Intended for healthcare professionals

Rapid response to:


MEPs devise strategy to tackle vaccine hesitancy among public

BMJ 2018; 360 doi: (Published 23 March 2018) Cite this as: BMJ 2018;360:k1378

Rapid Response:

Tricky statistics, vaccine hesitancy, and vaccine safety

I do not agree with all of the assertions made by Stone and Arumughan, but they are right on target where the statistical trickery of vaccine authorities is concerned. Manufacturers and their surrogates have systematically designed small safety studies prone to type 2 errors, allowing them to say that any increases in adverse events are “not significant.” Recent articles highlight the persistent uncertainty about important safety issues that have resulted from this policy.
We were recently reminded of the possible SIDS-vaccine link by Jacob Puliyel and colleagues, who observed a doubling of unexplained deaths within 3 days following pentavalent vaccine (DTP/Hib/hep B), compared with DTP. (Puliyel, Med J DY Patil Vidyapeeth, 3/17/18) This is on top of the SIDS risk associated with DTP alone, primarily due to the whole-cell pertussis vaccine. (Walker, AJPH 1987;77:945) US vaccine authorities dismissed DTP as a cause of SIDS many years ago, based on some observational studies, but there are other observational and ecological studies and case reports that suggest otherwise. Only proper randomized trials can resolve this issue, but they have never been done.
Vaccines are potent immune modifiers with general effects on our immune responses; the magnitude of the responses are in proportion to the number of vaccines given. US vaccine authorities have persistently tried to contradict these facts with articles asserting that there is no such thing as immune overload from the US vaccine schedule. (e.g., Glanz, JAMA 2018;319:906) This is manifestly untrue: infants have high fevers and seizures in proportion to the number of vaccines given at one time, and at least one healthy young adult died of a lupus-like syndrome shortly after receiving several vaccines at once. (Roos, “Vaccines might have contributed to death of Army reservist.” CIDRAP News, 11/19/03)…Kawasaki disease may well be the result of vaccine overload. It is an immune disorder of unknown cause occurring in young children getting frequent vaccinations, and its frequency rise has closely paralleled the expansion of the immunization schedules. Once again, there has been no attempt to study this “mystery disease” with a randomized vaccine trial….And then there is autism spectrum disorder….
Heplisav-B is a new vaccine against hepatitis B for adults. Its increased potency is ascribed to a new immunostimulatory adjuvant, CpG1018. The inflammatory response evoked by this adjuvant may account for a 7-fold increase in heart attack risk among vaccine recipients, a fact that is not acknowledged in published information. (Packer,, 11/9/17. Medical Letter, JAMA 2018;319:822)
I believe that diphtheria, pertussis, polio, and measles vaccines have been real lifesavers, notwithstanding some adverse effects, but I feel less certain about other vaccines. SIDS is a complex problem, but any vaccine risk could be largely circumvented by delaying vaccinations to 5-6 months of age. The same might also be true for other “mystery diseases.” Meanwhile, we need more honesty and less “window dressing research” from vaccine authorities.

Competing interests: No competing interests

29 March 2018
Allan S. Cunningham
Retired pediatrician
Cooperstown NY 13326, USA