Vaccines for preventing rotavirus diarrhoea: vaccines in use

UPDATE

Karla Soares‐Weiser1, Hanna Bergman2, Nicholas Henschke2, Femi Pitan3, Nigel Cunliffe4

1. Editorial & Methods Department, Cochrane, London, UK
2. Cochrane Response, Cochrane, London, UK
3. Chevron Corporation, Lagos, Nigeria
4. Institute of Infection and Global Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK

Soares‐Weiser  K, Bergman  H, Henschke  N, Pitan  F, Cunliffe  N. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database of Systematic Reviews 2019, Issue 3. Art. No.: CD008521. DOI: 10.1002/14651858.CD008521.pub4

Access the full text article here: DOI: 10.1002/14651858.CD008521.pub4/full

What is the aim of this review?

The aim of this Cochrane Review was to find out if rotavirus vaccines are effective in preventing diarrhoea and deaths in infants and young children. We also aimed to find out if the rotavirus vaccines are safe. We collected and analyzed all relevant studies to answer these questions, and found 55 studies.

Key messages

RV1, RV5, and Rotavac prevent episodes of rotavirus diarrhoea (moderate‐ to high‐certainty evidence). We found no increased risk of serious adverse events (moderate‐ to high‐certainty evidence) including intussusception (where the bowel telescopes on itself, and can cause obstruction) (very low to low‐certainty evidence).

What was studied in the review?

Rotavirus infection is a common cause of diarrhoea in infants and young children, and can cause mild illness, hospitalization, and death. Since 2009, the World Health Organization (WHO) has recommended that a rotavirus vaccine be included in all national infant and child immunization programmes, and 95 countries have so far followed this recommendation. In the years before infants and children started receiving rotavirus vaccine, rotavirus infection resulted in about half a million deaths a year in children aged under five years, mainly in low‐ and middle‐income countries.

In this review we included randomized controlled trials in infants and young children that evaluated a monovalent rotavirus vaccine (RV1; Rotarix, GlaxoSmithKline) or a pentavalent rotavirus vaccine (RV5; RotaTeq, Merck). These vaccines have been evaluated in several large trials and are approved for use in many countries. We also included trials that evaluated another monovalent rotavirus vaccine (Rotavac; Bharat Biotech), which is used in India only. The rotavirus vaccines were compared with placebo or with no vaccine. The included studies did not allow comparisons between the vaccines.

What are the main results of the review?

We found 55 relevant studies with 216,480 participants. The trials took place in several locations worldwide. These studies compared a rotavirus vaccine versus placebo or versus no vaccine for infants and young children. The vaccines tested were RV1 (36 trials with 119,114 participants), RV5 (15 trials with 88,934 participants), and Rotavac (four trials with 8432 participants). Fifty‐one studies were funded or co‐funded by vaccine manufacturers, while four were independent of manufacturer funding.

In the first two years of life, RV1:

●prevents more than 80% of severe cases of rotavirus diarrhoea in countries with low death rates (high‐certainty evidence)
●prevents 35% to 63% of severe rotavirus diarrhoea in countries with high death rates (high‐certainty evidence)
●probably prevents 37% to 41% of severe cases of diarrhoea from all causes (such as any viral infection, bacterial infection, or parasitic infection) in countries with low death rates (moderate‐certainty evidence)
●probably prevents 18% to 27% of severe cases of diarrhoea from all causes in countries with high death rates (moderate‐ to high‐certainty evidence).

In the first two years of life, RV5:

●probably prevents 82% to 92% of severe cases of rotavirus diarrhoea in countries with low death rates (moderate‐certainty evidence)
●prevents 41% to 57% of severe cases of rotavirus diarrhoea in countries with high death rates (high‐certainty evidence)
●probably prevents 15% of severe cases of diarrhoea from all causes in countries with high death rates (moderate‐ to high‐certainty evidence); we did not identify any studies that reported on diarrhoea from all causes in countries with low death rates.

In the first two years of life, Rotavac:

●probably prevents more than 50% of severe cases of rotavirus diarrhoea in India, a country with high death rates (moderate‐certainty evidence)
●probably prevents 18% of severe cases of diarrhoea from all causes in India (moderate‐certainty evidence). Rotavac has not been evaluated in a randomized controlled trial in a country with low death rates.

We found little or no difference in the number of serious adverse events (moderate‐ to high‐certainty evidence), or intussusception cases (low‐ to very low‐certainty evidence), between those receiving RV1, RV5, or Rotavac compared with placebo or no intervention.

How up‐to‐date is this review?

We searched for studies that had been published up to 4 April 2018.