(So my question of legality is how can Johnson & Johnson and Moderna be mandated if they have yet to be FDA approved? Also if the Pfizer vaccine having two products that are legally distinct with one being FDA approved ( Comirnaty ) how can the current available Pfizer-BioNTech vaccine be mandated if it is still technically under emergency use?)
The FDA accelerated its review process to speed up the release of COVID-19 vaccines. The regulator proceeded to grant emergency use authorization to Pfizer, Moderna, and Johnson & Johnson (JNJ) vaccines. In August 2021, the FDA granted full approval to the Pfizer vaccine.
The currently available COVID-19 vaccines (Janssen/Johnson & Johnson, Moderna) are only authorized for use under the EUA Statute
and have no general approval under federal law. Thus, the administration of such vaccines cannot be mandatory under the plain text of the EUA Statute.
The recent FDA biologics license application (BLA) approval of the product
COMIRNATY, COVID-19 Vaccine, mRNA, manufactured by BioNTech Manufacturing GmbH, does not change the EUA status of the Pfizer-BioNTech COVID-19 Vaccine that has been available under EUA since December 23, 2020. According to the EUA extension letter issued by the FDA to Pfizer on August 23, 2021, the Pfizer-BioNTech COVID-19 Vaccine and BioNTech’s
COMIRNATY, COVID-19 Vaccine, mRNA “are legally distinct” products.
Moreover, the now “approved” COMIRNATY vaccine cannot be distributed for use until BioNTech submits “final container samples of the product in final containers together with protocols showing results of all applicable tests” and BioNTech receives “a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).”
Thus, it is not clear when (or if) any employees will have access to the “approved” COMIRNATY vaccine, leaving all (or at least the vast majority of)
employees who elect to receive the “Pfizer” vaccine pursuant to company mandatory vaccine policy to receive a dose of the current stock of Pfizer-BioNTech vaccine still being administered
subject to EUA rules.
The Comirnaty vaccine received full FDA approval, but in the FDA documents they describe the Pfizer-BioNTech COVID-19 vaccine as “legally distinct” from the Comirnaty vaccine.
The following summarizes the current status of the Pfizer-BioNTech shots:
1. All existing Pfizer vials (in the hundreds of millions), remain under the federal
Emergency Use Authorization (EUA) (meaning people have the “option to accept or
refuse”);
2. The third or “booster” Pfizer shot is identical to the above and remains under the EUA
with limited use to certain categories of people;
I have requested a religious accommodation but preparing to fight for it with the EEO and groups like Liberty Council if denied.
Employees may have religious accommodation requests stating their sincerely held religious beliefs injecting any of the three currently available COVID-19 vaccines would be a sin and a violation of their religious beliefs because they are manufactured and produced with, tested on, or otherwise developmentally connected to aborted fetal cell lines. Many employers have responded to employee submissions with intrusive and irrelevant questions about employees’ past personal health decisions and the theological bases for those decisions, or demands that employees vet their religious beliefs about COVID-19 vaccines with a third party to justify their accommodation requests. The premises of these questions—that an employee’s current
request for religious accommodation must be consistent with the employees’ prior health decisions and religious understandings, or must be acknowledged by a person other than the employee—are legally invalid premises for deciding religious accommodation requests, and
any denial based on such premises violates Title VII.
Title VII of the Civil Rights Act of 1964 prohibits employers from discriminating against its employees on the basis of their sincerely held religious beliefs. See 42 U.S.C. §2000e-2(a) (“It shall be an unlawful employment practice for an employer . . . to fail or refuse to hire or to discharge any individual, or otherwise to discriminate against any individual with respect to his
compensation, terms, conditions, or privileges of employment because of such individual’s race, color, religion, sex, or national origin”);
The FDA accelerated its review process to speed up the release of COVID-19 vaccines. The regulator proceeded to grant emergency use authorization to Pfizer, Moderna, and Johnson & Johnson (JNJ) vaccines. In August 2021, the FDA granted full approval to the Pfizer vaccine.
The currently available COVID-19 vaccines (Janssen/Johnson & Johnson, Moderna) are only authorized for use under the EUA Statute
and have no general approval under federal law. Thus, the administration of such vaccines cannot be mandatory under the plain text of the EUA Statute.
The recent FDA biologics license application (BLA) approval of the product
COMIRNATY, COVID-19 Vaccine, mRNA, manufactured by BioNTech Manufacturing GmbH, does not change the EUA status of the Pfizer-BioNTech COVID-19 Vaccine that has been available under EUA since December 23, 2020. According to the EUA extension letter issued by the FDA to Pfizer on August 23, 2021, the Pfizer-BioNTech COVID-19 Vaccine and BioNTech’s
COMIRNATY, COVID-19 Vaccine, mRNA “are legally distinct” products.
Moreover, the now “approved” COMIRNATY vaccine cannot be distributed for use until BioNTech submits “final container samples of the product in final containers together with protocols showing results of all applicable tests” and BioNTech receives “a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).”
Thus, it is not clear when (or if) any employees will have access to the “approved” COMIRNATY vaccine, leaving all (or at least the vast majority of)
employees who elect to receive the “Pfizer” vaccine pursuant to company mandatory vaccine policy to receive a dose of the current stock of Pfizer-BioNTech vaccine still being administered
subject to EUA rules.
The Comirnaty vaccine received full FDA approval, but in the FDA documents they describe the Pfizer-BioNTech COVID-19 vaccine as “legally distinct” from the Comirnaty vaccine.
The following summarizes the current status of the Pfizer-BioNTech shots:
1. All existing Pfizer vials (in the hundreds of millions), remain under the federal
Emergency Use Authorization (EUA) (meaning people have the “option to accept or
refuse”);
2. The third or “booster” Pfizer shot is identical to the above and remains under the EUA
with limited use to certain categories of people;
I have requested a religious accommodation but preparing to fight for it with the EEO and groups like Liberty Council if denied.
Employees may have religious accommodation requests stating their sincerely held religious beliefs injecting any of the three currently available COVID-19 vaccines would be a sin and a violation of their religious beliefs because they are manufactured and produced with, tested on, or otherwise developmentally connected to aborted fetal cell lines. Many employers have responded to employee submissions with intrusive and irrelevant questions about employees’ past personal health decisions and the theological bases for those decisions, or demands that employees vet their religious beliefs about COVID-19 vaccines with a third party to justify their accommodation requests. The premises of these questions—that an employee’s current
request for religious accommodation must be consistent with the employees’ prior health decisions and religious understandings, or must be acknowledged by a person other than the employee—are legally invalid premises for deciding religious accommodation requests, and
any denial based on such premises violates Title VII.
Title VII of the Civil Rights Act of 1964 prohibits employers from discriminating against its employees on the basis of their sincerely held religious beliefs. See 42 U.S.C. §2000e-2(a) (“It shall be an unlawful employment practice for an employer . . . to fail or refuse to hire or to discharge any individual, or otherwise to discriminate against any individual with respect to his
compensation, terms, conditions, or privileges of employment because of such individual’s race, color, religion, sex, or national origin”);
