DAGIA (Doctors Active for Global Immunization Awareness) In our view the current regulatory practice does not meet the criteria for evidence-based use of vaccines. Nevertheless, there is no real discussion in professional circles about minimum requirements. As an independent institution, DAGIA hat set itself the goal of stimulating a corresponding specialist discussion. If you are a doctor and consider these 10 requirements (see below) to be useful, you can document this by entering your name in a list of supporters. Our goal is to give these demands a health policy weight by having as many supporters as possible. See the current list of supporters. For more information please get in touch: at info [@] dagia.org.
Definition of expectations
An individual guarantee of effectiveness and safety is neither given by the manufacturers nor by the responsible health authorities. However, a statistical health benefit of a defined group of vaccinated persons against the unvaccinated is promised. Before the evaluation of a vaccine, the definition of the expectations directed at it stands. Of course, these expectations have to be defined from the point of view of the one who is to benefit from the vaccine and carries the risk of any adverse effects, i.e. the vaccinee or his / her parents / guardians.
The need arises on the one hand from the realistic risk of contagion and disease, which is to be lowered by the vaccine and on the other hand from the lack of alternatives to treatment and prevention.
Significant health benefits
Vaccinated people must be able to show significant health benefits compared to the unvaccinated. Therefore, both the symptoms to be vaccinated against and any other health parameters that may indicate any side effects must be evaluated.
Measurability of impact risk
In order to enable a risk-benefit assessment, the statistical probability of adverse effects, in addition to the disease risk and the clinical efficacy of the vaccine, must be known.
Our concrete requirements for an admission study are:
1. Randomized placebo-controlled multi-blinded comparative studies
Of course, if you want to evaluate the health benefits that people who are vaccinated have against unvaccinated people, you have to compare vaccinated people with people who are not vaccinated in an open-ended study, excluding as many factors as possible which could distort the outcome. Randomised placebo-controlled double-blind studies are considered the standard of evidence-based medicine.
In the future, however, this should be the triple blinding in order to additionally prevent bias in the study evaluation.
2. Mandatory entry in a public study register
Last but not least, the scandal surrounding the study data on the flu medication TAMIFLU withheld by the manufacturer shows that a study may only become part of the admission procedure if it has been entered in a public study register in good time before its commencement. By falsifying important studies and study results, the presentation of the facts can be strongly influenced.
2. Mandatory Entry into a Public Clinical Study Register
The scandal surrounding the influenza drug TAMIFLU where the manufacturer withheld study data clearly shows that a study is only fit to be included in the licensing process if entered into a public study register well ahead of time before launching it. Non-disclosure of crucial clinical trials and study data can lead to a significant bias in presenting the facts.
3. Using a real placebo
A placebo is a dummy medication that has no effects or adverse effects, such as a physiological saline solution. Mock placebos containing components of the vaccine do not fulfil this criterion; the study results obtained in this way are, at most, academic. The comparison with other vaccines instead of a real placebo is just as meaningless. That this requirement is not self-evident. For example, the European approval of the HPV vaccines GARDASIL and CERVARIX or the rotavirus vaccines ROTARIX and ROTATEQ (all approved since 2006).
4. Sufficient study size and duration
The goal of a significant statement about a health benefit of the vaccinated group requires minimum sizes in the subject groups (test subjects) and a minimum duration of the study necessary. Only in this way can more rare, more serious side effects be recorded, which is important in order to calculate the risks of a vaccine and weigh it against the risks of a disease. The less frequently a ‘vaccine-preventable’ disease occurs in the population, the larger the study must be in order to record comparable disease rates. The duration must be at least one year but, better still, three years, given recent findings on the long-term effects of aluminium adjuvants.
5. Transparency in study design and data
The design of a study decisively determines its validity. Design and (anonymised) data must be publicly available. Changes to the design during the ongoing study must be documented in detail. This includes, for example, the methodology used in the grouping of study groups, the retention of dropouts and subjects excluded from the study, especially in the case of deaths.
6. Unrestricted coverage of clinical endpoints
Throughout the life of the study, all relevant health events should be recorded, not just selected symptoms or pure measures such as the antibody titer.
7. Proven independent steward
Experience has shown that doctors tend to ignore possible adverse effects on the test person. Therefore, the person must be provided with a demonstrably independent steward whom he can turn to at any time.
8. Manufacturer independence
Manufacturer-funded studies are demonstrably biased. There is a very simple explanation for this: if the study is unfavourable for the vaccine, the likelihood of follow-up orders for the commissioned institutes and their employees will decrease. It must, therefore, be ensured that the planning and execution of the admission studies are in the hands of financially independent institutions.
9. Realistic illustration of epidemiology in the population
The pivotal studies on the rotavirus vaccines have shown that the diseases covered by a study do not necessarily reflect the actual epidemiology of the population, given the diagnostic methodology chosen. For this reason, a third experimental group does not need to receive either drug or placebo for cross-checking. The capture strategy should include both retrospective and prospective elements.
10. Long-term observation of the subjects
Even after the approval of a vaccine, the long-term effects on the health of the subjects must be recorded in a long-term study.