Is the timing of recommended childhood vaccines evidence based?
BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i867 (Published 23 February 2016) Cite this as: BMJ 2016;352:i867All rapid responses
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To the recent comments of Dr Cunningham, Mr John Stone, may I add the following references:
Jefferys R. T cells and vaccination. The Lancet 2001;357:451
Anand JK. Multiple vaccination. The Lancet 2001;358:505
Competing interests: Waiting, waiting, waiting - for the eminences of imm and vac ( in the DoH, pharmaceuticals, academe) to respond.
John Stone asks authorities if they really believe that progressive expansion of the vaccine schedule is safe. The true answer is that authorities don't really concern themselves with safety (the true frequency of adverse effects) because they believe that vaccine effectiveness and its impact on public health trump any concern about safety. The randomized trials that lead to drug and vaccine licensure regularly yield evidence for serious adverse effects, but the trials are too small for the associations to be statistically significant. Current conventions permit the trialists to say "...there were no significant increases in adverse effects..."
although such effects would be quite significant clinically with larger study groups. This happens so frequently that one has to assume the manufacturers and trialists plan things this way; that is, the trials are designed with Type 2 errors built in......Post-marketing surveillance is supposed to provide the large numbers of patients that would allow the frequency of adverse effects to achieve statistical significance, but PMS is a neglected stepchild. Adverse effects are vastly underreported to our passive surveillance systems, sometimes less than 1%.
One could forgive this intentional neglect of safety/adverse effects if the effectiveness and wholesome impact of all drugs and vaccines on public health were unequivocal. However, they are not, and we need to take a careful look at the real balance between risks and benefits for some of our vaccines. Otherwise it is unethical to impose vaccine mandates on families, as we do in the U.S., and to devote limited resources to vaccines that may do more harm than good. Influenza vaccine is a case in point.
In 2000 Kenneth McIntosh published an editorial discouraging universal influenza vaccination for children. He believed we needed large randomized trials carried out over several seasons to get evidence that universal vaccination would do more good than harm. (NEJM). A policy of universal childhood vaccination was instituted without such trials. In 2014-15 the flu shot actually increased the risk of illness from influenza in children 64%. This was a limited observational study and did not look at adverse effects. (Skowronski et al, CID 3/29/16).
Mr. Stone mentions the concern about "vaccine overload." Perhaps it is "overload" that has produced the upward march in the frequency of Kawasaki disease in parallel with expansion of vaccine schedules. Another, related, concept is the"non-specific effect" of vaccines (Aaby, Shann, et al) whereby vaccines have positive and negative effects on morbidity and mortality unrelated to the vaccine-targeted diseases.
Competing interests: No competing interests
I hope that the eminent doctors in the DoH and on the staff of the vaccine manufacturers will respond to Mr Stone.
Neither Dr Havanga, nor I have yet succeeded in eliciting any response.
Competing interests: Previous posts. Many questions. None replied to.
Can I ask the authors of this article what is the core science for supporting the indefinite expansion of the vaccine schedule as safe, and with an industry with hundreds of new products which it wants added to the schedule? I only know of a speculative article by Offit et al (1) which was cited again only last year by a senior British health official, Prof Elizabeth Miller of Public Health England, but she only mentioned "strong scientific arguments about the immune overload hypothesis" (2) but no evidence that I can see. It seems to me an extraordinary supposition and not good enough if we are going to base global health policy on it.
I am also not clear that "immune overload" is the only thing at stake when an infant has to survive dozens and potentially hundreds of inflammatory products as if this was the human norm.
(1) Offit P et al "Addressing parents' concerns: do multiple vaccines overwhelm or weaken the infant's immune system?", Pediatrics. 2002 Jan;109(1):124-9.
(2) Miller E Pediatrics. "Controversies and challenges of vaccination: an interview with Elizabeth Miller", BMC Med. 2015; 13: 267.
Competing interests: No competing interests
Slightly at a tangent maybe but the correspondence reminded me of the Yellow Card Scheme . It is designed to be used by both health professionals and members of the public to report Adverse Drugs and Medical Devices Events. Those who are aware of it in the first place may report directly to the MHRA (Medicines and Healthcare Products Regulatory Agency) and/or request Yellow Cards via a free phone or internet link.
In 2015 39,000 reports were made; 45% directly from healthcare professionals; 14% from members of the public; 41% from pharmaceutical companies.
There is a scheme being developed to increase awareness of the Yellow Card Scheme via posters; leaflets; education of reporters and CPD Learning Modules.
With thanks to the Department of Vigilance and Risk Management (MHRA) for the information sent in response to a request. There is a comprehensive web site for further information.
Another useful way of sharing information, support and research is through 'Patients Like Me' (see web site) .
Competing interests: No competing interests
May I thank Dr Cunningham for the concise message from the article by Opel and colleagues ( Seattle).
Whether the CDC and other interested parties in the US will enter the arena of debate remains to be seen.
As for their counterparts in England and Wales - they have so far, remained mute.
Competing interests: Previous contributions to this thread
Dr. Anand refers to an article by Douglas Opel and 5 pediatric colleagues in Seattle. They go against official policies of the CDC, AAP and AMA by suggesting that non-medical exemptions in the U.S. should be permitted for all vaccines except measles. They assert that, except for measles, policies eliminating NMEs are scientifically and ethically problematic. They are strong vaccine advocates, but believe in balancing the competing values of individual liberty and the common good. Furthermore, they believe that a less restrictive policy on NMEs is more justifiable, sustainable, and enforceable and will be better for public health in the long run. (Pediatrics. 2016;137(4)e20154230. Seattle Times 3/17/16).
I suspect this view will strict a chord in many conscientious professionals who believe that vaccine officialdom has gone too far with vaccine mandates. (Cunningham, BMJ 2015;351:h4576). I believe we would have less difficulty balancing individual liberty and the common good and would have healthier populations if the authorities admitted that the safety and cost-effectiveness of many vaccines are not that certain.
Competing interests: No competing interests
Re: Is the timing of recommended childhood vaccines evidence based? Just one more pebble in the pool
Practitioners, policy makers (and possibly the public of these islands) might be interested in the thoughts of Opel DJ, Kronman MP, Diekema et al in Pediatrics 2016;137(4):20154230.
The paper is titled: Childhood Vaccine Exemption Policy. The Case for a Less Restrictive Alternative.
Competing interests: Previous comments on this web-site.
Jefferson and Demicheli's summation of "...comments and conflicts" is helpful, but at the risk of tiresome repetition I call attention to a population-based cohort study which found that children receiving DTaP-IPV-Hib after MMR at 12-15 months had 62% more hospitalizations for infections during the second year of life compared with those who received DTaP-IPV-Hib followed by MMR. (IRR , 1.62--CI, 1.28 to 2.05). This was a non-randomized observational study in Denmark, but provides some evidence that the timing of vaccines could be very important. (Sorup, Aaby, et al. JAMA 311:826, 2014).
Competing interests: No competing interests
Hey!! Watch out!! Small pox is still there!!
http://www.livescience.com/2403-climate-threat-thawing-tundra-releases-i... (as accessed on 20-08-2016), says,
"Climate Threat: Thawing Tundra Releases Infected Corpses.....................Smallpox was a vicious disease before its eradication in the 1970s, but the virus is hardy and can survive long-term storage. One such storage unit is the tundra of the high northern latitudes that preserves an unknown number of bodies that could have died from smallpox. Global warming is now rapidly thawing this freezer, increasing the chance that someone could come into contact with a smallpox-infested body, thereby reintroducing the disease.
Smallpox rivals malaria as the most deadly infectious disease ever to affect humans. Throughout history, people looked for ways to combat the disease, priming their immune systems with remedies such as sniffing ground-up scabs or smearing pus into open wounds. The first true vaccine — developed in 1796 by Edward Jenner — was for smallpox.................."
Competing interests: No competing interests