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A new study published in the New England Journal of Medicine has revealed that the rotavirus vaccine is associated with an increased risk of intussusception.
Intussusception is a bowel disorder where the intestines are pulled inside themselves causing a blockage. It is life threatening and requires immediate medical attention. The involved part of the intestine is compressed so the blood flow to the area is greatly reduced, which may cause that part of the intestine to die and lead to shock in the patient. Rapid detection is needed to avoid sepsis and possible death.
Symptoms of intussusception include abdominal pain, vomiting (babies will cry loudly and draw their legs up in pain), passing stools that are like jelly and have blood in them, fever, paleness and drowsiness.
Depending on the severity of the condition, intussusception can be treated with an enema to reverse the bowel obstruction. If the bowel has ruptured, this cannot be done because the enema itself can cause bowel perforation. More severe cases are treated by surgery to repair the bowel. Sometimes, part of the bowel has to be removed if a section of it has died.
About 615 patients were enrolled to receive a new rotavirus vaccine, RV1, and a further 2,050 people were enrolled as the control group. The medical journal didn’t say whether the control group was also vaccinated with other vaccines or what the placebo was.
In Mexico, there was an increased risk of intussusception between one and seven days after the first dose of RV1. In Brazil, an increased risk was noted one to seven days after the second dose of RV1, which amounted to one in 51,000 infants in Mexico, and one in 68,000 infants in Brazil.
This isn’t the first time such an association has been made. In October of 1999, the original rotavirus vaccine, RotaShield, was withdrawn 14 months after its approval by the FDA because it caused intussusception in about one in every 10,000 children. During that time, two children died, 47 required medical care and 53 needed surgery to fix bowel obstructions following vaccination.
John Livengood, director of the epidemiology and surveillance division of the National Immunization Program, said that if the vaccine had not been withdrawn, it could have led to 850 cases per year of nonfatal bowel obstructions, many of which would have required surgery.
There were also additional presumed cases of intussusception after vaccination. In early October of 1999, just before RotaShield was withdrawn, there were 101 cases of intussusception recorded on the vaccine adverse event reporting system (VAERS), 52 surgeries (including nine bowel resections) and one death. About 57 children developed intussusception within a week of being vaccinated.
In the study of the newer vaccine, an extra 96 cases of intussusception were found, with five deaths attributable to RV1. They say the benefits outweigh the risks because there are 1,300 deaths due to diarrhea in Mexico and Brazil every year. The figure for the US is around 20 deaths per year, and in England and Wales it causes three to four deaths per year. The UK does not have a vaccination for rotavirus.
However, authors of a paper in the Canadian Journal of Infectious Diseases admitted that vaccine adverse events are underreported, so these figures may be conservative estimates of the number of children affected by intussusception. A report in the Wall Street Journal said that even without vaccination, all children could be saved from hospitalization and death from rotavirus if their parents give them rehydration supplements. In the US, they are freely available from chemists. In poorer countries, access to rehydration supplements is limited, which is one of the reasons why they have higher death rates. Aid groups could save many lives if they made sure all families had access to this simple treatment that doesn’t have the same risks as the rotavirus vaccine.
Rotavirus is the leading cause of gastroenteritis in children, and it is caused by contamination from infected feces. This occurs if you go to the toilet or change your baby’s diaper without washing your hands, leaving tiny samples of feces on surfaces or even in the air that can spread to your child and result in diarrhea, vomiting, abdominal pain and fever. Most cases occur in early childhood, and the body develops a natural immunity after the infection; therefore, cases of rotavirus are extremely rare in adults.
Due to better healthcare, nutrition and access to clean water, deaths from rotavirus infections are very rare in developed countries.
If you or your child has rotavirus, the most important thing you can do is keep hydrated by drinking plenty of water. You can also buy oral rehydration solution from a chemist to give your child each time he or she has diarrhea. If your child is breast-fed, continue to breast-feed on demand.
Preventing Rotavirus Naturally
• Wash your hands after going to the toilet, after changing a diaper and before meals.
• Make sure your toilet is kept clean and that your child’s potty is clean.
• Don’t share eating utensils.
• Have a separate towel for each family member.
• If your child has diarrhea, keep him away from other children until he is better.
• Breast-feed! Breast-feeding protects against rotavirus and cuts diarrhea cases by 90 percent in breast-fed children. Breast-feeding actually performed better than the rotavirus vaccine, which was found to reduce cases by 40 percent.
Sources:
Intussusception Risk and Health Benefits of Rotavirus Vaccination in Mexico and Brazil, New England Journal of Medicine, 16th June 2011 - http://www.nejm.org/doi/full/10.1056/NEJMoa1012952
Rotavirus vaccine withdrawal in the United States; The role of postmarketing surveillance, Can J Infect Dis. 2000 Jan–Feb; 11(1): 10–12 - http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2094741/
American Home's Diarrhea Vaccine Loses Approval; Study Links Deaths, Wall Street Journal, 25th October 1999 - http://interactive.wsj.com/articles/SB940801692891105660.htm
Intussusception, MedicineNet.com - http://www.medicinenet.com/intussusception/article.htm
Rotavirus vaccine cuts deaths of Mexican babies from diarrhoea by 40%, BMJ 2010; 340:c511 - http://www.bmj.com/content/340/bmj.c511.short?rss=1&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%253A+bmj%252Frecent+(Latest+from+BMJ)
The epidemiological and clinical characteristics and nutritional development of infants with acute diarrhoea, in north-eastern Brazil, Ann Trop Med Parasitol. 2008 Jun;102(4):357-65 - http://www.ncbi.nlm.nih.gov/pubmed/18510816
Gastroenteritis in Children, NHS Direct Wales - http://www.nhsdirect.wales.nhs.uk/encyclopaedia/g/article/gastroenteritisinchildren/
Joanna is a freelance health writer for The Mother magazine and Suite 101 with a column on infertility, http://infertility.suite101.com/. She is author of the book, 'Breast Milk: A Natural Immunization,' and co-author of an educational resource on disabled parenting, in addition to running a charity for people damaged by vaccines or medical mistakes.
Reviewed June 20, 2011
Edited by Kate Kunkel
Add a Comment2 Comments
Great article Joanna... yet again breast feeding and common sense prevails in reducing disease. I am still in shock that up to a quarter a billion more children in Developing countries will be given this vaccine...in fact they are meeting this week behind closed doors in Seattle to discuss the distribution logistics! The Rotavirus vaccine should not be given to those with infections, esp Aids and HIV, and must be given 3 times under 6 months. 1 or 2 doses has no study for efficacy and over 6 months the risk of high fever is too great. I can't see NGOs (under pressure from GAVI perhaps) being able to deliver this vaccine safely.
June 21, 2011 - 3:15amAnna www.arnica.org.uk
This Comment
Yes, I worry how the third world campaigns are going to be managed and wonder if GAVI have put enough safety plans in place?? Children vaccinated in developed countries have access to adrenaline in the event of allergic reaction, they have vaccines that are 'safer' (such as IPV instead of live oral polio vaccine that can cause polio and DTaP that causes less local reactions than DPT), they have easy access to hospitals and it is easier to store the vaccines.
In third world countries they are routinely given vaccines ruled unsafe in the developed world (such as a brand of MMR that was withdrawn for causing meningitis and they then used it in Brazil), because it is cheaper to use these banned vaccines. Many vaccine camps I read about did not have adrenaline or any emergency facilities to deal with allergic reactions and many parents live in remote areas with no access to hospital in the event of a side-effect.
There are problems with the cold chain and keeping the vaccines at the right temperature so kids end up getting injected with spoiled vaccines and this can cause death. India have recorded officially 128 deaths from vaccines in 2010, which may be down to cold chain problems (http://articles.timesofindia.indiatimes.com/2011-05-29/india/29596453_1_vaccine-deaths-aefi-deaths-public-sector-vaccine-units).
I think if they are going to spend that much money on vaccine campaigns they need to improve the cold chain, improve the hospitals, make sure there are emergency facilities in areas where they vaccinate and there should be a blanket ban universally on all vaccines that were withdrawn.
June 22, 2011 - 3:31amThis Comment