The US recently approved COVID-19 vaccines in children 5 to 11-year-old, almost a year after in adults. Why the delay? It is based on the children-are-not-small-adults and children-are-therapeutic-orphans mantras that entered the world of drug development and treatment half a century ago. Mantras have a true core, but get flawed when applied blindly. Babies are indeed vulnerable, but minors do not stay babies until they come of age. An entire “industry” of academics emphasizes that “children” need separate studies, supported by regulatory authorities and others. They emphasize for good reason. Many specialists in research, authorities, & more, making a living of preaching and performing separate pediatric studies, exploiting the public trust in science and our protective instincts towards children. Which villain would dare speak out against better medicine for children? But medicines and vaccines treat the body, not the legal status. Adolescents have a mature body long before the 18th birthday, although the mind usually lags behind. Bodily, they are no longer “children”.
The first vaccine studies included persons from 16 and 18 years on, followed by separate studies in 12-15-year-olds, then in 5-11-year olds. The narrative claims that vaccines’ efficacy needs to be proven in “children” of the various age groups. But adolescents are bodily no longer “children”, 5-11-year-olds are no longer babies. When viruses attack minors, they do not ask for an ID. Minors need adequate doses for drugs and vaccines, not separate proof of efficay. The studies in thousands of minors that led to approval of COVID-19 vaccines in adolescents were futile, those in younger children grossly exaggerated. Dose calculations were all that was needed, followed by confirmation studies with few participants.
The outlined framework is not specific for COVID-19. It regards all drugs and vaccines. That is one reason why it is so difficult to crack. After the thalidomide desaster with thousands of birth defects worldwide the world was in shock. Nobody wanted any more disasters. But the alleged protection of “children” has become a machinery for justifying and conducting at best pointless and often harmful studies.
The more people are vaccinated against COVID-19 and the more more contagious virus variants emerge through mutation, the more also minors are infected. We could have started protecting minors much earlier. For those over 5 we “only” waited a year, for the younger ones we continue to wait, justified by flawed mantras.
European Union (EU)-demanded “pediatric studies” will be performed until 2024. Parents should refuse to allow participation of their loved ones, specically in age groups where vaccines are already available.
Parent and patient advocacy groups should take up this issue and critically discuss the justification of separate studies in “children”. Without pressure on politicians, the relevant laws will never be changed, and the theater of pointless studies will go on forever. Not only will this damage confidence in science and clinical research, but there is also the risk that parents will, out of general fear, refuse to allow their children to participate in meaningful studies that might save their lives. The more this will be discussed, the more also
professional groups of nurses, pharmacists, medical doctors and other health professionals will hopefully take a position and distance themselves from questionable “pediatric” studies.