Rotavirus Vaccines

According to the Vaccine Information Statement (VIS), Rotavirus is responsible for 20-60 deaths per year.

However, no safety or efficacy data are available for the administration of RotaTeq to infants who are immunocompromised or who have a history of gastrointestinal disorders. (See RotaTeq Product Insert)  From a basic understanding of health, it would be this group that would be most susceptible to serious complications or death due to severe diarrhea.

A previous Rotavirus vaccine (RotaShield) was taken off the market in 1999 because it was found to cause intussusception (a type of bowel obstruction that occurs when the bowel folds in on itself).

In February 2007 the FDA issued a public health notification following 28 postmarketing reports of intussusception in pediatric patients who received RotaTeq.  Although no deaths resulted, 16 infants required hospitalization and intestinal surgery.


RotaTeq – Merck – Package Insert

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age. (Page 1)

No safety or efficacy data are available for the administration of RotaTeq to infants who are potentially immunocompromised. (Page 1)

No safety or efficacy data are available for the administration of RotaTeq to infants with a history of gastrointestinal disorders (e.g., active acute gastrointestinal illness, chronic diarrhea, failure to thrive, history of congenital abdominal disorders, and abdominal surgery). (Page 1)

Transmission of vaccine virus strains from vaccinees to non-vaccinated contacts has been observed in clinical trials and post-marketing. (Page 4)

Most common adverse events included diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm. (Page 1)

Clinical Studies:  71,725 infants were evaluated in 3 placebo controlled clinical trials.  Serious adverse events occurred in 2.4% of recipients of RotaTeq when compared to 2.6% of placebo recipients within the 42-day period of a dose in the phase 3 clinical studies of RotaTeq.

Across the clinical studies, 52 deaths were reported. There were 25 deaths in the RotaTeq recipients compared to 27 deaths in the placebo recipients. The most commonly reported cause of death was sudden infant death syndrome, which was observed in 8 recipients of RotaTeq and 9 placebo recipients.

There were also 11 cases of intussusception in the clinical trials, 6 in the RotaTeq group and 5 in the placebo.  One child died. (Page 5)

Remember however, that in clinical studies for vaccines, placebo does not mean they were given an inert substance.  “In clinical trials, RotaTeq was administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine.” (Page 8)

Therefore the placebo was DTaP, IPV Hib, Hep B and pneumococcal conjugate vaccines, just minus RotaTeq.  So what the safety studies tell us is that the addition of RotaTeq to all these vaccines doesn’t really add any serious adverse reactions, just more diarrhea, vomiting, irritability, otitis media, nasopharyngitis, and bronchospasm.

Post-marketing adverse events:  Intussusception (including death), Hematochezia, Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID), Urticaria, Angioedema, Kawasaki disease, Transmission of vaccine virus strains from vaccine recipient to non-vaccinated contacts. (Page 7)

RotaTeq Ingredients: sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, fetal bovine serum, vero cells [DNA from porcine circoviruses (PCV) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 are not known to cause disease in humans.]


Rotarix – GlaxoSmithKline – Package Insert

ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis by G1 and non-G1 types (G3, G4, and G9).  ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.  (Page 1)

Infants with a history of intussusception should not receive ROTARIIX.  In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose. (Page 4)

Safety and effectiveness of ROTARIX in infants with chronic gastrointestinal disorders have not been evaluated. (Page 5)

Rotavirus shedding in stool occurs after vaccination with peak excretion occurring around day 7 after dose 1. (Page 5)

The safety studies included 8 clinical studies evaluating a total of 71,209 infants who received ROTARIX.  The placebo used for these studies was referred to as a "Total vaccinated cohort", which was defined as "all vaccinated infants for whom safety data was available". (Page 6-7)

Serious adverse events occurred in 1.7% of recipients of ROTARIX, which included diarrhea, dehydration, and gastroenteritis. (Page 7)

During the entire course of 8 clinical studies, there were 68 deaths (0.19%) following administration of ROTARIX and 50 deaths (0.15%) following placebo (total vaccinated cohort) administration. (Page 7)

Adverse Reactions seen in Postmarketing Experience: Intussusception (including death), recurrent intussusception (including death), hematochezia, gastroenteritis with vaccine viral shedding in infants with SCID, Idiopathic thrombocytopenia purpura, Kawasaki disease. (Page 10)

ROTARIX Ingredients: amino acids, dextran, sorbitol, sucrose, calcium carbonate, xanthan, Dulbecco's Modified Eagle Medium (sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate D-glucose, concentrated vitamin solution, L-cysteine, L-tyrosine, amino acids solution, L-250 glutamine, calcium chloride, sodium hydrogencarbonate, and phenol red) [Porcine circovirus type 1 (PCV-1) is present in Rotarix.  PCV-1 is not known to cause disease in humans.]

Rotarix rotavirus vaccine contaminated, officials say

© 2011 - •