On April 3, 2008, the FDA approved ROTARIX, a second live oral rotavirus vaccine for use in infants six through 24 weeks of age. Manufactured by GlaxoSmithKline, this vaccine was approved to be administered at as a 2-dose series for the prevention of rotavirus gastroenteritis cause by serotypes G1, G3, G4, and G9.
Pre-licensing clinical trials of ROTARIX involved approximately 63,000 infants. In these trials, ROTARIX was tested against a placebo; however, both the ROTARIX group as well as the placebo group also received all additionally recommended age-appropriate vaccines (pertussis, diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b (Hib), pneumococcal conjugate, and poliovirus) in nearly all studies.
No increased risk of intussusception was noted in the pre-licensing clinical trials; however, other serious adverse events including deaths were reported. Among all studies, 118 deaths were reported, with a statistically significant increase in the number of pneumonia-related deaths reported among infants who received ROTARIX in comparison to those who received the placebo. Additionally, higher rates of convulsions and pneumonia as well as irritability, flatulence, and bronchitis were seen among ROTARIX vaccine recipients.
In June 2008, ACIP voted to recommend the use of ROTARIX as a second option for the prevention of rotavirus gastroenteritis but no preference was given to either rotavirus vaccine. ACIP also stated that the first dose of rotavirus vaccine needed to be administered between six weeks and 14 weeks and 6 days of age and that the vaccine series must be completed prior to 8 months of age.
