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1. Pfizer/BioNTech, Moderna V granted emergency use authorisation. 12/2020
2. Trials still underway for next 2 yrs, to collect adequate data to determine if safe enough to be licensed by FDA.
3. You are being used to test drugs that may or may not have serious side effects
2. Trials still underway for next 2 yrs, to collect adequate data to determine if safe enough to be licensed by FDA.
3. You are being used to test drugs that may or may not have serious side effects
2. "Same section of Federal Food, Drug, & Cosmetic Act that authorizes FDA to grant emergency use also requires secretary of Health & Human Services to “ensure individuals to whom product is administered r informed … of option to accept or refuse administration of product"
3. "Likewise, the FDA’s guidance on emergency use authorization of medical products requires the FDA to “ensure that recipients are informed to the extent practicable given the applicable circumstances … That they have the option to accept or refuse the EUA product …”
4. "Dr. Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, was asked if Covid-19 vaccination can be required, she responded that under an EUA, “vaccines are not allowed to be mandatory."
5. "So, early in this vaccination phase, individuals will have to be consented and they won’t be able to be mandatory.” Cohn later affirmed that this prohibition on requiring the vaccines applies to organizations, including hospitals."
6. "The EUAs for both the Pfizer/BioNTech and Moderna vaccines require facts sheets to be given to vaccination providers and recipients. These fact sheets make clear that getting the vaccine is optional."
7. "For example, the one for recipients states that, “It is your choice to receive or not receive the Covid-19 Vaccine,” and if “you decide to not receive it, it will not change your standard of medical care.”
8. "This means that an organization will likely be at odds with federal law if it requires its employees, students or other members to get a Covid-19 vaccine that is being distributed under emergency use authorization."
9. "State law often prohibits retaliating against an employee for refusing to participate in a violation of federal law. Organizations that require Covid-19 vaccination in violation of federal law may face lawsuits under these state laws.."
10. V persuasion measures - "(1) they are not viewed as coercive, (2) the organization makes clear the decision regarding whether to receive the vaccine is voluntary, and (3) the measures comply with the requirements in the EUAs and the related regulations for these products."
