The FDA is expected to give full approval next month to the Pfizer COVID-19 vaccine for adults, upgrading it from its current Emergency Use Authorization. Tulane School of Medicine Epidemiologist Dr. Susan Hassig said they are reviewing things like storage, dosing, and distribution data.
“The full authorization requires a particularly defined amount of safety and observation time to reach full authorization,” said Hassig.
Hassig said the FDA is also reviewing the lengthy package insert that will accompany the vaccine, which she said is very important for how companies could dictate their vaccine policies.
“Worksite vaccination policies perhaps, as well as a whole range of adults who have been sitting and waiting to get the vaccine. So, I am really looking forward to it and I really can’t wait for it to happen,” said Hassig.
What makes this authorization process different from other FDA approvals Hassig said is because we are in a pandemic and most medications, etc. would only receive full approval after a lengthy process and not a EUA. So, the FDA reviewed preliminary data from the vaccine clinical trials and issued EUA.
“And they looked at it and said yes, this meets the criteria that we would have for emergency use, we’re in a pandemic, we’re going to go ahead and authorize the use of this vaccine,” said Hassig.
The FDA is reportedly aiming to grant full approval by Labor Day or sooner.
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