South Africa: Rotavirus vaccination programme delayed

South Africa’s introduction of a rotavirus vaccine will be launched at the earliest on 1 August 2009, after a three-month delay in its registration by the Medicines Control Council (MCC). About four-fifths of rotavirus infections occur in Africa and Asia; it is the leading cause of severe, dehydrating diarrhoea in children younger than five years, and is blamed for the deaths of between 140,000 and 150,000 children annually in Africa and 500,000 globally.

In the developing world, diarrhoeal diseases account for 20 percent to 25 percent of deaths among children aged under five years. According to a 2005 World Health Organization report on rotavirus vaccine research, infection occurs in 25 percent to 40 percent of children hospitalized with diarrhoeal illness in Africa.

[...] Most of the world’s children – 95 percent – will have suffered a rotavirus infection by the time they are between three and five years old, but in Africa this has usually happened by the time a child reaches the age of two. Peak incidence occurs in children aged between 6 months and 18 months, and the younger the child the higher the risk posed by the rotavirus. [C]hildren were usually infected numerous times, but the first infection was almost always the most severe, becoming milder with each subsequent bout.

The vaccine was designed to protect against the first infection, and would also alleviate the burden of hospitalization in already stretched health infrastructure.

Infections of the highly contagious rotavirus occur seasonally in South Africa, usually during the winter months from late March to August.

Reasons for delay

[A]ccording to reports the company awarded the tender to supply the vaccine had discontinued manufacture of the powder form registered by the MCC, and was only available as a liquid, which had not been registered. The vaccine had to be re-registered by the MCC, which took place in March [2009].