Open letter to Dr Robert Califf, FDA Commissioner: I wish to better understand the decision-making process that authorized Moderna’s booster vaccine to be shipped despite serious quality issues

Califf has left now - whoever takes over should act on this with haste and determination

Open letter to Dr Robert Califf, FDA Commissioner

This is an open letter on my PharmaFlow website, dated June 9, 2024. It outlines communications I had been having with FDA staff at the FDA’s Center for Biologics Evaluation and Research (CBER):

“Dear Dr Califf,

This is an open letter in follow-up to a question I have submitted to the FDA’s Center for Biologics Evaluation and Research (CBER). The question is repeated below:

Dear FDA,

My question relates to FDAs release of the Moderna booster vaccine, reported in a Fierce Pharma article dated September 21, 2022, titled:

Moderna’s new booster launch tripped up by production issues at Catalent plant: reports

This is a short excerpt:

On Tuesday night, the FDA released (PDF) a Form 483 notice it had sent to Catalent, citing 12 observations from a lengthy August inspection of its Bloomington, Indiana, site. The massive facility is among the largest in the portfolio of contract manufacturing powerhouse Catalent. Most of the observations had to do wit…