One of the major themes in Bad Pharma revolves around a failed experimental vaccine that did not compare favorably to the existing licensed vaccine for at least three of the types of bacteria it was supposed to protect against. When comparing a new vaccine to an existing one, one has to show that the new vaccine produces antibody levels that are comparable (non inferior) to all of the infectious agents it shares in common with the licensed vaccine. If the new vaccine cannot meet this standard it will not be given a license. That part is clear.
The part that is “muddy” is how the vaccine developer handles a trial in which its experimental vaccine “fails” in the comparison to the licensed vaccine. Should the vaccine company decide whether or not the children given the “failed” vaccine merit the licensed product? Should the FDA (or other regulatory agency) make the decision? Should the results be passed on to the patient’s caregiver for them to make, in concert with the patient (in this case, the child).
What are your opinions here? Are you comfortable with the vaccine manufacturer making the decision or do you feel otherwise? Love to hear your thoughts.