Rotashield, intussusception

Rasagiline, 31.270 Rasburicase, 31.203 Renin inhibitors, 30.242 Rhesus anti-D, prophylaxis, 13.297 Ribavirin - - interferon, 30.344 Ribostamydn, and aminoglycosides, 15.270 Rocuronium, allergic reactions, 26.150 and pholcodine, 31.249 Rotashield, intussusception, 23.354 Rotavirus vaccine, Kawasaki disease, 31.522 Rubella vaccine, joints, 11.295... 

Rotavirus — the most common cause of severe diarrhea in infanfs, with approximately 125 million cases worldwide per year and 600,000 deaths — vaccines have been linked with intussusceptions (a problem with the intestine in which one portion of the bowel slides into the next) at a rate of between 1 in 5000 and 1 in 11,000 infants. The only rotavirus vaccine approved in the United States, RotaShield (Wyeth-Ayerst), was withdrawn from market on October 22, 1999, about 1 year after licensure. 

Current prelicensure trials of newly developed rotavirus vaccines are taking into consideration the experiences gained during the licensure process of Rotashield. Phase 3 clinical trials have included over 10 000 volunteers in order to exclude the potential risk of intussusception. 

The first vaccine (RotaShield) to prevent rotavirus infection was licensed for use in the United States in 1998, but it was withdrawn from the market after 1.5 million doses were administered owing to an increased rate of idiopathic intussusception. A number of rotavirus vaccines are under development, but the one that shows early promise is the rotavirus oral vaccine (Rotateq, Merck). This is a reassortant pentavalent vaccine with a backbone of bovine rotavirus and surface proteins of virus strains representing G types (G1-G4) and PI A. The preliminary results from the trial of 1946 healthy infants (aged 2 to 8 months) showed a level of protection of approximately 75%. ... 

A previous rotavirus vaccine, RotaShield, was approved by the FDA in 1998, but was removed from the market only a little more than a year later, after post-licensing studies had shown a risk of intussusception of 1 in 10000 recipients. 

A WHO expert group has reported its view that post-marketing surveillance of both currently available rotavirus vaccines has detected a small increased risk of intussusception (about 1-2/100000 infants vaccinated) in some settings shortly after the first dose [2 ]. The risk is 5-10 times lower than that observed with the previously licensed vaccine, RotaShield, and the benefits of rotavirus immunization against severe diarrhea and death from rotavirus infection far exceed the risk of intussusception. After reviewing the... 

The associahon of intussusception (IS) and rotavirus (RV) vaccination surfaced with the introduction of the first licenced RV vaccine, Rotashield . It has been a focus of interest during the development of Rotateq (RV5) and Rotarix (RVl), and in particular during the post-licensure surveillance of these vaccines. 

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