Conditions Related to Printed Matter, Advertising, and Promotion
All descriptive matter advertising,and promotional material,relating to the use of the Pfizer-BioNTech COVID‐19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
Y. All descriptive material pertaining to advertising,and promotional use of the Pfizer-BioNTech COVID‐19 Vaccine clearly and conspicuously shall state that:
Page 12 – Pfizer Inc.
• This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner
Everything after the first paragraph on page 2, is strictly for the EUA, even though they use the term “this product” and it is the same product as now approved for 16+.
Yeah, they could have worded it better.
Right - legally the APPROVED Covid vaccine from Pfizer is now called “COMIRNATY” - and that will have no black box warnings on it about non-approved use.
For those under 16 and taking a third booster shot - they’ll be using the off-brand Pfizer Covid-19 vaccine (which in theory is still the same as COMIRNATY but has different distributions and legal bounds) - but it’s use still falls under EUA and the offbrand packaging (which will still be made) must carry the warning.