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Dosing is capped under emergency use authorizations, but studies show reduced antibody response following primary vaccination series in individuals with compromised immune systems; although BLA approval could allow for off-label prescribing, government officials are exploring other regulatory options for earlier access, including through a study.
Pharma moves Phase III-ready antibody to prevent pneumonia to Aridis, licenses preclinical STING inhibitors from F-star. Sanofi teams with SRI on AI-directed discovery, Biogen licenses BTK inhibitor from InnoCare.
COVID-19 Vaccines: Declining Antibody Levels, Breakthrough Infections Could Spur Booster Recommendations
Although data to support use of booster doses currently are lacking, members of the US CDC's Advisory Committee on Immunization Practices suggest potential triggers for recommending revaccination after the primary series.
Concerns about cases of heart muscle inflammation occurring in older male adolescents and young men shortly after the second dose of Pfizer and Moderna mRNA vaccines hung over FDA advisory committee discussions on pediatric safety data requirements for COVID-19 vaccines; CDC’s ACIP will take up the myocarditis issue at an 18 June meeting.