rotavirus oral vaccine, live

Action and Spectrum

Actions and Spectrum 

Action: 

Induction of Immune Response: The vaccine works by introducing live attenuated rotavirus strains into the gastrointestinal tract. These strains are weakened versions of the wild-type rotavirus that cause the infection. Upon administration, the vaccine replicates in the intestines, stimulating an immune response.  

Immunization against Rotavirus: As the attenuated rotavirus strains replicate, they trigger the production of specific antibodies and immune cells in the body. The immune response plays a crucial role in enabling the body to identify and initiate a protective mechanism against the naturally occurring rotavirus variants.  

Protection against Infection: The vaccine’s primary goal is to provide protection against rotavirus infection. By inducing an immune response, it aims to prevent or reduce the severity of rotavirus-associated diarrhea and related complications. 

Spectrum 

The vaccine is primarily targeted against the most common rotavirus serotypes, including G1, G2, G3, and G4. These serotypes are responsible for most rotavirus infections worldwide. The vaccine provides a broad spectrum of protection against these strains, reducing the risk of rotavirus gastroenteritis in vaccinated individuals. 

Drug Interaction

Adverse Reaction

Frequency defined  

>10% 

Fussiness/irritability (3-52%) 

Diarrhea (24.1%) 

Fever (17-43%) 

Otitis media (14.5%) 

Vomiting (15.2%)  

1-10% 

Flatulence (2%) 

Nasopharyngitis (6.9%) 

Bronchospasm (1.1%) 

Black Box Warning

Black Box Warning:  

None

Contraindication / Caution

Contraindication/Caution:   

Severe allergic reaction: when a person has experienced a severe allergic response to a previous administration of the vaccine or any of its constituents, it is generally recommended not to administer further doses. 

History of intussusception: Intussusception is a condition where one segment of the intestine slides inside another, causing a blockage. If an individual has a history of intussusception or if it runs in their family, the vaccine may not be recommended due to a potential risk of recurrence. 

Severe immunodeficiency: If a person has a severe immunodeficiency, such as severe combined immunodeficiency (SCID) or other conditions affecting the immune system, the rotavirus vaccine is generally contraindicated. Live vaccines may pose a risk to individuals with compromised immune systems. 

Acute severe gastroenteritis: If an individual is currently experiencing acute severe gastroenteritis (inflammation of the stomach and intestines), it is generally recommended to delay administration of the vaccine until the condition improves. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category:
AU TGA pregnancy category B2 

US FDA pregnancy category C 

Lactation: Excreted into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology:  

rotavirus oral vaccine, live, is an immunization agent used to protect against rotavirus infection, which is a common cause of severe diarrhea in infants and young children. 

Pharmacodynamics:  

The vaccine works by introducing live attenuated strains of rotavirus into the gastrointestinal tract. These weakened strains replicate in the intestine, leading to a localized immune response. The immune system recognizes the viral proteins and generates an immune response, including the production of antibodies and the activation of immune cells. This immune response provides protection against future rotavirus infections by quickly recognizing and neutralizing the virus.   

Pharmacokinetics 

Absorption 

The vaccine is typically administered orally in multiple doses. The weakened strains of rotavirus in the vaccine can infect and replicate within the intestinal cells, stimulating an immune response. 

Distribution 

The distribution of the vaccine is primarily localized to the gastrointestinal tract. The live rotavirus strains replicate within the intestinal cells, leading to the production of viral proteins and stimulation of the immune system. 

Metabolism 

The metabolism of vaccine, live, primarily involves the replication of the attenuated viral strains within the intestinal cells. The replication process allows the vaccine to induce an immune response. 

Excretion and Elimination 

The vaccine is eliminated primarily through the feces. After administration, the live rotavirus strains shed in the stool for a period.

Adminstartion

Administration:  

Number of doses: The vaccine is usually given in 2 or 3 doses, depending on the brand used. The common brands include Rotarix and RotaTeq. Rotarix requires two doses, while RotaTeq requires three doses.  

Age of administration: The first dose of the vaccine is generally given when the baby is around six weeks old. The subsequent doses are given at recommended intervals, usually at two or four-month intervals depending on the brand. 

Method of administration: The vaccine is given as an oral solution, which means it is administered by mouth. The vaccine is typically provided in a dropper or oral syringe and is given by squirting it into the baby’s mouth. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: rotavirus oral vaccine, live 

Why do we use rotavirus oral vaccine, live?  

Prevention of Rotavirus Infection: The primary use of the rotavirus oral vaccine is to prevent rotavirus infection, which is a common cause of severe diarrhea in infants and young children. The vaccine contains weakened live strains of the rotavirus, which stimulate an immune response in the body without causing the disease. 

Reduction of Rotavirus-related Hospitalizations: rotavirus infection can lead to severe dehydration, especially in young children. By vaccinating infants with the rotavirus oral vaccine, the risk of severe rotavirus-associated illness and hospitalization can be significantly reduced. 

Protection Against Rotavirus Gastroenteritis: rotavirus gastroenteritis is characterized by symptoms such as severe diarrhea, vomiting, fever, and abdominal pain. The vaccine helps protect children from developing these symptoms and experiencing the associated discomfort. 

Prevention of Rotavirus Transmission:  

By vaccinating infants with the oral vaccine, the transmission of rotavirus within the community can be reduced, protecting not only the vaccinated individuals but also unvaccinated individuals who may meet them. 

Herd Immunity: Widespread use of the rotavirus oral vaccine can contribute to herd immunity, it indirectly protects those who are not vaccinated or are unable to receive the vaccine due to medical reasons, such as infants who are too young.