Immediately after The Lancet published the paper in 1998, the medical community quickly rose up to refute the study for some obvious issues. Despite these painstaking procedures, mistakes still happen all research reports have the potential for bias and, on occasion, a flawed, mistaken, or even outright fraudulent paper somehow gets through. Reports are peer reviewed by the journals’ medical panels, a rigorous process that can take months or years before a study sees publication. 5Ĭredible medical journals publish many hundreds of research studies each year. This of course has also lead to an increase in recent years of cases of measles, which the vaccine could have prevented. As a result of this global vaccine scare, immunization rates dropped in the UK 3 and North America 4. For more than a decade, the media has widely reported on the study, leading tens of thousands of people to believe that the suggestion about the MMR vaccine must be true. In 1998, a major medical journal based in the UK, The Lancet, published a report 2 headed by Andrew Wakefield, who was at that time a gastroenterological surgeon and medical researcher.The report implied a causal link between the measles, mumps, and rubella (MMR) vaccine and the development of autism combined with IBD in children, which Wakefield described as a new syndrome he named “autistic entercolitis”. In the case of COVID-19, the researchers note that risk/benefit analyses of the vaccine were more heavily focused on physical health concerns, rather than those related to education and social well-being.Andrew Wakefield’s Harmful Myth of Vaccine-induced “Autistic Entercolitis” On January 5, 2011, The British Medical Journal declared fraudulent the published medical study that launched a global vaccine scare. Examples include "tension of protection," which refers to the competing interests of protecting children from potential risks associated with vaccine studies and protecting them from diseases that new vaccines are designed to guard against the "moving target problem," which can occur when dominant variants of a virus change in the time it takes for younger children to be enrolled in a vaccine trial and the problem of "narrow conception of risk," which happens when certain risks are emphasized while others are perceived to be less important. The article presents a number of ethical concerns to consider when performing this risk-benefit analysis. However, the researchers contend that the benefits of age de-escalation approaches should be weighed against potential drawbacks. Also, since children are unable to provide informed consent, they should not be subjected to the same level of risk as consenting adults. There is a moral imperative to protect children from the uncertainties of novel interventions. The researchers acknowledge ethical advantages to using age de-escalation in pediatric vaccine trials. "We want to help make sure researchers and pharmaceutical companies have the resources they need in advance of future vaccine development, to design trials in ways which will prioritize the development of safe and effective vaccines for all ages, in as efficient a manner as is appropriate." "In the development of the COVID-19 vaccines, infants, toddlers and preschoolers were the last to receive access to the vaccines, and for many families the wait felt very long," said Dr. The researchers clarify the benefits, risks, and trade-offs involved in age de-escalation approaches and call for the development of evidence-based best practice guidelines that can help policymakers more effectively protect the health and well-being of children in pediatric vaccine trials. Oakland University Professors Ami Harbin and Mark Navin, with University of Michigan Professor Naomi Laventhal, M.D., have co-authored an article titled "Ethics of age de-escalation in pediatric vaccine trials: Attending to the case of COVID-19," which appears in the journal Vaccine.įocusing on pediatric COVID-19 vaccine development as a key case study, the article delineates important ethical factors to consider when employing age de-escalation.
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