cause of infant death. Vaccination prevents deadly results from rotavirus-induced diarrhoea, particularly in regions with limited medical care or underdeveloped countries.
• Reduced Hospitalizations: The vaccination significantly reduces hospitalisation rates for dehydration and associated complications, reducing healthcare costs by lowering the prevalence of severe rotavirus gastroenteritis.

It is typically administered to infants to protect them against rotavirus infection, which can cause severe diarrhoea and dehydration in newborns and young children.

• Rotarix is indicated for use in infants aged 6-24 weeks to prevent rotavirus gastroenteritis caused by G1, G3, G4, and G9 strain types.
• Rotateq is indicated for use in infants aged 6-32 weeks to prevent rotavirus gastroenteritis caused by G1, G2, G3, G4, and G9 strains.

Orally: The rotavirus vaccination is given orally, usually through multiple liquid drops. Infants receive it in doses, generally beginning at 2 months and terminating by 8 months. As the vaccine is swallowed, it makes it easy and convenient for young children to receive it.

A healthcare professional can give the vaccine in a hospital setting or during routine immunization programs.

The dosage and duration of treatment should be as per the clinical judgement of the treating physician

Suspension oral solutions (Single dose): 0.5 ml, 1 ml, 1.5 ml, 2 ml

oral vaccine

Rotarix Live-attenuated, monovalent

89-12 strain (G1P[8] type)that is ≥10^6 cell culture infective dose

RotaTeq

Dosage Adjustment for Adult Patients

There are no specific dosage adjustments provided as the rotavirus vaccine is usually not indicated in adults.

Rotavirus vaccine is available in the form of suspension oral solutions.

Rotavirus vaccine should be used to prevent gastroenteritis due to rotavirus infection in infants, along with no appropriate dietary restrictions. Rotavirus vaccine usually has little effect on dietary or food substances when administered. Regular diet, including breastfeeding or formula feeding, is safe before and after receiving the vaccine.

The dietary restriction should be individualized as per patient requirements.

Rotavirus vaccine may be contraindicated in the following conditions-

• Hypersensitivity (previous dose of vaccine or any of its components)
• Acute febrile illness
• Infants aged less than 6 weeks and more than 32 weeks
• Acute gastroenteritis
• Severe combined immunodeficiency disease (SCID)
• congenital stomach disorder or recent stomach surgery
• Blood transfusion
• An intestinal problem called intussusception.
• Allergic to latex rubber
• Immune conditions such as HIV or AIDS

The treating physician must closely monitor the patient and keep pharmacovigilance as follows.

• Those who intend to receive any live virus vaccinations, such as measles, mumps, rotavirus, smallpox, etc., must consult a healthcare professional within a month of taking rotavirus vaccine.
• Rotavirus vaccine should not be administered to patients receiving immunosuppressive medication (such as chemotherapy or high-dose corticosteroids) as it might not work in such cases and could increase the risk of vaccine-related complications.
• Infants with a history of GI disorders should be cautious while taking this vaccine.
• If the infant has a moderately critical acute sickness (with or without fever), administration of vaccine should be postponed.
• Individuals with cancer or weakened immune systems with frequent close contact with a child receiving this vaccine may have a rare risk of Retrovirus transmission.

Caution is advised when consuming alcohol with rotavirus vaccine.

Unlikely to be used during breastfeeding.

Unlikely to be used during pregnancy.

There is no sufficient scientific evidence traceable regarding the use and safety of rotavirus vaccine in concurrent use with any particular food.

The adverse reactions related to the Rotavirus vaccine can be categorized as

• Common: Diarrhoea, vomiting, otitis media, fever, fussiness/irritability.
• Less Common: Nasopharyngitis, allergic reactions and intussusception:
• Rare: Bronchospasm and flatulence

The clinically relevant drug interactions of the Rotavirus Vaccine are briefly summarized here:

• Immunosuppressants- The immunological response to ROTARIX may be suppressed by immunosuppressive treatments such as radiation, antimetabolites, alkylating agents, cytotoxic medicines, and corticosteroids (used in dosages larger than therapeutic doses).
• Other Vaccines- Multiple vaccinations, including rotavirus, given at the same time may increase the risk of adverse reactions. To reduce such a risk, medical professionals frequently adhere to vaccination regimens considering the time and space of vaccines.

The use of Rotavirus vaccine should be prudent in the following group of special populations

• Pregnancy: Rotavirus vaccine is not used in adults.

There is no sufficient scientific evidence regarding the use and safety of rotavirus vaccine for geriatric populations.

• Paediatrics: The rotavirus vaccination improves paediatric patients by avoiding severe diarrhoea and dehydration caused by rotavirus infection, lowering hospitalisations, saving lives, and enhancing the overall well-being and health of infants and young children.

Dosage Adjustment for Paediatric Patients

Rotavirus Gastroenteritis Prophylaxis

Rotarix: 2 Dose Regimen

A monovalent vaccine that is used in the prevention of rotavirus gastroenteritis that is caused by G1 and non-G1 strain serotypes (G3, G4, and G9)

A total of two oral dosages of 1 mL doses were administered

First dose given to infants beginning at 6 weeks of age

A second dose before the child reaches the age of 24 weeks, at least 4 weeks after the first.

RotaTeq: 3 Dose Regimen

A pentavalent vaccine which is used in the prevention of rotavirus gastroenteritis that is caused by the G1, G2, G3, and G4 strain serotypes, as well as attachment protein serotype P7

A total of three oral dosages of 2 mL doses were administered

The first dose is given at 6 to 12 weeks of age

Second and third doses are administered at 4 to 10 weeks intervals. After 32 weeks of age, a third dose should not be given.

• Geriatrics: Rotavirus vaccine is not used in adults.

There is no sufficient scientific evidence traceable regarding the use and safety of rotavirus vaccines for geriatric populations.

• Lactating mothers: Rotavirus vaccine is not used in adults.

There is no sufficient scientific evidence traceable regarding the use and safety of rotavirus vaccine for lactating mothers populations.

Dosage Adjustment in Kidney Impairment

There are no specific dosage adjustments provided.

Dosage Adjustment in Hepatic Impairment

There are no specific dosage adjustments provided.

Overdosage of Rotavirus vaccine suspension rarely occurs because healthcare professionals administer it according to specific or precise dosing guidelines.

There is no specific antidote or treatment for excessive intake of rotavirus vaccine. Medical attention should be sought immediately when an overdose is suspected, followed by monitoring any adverse effects or allergic reactions. Supportive therapy should also be given, addressing any symptoms that persist or worsen. Physical treatment might be added if necessary.

Pharmacodynamics of Rotavirus vaccine:

Rotavirus vaccines like Rotarix and RotaTeq work by introducing weakened forms of the virus into the intestine. This induces the immune system to produce antibodies to fight against rotavirus.

When administered, these viruses replicate in the intestine and cause the immune system to develop immunity by producing antibodies. After immunisation, babies who previously lacked anti-rotavirus IgA antibodies in their blood now exhibit these antibodies at quantities more than 20 U/mL, known as the seroconversion process. This process demonstrates a positive immunological response to the vaccination and the development of rotavirus immunity. These vaccines are produced to protect against rotavirus infection by stimulating the production of specific antibodies, ultimately reducing the risk and severity of rotavirus-related illnesses in those individuals who have been vaccinated.

Pharmacokinetics of Rotavirus vaccine:

Absorption: Rotavirus vaccinations are often given orally in the form of drops and absorbed in the GI tract, which prompts the immune system to produce defence-enhancing antibodies.

Distribution: Once absorbed, the vaccine antigens are circulated throughout the body via the bloodstream to the immune system's target sites, such as the gut's lymph nodes and mucosal-associated lymphoid tissue (MALT).

Metabolism: As rotavirus vaccines are made of viral particles or proteins, they do not generally undergo significant metabolic processes. Instead, they interact with the immune system to trigger a reaction. The immune system generates immune memory and antibodies by processing the vaccine antigens.

Elimination: After triggering the immune response, the vaccine antigens are generally eliminated from circulation. However, memory cells in the immune system retain information about the virus and provide an ongoing defence against rotavirus infection. The body's normal physiological processes will likely remove any excess vaccine components.

• Glass RI, Tate JE, Jiang B, Parashar U. The Rotavirus Vaccine Story: From Discovery to the Eventual Control of Rotavirus Disease. J Infect Dis. 2021 Sep 30;224(12 Suppl 2): S331-S342. doi: 10.1093/infdis/jiaa598. PMID: 34590142; PMCID: PMC8482027.

• Giri, S., Nair, N.P., Mathew, A. et al. Rotavirus gastroenteritis in Indian children less than 5 years hospitalized for diarrhoea, 2012 to 2016. BMC Public Health 19, 69 (2019). https://doi.org/10.1186/s12889-019-6406

• Inform the caregivers of the schedule for administering the rotavirus vaccine doses, including the specific ages they should be given.
• Assure caregivers that rotavirus immunizations are generally safe, with only minor, short side effects. Encouraging them to immediately report any unexpected or severe responses to the healthcare physician and, whenever applicable, to use reporting systems like the Vaccine Adverse Event Reporting System (VAERS)
• Inform caregivers of the recommended immunization schedule, which usually consists of two or three doses, depending on the vaccine brand used. Also, mention the ages at which the doses should be administered and give the Vaccine Information Statements, which must be disclosed before immunisation by the National Childhood Vaccine Injury Act of 1986 about the Centres for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines), these resources are freely accessible.

• https://www.ncbi.nlm.nih.gov/books/NBK558951/
• https://medicalguidelines.msf.org/
• https://www.cdc.gov/vaccines/vpd/rotavirus/public/index.html
• https://www.nhs.uk/conditions/vaccinations/rotavirus-vaccine/
• Parashar UD, Nelson EA, Kang G. Diagnosis, management, and prevention of rotavirus gastroenteritis in children. BMJ. 2013 Dec 30;347:f7204.