Professional Documents
Culture Documents
STUDENTS CORNER
NARRATIVE REVIEW
Rotavirus vaccine a new hope
Haider Ghazanfar,1 Sajida Naseem,2 Ali Ghazanfar,3 Sana Haq4
grade fever, occasional headache, chills, poor feeding, intussusception, the Centre for Disease Control (CDC)
abdominal cramps and pain. There is associated withdrew the vaccine from the market in October 1999.8,9
malabsorption.
What Are The New Vaccines Against
Is There Any Role Of Cleaning Water In Rotavirus?
Preventing Viral Diarrhoea? Currently there are two live, orally-administered Rotavirus
In developing countries, purification of water is vaccines: Rotarix and RotaTeq.10 Both the vaccines
imperative in controlling and limiting the spread of showed excellent safety and efficacy profile in studies
several infectious diseases. Improvement in sanitation conducted so far.11-13 After the introduction of the
and hygiene has been found to significantly decrease the vaccines, there has been a marked reduction in the
incidence of diarrhoea of bacterial origin but viral incidence of viral diarrhoea especially in Europe, Australia
diarrhoea, by and large, is unaffected by it.4,7 Though the and the USA. The Rotavirus vaccine has been approved
role of sanitation and improvement in hygiene cannot be and licensed in more than 100 countries all over the
underplayed, there has not been a marked decrease in the world. A global recommendation for the vaccine and
number of hospital admissions due to viral gastroenteritis emphasis on the economic and social impact of the
despite good hygiene. disease can lead to a swift introduction of the vaccine.
Therefore, the WHO is now recommending the inclusion
After analysing the epidemiological trends of Rotavirus of Rotavirus vaccine in the EPI schedule globally.
disease, the use of a vaccine presents as an effective
measure to reduce the burden of gastroenteritis. RotaTeq
Vaccination is the prime element of primary level RotaTeq was approved by FDA in 2006. It contains five live
healthcare and introduction of routine Rotavirus vaccine human-bovine re-assortment strains of Rotavirus, which
can markedly decrease the number of hospital are G1, G2, G3, G4 and P1A.8 serotype.14 Three oral doses
admissions, which are otherwise unaffected by sanitation are required for effective vaccination, starting with first
and hygiene. dose at 6-12 weeks of age, second dose with an interval of
4-10weeks, and the third dose within 32 weeks.
What is RotaShield?
RotaShield was introduced in 1998. It was the first vaccine The vaccine causes an increase in the serum anti-
against Rotavirus marketed publicly. Because of Intestinal Rotavirus immunoglobulin A (anti-RV-IgA) titer. It is also
enzyme-linked immunosorbent assay (ELISA) and 60-80% to be 82.1% against wild-type G1. The vaccine efficacy for
of the infants were documented to shed the virus after the hospital admission for Rotavirus gastroenteritis was
first, and some after the second dose of the vaccine. This shown to be 83.0%.22
poses an increased risk of vertical transmission to contacts
who are not vaccinated. Various other studies done in Africa, Latin America, Asia
and Europe proved that Rotavirus vaccine was very
Post-licensure studies conducted in Mexico evaluated the effective against severe Rotavirus gastroenteritis which
adverse effects of the vaccine with intussusception being occurred during the first 2 years of life.24,25 Rotavirus
the prime focus. One study was done by the company vaccine significantly reduced the infant mortality rate
which manufactured the vaccine. The results of the study (IMR) in Sudan (Figure-2) while no significant decrease in
showed a 1.7 fold increase in the risk of intussusception 0- IMR was seen in Ethiopia where Rotavirus vaccine was not
30 days after the administration of the vaccine with introduced (Figure-3). According to another study,
majority of the cases clustering in the first week. No vaccination in Global Alliance for Vaccines and
intussusception cases were reported within 31 days post- Immunisation (GAVI)-eligible countries would prevent
vaccination in a randomised double-blinded study done 2.46 million childhood deaths and 83 million disability-
in Asia.21 adjusted life years (DALYs) from 2011 to 2030, with annual
reductions of 180,000 childhood deaths at peak vaccine
A randomised, double-blinded, placebo-controlled phase uptake.26
III study conducted in 10 Latin American countries
included more than 15,183 healthy infants aged 6-13 Post-licensure studies of RotaTeq and Rotarix found
weeks. Two oral doses of the vaccine were delivered and evidence of porcine circoviruses (PCV) type 1 in Rotarix
the participants were followed up for two years. There vaccines. However, there is no evidence of PCV disease in
were fewer cases of severe gastroenteritis in infants who humans. Moreover, clinical trials did not detect PCV in the
were vaccinated, and the efficacy of the vaccine against serum of vaccinated infants. It was suspected that PCV
severe Rotavirus hospital admissions was reported to be came from the growth of Rotavirus in vitro. After advisory
83%. The same trial had evaluated rates of meetings and evaluation of the available evidence, the FDA
intussusception in recipients and non-vaccinees and
reported that there was no case of intussusception
reported till two years after vaccination.22
7. Dennehy PH. Rotavirus vaccines: an overview. Clin Microbiol Rev Safety and efficacy of human rotavirus vaccine during the first 2
2008; 21:198-208. years of life in Asian infants: randomised, double-blind, controlled
8. Intussusception among recipients of rotavirus vaccine - United study. Vaccine 2009; 27: 5936-41.
States, 1998-1999. MMWR Morb Mortal Wkly Rep 1999; 48: 577-81. 22. Linhares AC, Velzquez FR, Prez-Schael I, Sez-Llorens X, Abate H,
9. Withdrawal of rotavirus vaccine recommendation. MMWR Morb Espinoza F, et al. Efficacy and safety of an oral live attenuated
Mortal Wkly Rep 1999; 48: 1007. human rotavirus vaccine against rotavirus gastroenteritis during
10. Ustrup M, Madsen LB, Bygbjerg IC, Konradsen F. Outstanding the first 2 years of life in Latin American infants:randomised,
challenges for rotavirus vaccine introduction in low-income double-blind controlled study. Lancet 2008; 371: 1181-9.
countries--a systematic review. Dan Med Bull 2011; 58: A4323. 23. Madhi SA, Cunliffe NA, Steele D, Witte D, Kirsten M, Louw C, et al.
11. Grimwood K, Buttery JP. Clinical update: rota virus gastroenteritis Effect of human rotavirus vaccine on severe diarrhea in African
and its prevention. Lancet. 2007; 370: 302-4. infants. N Engl J Med 2010; 362: 289-98.
12. Ruiz-Palacios GM, Prez-Schael I, Velzquez FR, Abate H, Breuer T, 24. Justino MC, Arajo EC, van Doorn LJ, Oliveira CS, Gabbay YB,
Clemens SC, et al. Safety and efficacy of an attenuated vaccine Mascarenhas JD, et al. Oral live attenuated human rotavirus
against severe rotavirus gastroenteritis. N Engl J Med 2006; 354: vaccine (Rotarix) offers sustained high protection against severe
11-22. G9P[8] rotavirus gastroenteritis during the first two years of life in
13. Bgu RE, Perrin K. Reduction in gastroenteritis with the use of Brazilian children. Mem Inst Oswaldo Cruz 2012; 107: 846-53.
pentavalent rotavirus vaccine in a primary practice. Pediatrics 25. Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van
2010; 126: e40-5. Doorn LJ, et al. Efficacy, safetyand immunogenicity of RIX4414 in
14. Merck & Co Inc. (2013) Package insert RotaTeq. Japanese infants during the first two years of life. Vaccine 2011; 29:
15. Committee on Infectious Diseases; American Academy of 6335-41.
Pediatrics. Prevention of Rotavirus Disease: Updated Guidelines 26. Atherly DE, Lewis KD, Tate J, Parashar UD, Rheingans RD. Projected
for Use of Rotavirus vaccine. Pediatrics 2009; 123: 1412-20. health and economic impact of rotavirus vaccination in GAVI-
16. Payne DC, Edwards KM, Bowen MD, Keckley E, Peters J, Esona MD, eligible countries: 2011-2030. Vaccine 2012; 30 Suppl 1: A7-14.
et al . Sibling transmission of vaccine-derived rotavirus (RotaTeq) 27. Plosker GL. Pentavalent rotavirus vaccine (RotaTeq): a review of its
associated with rotavirus gastroenteritis. Pediatrics 2010; 125: use in the prevention of rotavirus gastroenteritis in Europe. Drugs
e438-41. 2010; 70: 1165-88.
17. Vesikari T, Karvonen A, Ferrante SA, Ciarlet M. Efficacy of the 28. Centers for Disease Control and Prevention. Rotavirus. (Online)
pentavalent rotavirus vaccine, RotaTeq, in Finnish infants up to 3 (Cited 2014 Feb 3). Available from: URL:
years of age: the Finnish Extension Study. Eur J Pediatr 2010; 169: http://www.cdc.gov/vaccinesafety/vaccines/rotavsb.html.
1379-86. 29. Nakagomi O, Iturriza-Gomara M, Nakagomi T, Cunliffe NA.
18. Yih WK, Lieu TA, Kulldorff M, Martin D, McMahill-Walraven CN, Platt Incorporation of a rotavirus vaccine into the national
R, et al. Intussusception risk after rotavirus vaccination in U.S. immunisation schedule in the United Kingdom: a review. Expert
infants. N Engl J Med 2014; 370: 503-12. Opin Biol Ther 2013; 13: 1613-21.
19. GlaxoSmithKline (2012) WHO Package insert Rotarix (liquid 30. Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS,
formulation). Parashar UD. Economic costs of rotavirus gastroenteritis and cost-
20. Dennehy PH, Brady RC, Halperin SA, Ward RL, Alvey JC, Fischer FH effectiveness of vaccination in developing countries. J Infect Dis
Jr, et al. Comparative evaluation of safety and immunogenicity of 2009; 200: S16-27.
two dosages of an oral live attenuated human rotavirus vaccine. 31. Kim SY, Sweet S, Slichter D, Goldie SJ. Health and economic impact
Pediatr Infect Dis J 2005; 24: 481-8. of rotavirus vaccination in GAVI-eligible countries. BMC Public
21. Phua KB, Lim FS, Lau YL, Nelson EA, Huang LM, Quak SH, et al. Health 2010; 10: 253.