FDA approves rotavirus vaccine for infants

The US Food and Drug Administration (FDA) has given its approval to RotaTeq, a live, oral vaccine for preventing rotavirus gastroenteritis in infants. Manufactured by US-based Merck & Co, RotaTeq is the only vaccine approved in the US that can help protect against the viral infection that may cause diarrhoea, vomiting, fever, and dehydration.

The Centers for Disease Control and Prevention (CDC) has estimated that the infection results in some 55,000 US hospital visits each year for infants and children. In the US, death from the virus is rare but in developing countries it has been estimated to cause several hundred thousand infant and child deaths annually.

The liquid vaccine is given by mouth in three doses, between the ages of 6 and 32 weeks, and in a recent study was found to prevent over 70% of rotavirus gastroenteritis cases.

In 1998, FDA approved a different live vaccine against rotavirus that was later withdrawn from the market because of its association with an increased risk of intussusception, a rare, life-threatening type of blockage or twisting of the intestine. Intussusception occurs spontaneously in 1 in 2,000 healthy young children a year, but occurred at an increased rate during the first weeks following vaccination with the previous rotavirus vaccine.

RotaTeq was evaluated in a trial of over 70,000 children and shown not to increase the risk of intussusception. However, Merck has agreed to conduct a post-licensure study of approximately 44,000 children. CDC will also conduct a large study designed to rapidly detect any association of intussusception with RotaTeq. For the first three years of licensure, the manufacturer will also report cases of intussusception and all serious adverse events to the FDA within 15 days, and all other side effects on a monthly basis.