COVID-19 Vaccines: Updated FDA EUA Gave CDC Wiggle Room In Defining Population For Third Shot
Updated EUA for mRNA COVID-19 vaccines left CDC room to define the type of conditions that meet the immunocompromised level described by the FDA. The recommendation for a third shot for immunocompromised patients was based on small studies using surrogates for vaccine efficacy, not hard clinical outcomes.
You may also be interested in...
11 Going On 12: CDC Panel Pays Special Attention To Kids Caught In Middle Of Pfizer/BioNTech Vaccine Dose Increase
Whether a child receives the 10 mcg dose of COVID-19 vaccine authorized for 5-11 year-olds or the 30 mcg dose authorized for ≥12 year-olds should be based on age on day of vaccination, CDC says, but FDA is allowing some dosing flexibility for kids who celebrate their 12th birthday in the middle of the primary series.
Immunocompromised May Be Able To Get Fourth COVID Vaccine, FDA Suggests
But CDC seems more skeptical, postponing discussion during the ACIP meeting and aiming to talk to FDA about the issue ‘in the appropriate timeline.’
One Down, Two To Go: Pfizer/BioNTech Booster Decision Creates Pressure For More Extra Shot Authorizations
Inequity created by limiting the mRNA vaccine’s third dose to only those individuals who received a primary series of the same vaccine, as well as resulting operational complexities, warrant consideration of a mix-and-match approach with Moderna and J&J products, CDC advisors say; however, FDA appears most focused on vetting manufacturer-specific data on homologous boosting.