Update: Vaccines for preventing rotavirus diarrhoea: vaccines in use

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 analysed all relevant studies to answer these questions.

Key messages

Rotarix, RotaTeq, Rotasiil, and Rotavac prevent  the large majority of episodes of rotavirus diarrhoea during the first year of a child's life, when diarrhoea is most dangerous, with a slightly lower efficacy during the second year. 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).

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. To date, 96 countries have 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 rotavirus vaccination with Rotarix (GlaxoSmithKline) or 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 Rotavac (Bharat Biotech Ltd.) and Rotasiil (Serum Institute of India Ltd.), rotavirus vaccines which are currently used in India only. The rotavirus vaccines were compared with placebo or with no vaccine. The included studies did not allow comparisons between the different rotavirus vaccines.

What are the main results of the review?

We found 60 relevant studies with a total of 228,233 participants. The trials took place in several locations worldwide. The vaccines tested were Rotarix (36 trials with 119,114 participants), RotaTeq (15 trials with 88,934 participants), Rotasiil (five trials with 11,753 participants), and Rotavac (four trials with 8432 participants). Fifty‐six studies were funded or co‐funded by vaccine manufacturers, while four were independent of manufacturer funding.

In the first two years of life, we found that rotavirus vaccines prevent more than 90% of severe cases of rotavirus diarrhoea in countries with low child mortality rates, more than 75% in countries with medium child mortality rates, and 35% to 58% in countries with high child mortality rates.

Rotavirus vaccines probably prevent more than 50% of severe cases of diarrhoea from all causes (such as any viral infection, bacterial infection, or parasitic infection) in countries with low child mortality rates, 26% to 36% in countries with medium child mortality rates, and none to 27% in countries with high child mortality rates.

The evidence for countries with low and medium child mortality rates comes from studies of Rotarix and RotaTeq vaccines; these two vaccines have been evaluated in all settings. Rotasiil and Rotavac vaccines have only been assessed in countries with high child mortality rates.

We found little or no difference in the number of serious adverse events between those receiving rotavirus vaccines compared with placebo or with no vaccine.

Rotavirus vaccines may make little to no difference to the number of deaths or to intussusception cases, compared with placebo or no vaccine, but the certainty of the evidence was limited for these rare outcomes.

How up‐to‐date is this review?

We searched for studies that had been published up to 30 November 2020.