Hep B Recombivax HB Package Insert
I´m reading the package insert for Recombivax HB and on page 7 under adverse reactions, it mentions their clinical trials. It reads: "In three clinical studies, 434 doses of RECOMBIVAX HB, 5mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic complaints were reported following 0.2% and 10.4% of the injections, respectively. ..." Were only 147 CHILDREN TESTED???? COULD THAT BE POSSIBLE???
If so I am just blown away. And the children were monitored for 5 days after each dose? That´s it?? I also think it is complete nonsense how the rate of reported reactions is so low for vaccines administered at 12 hours, 2 months...etc. Ummmm...the 12 hour old baby didn´t really know how to report how crappy she was feeling! So many times you hear parents talking about how tough it was those first few days when we "had to deal with my milk coming in and adjusting to that..." Meanwhile, the baby could be having an adverse reaction but it isn´t thought of like that. ugh. 
If anyone has more info on the testing for RECOMBIVAX HB, I´d appreciate it.
