Pfizer told the FDA on Friday that it wants a delay on the company’s EUA request for a two-dose Covid vaccine for children under five. . .

. . .and that’s because Pfizer thinks three doses “may provide a higher level of protection in this age group”:

Here’s the statement from the FDA:

The U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.

Something just doesn’t add up here, right?

The FDA was going to meet on February 15 to discuss the authorization for this age group:

Pfizer expects to have data from the three-dose vaccine in April:

In other words, “back to the drawing board”:

Do you mean to tell us our health experts have a messaging problem?


Tags: Pfizer

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