I thank Dr Peter Flegg for his continued interest in our paper and our response to the comments made by him. I am however surprised that he has not heard of skin testing for sensitivity to penicillin. The link here refers to a ‘Mayo Clinic’ article about skin testing in this context, written without medical jargon such that non-medical health policy planners can also understand it. (1) It is another matter that penicillin sensitivity is rare in infancy.

Peter Flegg castigates me for not providing “verifiable evidence that these sporadic and infrequent deaths are linked to vaccine”. I hope he appreciates the fact that ‘re-challenge’ with the vaccine will be impossible when the child dies as reaction to the drug. We are forced to consider statistical probabilities to draw conclusions. I will discuss them below.

1. It is often suggested that there is a background rate of Sudden Infant Death Syndrome (SIDS) and it is possible that an infant may have received immunization, purely by chance, on the day he/she was to die of SIDS. The USA has one of the highest SIDS rates in the developed world (countries from where such data is available). 0.5 deaths occur due to SIDS per 1000 live births in the USA. (2) It is possible that a death on the day of vaccination may occur due to chance but what are the chances?

If every infant born in the USA is vaccinated on every day during his first year of life (365 vaccinations on 365 days) then 0.5 babies will die by chance on the day of vaccination per 1000 children subjected to such intensive vaccination.

If we look at death on the day the child receives the first dose of Pentavalent vaccine then there will be 0.5 deaths by chance on the day of vaccination, per 365,000 infants vaccinated (or 1 death per 720,000 infants vaccinated).

In Kerala, India there was 1 death per 10,000 vaccinated with the first dose of Pentavalent vaccine. (Data is from the first 6 months of introducing the vaccine). This can happen by chance, if the SIDS rate in Kerala is 70 times higher than the SIDS rate in the USA. We do not know the SIDS rate in Kerala but the SIDS deaths cannot be double the ‘all-cause’ infant mortality rate in the State (Kerala IMR 14/1000),(3) so we can dismiss the possibility that vaccine deaths are all coincidental SIDS deaths.

2. Most of the deaths following Pentavalent vaccine have occurred with the first dose of the vaccine. This further militates against the possibility that the association of death on day of vaccination is purely by chance. The SIDS rate in the 2nd month (when the first dose of Pentavalent vaccine is administered) is not that very different from the SIDS rate in the 3rd and 4th months (when the second and third doses are given).

This pattern of increased occurrences of adverse events with the initial dose, was also witnessed with rotavirus-vaccine, where most of the intussusceptions happened after the first dose.

3. SIDS by definition relates the sudden death of an infant that is not predicted by medical history and remains unexplained after a thorough forensic autopsy and detailed death scene investigation. With deaths following Pentavalent vaccine, there is a history of having received the vaccine. Many of those who die have had high fever, excessive crying and breathlessness. The deaths cannot be said to be ‘unexplained’ unless one stubbornly and irrationally refuses to countenance the possibility of an adverse drug reaction.

4. All this evidence suggests that deaths following Pentavalent vaccine cannot be passed off as a chance (natural) event. The next question then is how many vaccine related deaths can be tolerate as ‘acceptable collateral damage’ in our campaign against disease. We had previously calculated that vaccinating the birth cohort of 25 million in India will result in 3250 deaths from vaccine related adverse events.

Hib meningitis in this cohort is likely to cause 875 deaths over the next five years. The incidence of Hib pneumonia is higher but mortality from chest infections is very much lower. Assuming an equal number of deaths from pneumonia may be averted (we can assume another 875 lives saved) the total number of Hib deaths averted by vaccination is 1750. Nearly twice as many (3250) will die from the intervention (vaccination). Can that be considered as acceptable collateral damage? This is why we are alarmed when international organizations promote this vaccine in Asia as a life saving measure, in the face of such stark evidence to the contrary.

References

1. http://www.mayoclinic.com/health/penicillin-allergy/DS00620/DSECTION=tes...

2. Hauck FR, Tanabe KO. International trends in sudden infant death syndrome: stabilization of rates requires further action. Pediatrics. 2008 Sep;122(3):660-6. doi: 10.1542/peds.2007-0135.

3. http://en.wikipedia.org/wiki/Kerala_model

Competing interests: None declared