Re: What value the evidence from child trials?
It appears that the Oxford vaccine trial in children aged 6-11 years of age proposes to use Meningitis B vaccine as ‘placebo’ in the control arm (1).
The Summary of Product Characteristics Undesirable Effects for infants and children up to 10 years of age, includes: allergic reactions (including anaphylactic reactions), eating disorders, sleepiness, unusual crying, headache, seizures (including febrile seizures), hypotonic-hyporesponsive episode, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia), pallor, Kawasaki syndrome, diarrhoea, vomiting, rash, eczema, urticaria, arthralgia.(2)
How, therefore, will the ADR profile of the ‘Covid’ vaccine be determined?
And, despite the storybook language of the Participant Invitation Sheet (1), how are children as young as 6 years of age expected to understand the meaning and consequences of a clinical trial?
And, given the level of fear and anxiety amongst their parents, wouldn’t any such ‘Informed Consent’ be legally and ethically invalid? (3)
Competing interests: No competing interests