September 2013 – Melbourne researchers are recruiting infants for a world’s first BCG (Bacillus Calmette-Guerin tuberculosis vaccine) study to determine if it can prevent babies’ allergies. Allergic disease in children has skyrocketed worldwide. In Australia, 1 in 10 children have a food allergy and 27% have suffered from eczema by the age of 12 months. The cost to the country’s health budget due to the food allergies alone is $3 billion. The American Academy of Allergy, Asthma & Immunology reports that “Worldwide, sensitization rates to one or more common allergens among school children are currently approaching 40%-50%.”
The study “is based on the idea that BCG vaccination will promote the development of an immune system that is better at fighting infection and less prone to allergy. Each of the 1,400 babies enrolled in the BAIR study will be randomly allocated, shortly after birth, to be given the BCG vaccine or not. Then we will follow each baby until they are about one year old looking for the causes and signs of infection, food allergy and eczema.”
The Australian vaccination schedule already has babies receiving 35 doses of vaccine up to the age of 18 months. The BCG vaccine had been phased out of the Australian vaccine schedule 30 years ago.
Knowledge of the workings of the immune system, including the hygiene hypothesis and Th1 (cellular) vs. Th2 (humoral / allergy) balance continue to be debated and studied around the world.
BCG vaccine is known to shift the delicate immune system Th1/Th2 balance to the Th1 side. The Melbourne study website doesn’t seem to mention the other vaccines babies receive that skew the immune system towards the Th2 (allergy) side. The Melbourne Herald Sun reported, “Melbourne researchers believe the TB jab not only protects against the disease, but it could also inadvertently act as an anti-hygiene vaccine that counteracts children’s over-clean start to life.”
In an interview with the Herald Sun, infectious disease expert, Professor Nigel Curtis, also neglects to mention the numerous infant vaccines affecting the Th1/Th2 shift while stating: “The hygiene hypothesis was one theory explaining the dramatic increase in allergies in recent decades. The theory is that in our over-clean world babies aren’t exposed to enough good bugs shortly after birth and this sets the immune system off in the wrong direction.”
The vaccine schedule in Australia lists Hepatitis B vaccine for newborns. A 2004 study showed that, “At 1 year, the infant memory response to HBs Ag [anti-hepatitis B surface antigen] was characterised by higher Th2 responses than those of adults.”
The Melbourne study follows the babies to 1 year of age, which will not be long enough to show food allergic reactions that may happen after toddlers are introduced to a varied diet. Also, stopping the study at 1 year will eliminate the data collected from the MMR (Measles, Mumps, Rubella) vaccine which is known for skewing to the Th2 (allergic) side. The MMR vaccine is also connected with higher IgE (allergy) levels.
In addition to the MMR, effects from the vaccines given at 12 months including Hib and Meningococcal C, will also be left out of the data collected by the study if data collection ends at 1 year.
Some previous studies looking into BCG vaccination and allergy have been inconclusive. VaccineNation reports that “The link between BCG vaccination and allergic sensitization has been studied before, with a 2011 systematic review and meta-analysis published in Journal of Allergy and Clinical Immunology concluding that the association is unlikely.”
A March 2003 study with 309 BCG-vaccinated subjects and 442 non-BCG-vaccinated subjects found that, “BCG-vaccinated subjects did not have a lower rate of allergic sensitization than nonvaccinated subjects. However, among the subgroup of subjects with a family history of rhinitis or eczema, BCG vaccination was associated with a lower prevalence of current asthma…”
A May 2000 study titled, ‘Early BCG vaccination and reduction in atopy in Guinea-Bissau’ concluded that “BCG vaccination given early in infancy may prevent the development of atopy in African children.”
A 1997 study in the Lancet concluded “early BCG vaccination in children with atopic heredity does not seem to affect the development of atopic disease before school age.”
The BCG vaccine is live attenuated vaccine containing monosodium glutamate and polysorbate 80. It can cause ulceration and leave a scar. The Canadian package insert states, “BCG Vaccine (Freeze-Dried) contains viable attenuated mycobacteria and should be handled as an infectious agent at all times. After use, any unused vaccine and all equipment, packaging and materials exposed to the product should be immediately placed in a container for biohazardous materials and disposed of as biohazardous waste.”
Is giving newborns a decades-old Th1-skewing vaccine with questionable efficacy (60% efficacy rate for those vaccinated at birth) and a biohazardous ingredient a good way to balance the overloaded Th2-skewing, allergy producing vaccine schedule?