by squaremild
Immunocompromised people were given priority throughout the vaccination campaign — but in the Comirnaty Biologics Application the reviewers specifically acknowledge there is ZERO data on safety or efficacy in the immunocompromised.
right (pdf): www.fda.gov/media/152256/download
the context of the paragraph cut off on the right:
Due to study exclusion criteria described above, data in the BLA submission are insufficient to inform vaccine safety and effectiveness in immunocompromised populations. Based on published reports of low antibody responses and breakthrough infections among significantly immunocompromised individuals (mainly solid organ transplant recipients) who received the two-dose vaccination series under EUA, FDA amended the EUA for the Pfizer COVID-19 Vaccine in August 2021 to allow for a third dose, at least 28 days following the second dose, in individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.