Levine dismisses Comirnaty labeling issue as ‘misinformation’
By Guy Page
Gov. Phil Scott thinks financial incentives will help students “get enthusiastic about the process” of widespread vaccination. He’s pressing on with mandatory mandatory vaccination despite concern about fraudulent Covid-19 vaccine cards. And Health Commissioner Mark Levine dismisses concern about the lack of labeled, approved Cormirnaty vaccine as “misinformation.”
Below, find a transcript from yesterday’s press conference (at 1:18:20 mark) of state leaders’ answers to three questions asked by the Vermont Daily Chronicle.
Chronicle: Governor, your new school guidance gives students a say on how to spend millions in state grants if their school gets to 80%. It’s dangling a lot of money in front of children. Are you trying to incentivize children to exert peer pressure? In any case, how will you prevent zealous students from ‘stigmatizing,’ to use Commissioner Levine’s word, or even bullying uncooperative peers?
Scott: We haven’t gotten specific as to whether it’s going to be the 80 percent or whatever benchmarks we come up with. I think it’s a good project for kids to get involved in. I think they should be involved in determining whether they get vaccinated or not. I think it’s just a good exercise and taking full advantage of their own health. It’s a learning experience for them.
“We will be, I’m sure, our educational partners – teachers and superintendents and principals and so forth – will be monitoring this situation. But we want them to get enthusiastic about the process. We thought this was one way of doing so.”
Chronicle: A UVMMC nurse told me today “a significant number of staff RNs and respiratory therapists are not planning to get vaccinated and will leave jobs if the exemption is not given.” Other health agencies dependent on UVMMC are falling into line with that. So in Vermont, there’s nowhere else for these needed, trained health care providers to work. Are you concerned that your new state employee mandate will create a demand for fake cards, as has been seen in other states?
Scott: “Well, there’s always a concern as we’ve witnessed with the VSP issue. But again, we believe that vaccines are our way out of this. If we want to go back to some sort of normal and not have to live with this in perpetuity, we have to take this on ourselves and mitigate this in the best way that we we know of at this point in time. We believe in the science. We believe that this is the best approach. And we’ll continue to push forward on this.”
Chronicle: Children’s Health Defense says that a close reading of the FDA approval of the Pfizer vaccine only gives full approval actually to the German BionTech Comirnaty vaccine, of which there’s now almost none in the U.S., and that any vaccine from a Pfizer, Moderna, or J&J vial is actually legally still under the EUA, which has ramifications for any mandate. Are you aware of this concern, and if so what do you think?
Scott passed the question to Dr. Mark Levine, VT Commissioner of Health.
Levine: “I am very aware of this. Thanks for bringing it to the public’s attention. This goes under the category of misinformation, and it is abundant on the internet.
“There have been abundant legal opinions from respected legal scholars and policy makers, none of whom see this as a concern at all. The new name of the vaccine is just that – it’s a name, but it is not a new vaccine. It is the same vaccine that’s been in use. Now that it’s got approval, they’ve given it a true name not just the generic vaccine. But there’s no difference in the formulation or anything. The only difference will be the label will have a name of a vaccine that wasn’t present before. So people who are holding this up in a way of trying to be in the anti-vaccination cadre of people are actually just spreading misinformation.”
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Categories: Covid-19
Read page 2 second paragraph….
Attention: Ms. Elisa Harkins 500 Arcola Road Collegeville, PA 19426
Dear Ms. Harkins:
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2
On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‐19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the Act. FDA reissued the letter of authorization on: December 23, 2020,3 February 25, 2021,4 May
1 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020.
2 U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020).
3 In the December 23, 2020 revision, FDA removed reference to the number of doses per vial after dilution from the letter of authorization, clarified the instructions for vaccination providers reporting to VAERS, and made other technical corrections. FDA also revised the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to clarify the number of doses of vaccine per vial after dilution and the instructions for reporting to VAERS. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and the Fact Sheet for Recipients and Caregivers were revised to include additional information on safety monitoring and to clarify information about the availability of other COVID-19 vaccines.
4 In the February 25, 2021 revision, FDA allowed flexibility on the date of submission of monthly periodic safety reports and revised the requirements for reporting of vaccine administration errors by Pfizer Inc. The Fact Sheet for Health Care Providers Administering Vaccine (Vaccination Providers) was revised to provide an update to the storage and transportation temperature for frozen vials, direct the provider to the correct CDC website for information on monitoring vaccine recipients for the occurrence of immediate adverse reactions, to include data from a developmental toxicity study, and add adverse reactions that have been identified during post authorization use. The Fact Sheet for Recipients and Caregivers was revised to add adverse reactions that have been identified during post authorization use.
August 23, 2021

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10, 2021,5 June 25, 2021,6 and August 12, 2021.7
On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The Fact Sheet for Recipients and Caregivers was updated as the Vaccine Information Fact Sheet for Recipients and Caregivers, which comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID- 19 Vaccine, mRNA).
Pfizer-BioNTech COVID‐19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer- BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.8
5 In the May 10, 2021 revision, FDA authorized Pfizer-BioNTech Vaccine for the prevention of COVID-19 in individuals 12 through 15 years of age, as well as for individuals 16 years of age and older. In addition, FDA revised the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include the following Warning: “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.” In addition, the Fact Sheet for Recipients and Caregivers was revised to instruct vaccine recipients or their caregivers to tell the vaccination provider about fainting in association with a previous injection.
6 In the June 25, 2021 revision, FDA clarified terms and conditions that relate to export of Pfizer-BioNTech COVID‐19 Vaccine from the United States. In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning about myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine. The Fact Sheet for Recipients and Caregivers was updated to include information about myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID‐19 Vaccine.
7 In the August 12, 2021 revision, FDA authorized a third dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least 28 days following the two dose regimen of this vaccine in individuals 12 years of age or older who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
8 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.

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For the December 11, 2020 authorization for individuals 16 years of age and older, FDA reviewed safety and efficacy data from an ongoing phase 1/2/3 trial in approximately 44,000 participants randomized 1:1 to receive Pfizer-BioNTech COVID‐19 Vaccine or saline control. The trial has enrolled participants 12 years of age and older. FDA’s review at that time considered the safety and effectiveness data as they relate to the request for emergency use authorization in individuals 16 years of age and older. FDA’s review of the available safety data from 37,586 of the participants 16 years of age and older, who were followed for a median of two months after receiving the second dose, did not identify specific safety concerns that would preclude issuance of an EUA. FDA’s analysis of the available efficacy data from 36,523 participants 12 years of age and older without evidence of SARS-CoV-2 infection prior to 7 days after dose 2 confirmed the vaccine was 95% effective (95% credible interval 90.3, 97.6) in preventing COVID-19 occurring at least 7 days after the second dose (with 8 COVID-19 cases in the vaccine group compared to 162 COVID-19 cases in the placebo group). Based on these data, and review of manufacturing information regarding product quality and consistency, FDA concluded that it is reasonable to believe that Pfizer-BioNTech COVID‐19 Vaccine may be effective. Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Pfizer-BioNTech COVID‐19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 16 years of age and older. Finally, on December 10, 2020, the Vaccines and Related Biological Products Advisory Committee voted in agreement with this conclusion.
For the May 10, 2021 authorization for individuals 12 through 15 years of age, FDA reviewed safety and effectiveness data from the above-referenced, ongoing Phase 1/2/3 trial that has enrolled approximately 46,000 participants, including 2,260 participants 12 through 15 years of age. Trial participants were randomized 1:1 to receive Pfizer-BioNTech COVID-19 Vaccine or saline control. FDA’s review of the available safety data from 2,260 participants 12 through 15 years of age, who were followed for a median of 2 months after receiving the second dose, did not identify specific safety concerns that would preclude issuance of an EUA. FDA’s analysis of SARS-CoV-2 50% neutralizing antibody titers 1 month after the second dose of Pfizer- BioNTech COVID-19 Vaccine in a subset of participants who had no serological or virological evidence of past SARS-CoV-2 infection confirm the geometric mean antibody titer in participants 12 through 15 years of age was non-inferior to the geometric mean antibody titer in participants 16 through 25 years of age. FDA’s analysis of available descriptive efficacy data from 1,983 participants 12 through 15 years of age without evidence of SARS-CoV-2 infection prior to 7 days after dose 2 confirm that the vaccine was 100% effective (95% confidence interval 75.3, 100.0) in preventing COVID-19 occurring at least 7 days after the second dose (with no COVID-19 cases in the vaccine group compared to 16 COVID-19 cases in the placebo group). Based on these data, FDA concluded that it is reasonable to believe that Pfizer- BioNTech COVID‐19 Vaccine may be effective in individuals 12 through 15 years of age. Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Pfizer-BioNTech COVID‐19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 12 through 15 years of age.
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For the August 12, 2021 authorization of a third dose of the Pfizer-BioNTech COVID-19 Vaccine in individuals 12 years of age or older who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, FDA reviewed safety and effectiveness data reported in two manuscripts on solid organ transplant recipients. The first study was a single arm study conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) a median of 97±8 months earlier. A third dose of the Pfizer-BioNTech COVID-19 Vaccine was administered to 99 of these individuals approximately 2 months after they had received a second dose. Levels of total SARS-CoV-2 binding antibodies meeting the pre-specified criteria for success occurred four weeks after the third dose in 26/59 (44.0%) of those who were initially considered to be seronegative and received a third dose of the Pfizer-BioNTech COVID-19 Vaccine; 67/99 (68%) of the entire group receiving a third vaccination were subsequently considered to have levels of antibodies indicative of a significant response. In those who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 events were reported. A supportive secondary study describes a double-blind, randomized-controlled study conducted in 120 individuals who had undergone various solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) a median of 3.57 years earlier (range 1.99- 6.75 years). A third dose of a similar mRNA vaccine (the Moderna COVID-19 vaccine) was administered to 60 individuals approximately 2 months after they had received a second dose (i.e., doses at 0, 1 and 3 months); saline placebo was given to 60 individuals or comparison. The primary outcome was anti-RBD antibody at 4 months greater than 100 U/mL. This titer was selected based on NHP challenge studies as well as a large clinical cohort study to indicate this antibody titer was protective. Secondary outcomes were based on a virus neutralization assay and polyfunctional T cell responses. Baseline characteristics were comparable between the two study arms as were pre-intervention anti-RBD titer and neutralizing antibodies. Levels of total SARS-CoV-2 binding antibodies indicative of a significant response occurred four weeks after the third dose in 33/60 (55.0%) of the Moderna COVID-19 vaccinated group and 10/57 (17.5%) of the placebo individuals. In the 60 individuals who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no grade 3 or grade 4 adverse events were reported. Despite the moderate enhancement in antibody titers, the totality of data (i.e., supportive paper by Hall et al. demonstrated efficacy of the product in the elderly and persons with co-morbidities) supports the conclusion that a third dose of the Pfizer-BioNTech COVID-19 vaccine may be effective in this population, and that the known and potential benefits of a third dose of Pfizer-BioNTech COVID-19 Vaccine outweigh the known and potential risks of the vaccine for immunocompromised individuals at least 12 years of age who have received two doses of the Pfizer-BioNTech COVID-19 Vaccine and who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‐19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years, or
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to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of Pfizer-BioNTech COVID‐19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:
II.
A. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
B. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‐19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Pfizer-BioNTech COVID‐19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and
C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‐19 Vaccine to prevent COVID-19.10
Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows:
• Pfizer Inc. will supply Pfizer-BioNTech COVID‐19 Vaccine either directly or through authorized distributor(s),11 to emergency response stakeholders12 as directed by the U.S.
9 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in this EUA.
10 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
11 “Authorized Distributor(s)” are identified by Pfizer Inc. or, if applicable, by a U.S. government entity, such as the Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to distribute authorized Pfizer-BioNTech COVID‐19 Vaccine.
12 For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates that have legal responsibility and authority for responding to an incident, based on political or geographical boundary lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some cases (e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans), there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an

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government, including the Centers for Disease Control and Prevention (CDC) and/or
other designee, for use consistent with the terms and conditions of this EUA;
• The Pfizer-BioNTech COVID‐19 Vaccine covered by this authorization will be administered by vaccination providers13 and used only to prevent COVID-19 in
individuals ages 12 and older; and
• Pfizer-BioNTech COVID‐19 Vaccine may be administered by a vaccination provider
without an individual prescription for each vaccine recipient.
This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Product Description
The Pfizer-BioNTech COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. The Pfizer-BioNTech COVID-19 Vaccine does not contain a preservative.
Each 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine contains 30 mcg of a nucleoside- modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Pfizer-BioNTech COVID-19 Vaccine also includes the following ingredients: lipids (0.43 mg (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.09 mg 1,2-distearoyl-sn-glycero-3- phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection) contributes an additional 2.16 mg sodium chloride per dose.
official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination providers will all be met.
13 For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health officer) to administer or provide vaccination services in accordance with the applicable emergency response stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC COVID-19 Vaccination Program. If the vaccine is exported from the United States, a “vaccination provider” is a provider that is authorized to administer this vaccine in accordance with the laws of the country in which it is administered. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S. Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020).

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The dosing regimen is two doses of 0.3 mL each, 3 weeks apart. A third dose may be administered at least 28 days following the second dose of the two dose regimen of this vaccine to individuals 12 years of age or older who have undergone solid organ transplantation, or individuals 12 years of age or older who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
The manufacture of the authorized Pfizer-BioNTech COVID‐19 Vaccine is limited to those facilities identified and agreed upon in Pfizer’s request for authorization.
The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Pfizer-BioNTech COVID‐19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act.
Pfizer-BioNTech COVID‐19 Vaccine is authorized for emergency use with the following product-specific information required to be made available to vaccination providers and recipients, respectively (referred to as “authorized labeling”):
• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‐19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)
• Vaccine Information Fact Sheet for Recipients and Caregivers About COMIRNATY (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease (COVID-19).
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of Pfizer-BioNTech COVID‐19 Vaccine, when used to prevent COVID-19 and used in accordance with this Scope of Authorization (Section II), outweigh its known and potential risks.
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that Pfizer-BioNTech COVID‐19 Vaccine may be effective in preventing COVID-19 when used in accordance with this Scope of Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act.
Having reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, I have concluded that Pfizer-BioNTech COVID‐19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of Pfizer-BioNTech COVID‐19 Vaccine under this EUA must be consistent with, and may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and
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under the circumstances set forth in the Secretary of HHS’s determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), Pfizer-BioNTech COVID‐19 Vaccine is authorized to prevent COVID-19 in individuals 12 years of age and older as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law.
III. Conditions of Authorization
Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization: Pfizer Inc. and Authorized Distributor(s)
A. PfizerInc.andauthorizeddistributor(s)willensurethattheauthorizedPfizer- BioNTech COVID‐19 Vaccine is distributed, as directed by the U.S. government, including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets) will be made available to vaccination providers, recipients, and caregivers consistent with the terms of this letter.
B. PfizerInc.andauthorizeddistributor(s)willensurethatappropriatestorageandcold chain is maintained until delivered to emergency response stakeholders’ receipt sites.
C. PfizerInc.willensurethatthetermsofthisEUAaremadeavailabletoallrelevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Pfizer- BioNTech COVID‐19 Vaccine. Pfizer Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling.
D. PfizerInc.maydevelopanddisseminateinstructionalandeducationalmaterials(e.g., video regarding vaccine handling, storage/cold-chain management, preparation, disposal) that are consistent with the authorized emergency use of the vaccine as described in the letter of authorization and authorized labeling, without FDA’s review and concurrence, when necessary to meet public health needs during an emergency. Any instructional and educational materials that are inconsistent with the authorized labeling are prohibited.
E. Pfizer Inc. may request changes to this authorization, including to the authorized Fact Sheets for the vaccine. Any request for changes to this EUA must be submitted to Office of Vaccines Research and Review (OVRR)/Center for Biologics Evaluation and Research (CBER). Such changes require appropriate authorization prior to implementation.14
14 The following types of revisions may be authorized without reissuing this letter: (1) changes to the authorized labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new fact sheets; (4) new carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing

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F. Pfizer Inc. will report to Vaccine Adverse Event Reporting System (VAERS):
• Serious adverse events (irrespective of attribution to vaccination);
• Cases of Multisystem Inflammatory Syndrome in children and adults; and
• Cases of COVID-19 that result in hospitalization or death, that are reported to
Pfizer Inc.
These reports should be submitted to VAERS as soon as possible but no later than 15 calendar days from initial receipt of the information by Pfizer Inc.
G. PfizerInc.mustsubmittoInvestigationalNewDrugapplication(IND)number 19736 periodic safety reports at monthly intervals in accordance with a due date agreed upon with the Office of Biostatistics and Epidemiology (OBE)/CBER beginning after the first full calendar month after authorization. Each periodic safety report is required to contain descriptive information which includes:
• A narrative summary and analysis of adverse events submitted during the reporting interval, including interval and cumulative counts by age groups, special populations (e.g., pregnant women), and adverse events of special interest;
• A narrative summary and analysis of vaccine administration errors, whether or not associated with an adverse event, that were identified since the last reporting interval;
• Newly identified safety concerns in the interval; and
• Actions taken since the last report because of adverse experiences (for example,
changes made to Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet, changes made to studies or studies initiated).
H. Nochangeswillbeimplementedtothedescriptionoftheproduct,manufacturing process, facilities, or equipment without notification to and concurrence by FDA.
I. All manufacturing facilities will comply with Current Good Manufacturing Practice requirements.
J. Pfizer Inc. will submit to the EUA file Certificates of Analysis (CoA) for each drug product lot at least 48 hours prior to vaccine distribution. The CoA will include the established specifications and specific results for each quality control test performed on the final drug product lot.
K. PfizerInc.willsubmittotheEUAfilequarterlymanufacturingreports,startingin July 2021, that include a listing of all Drug Substance and Drug Product lots produced after issuance of this authorization. This report must include lot number, manufacturing site, date of manufacture, and lot disposition, including those lots that
processes, including tests or other authorized components of manufacturing; (7) new conditions of authorization to require data collection or study. For changes to the authorization, including the authorized labeling, of the type listed in (3), (6), or (7), review and concurrence is required from the Preparedness and Response Team (PREP)/Office of the Center Director (OD)/CBER and the Office of Counterterrorism and Emerging Threats (OCET)/Office of the Chief Scientist (OCS).

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were quarantined for investigation or those lots that were rejected. Information on the reasons for lot quarantine or rejection must be included in the report.
L. Pfizer Inc. and authorized distributor(s) will maintain records regarding release of Pfizer-BioNTech COVID‐19 Vaccine for distribution (i.e., lot numbers, quantity, release date).
M. Pfizer Inc. and authorized distributor(s) will make available to FDA upon request any records maintained in connection with this EUA.
N. PfizerInc.willconductpost-authorizationobservationalstudiestoevaluatethe association between Pfizer-BioNTech COVID-19 Vaccine and a pre-specified list of adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19. The study population should include individuals administered the authorized Pfizer-BioNTech COVID-19 Vaccine under this EUA in the general U.S. population (12 years of age and older), populations of interest such as healthcare workers, pregnant women, immunocompromised individuals, subpopulations with specific comorbidities. The studies should be conducted in large scale databases with an active comparator. Pfizer Inc. will provide protocols and status update reports to the IND 19736 with agreed-upon study designs and milestone dates.
Emergency Response Stakeholders
O. Emergencyresponsestakeholderswillidentifyvaccinationsitestoreceiveauthorized Pfizer-BioNTech COVID‐19 Vaccine and ensure its distribution and administration, consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program.
P. Emergency response stakeholders will ensure that vaccination providers within their jurisdictions are aware of this letter of authorization, and the terms herein and any subsequent amendments that might be made to the letter of authorization, instruct them about the means through which they are to obtain and administer the vaccine under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Vaccine Information Fact Sheet for Recipients and Caregivers] is made available to vaccination providers through appropriate means (e.g., e-mail, website).
Q. EmergencyresponsestakeholdersreceivingauthorizedPfizer-BioNTechCOVID‐19 Vaccine will ensure that appropriate storage and cold chain is maintained.
Vaccination Providers
R. Vaccinationproviderswilladministerthevaccineinaccordancewiththe authorization and will participate and comply with the terms and training required by CDC’s COVID-19 Vaccination Program.

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S. Vaccination providers will provide the Vaccine Information Fact Sheet for Recipients and Caregivers to each individual receiving vaccination and provide the necessary information for receiving their second dose and/or third dose.
T. Vaccination providers administering the vaccine must report the following information associated with the administration of the vaccine of which they become aware to VAERS in accordance with the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers):
• Vaccine administration errors whether or not associated with an adverse event
• Serious adverse events (irrespective of attribution to vaccination)
• Cases of Multisystem Inflammatory Syndrome in children and adults
• Cases of COVID-19 that result in hospitalization or death
Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the words “Pfizer-BioNTech COVID‐19 Vaccine EUA” in the description section of the report. More information is available at vaers.hhs.gov or by calling 1-800-822- 7967. To the extent feasible, report to Pfizer Inc. by contacting 1-800-438-1985 or by providing a copy of the VAERS form to Pfizer Inc.; Fax: 1-866-635-8337.
U. Vaccination providers will conduct any follow-up requested by the U.S government, including CDC, FDA, or other designee, regarding adverse events to the extent feasible given the emergency circumstances.
V. Vaccination providers will monitor and comply with CDC and/or emergency response stakeholder vaccine management requirements (e.g., requirements concerning obtaining, tracking, and handling vaccine) and with requirements concerning reporting of vaccine administration data to CDC.
W. Vaccination providers will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to CDC, and FDA for inspection upon request.
Conditions Related to Printed Matter, Advertising, and Promotion
X. Alldescriptiveprintedmatter,advertising,andpromotionalmaterial,relatingtothe use of the Pfizer-BioNTech COVID‐19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations.
Y. Alldescriptiveprintedmatter,advertising,andpromotionalmaterialrelatingtothe use of the Pfizer-BioNTech COVID‐19 Vaccine clearly and conspicuously shall state that:

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• This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Condition Related to Export
Z. If the Pfizer-BioNTech COVID‐19 Vaccine is exported from the United States, conditions C, D, and O through Y do not apply, but export is permitted only if 1) 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 and 2) the intended use of the vaccine will comply in all respects with the laws of the country in which the product will be used. The requirement in this letter that the authorized labeling (i.e., Fact Sheets) be made available to vaccination providers, recipients, and caregivers in condition A will not apply if the authorized labeling (i.e., Fact Sheets) are made available to the regulatory authorities of the country in which the vaccine will be used.
Conditions With Respect to Use of Licensed Product
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals
16 years of age and older. There remains, however, a significant amount of Pfizer- BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).
BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Conditions A through W in this letter apply when COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses described in this subsection III.BB, except that product manufactured and labeled in accordance with the approved BLA is deemed to satisfy the manufacturing, labeling, and distribution requirements of this authorization.
IV. Duration of Authorization

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This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.
Enclosures
Sincerely, –/S/–
____________________________ RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration
It is so easy to claim misinformation and leave it at that. Dr. Levine is the one providing misinformation.
If the FDA had intended what Dr. Levine is suggesting is the reality, they could have modified the EUA for the Pfizer-BioNTech vaccine by declaring it to be fully approved. They did not do that, and the injection being used today is still only approved under the Emergency Utilization Authorization and as such cannot be mandated by the governor or anyone as a condition of employment.
Dr. Levine, instead of making bald, misinformation statements, should explain the law, not by saying some unidentified expert said, but by citing chapter and verse to prove what he says is true. Dr. Levine is wrong and you know it and you should know better. Is the Comirnaty vaccine even available for use? Are you saying there are no differences, not even in the indemnity afforded the manufacturer and the recognition now with Comirnaty that there are some serious side effects that were not reported with the currently used injection?
Very disappointing.
Truly evil.
Welcome to the Phil Scott 5 Ring Fear Circus. I am truly disappointed that Dr. Mark Levine has opted to behave with hubris, similarly to anthony fauci and obfuscate fact to fulfill an agenda.
To wit:
Page 2 Paragraph 8:
8 The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
Page 7 paragraph 3:
The Pfizer-BioNTech COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Pfizer-BioNTech COVID‐19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act.
But this is just “misinformation”.


When does Vermont get their name changed, to Nazimont? Or Patikmont.?
Old Scott is telling students to not listen to their parents, to listen to him and Levine and all of the other idiots here in Vermont…..Listen to us and we will pay you to go against your parents. Lets give them money. but not tell them that the Vaxx can harm them. People who have had the job are getting covid-19 Even getting the Jab twice is still making you get the corvid.
Now numnuts Fauci is saying that you will have to get jab a third time or maybe for the rest of your life.
Face it people the left and the RINOs want to keep people under their control, they don’t want us to have a normal life.
Thanks to Governor Scott our kids are also being brainwashed into early and risky sexual activity by Planned Parenthood’ and their “peer educators” who also promote undermining parents and parental rights – and all with the taxpayer dollars Scott gives to them.
It is significant that money is offered for children to get vaccinated ;it shows the attitude of our State leaders that they are promoting an agenda,rather what is needed!!Plain an simple people more and more just do not trust the State Government!!Public schools are a complete mess,businesses are way over taxed,our State is far too expensive invasive and corrupt!!Most of what is being done is unconstitutional manipulation to promote Socialism backed up by Biden’s magic money that it has driven the debt ceiling so high it will never be paid!! We need to take off the silly face masks,get to work,care for the poor,and stop the freebies!! The real problem is not anything Covid,it is corrupt politicians.We are not a democracywhere that majority rules,we are a and always have been,a constitutional republic that protects its people with life liberty and the pursuit of happiness through hard work!!
Israel is the most vaccinated nation in the world yet hospitals are full and deaths are skyrocketing. Why is forcing Americans to get vaccinated so important at the exact time Israel is proving that this “experimental vaccine” is a dangerous and deadly failure. Mask do nothing… the vaccine is morphing into another strain. When are our leaders going to step up and stop this genocide.
What’s this “we” stuff w/Scott? Has he got a mouse in his pocket? “No stigmatization” by peers & “monitoring by our education partners”, & “we want them to get enthusiastic about the process”? Does this apply to OTHER “health decisions” by KIDS that don’t involve their parents? And Levine talking about “misinformation”. THAT’s CLASSIC! This from a guy who has been fomenting “misinformation” since Day 1, including his Fauci-worship, which thanks to the Intercept & Rand Paul we now KNOW that WE paid for the Commie Chinese to weaponize this virus, something Lord Fauci claimed was “worth the risks” of a pandemic in 2011, and all for the “development of modern vaccines”..OK then! The worst wounds are ALWAYS self-inflicted, eh? Will Fauci be busted for lying to Congress, ala Roger Stone w/the FBI goons raiding HIS home at 5 AM & CNN cameras in tow? Of course NOT, seems the DOJ’s been “weaponized” also but only against conservatives. And if one doesn’t tow the Company line they get cancelled like Alex Berenson found out recently, find him on Substack now where they don’t CENSOR people who question or even CITE the CDC’s own NUMBERS & conclusions. Remember that 2 decisions STILL allow the Gov.’t to A) Sterilize you against your will (Buck v. Bell) and B) Mandate “vaccination” (Jacobsen) BUT Jacobsen involved SMALLPOX that did NOT have a 99.7% survival rate. You want to vax me against my will? COME & get me, fools.
Children are under the authority of their parents for a reason. Most do not yet have the maturity to make decisions of this magnitude without being influenced by peer pressure or the offer of a short-term reward. Shame on Phil Scott and Mark Levine for trying to bribe them into accepting a medical procedure that is still experimental, and, despite the intentionally confusing wording of the supposed approval, has absolutely not been proven to be either safe or effective. It isn’t enough to try to force healthcare workers, first responders, and all state employees to risk their health and possibly their very lives in order to be allowed to keep their jobs. Now they are going after our children. I have to love their claims that people are spreading “misinformation”. Maybe they should actually read some of it, and stop spreading misinformation themselves.
https://americasfrontlinedoctors.org/
https://en-volve.com/2021/05/08/57-top-scientists-and-doctors-release-shocking-study-on-covid-vaccines-and-demand-immediate-stop-to-all-vaccinations/
https://www.davidmartin.world/wp-content/uploads/2021/01/The_Fauci_COVID-19_Dossier.pdf
I find it interesting that Fauci documents via FOIA prove that he committed crimes. And subsequently the news cycle gets changed to the Biden EAU vaccine mandate. And then that discussion is mute by the news cycle covering the anniversary of 911. The FDA is fallible. We don’t care whether the FDA puts a stamp of “approval” on deadly products of the past ie: swineflu vaccine and others like Vioxx. We are very informed and educated citizens and parents of the USA will not give our consent. Traditional vaccine approval studies take 5 to 10 years of analysis to verify safety in the long term. NO Trump warp speed tactic can change that. Fact: the spike protein is dangerous to the human body per experts in the field at the Salk Institute. The vaccine makes your body produce spike protein and potentially can keep producing the protein for life through a process called gene transcription. Spike protein potentially scars blood vessels, causes capillary blood clots (test D-dime) and interferes with all functions of the body by binding to ACE2 receptors (published peered reviewed paper by Stephanie Seneff). The FDA is negligent in any approval by not addressing these concerns. It became apparent over time that VIOXX was killing people long after approval. I’ll be damned if I let this be administered to my kids given the science that is already known. The vaccine accomplishes one thing. And that is it creates antibodies against the spike protein and in the process the aftermath of the mRNA components destroy internal organs only to kill its host by what is seen to be “natural causes”. We see the vaccine in its present form to be lethal especially long term. As such, any mandate issued by authorities will be looked upon as a bodily lethal threat that requires defending against.
Don’t Comply with the LIE! Time for Peaceful Civil Disobedience in Vermont! We all know that Commie Scott, Levine and the administration is against We The People and the U.S. Constitution, Vermont Constitution and Parental Rights. They are all pushing for a Marxist One World Order.
We are Americans and We Have our God-Given Rights. We have Rights under the Law.
21 U.S.C. Section 360 bbb-3
The Nuremberg Code of 1947
Title 45 CFR 46
Don’t forget that the PREP Act of 2005 shields Pharmaceutical Companies from Liability. However, it does not shield businesses, schools, colleges, municipalities, local governments, etc.
Liberty is from God not men!
Mandates, federal or state, requiring the injection of an Emergency Use Authorization (EAU) product as a condition of employment are illegal and it is just a matter of time before a court makes it clear that is so. Employees who are being forced to submit or be fired, have a right to refuse and should see a lawyer. Beside the fact that this is and should be a personal medical choice, there is no fully FDA approved vaccine available (Comirnaty) for use by September 15th and there probably will not be for some time.
The law is the law, and the facts are the facts and Mark Levine’s unsupported, false declaration that this is misinformation should result in his firing or resignation.
We all have much to learn – this “does” fit here if you let it sink in – Maritime Law lifted – Common Law back – DC Corp dissolved – Act of 1871 dead – words – titles – chattel – need to keep waking up – just search…
https://drcharlieward.com/peter-stone-talks-common-law-being-sovereign/?utm_content=12911401&utm_medium=Email&utm_name=Id&utm_source=Actionetics&utm_term=Email
Your Straw Man Is an Artificial Person
At the time of birth, each person is issued their own straw man, legally speaking. On a birth certificate, the name that appears is in all capital letters. This name is a person’s legal name. However, people often write their name using a combination of lowercase and capital letters, which is, legally speaking, a separate entity.
Even names appearing on official licenses, such as those issued for marriage, appear in all capital letters. Until the time that a person (name in lowercase letters) reclaims their straw man (the name in all capitals), the state owns the name, not the person.
Biden and Scott are targeting the most singular group of non-vaccinated. 75% of Black Americans have exercised their right of refusal. The Black community is well informed and I respect that. Anyone voicing an opinion to the contrary must be considered a racist IMHO. The Black community got Biden elected and this is how he treats them? Threats of job loss, denial of therapeutics, denial of access to travel, denial of health benefits and SNAP. We made Biden work for us. He has abused his oath of office by threatening to remove Governors that don’t comply with any and all of his illegal mandates. We must not become violent. We must carry on to provide healthcare, food, electricity, computer chips to keep society running despite Joe and Phil trying to pit vaccinated against unvaccinated. Just like the over use of anti-biotics causes new virulent strains to emerge so has the proliferation of the spike protein vaccine. Do not allow authorities to demonize “resisters” because dictators don’t stop mandating and their will be no one left to help you when you decide the mandates have gone too far! We will win against racism. We will win against totalitarianism. We will win against the eugenics mentality. It won’t be easy but freedom is not given, it is taken.