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Author: alexander-a-tin.bsky.social (did:plc:uxvc5nwyutzf5gtu4x7jqyk3)

Record🤔

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"It comes as FDA is preparing for a meeting tomorrow of advisers to weigh a rare option to accelerate next-generation whooping cough shots hoped to be more effective:

a "controlled human infection model" trial where vaccinated volunteers are intentionally infected

www.fda.gov/advisory-com..."
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    "A screenshot of text that reads in part: "Section 6: Pertussis Controlled Human Infection Models A significant challenge to the introduction of new pertussis vaccines lies in developing substantial evidence of effectiveness. The aP-containing vaccines currently in use were shown to protect against disease in prospective, clinical endpoint efficacy studies conducted in populations with high incidence of pertussis. Comparable studies would be difficult if not impossible to conduct today. Although the incidence of pertussis is increasing in highincome countries, the incidence is likely too low for a prospective clinical endpoint study to be feasible. The difficulty of conducting prospective pertussis vaccine studies in humans is compounded by the fact that pertussis incidence is cyclical, with peaks of disease alternating with troughs, and different regions experiencing peaks and troughs of pertussis incidence in different years. The baboon model of pertussis provid"
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createdAt:
"2024-09-19T21:56:01.737Z"