I've been searching for a couple of hours but can't find exact wording anywhere. I thought I had the info saved but can't find it there. Any help would be greatly appreciated. Thank you
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I have some sources here at the bottom of my employer letter:
Dear xxx,
I received notice that the COVID-19 vaccine is FDA approved and that you are requiring the vaccination for continued employment. I would be happy to take the vaccine. On advice of my attorney xxx (my sister-in-law, but you can use a doctor or whoever) it was recommended that I should opt to take the FDA approved vaccine called Comirnaty for legal reasons. On further review, however, it appears that the FDA vaccine is not available yet in the US. Please see the sources below this letter. Could you provide an exception for this until the vaccine comes onto the market. It was indicated by the justification for the company mandate that the vaccine is FDA approved and I would therefore be more comfortable taking the FDA approved vaccine.
Thank you, xxx
My lawyer can be contacted at: xxx xxx
Sources:
https://www.documentcloud.org/documents/21054683-sen-johnson-letter-to-fdas-woodcock
https://www.theepochtimes.com/newly-approved-covid-19-vaccine-not-yet-available-in-us_3976794.html
https://lynnwoodtimes.com/2021/09/14/is-the-pfizer-vaccine-fda-approved/
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
see page 14: 4. NonclinicalPharmacology/Toxicology
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.3
Bioequivalence is also defined on that page:
The definition includes extended-release dosages and alternatives. The terminology appears to be fairly loose. Same formulation means that it may have a different composition and delivery mechanism but it's bioequivalent if the right active ingredient goes to the right places. According to the above definition it could be a completely different alternative drug and still be a 'same formulation'. However, the main concern is that the two vaccines are "legally distinct" and may come with different legal consequences.
Also, this link has info that might be able to be referenced:
https://aapsonline.org/aaps-statement-on-fdas-approval-decision-on-pfizer-biontech-covid-19-vaccine/
Oh wow!!! Thank you!!!
This is a great compilation. Thank you! Commenting for more exposure for OP