On August 23, the FDA finally approved the Pfizer vaccine for age 16 years and older. Rah!
Oh wait, hang on… Even though it was only granted Emergency Use Authorization (EUA), it was pushed with over 206 million doses already administered in the US with all the medical and legal implications.
No matter, I should be grateful that it’s finally approved. Rah!
Oh wait… According to the approval document, there seems to be a distinction between “Pfizer-BioNTech” and “COMIRNATY” even though the two “can be used interchangeably”. Great, so what exactly is approved?
And in footnote 9 (p. 5), “there is not sufficient approved vaccine [COMIRNATY] available for distribution…” So it’s approved but there aren’t enough. Rah!
In case all that isn’t cause for relief, there is a pre-print study (yet to be fully peer-reviewed) by Arjun Puranik et al titled “Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence” that should inspire confidence.
In the context of increasing cases in Minnesota during July (Figure S3), the effectiveness against infection was lower for mRNA-1273 (76%, 95% CI: 58-87%) compared to prior months, with an even more pronounced reduction for BNT162b2 (42%, 95% CI: 13-62%) (Figure 2A; Table 3).
The Pfizer vaccine has dropped to 42% effectiveness! But do not fret because it’s been approved. Rahhh!
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