Current Events-Vaccines(EMERGENCY ALERT)

https://www.fda.gov/media/150386/download

Last week, the FDA issued a new report about the Pfizer vaccines it has approved. In all, 19 pages worth of redundancy, were apparently nullified, or at least undermined by the "Acting Chief Scientist" when she sincerely signed the correspondence, in wholeness, where:

IV. Duration of Authorization This EUA(1) will be effective until the declaration that circumstances exist justifying the authorization of the emergency use(2) of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA(3) is revoked under Section 564(g) of the Act.  

Is the FDA still viewing the PFIZER product as a resource to be used under Emergency Use Authorization (EUA)? 

The verbage would seem to indicate so since the abbreviation "EUA" is mentioned twice and "emergency use" is mentioned once, just in the closing statement.

It is mentioned once on page 1 (citation), thrice on page 3 (citation), once on page 4 (no basis for preclusion), once on page 6 (no basis for preclusion), twice on page 7 (support authorization of booster), thrice on page 8 (booster, twice for authorization), once on page 9 (terms and conditions), 5 times on page 14 (consistency-twice, scope twice,  "despite the fact that it does not meet certain requirements otherwise required by applicable federal law", terms/availability), once on page 15 (issuer request for change), 4 times on page 16 (submission of CoA's, submission of quarterly reports, availability of records, post-authorization studies of target population), once on page 17 (stakeholder administration of vaccine), thrice on page 18 (providers' recordkeeping, advertisement, AND THE WHAMMY OF ALL WHAMMIES!!!!!)

Condition Related to Export Z. If the Pfizer-BioNTech COVID‑19 Vaccine is exported from the United States, conditions C, D, and O through Y do not apply, but export is permitted only if 1) the regulatory authorities of the country in which the vaccine will be used are fully informed that this vaccine is subject to an EUA and is not approved or licensed by FDA and 2) the intended use of the vaccine will comply in all respects with the laws of the country in which the product will be used. The requirement in this letter that the authorized labeling (i.e., Fact Sheets) be made available to vaccination providers, recipients, and caregivers in condition A will not apply if the authorized labeling (i.e., Fact Sheets) are made available to the regulatory authorities of the country in which the vaccine will be used.

The term "Comirnaty" is mentioned in the letter but it would appear to be for naught, or perhaps only mentioned for legal purposes. 

The letter also explicitly states that the "known and potential benefits" outweigh the "known and potential risks" which brings the Nuremberg Code to mind.

For me, personally, if there is a risk, of any size, there must be a choice.