A Fact Sheet for Vaccine Providers published on the Food and Drug Administration (FDA

[SAN compnerd]

A Fact Sheet for Vaccine Providers published on the Food and Drug Administration (FDA) website

Dated October 20, 2021
Some highlights:

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to permit the emergency use of the unapproved product,
Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent
COVID-19 in individuals 12 years of age and older.

Myocarditis and Pericarditis

Postmarketing data demonstrate increased risks of myocarditis and pericarditis,
particularly within 7 days following the second dose. The observed risk is higher
among males under 40 years of age than among females and older males. The
observed risk is highest in males 12 through 17 years of age. Although some
cases required intensive care support, available data from short-term follow-up
suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.
The CDC has published considerations related to myocarditis and pericarditis
after vaccination, including for vaccination of individuals with a history of
myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-1...ocarditis.html).

Syncope (fainting) may occur in association with administration of injectable
vaccines, in particular in adolescents. Procedures should be in place to avoid injury
from fainting.

Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant
therapy, may have a diminished immune response to the Pfizer-BioNTech
COVID-19 Vaccine.

Limitation of Effectiveness
Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions in Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity
reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in
extremity (arm), and syncope have been reported following administration of the
Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.
Myocarditis and pericarditis have been reported following administration of the
Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.
Additional adverse reactions, some of which may be serious, may become
apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19
Vaccine, which is not an FDA-approved vaccine.The recipient or their caregiver has the option to accept or refuse
Pfizer-BioNTech COVID-19 Vaccine.The significant known and potential risks and benefits of Pfizer-BioNTech
COVID-19 Vaccine, and the extent to which such risks and benefits are
unknown.

In order to mitigate the risks of using this unapproved product under EUA and to
optimize the potential benefit of Pfizer-BioNTech COVID-19 Vaccine, the following
items are required. Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for
active immunization to prevent COVID-19 under this EUA is limited to the following
(all requirements must be met):

The vaccination provider is responsible for mandatory reporting of the
following to the Vaccine Adverse Event Reporting System (VAERS):

Interesting that they have verbiage that this vaccine is not approved even though the CDC jumped through hoops a few weeks back insisting that it is approved.

[NRA-Rider]

[Deadon]

Look, we can't approve this because people will sue for adverse reactions. Then we would know the real numbers. We can't have that!

[SPUTTER]

^ Yep, that's a big part of it. Also EUA allowed them to fool around with the formulation.

[Wherryj]

Look, we can't approve this because people will sue for adverse reactions. Then we would know the real numbers. We can't have that!

Even if they approve it, they went through a sham process to do so and are actively suppressing post-marketing surveillance. Approval or not, we'll likely never know the full scope of the issues with the product. Hopefully they aren't as bad as it appears.