Per Wikipedia:  “Rotavirus is a genus of double-stranded RNA viruses in the family Reoviridae. Rotaviruses are the most common cause of diarrhoeal disease among infants and young children. Nearly every child in the world is infected with a rotavirus at least once by the age of five. Immunity develops with each infection, so subsequent infections are less severe; adults are rarely affected. There are nine species of the genus, referred to as A, B, C, D, E, F, G, H and I. Rotavirus A, the most common species, causes more than 90% of rotavirus infections in humans.

“The virus is transmitted by the faecal-oral route. It infects and damages the cells that line the small intestine and causes gastroenteritis (which is often called “stomach flu” despite having no relation to influenza). Although Rotavirus was discovered in 1973 by Ruth Bishop and her colleagues by electron micrograph images and accounts for approximately one third of hospitalisations for severe diarrhoea in infants and children, its importance has historically been underestimated within the public health community, particularly in developing countries. In addition to its impact on human health, rotavirus also infects animals, and is a pathogen of livestock.”

According to the CDC, 20 to 60 infants died each year from rotavirus infections due to profound deydration caused by diarrhea prior to the vaccine’s release in 2006.  Like the pertussis vaccine, the rotavirus vaccine does not confer immunity to the disease:  it only lowers the severity of sympoms once infected.  Since rotavirus is endemic and has reservoirs in multiple other animal species, there is no possibility of it being eliminated entirely from the population.

Vaccine Statistics

When debating informed consent, it is important that people calculate the risk versus the reward for all options.  Here are some facts, according to VAERS and the CDC.

  • Prior to vaccination, an average of 40 infants died each year due to rotavirus infection
  • Since 2006, there have been 414 deaths reported to VAERS associated with the rotavirus vaccine
  • Since 2006, there have been 15,930 adverse events reported to VAERS, with the vast majority of them in children under one year of age
With no other data, children face an equivalent risk of death from the rotavirus vaccine and rotavirus infection.  When the bigger picture is looked at, however, the numbers get fuzzier.  Since 2006, there have been an average of 3.8 million live births in the US annually.  Most states don’t mandate the rotavirus vaccine, but based upon the current figures from 25 consistently reporting laboratories across the US (10% positive versus 26% prior to vaccination), a forgiving interpretation for purposes of these statistics would be a 30% average vaccination rate since release (1.14 million children, or 2.28 million doses per annum).  This leaves the odds of death at 1 in 66,000 per dose, or 1 in ~30,000 per full vaccination series.  This is roughly comparable to odds of death prior to vaccination.  If the FDA’s assessment of reporting compliance is correct (<1%), a correct comparison might sway the odds by two orders of magnitude in terms of infection as opposed to vaccination.  The problem with this calculation, however, is that we simply do not know the true number of deaths attributable to the rotavirus vaccine due to our faulty reporting system.  Other statistics (based upon estimated numbers of doses administered per the above calculation) reported since 2006 (rate reported/rate possible per FDA):
 
  • 745 immediately life threatening complications (1 in 37,000/1 in 370)
  • 200 permanent disabilities (1 in 137,000/1 in 1370)
  • 2895 hospitalizations or extensions of hospitalizations (1 in 9400/1 in 94)
  • 5317 emergency room or office visits related to complications (1 in 5100/1 in 51)
In terms of hospitalizations, the CDC reports a reduction of 40-50,000 per annum nationwide relating to infant dehydration or diarrhea.  In contrast, given the reports of laboratory testing facilities, a more realistic rate of reduction due to rotavirus would be closer to 8000 per year.  In the link in the prior paragraph, the CDC itself confesses to a total lack of reporting regarding this disease, making any comparisons problematic.

Vaccine Safety

Vaccine Type:  live virus/known vector of transmission

Pregnancy Class:  C

This section will reference the RotaTeq vaccine insert as provided by the FDA.  It should be noted that the rotavirus vaccine (all types) are one of the few vaccines on the market that doesn’t use aluminum adjuvants.

Contraindications (do not vaccinate):

  • Hypersensitivity to any component of the vaccine
  • History of intussusception
  • Immunosuppressed (such as with steroids) or immunocompromised
  • Fever

Adverse Reactions (as reported by the manufacturer):

  • Hematochezia, siezures, Kawasaki disease, diarrhea, vomiting, irritability, otitis media, nasopharyngitis, bronchospasm, anaphylaxis, intussusception, gastroenteritis, urticaria, angioedema, death

It should be concerning to those that acknowledge the risks involved in vaccination that the control group’s “placebo” was DTaP, which is known to have high risk factors itself.

Editor’s Opinion

At first blush, the rotavirus vaccine appears to afford no greater protection than the disease it is designed to protect due to the risks inherent in the disease itself.  With further consideration, given that the rotavirus vaccine does not confer total immunity but only seeks to lessen the severity of symptoms of an infection that every child will statistically contract before the age of 10, and considering the under-reporting of severe adverse events to VAERS, we can see no cumulative benefit from vaccination and only the amplification of risk.  For example:  1 in 7,200 children during clinical trials developed Kawasaki’s disease, whereas this is not a condition that can arise from rotavirus infection … ever.  When dealing with a disease that kills 1 in 285,000 children each year (over four times more unlikely than being hit by lightning during your lifetime), it makes no sense to expose a child to additional risk to possibly lessen their inevitable symptoms.  We do that anyone administer the rotavirus vaccine to their children.