According to recently released documents, the FDA acknowledged deviating from the normal vaccination approval process when dealing with Pfizer's COVID-19 vaccine approval.
A U.S. Food and Drug Administration official issued a memo allowing the publication of a Biologics License Application (BLA) number for the injection weeks after Pfizer and its partner BioNTech revealed they began a rolling submission of documentation for approval of their COVID-19 vaccine. One of the documents (pdf below) reveals that regulators were still considering whether to approve the BLA.
“This deviation from our normal practice is done to facilitate product labeling and distribution and is consistent with other Center practices to facilitate vaccine delivery during the declared Public Health Emergency,” Christopher Joneckis, the FDA’s associate director for review management, wrote in the June 17, 2021, memo. “When providing the license number, we should communicate that this license number does n...
Full Access
Included:
-
Access to All Articles.
-
One Plan. No Tiers.
-
No Ads.
-
Cancel anytime.
