How to Be a Lab Rat: The WHO’s Risk-Benefit Balance

rat trap h1n1

By Aussie Oz

In the World Health Organization’s “Regulatory Preparedness for Human Pandemic Influenza Vaccines,” we see a detailed method of surveillance to monitor those who caught the flu.  It’s curious, prescient almost, that this starts on mythical 2012 (the line number in the WHO document).

Really, I think anyone who gives a rat, needs to just read this couple of paragraphs. (And then go read the rest, but have coffee and aspirin ready.)

Surveillance…someone needs watching, but I suspect it isn’t the general population.

I stopped reading at line 600 a few weeks back. I got so angry. Today I came across this WHO info again, but on a different topic. So, I scrolled at random, stopped, and found this at pp. 47-48, Lines 2012-2036. 

World Health Organization

WHO/BS/07.2074
EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION
Geneva – 8 to 12 October 2007.  Version endorsed by ECBS.
Proposed Guidelines:
Regulatory Preparedness for Human Pandemic Influenza Vaccines

Part G. Post-marketing surveillance

G.3.7 Considerations for specific types of pandemic influenza vaccines

2012 G.3.3.8 Use of large computerized database

2013 Systems allowing automated data extraction (safety and efficacy) might exist or be set up in

2014 some countries. Systems requiring specific conditions that do not probably exist in many

2015 countries include the electronic network and legal framework to extract patient-based

2016 information from electronic systems to be used by health care professionals. If such systems

2017 exist or are currently developed, testing of these systems in the inter-pandemic period might

be useful. These databases might also be useful for evaluation of 2018 delayed AEFIs and

2019 effectiveness of pandemic-specific strains.

2020 G.3.4 Immunogenicity and efficacy/effectiveness

2021 Disease incidence during an influenza pandemic cannot be anticipated. Unlike other diseases,

2022 measuring vaccine effectiveness as ‘the protection rate conferred by vaccination in a certain

2023 population’ will be impossible and the true vaccination impact on a population cannot be

2024 determined. However, an estimation of protection in individuals may be performed.

2025

2026 In addition to existing surveillance systems to monitor the onset and evolution of the

2027 pandemic, Public Health Authorities may consider the installation of enhanced surveillance

2028 tools to analyze the ‘effectiveness’ of vaccination campaigns. Protocols should be developed

2029 in the inter-pandemic phase. The study design may need to be reviewed in light of the

2030 anticipated epidemiological features of the pandemic. Methods to use will depend on existing

2031 vaccination strategy and tools. For example, if the entire population was vaccinated, non

2032 vaccinated groups would not be available for comparison cohort studies (although pre

2033 vaccination person-time could be useful). The analysis of data from electronic registries or

2034 highly linked databases may only be feasible in a few countries. Different methods and

2035 strategies may be used in different countries. A number of examples are provided in section

2036 G.3.5 and its subsections.

####

That sort of sat me back for a while. Welcome to the world of “How to Be a Lab Rat ” in one easy lesson, Folks. For a real Rage Rush, scroll down to line 2176 and read that section:

2176 G.3.8 Risk Benefit Assessment

2177 In contrast to other biologicals and drugs used to treat clinical disease, vaccines differ in safety

2178 considerations. Vaccines are a preventive measure mainly given to healthy individuals. In

2179 consequence, a very high standard of safety is usually expected for vaccines used in non

2180 epidemic situations. However, in a pandemic situation the risk benefit balance shifts to the

2181 benefit. As a rapid health benefit is expected to become evident for the individual vaccinee,

2182 certain probability of adverse event(s) might be acceptable for the individual, even if the

2183 incidence of adverse event is higher than for seasonal influenza vaccines.

2184

2185 The risk benefit balance for pandemic influenza vaccines depends not only on the efficacy and

2186 safety of the vaccines but also on the incidence of infectious disease in the target population,

2187 the proportion of infected persons with clinical disease, the severity of clinical disease, the

2188 identification of high risk groups, and the risk of transmission. The benefit risk assessment

2189 may differ in different target populations.

2190

2191 The benefit of a pandemic influenza vaccine may decline for an individual as vaccine

2192 coverage rises, the disease incidence decreases, and herd immunity occurs. Despite a decrease

2193 in disease incidence, the public health benefit of vaccination might remain high if the

2194 probability of disease re-emergence increases when vaccine coverage rate in the population

2195 becomes too low. Thus, the risk benefit balance of using a pandemic influenza vaccine has

2196 both public and individual health aspects.

2197

2198 In all circumstances, any safety concern arising from the use of a pandemic influenza vaccine

2199 will concern a very large number of actual and potential vaccinees. Therefore, safety issues

2200 need to be evaluated promptly.

####

Even if it proves to cause harm, more than the pandemic itself, it’s still okay to vaccinate anyway?

3 responses to “How to Be a Lab Rat: The WHO’s Risk-Benefit Balance

  1. I refuse to read any more of that document until you clean my cage and give me a more bits of cheese.

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