The data sheet for Rotarix says:
‘The exact immunologic mechanism by which ROTARIX protects against rotavirus gastroenteritis is unknown….. Pharmacodynamics Immunogenicity: A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastroenteritis has not been established.’
The vaccine has never been tested to see if it causes cancer, mutates into another illness or impairs fertility, so if doctors say it’s safe they’ve not done the testing to show that.
The trial information did not state what the placebo was. In many trials, aluminium or another vaccine are often used.
The most common side-effects are fussiness and irritability (in more than half the children vaccinated), cough and runny nose, fever, loss of appetite, vomiting and diarrhoea (diarrhoea occurs in 4% of those vaccinated and it is a vaccine designed to prevent diarrhoea).
In the post-trial phase, intussusception (where the bowel folds in on itself and becomes blocked) was noticed to be occurring in children, most commonly in the first week after vaccination. This is a life threatening condition that is only fixable by surgery. The rate of intussusception was estimated to be anything from 0 to 4 cases per 100,000 children vaccinated with Rotarix. The CDC rather casually say:
‘Given that the information available suggests a small risk of intussusception caused by Rotarix, and given that the benefits of rotavirus vaccination are great, CDC continues to recommend Rotarix to prevent rotavirus disease.’
The first rotavirus vaccine to be licensed in the US, Rotateq, was withdrawn in October 1999, only a year after its introduction because it caused intussusception in 10 out of every 100,000 vaccinated children.
Then in March 2010 the subsequent vaccine, Rotarix, was found to contain pig DNA from circovirus type one. This virus wasn’t supposed to be in the vaccine and they had only just discovered that in fact, it had been present in the initial stages of the development of the vaccine and it had been present during the clinical trials, without the FDA’s knowledge.
“In many countries, rotavirus causes so much severe illness and death that the known benefits of continued use of Rotarix far outweigh any theoretical risk of harm from the vaccine,” said Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention, in a damage control statement to the press.
But how do they know if the benefits outweigh the risks when they don’t know what those risks are and they weren’t even aware that the vaccine contained pig virus DNA?
Now, the same vaccine that was temporarily withdrawn in the US is coming to the UK and what’s more, it still has pig virus in it. This is listed in the ingredients section of the manufacturer’s data sheet.
As this vaccine is live it is shed in the faeces, urine and saliva of the recipient. In a study in Singapore looking at shedding, stool samples were collected and it was found that up to 80.0% of people were shedding live rotavirus a week after their vaccine. Up to 64.1% were shedding the virus 15 days after the vaccine, 24.3% were shedding it a month later and 2.6% were still shedding it two months later.
The ability of the rotavirus vaccine virus to transmit to others has not been evaluated in any study. If the aim of the vaccine is to reduce rotavirus related hospitalisations, giving the live virus on a mass scale may in fact put newborn babies at risk of getting the disease.
In eight trials of the vaccine, there were 68 recorded deaths (out of 36,755 children) in the 31 day post-vaccination follow up, making the official rate of death from the vaccine 0.19%. The actual rate of death is probably higher, given that the follow up period is so short. The most common cause of death after vaccination was pneumonia, which occurred in 19 of the 68 deaths.
In the Rotarix BLA clinical review, the Vaccine Clinical Trials Branch admit that there is an increased risk of death from pneumonia after getting the vaccine.
Despite all this health authorities continue to recommend it when good old fashioned mother’s milk can prevent rotavirus without any of the risk.
NHS Choices, Gastroenteritis in Children. Web. 24th February 2013.
NHS Choices, Rotavirus Vaccine to be Introduced for Babies. Web. 24th February 2013.
Burden of community-acquired and nosocomial rotavirus gastroenteritis in the pediatric population of Western Europe: a scoping review. BMC Infectious Diseases 2012, 12:62.
Estimated rotavirus deaths for children under 5 years of age: 2008, 453 000. World Health Organisation. Web. 24th February 2013.
Rotarix BLA Clinical Review. Food and Drug Administration. Web. 24th February 2013.
Updated Label for Rotarix. Centers for Disease Control and Prevention. Web. 24th February 2013.
Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk. FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as Agency Learns More. FDA News Release (22nd March 2010). Web. 24th February 2013.
Breastfeeding protects against acute gastroenteritis due to rotavirus in infants. Eur J Pediatr. 2010 Dec;169(12):1471-6.
Rotarix GlaxoSmithKline Vaccine Data Sheet (undated), Food and Drug Administration. Web. 24th February 2013.
Bottle-feeding might turn your baby into a sitting duck for a number of diseases, say doctors. The Express Tribune. Web. 24th February 2013.
Human milk mucin inhibits rotavirus replication and prevents experimental gastroenteritis, J Clin Invest. 1992 November; 90(5): 1984–1991.