Focusing on orphan-first drugs may be best route to address pricing concerns, Health Affairs study suggests after finding that just one-fifth of spending on 15 top-selling partial orphan drugs was for the drugs’ rare disease indications.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices concerns about making COVID-19 vaccine dose regimen changes based on unproven immune correlates of protection could be a warning sign to sponsors about roadblocks they might face if updating vaccines to address viral variants or conducting pediatric studies relying on such surrogate endpoints.

J&J’s COVID-19 vaccine sails through its US FDA advisory panel, but that just means the subpopulation efficacy questions need to be wrestled with by other public health space, as CDC and the states must figure out the best way to distribute multiple vaccines with differing efficacy profiles, regimens and storage requirements.