“Recommends that multiple steps must be taken before ethical pediatric anthrax vaccine trials can be considered by the U.S. government…
In keeping with its recommendation of a strict risk limit in pre-event pediatric MCM research, the Bioethics Commission called for completing all prior ethically sound testing – for example, modeling, testing in animals, and testing in the youngest adults – to assess the level of risk likely posed by pre-event pediatric MCM research. If the risk level for the oldest group of children is determined to be minimal, then progressive testing with younger and younger children should be employed, beginning with the oldest children in order to provide additional protection to younger children. This approach—called age de-escalation—would help to ensure that data from an older age group inform the research design and risk level for the next younger age group. For example, an intervention shown to be minimal risk in the youngest adults – adults 18 years of age –may make it possible to infer that a study with the oldest children of 16 and 17 years of age would present only minimal risk.”
Sounds good. But let’s carefully examine the “multiple steps” and the process laid out by the Commission. Here’s the meat:
- Complete all prior ethically sound testing: for example, modeling, testing in animals, and testing in the youngest adults, to assess the level of risk.
- If the risk level, based on this testing, is determined to be minimal, start testing in children in a stepwise manner, starting with the oldest children and going stepwise down the ages in younger and younger groups, while assessing safety for each group before enrolling the next younger group.
This method assumes that the risk of the test may be greater for younger children, and you therefore establish a new risk level with each group you test, thereby reducing risk for the youngest children.
- Risk has already been established in thousands of young adults, as made clear in the label and extensive vaccine literature, and this is a dangerous vaccine
- Risk might be highest in the older children, for whom pregnancy (FDA Risk Category D–evidence of fetal harm, according to the vaccine label) is a big risk, indicating the theory that age de-escalation will reduce risk to child subjects does not stand up
- Modeling, not further defined or explained by the Commission, is not a standard or approved method for assessing risk in humans from vaccine research
- Animal testing is of little value, and only used for pre-clinical research. Given the extensive human testing already completed, it adds nothing.
Now you understand what this whole charade was really about: lowering the safety standards for using medical countermeasures in humans, including children.
“From a regulatory perspective, there are four major stages in vaccine development. These stages include:
The preclinical stage which consists of the development and testing of the product prior to the product being tested in humans. Early in the product development process, sponsors test candidate vaccines in-vitro (e.g., in laboratory assays, studies in cell lines, etc) and in animals. These early nonclinical studies give an indication of whether studies would be reasonably safe to proceed in humans and may also provide information regarding the potential effectiveness of the product.
- The Investigational New Drug (IND) stage consisting of multiple phases where the investigational product is studied in human subjects under well-defined conditions and with careful monitoring. In certain cases where studies to demonstrate efficacy in humans are not ethical or feasible, sponsors may conduct studies to demonstrate efficacy of the product in appropriate animal models.
- The license application stage is when manufacturers submit data and information regarding the results of the clinical and nonclinical studies, as well as complete information regarding the product and its manufacturing process to FDA for a complete review of product manufacturing, safety and effectiveness in support of licensure.
- Finally, for products that are approved, FDA continues its oversight during the post licensure stage to include review of post-marketing safety information from adverse event reports, periodic reports, post-marketing studies, review of lot release information and testing, and inspections of manufacturing facilities.
- FDA often provides guidance to sponsors, even prior to submission of an IND, in regard to both the types of preclinical studies needed and the design of the clinical trials needed to assess the intended use(s) of the product. FDA’s guidance is intended both to help protect human subjects and to assure that the studies performed are designed in such a manner that the study results are likely to provide sufficient information to allow a determination of the product’s safety and efficacy…
- FDA strives to develop processes that facilitate product development to meet emerging public health needs, such as protection from terrorist agents and prevention of pandemic influenza and other emerging threats. The regulation known as the “Animal Rule” provides a mechanism for FDA to approve medical treatments based on effectiveness data from animal studies when human efficacy studies are unethical and/or not feasible. Under the “Animal Rule,” effectiveness would be evaluated in adequate and well-controlled animal studies that establish that the product is reasonably likely to produce clinical benefit in humans. Such approvals also require the demonstration of safety in humans. These safety studies may be conducted concurrently with the animal studies.