The Defender 12/22/2021
Pfizer and the U.S. Food and Drug Administration last week failed to directly address questions by two media outlets about whether Pfizer’s Comirnaty vaccine is available in the U.S.Two media outlets last week requested, but failed to obtain, clarity from Pfizer on whether its fully licensed Comirnaty COVID vaccine is available in the U.S.
Reporting by The Ohio Star and National File highlighted the ongoing debate over whether the vaccine can legally be mandated, and whether Pfizer can be held liable for injuries related to the vaccine.
The Star reported that despite asking multiple times whether the Comirnaty vaccine is in use, Pfizer would not answer the question.
The U.S. Food and Drug Administration (FDA) in August granted full approval, or Biological License Application Approval (BLA) — for the Comirnaty vaccine for individuals age 16 and older.
The approval, granted without a formal advisory committee meeting or public comments, prompted a number of questions including:
What, if any, differences exist between the formulations used in the fully licensed Comirnaty vaccine and the Pfizer-BioNTech vaccine being distributed under Emergency Use Authorization (EUA).
If/when the fully licensed vaccine would be available in the U.S.
Seeking an answer to the latter question, The Star reached out to Pfizer, the FDA and to Ohio’s largest health system, OhioHealth.
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Pfizer’s claim that the two vaccines can “be used interchangeably” is inconsistent with FDA statements, The Star said, citing an FDA Q&A page that states the two vaccines are “legally distinct.”
The FDA reaffirmed that distinction, telling The Star the “statutory authorities governing BLAs and EUAs are distinct and provide different legal requirements.”
“At present, Pfizer does not plan to produce any product with these new NDCs (National Drug Code) and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA (American Medical Association), and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”
According to a Dec.16 letter from the FDA’s acting chief scientist, Jacqueline A. O’Shaughnessy, Pfizer-BioNTech vaccines exported from the U.S. are allowed only if “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.”
Can vaccines be ‘interchangeable’ and ‘legally distinct’ at the same time?“It is an illicit bait and switch. There is no FDA-approved COVID-19 vaccine available in the U.S. The unavailable FDA biologic license approved drug is not medically identical and has to abide different manufacturing standards. As important, you have fewer legal rights and fewer legal remedies when you take an EUA drug than a biologic licensed drug. This directly impacts the legal rights of all Americans.”
Another key difference between fully licensed and EUA vaccines relates to the issue of liability. Under the 2005 Public Readiness and Preparedness Act (PREP Act), EUA vaccines are accompanied by a far-reaching liability shield that protects all parties involved with the product from lawsuits.
Specifically, if one is injured by an EUA vaccine, the only way to claim damages and receive compensation is to apply to the Countermeasures Injury Compensation Program, an administrative process under the U.S. Department of Health and Human Services (HHS), which authorized the vaccines.
At this time, the Pfizer Comirnaty vaccine may have no liability shield, making it subject to product liability laws that allow those injured by it to potentially sue for damages, although Pfizer asserts the vaccine is protected under the PREP Act as well.
More:
https://childrenshealthdefense.org/defender/pfizer-fda-media-pfizer-comirnaty-vaccine/
