Intended for healthcare professionals

CCBYNC Open access

Non-publication and delayed publication of randomized trials on vaccines: survey

BMJ 2014; 348 doi: (Published 16 May 2014) Cite this as: BMJ 2014;348:g3058

Re: Non-publication and delayed publication of randomized trials on vaccines: survey

Worse than non- or delayed publication, despite that more than 6
billion people are vaccinated, there are no consistent long term
vaccine safety trials.

The endemic increase in NCDs (Non-communicable diseases) is in the
medical literature attributed to "environmental factors", where as vaccines
are consistently ignored.

However, do vaccines have an effect on genes, the microbiome and the
maturation of the infants immune system? Is the burden of disease due
to chronic NCDs overtaking serious cases of acute infectious diseases
(taking into account the beneficial effects of improved living

Bad sanitation, malnutrition, overcrowding and stress are the main
drivers of morbidity and mortality of infectious diseases. The Spanish
flu is a good example of that and of course the morbidity and
mortality due to infectious diseases in poverty stricken developing

The effects of poor living conditions and their negative effects on
health in the early part of the 20th century in the Western world have
been described. 1
But was the prevalence of NCDs those times, in that part of the world,
lower than now, what new NCDs are now emerging as compared to the
pre-vaccination era?

Do public health departments and the WHO have prevalence data on NCD
in populations in Africa for example and do they have any long term
vaccine cohorts on harm in place to check on NCD incidence following
immunisation? Would it be better to postpone vaccination until the infant immune system has matured? 2

There is no reluctance to discuss possible side-effects of statins
into minutia of details (3,4), similar debate exists with reference to
antivirals (5) but when the product (vaccines) affects potentially all
the people in the world, research on harm is systematically ignored.

1) Lessons from the past: celebrating the 75th anniversary of Poverty
and Public Health Bambra C. J Public Health (2011) 33 (4): 475-476.

2) Delay in diphtheria, pertussis, tetanus vaccination is associated with a reduced risk of childhood asthma. McDonald KL, Huq SI, Lix LM, Becker AB, Kozyrskyj AL. J Allergy Clin Immunol. 2008 Mar;121(3):626-31.

3) More Than a Billion People Taking Statins? Potential Implications
of the New Cardiovascular Guidelines. Ioannidis JPA, JAMA.

4) Adverse effects of statins. Godlee F. BMJ 2014;348:g3306

5) Multisystem failure: the story of anti-influenza drugs. Jefferson
T, Doshi P. BMJ 2014;348:g2263

Competing interests: No competing interests

24 May 2014
Wouter Havinga
GP locum