Intended for healthcare professionals

Rapid response to:

Letters Child influenza vaccination

Ramifications of adverse events in children in Australia

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c2994 (Published 09 June 2010) Cite this as: BMJ 2010;340:c2994

Rapid Response:

Fever, convulsions, vaccines and...Kawasaki Disease?

The H1N1 vaccine study discussed by Collignon et. al. (JAMA 303:37,
2010)
reported a Kawasaki-like syndrome in a 2 year-old boy 4 days after
receiving
a 30 microgram dose of the vaccine, but the authors stated that this
"...adverse event of special interest was considered unrelated to the
vaccine."

In another trial one of 201 infants 6-12 weeks old developed Kawasaki
Disease after receiving seasonal flu vaccine (TIV) along with regularly
scheduled vaccines. This case also was considered "...unrelated to
vaccines."
(Pediatr ID Journal 28:1099, 2009)

Vaccine developers, the FDA and
the
CDC seem to be doing their best to obscure any links between vaccines and
serious adverse effects like KD. In a Vaccine Safety Datalink study
Prevnar
was associated with a 3-fold risk of KD, but after adjustment the
association
became statistically non-significant, P= 0.083. (Pediatr ID Journal
28:438,
2009) In June, 2007 we were alerted by the FDA to the possibility that
RotaTeq was associated with a 5-fold risk od KD, P=0.10. VAERS data were
later used by the FDA and the CDC to conclude, "Our review does not
suggest
an elevated KD risk for RotaTeq or other vaccines." (Pediatr ID Journal
28:943,
2009)

VAERS vastly underreports adverse events; for example the
U.S.
background rate of children under 5 is at least 12-14 per 100,000 child-
years.(Pediatrics 109:e87, 2002) The KD rate derived from VAERS reports
was
0.12 per 100,000 child-years!!! Incidentally, the KD rate in Prevnar
recipients
was 36 per 100,000 child-years, and during the 6 weeks of the RotaTeq
trial
there were 5 cases of KD in 36,150 vaccine recipients, a rate of 120 cases
per
100,000 child-years!

Parenthetically, KD is still a mystery
disease,
cause unknown. It was first reported in 1976 and its frequency since then

has progressively increased in North America, Europe and Japan.
Vaccine
research suffers from the same deep flaw that we find in drug/device
research: licenses are granted based on studies that are too small to
detect
serious effects, whose detection are then left to "post-marketing
surveillance"
which is generally capricious or mythical. Is it cynical to suggest that
this is
no accident, that the manufacturers--with the consent of medical
scientists
and public health officials--depend on small sample sizes and defective
reporting systems to subvert the detection of uncommon but serious adverse

effects? Do all vaccines save so many lives, so much misery, and so much
money that obscuring the adverse effects is ethically justified?

In a
recent trial Prevnar-13 was given to 122 infants along with their
regularly
scheduled vaccines. No cases of KD were reported, but 20% developed fever

(3% had temperatures >39 degrees C.) and 80% developed one or more
systemic symptoms after the vaccinations. (Pediatrics 124:866, 2010) How
many febrile convulsions and how many cases of KD will occur after the
vaccine is marketed? Will we ever know? Do we care?

Allan S.
Cunningham, retired pediatrician, Cooperstown NY

cunningham386@yahoo.com>

Competing interests:
None declared

Competing interests: No competing interests

11 June 2010
Allan S. Cunningham
Retired pediatrician
Cooperstown NY 13326