By Christina England
The trial, whilst sickening in itself, was testing out the rotavirus vaccine on a group of 988 premature babies ranging between 27 weeks and 36 weeks.
The paper reporting the trial was published on the ‘Pediatric SuperSite’ and was entitled ‘Human rotavirus immunogenic, well-tolerated for preterm infants’ by Felix Omenaca MD. PhD, and colleagues (1) The paper stated the following:
“The researchers grouped preterm infants by ages — infants born at gestational ages 27 to 30 weeks and those born at 30 to 36 weeks. They administered rotavirus vaccine (RIX4414, GlaxoSmithKline) in two doses to 658 preterm infants, and 330 received a placebo along with routine vaccinations, including diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type B and poliovirus. Infants from France and Spain also received Streptococcus pneumoniae concomitantly; infants from Portugal and Spain also received Neisseria meningitides.
The researchers then asked parents/guardians to report adverse effects, and they noted no statistically significant difference in the reporting of severe adverse reactions in the vaccine or placebo group (5.1% and 6.2%, respectively). Unsolicited adverse effects, which included fever of more than 39.5·C, six or more bouts of diarrhea per day, three or more episodes of vomiting per day, appetite loss and irritability, were reported in 29.3% of preterm infants in the vaccine group and 40.7% in the placebo group. (own emphasis)
The problems I see are as follows:
- All the infants were given multiple vaccinations, therefore, there was no control group.
- Of a group of 988 children, approx 2/3 were given the vaccine for rotavirus and 1/3 were given the placebo, then the researchers compared the results like for like. This cannot be done because one group is significantly larger than the other.
- Because all of the infants received multiple vaccinations it is impossible to tell which vaccine if any caused the side effects.