Safety Records

Benefits Far Outweigh Risks

Rotavirus vaccines currently available on the international market have been shown to be safe. The main safety concern has been a very small increased risk of a rare obstructed bowel syndrome called intussusception. Intussusception occurs naturally in infants under 12 months of age regardless of rotavirus vaccination status, but a very small increased risk has been found in some countries following the introduction of rotavirus vaccines, especially within the first week after the first dose is given.

No increased risk of intussusception following the rotavirus vaccination was shown in a seven-country post-marketing evaluation in Africa.⁽¹⁾

Risk-Benefit Ratio

An analysis of 14 Latin American countries encompassing 9.5 million infants found a benefit-to-risk ratio of 841:1 for hospitalizations and 345:1 for deaths.⁽²⁾ A similar study conducted in France estimated, assuming a coverage rate of 92% for two doses of ROTARIX, a benefit-to-risk ratio of 221 rotavirus hospitalizations avoided for every hospitalization caused by intussusception and 284 rotavirus-related deaths prevented for every death due to intussusception.⁽³⁾

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WHO Recommendation

WHO recommends that the first dose of rotavirus vaccine be administered as soon as possible after 6 weeks of age, along with DPT vaccination.

References

^{1.Tate, J.E., et al., Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa. N Engl J Med, 2018. 378(16): p. 1521–1528}

^{2. Desai, R., et al., Potential intussusception risk versus health benefits from rotavirus vaccination in Latin America. Clinical Infectious Diseases, 2012. 54(10): p. 1397–1405.}

^{3. Lamrani, A., et al., A benefit-risk analysis of rotavirus vaccination, France, 2015. Euro Surveill, 2017. 22(50): p. 28–37.}