| Vaccine description | |
|---|---|
| Target disease | rotavirus |
| Type | Attenuated virus |
| Clinical data | |
| MedlinePlus | a607024 |
| Pregnancy cat. | ? |
| Legal status | ? |
| Routes | oral |
| Identifiers | |
| ATC code | J07BH02 |
| (what is this?) (verify) |
|
A rotavirus vaccine protects children from rotaviruses, which are the leading cause of severe diarrhea among infants and young children.[1] Each year an estimated 453,000 children die from diarrhoeal disease caused by rotavirus,[2] and another two million are hospitalised.[3] Nearly every child in the world will suffer an episode of diarrhea caused by rotavirus before age five.[4] Although the severity of rotavirus infections differs between children living in developed and developing countries, the rates of infection is similar in both settings.[5] Clean water supplies and good hygiene have little effect on the transmission of infection, and further improvements are unlikely to prevent disease.[5]
There are two effective rotavirus vaccines: Rotarix by GlaxoSmithKline and RotaTeq by Merck.[6]
On June 5, 2009, the World Health Organization (WHO) recommended that rotavirus vaccine be included in all national immunization programs. The Rotavirus Vaccine Program aims to reduce child morbidity and mortality from diarrhoeal disease by accelerating the availability of rotavirus vaccines in developing countries. The Rotavirus Vaccine Program is a collaboration between PATH, WHO, and the U.S. Centers for Disease Control and Prevention, and is funded by the Global Alliance for Vaccines and Immunization.[7]
Contents |
In 1998 a rotavirus vaccine (RotaShield, by Wyeth) was licensed for use in the United States. Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe diarrhea caused by rotavirus A, and researchers had detected no statistically significant serious adverse effects. The manufacturer of the vaccine, however, withdrew it from the market in 1999, after it was discovered that the vaccine may have contributed to an increased risk for intussusception, or bowel obstruction, in one of every 12,000 vaccinated infants. The experience provoked debate about the relative risks and benefits of a rotavirus vaccine.[8]
In 2006, two vaccines against Rotavirus A infection were shown to be safe and effective in children: Rotarix by GlaxoSmithKline[9] and RotaTeq by Merck.[10] Both are taken orally and contain disabled live virus.
Rotarix is a human, live attenuated rotavirus vaccine containing a rotavirus strain of G1P[8] specificity. ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children.[9] In March 2010 FDA officials urged pediatricians to temporarily stop using GlaxoSmithKline's Rotarix because they found it contaminated with fragments of DNA from porcine circovirus-1. Although this contamination was thought to be benign, vaccines are supposed to be sterile. Since there was a competing vaccine against diarrhea-causing rotavirus that free of this contamination (Merck's RotaTeq), the FDA decided to err on the side of caution. In May 2010 the suspension of the vaccine was lifted. [11]
RotaTeq is a live, oral pentavalent vaccine that contains five rotaviruses produced by reassortment. The rotavirus A parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid, VP7, proteins (serotypes G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein VP4 (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein VP4, (type P1A), from the human rotavirus parent strain and the outer capsid protein VP7 (serotype G6) from the bovine rotavirus parent strain. In February 2006, the U.S. Food and Drug Administration approved RotaTeq for use in the United States. In August 2006, Health Canada approved RotaTeq for use in Canada.[12] Merck is working with a range of partners including the Rotavirus Vaccine Program, PATH, (Program for Appropriate Technology in Health) and other governmental and non-governmental organisations to develop and implement mechanisms for providing access to this vaccine in the developing world.[13]
A 2009 review estimated that vaccination against rotavirus would prevent about 45% of deaths due to rotavirus gastroenteritis, or about 228,000 deaths annually worldwide. At $5 per dose the estimated cost per life saved was $3,015, $9,951 and $11,296 in low-, lower-middle-, and upper-middle-income countries, respectively.[14]