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Biologics license, BioNtech, BLA, Comirnaty, Covid 19 vaccine, Emergency Use Authorization, EUA, FDA, mRNA, mRNA vaccine, myocarditis, pediatrics, pericarditis, Pfizer, Pfizer-BioNTech, pregnancy, SARS-CoV-2, Vaccine approval, vaccine licensing
Pfizer was not approved-licensed by the FDA, apart from Emergency Use Authorization. Rather, the European BioNTech mRNA vaccine, which is “legally distinct with certain differences” from Pfizer vaccine, was approved, but with conditions. There are many studies that the FDA is requiring them to complete, which won’t be finished until 2027. In the interim, we predict that these products will be removed from the market. This Emergency Use Authorization apparently protects Pfizer from liability. However, from our understanding, vaccine mandates for military, etc., cannot be undertaken for non-licensed vaccines. Currently, Comirnaty is not available in the United States. The manufacturing location is hidden in the approval. Why? Maybe it is made in Pfizer China? In the letter to BioNTech, it says: “Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug substance at (b) (4) The final formulated product will be manufactured, filled, labeled and packaged at Pfizer (b) (4). The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at (b) (4)”
The letter to BioNTech is literally signed Mary Malarkey! Didn’t Biden say No Malarkey?
Excerpt from letter to Pfizer: “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
[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….” Letter to Pfizer: https://www.fda.gov/media/150386/download
They were only studied for an average of 2 months after the second vaccine dose (median=half above and half below). This was apparently only for the original variant.
“C. There is no adequate, approved, and available9 alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-1 [9][10 ]
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….
The Pfizer-BioNTech COVID‑19 Vaccine covered by this authorization will be administered by vaccination providers 13 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…
Pfizer Inc. will conduct post-authorization observational studies to evaluate the 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…
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
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.
Sincerely,
–/S/–
____________________________ RADM Denise M. Hinton Chief Scientist Food and Drug Administration” Letter to Pfizer: https://www.fda.gov/media/150386/download
In the letter to BioNTech: “You may label your product with the proprietary name, COMIRNATY, and market it in 2.0 mL glass vials, in packages of 25 and 195 vials. We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”
YET FOR BIONTECH-Comirnaty, SAFETY STUDIES STILL REQUIRED UNTIL 2027:
Pediatric studies final report due October 31, 2024 (see list of studies below);
Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY, Final report October 31, 2025”.
“Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY. Final Report Submission: September 30, 2024”;
“Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network). Final Report Submission: May 31, 2027.”
“Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age. Final Report Submission: May 31, 2024 “
“Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age. Final Report Submission: December 31, 2022 https://www.fda.gov/media/151710/download
WHY ARE THEY HIDING THE MANUFACTURING LOCATIONS? BECAUSE THEY WILL BE MADE IN CHINA?
The letter, below, is literally signed Mary Malarkey! Didn’t Biden say No Malarkey?
“Our STN: BL 125742/0 BLA APPROVAL
BioNTech Manufacturing GmbH August 23, 2021 Attention: Amit Patel Pfizer Inc. 235 East 42nd Street New York, NY 10017
Dear Mr. Patel:
Please refer to your Biologics License Application (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA.
LICENSING
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 w ww.fda.gov
We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.
Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
The review of this product was associated with the following National Clinical Trial (NCT) numbers: NCT04368728 and NCT04380701.
MANUFACTURING LOCATIONS
Under this license, you are approved to manufacture COVID-19 Vaccine, mRNA drug substance at (b) (4) The final formulated product will be manufactured, filled, labeled and packaged at Pfizer (b) (4). The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at (b) (4)
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You may label your product with the proprietary name, COMIRNATY, and market it in 2.0 mL glass vials, in packages of 25 and 195 vials. We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion…
PEDIATRIC REQUIREMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
We are deferring submission of your pediatric studies for ages younger than 16 years for this application because this product is ready for approval for use in individuals 16 years of age and older, and the pediatric studies for younger ages have not been completed.
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Your deferred pediatric studies required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of these postmarketing studies must be reported according to 21 CFR 601.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments or required studies or clinical trials.
Label your annual report as an “Annual Status Report of Postmarketing Study Requirement/Commitments” and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements under section 506B of the FDCA are released or fulfilled. These required studies are listed below:
1. Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age.
Final Protocol Submission: October 7, 2020
Study Completion: May 31, 2023
Final Report Submission: October 31, 2023
2. Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of COMIRNATY in infants and children 6 months to <12 years of age.
Final Protocol Submission: February 8, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
3. Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age.
Final Protocol Submission: January 31, 2022
Study Completion: July 31, 2024
Final Report Submission: October 31, 2024
Submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMR sequential number for each study/clinical trial and the submission number as shown in this letter. Submit final study reports to this BLA STN BL 125742. In order for your PREA PMRs to be considered fulfilled, you must submit and receive approval of an efficacy or a labeling
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supplement. For administrative purposes, all submissions related to these required pediatric postmarketing studies must be clearly designated as:
• Required Pediatric Assessment(s)
We note that you have fulfilled the pediatric study requirement for ages 16 through 17 years for this application.
POSTMARKETING REQUIREMENTS UNDER SECTION 505(o)
Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological product applications to conduct postmarketing studies and clinical trials for certain purposes, if FDA makes certain findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)).
We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.
Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Therefore, based on appropriate scientific data, we have determined that you are required to conduct the following studies:
4. Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 31, 2021
Monitoring Report Submission: October 31, 2022
Interim Report Submission: October 31, 2023
Study Completion: June 30, 2025
Final Report Submission: October 31, 2025
5. Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus
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Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: August 11, 2021
Progress Report Submission: September 30, 2021
Interim Report 1 Submission: March 31, 2022
Interim Report 2 Submission: September 30, 2022
Interim Report 3 Submission: March 31, 2023
Interim Report 4 Submission: September 30, 2023
Interim Report 5 Submission: March 31, 2024
Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
6. Study C4591021 substudy to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: January 31, 2022
Study Completion: March 31, 2024
Final Report Submission: September 30, 2024
7. Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network).
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021
Study Completion: December 31, 2026
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Final Report Submission: May 31, 2027
8. Study C4591007 substudy to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this assessment according to the following schedule:
Final Protocol Submission: September 30, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
9. Study C4591031 substudy to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age.
We acknowledge the timetable you submitted on August 21, 2021, which states that you will conduct this study according to the following schedule:
Final Protocol Submission: November 30, 2021
Study Completion: June 30, 2022
Final Report Submission: December 31, 2022
Please submit the protocols to your IND 19736, with a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMR sequential number for each study/clinical trial and the submission number as shown in this letter.
Please submit final study reports to the BLA. If the information in the final study report supports a change in the label, the final study report must be submitted as a supplement to this BLA STN BL 125742. For administrative purposes, all submissions related to these postmarketing studies required under section 505(o) must be submitted to this BLA and be clearly designated as:
• Required Postmarketing Correspondence under Section 505(o) • Required Postmarketing Final Report under Section 505(o) • Supplement contains Required Postmarketing Final Report under Section 505(o)
Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any study or clinical trial required under this section. This section also requires you to periodically report to FDA on the status of any study or clinical trial otherwise
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undertaken to investigate a safety issue. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments or required studies or clinical trials.
You must describe the status in an annual report on postmarketing studies for this product. Label your annual report as an Annual Status Report of Postmarketing Requirements/Commitments and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released. The status report for each study should include:
• the sequential number for each study as shown in this letter; • information to identify and describe the postmarketing requirement; • the original milestone schedule for the requirement; • the revised milestone schedule for the requirement, if appropriate; • the current status of the requirement (i.e., pending, ongoing, delayed, terminated, or submitted); and, • an explanation of the status for the study or clinical trial. The explanation should include how the study is progressing in reference to the original projected schedule, including, the patient accrual rate (i.e., number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our website at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.
We will consider the submission of your annual report under section 506B of the FDCA and 21 CFR 601.70 to satisfy the periodic reporting requirement under section 505(o)(3)(E)(ii) provided that you include the elements listed in section 505(o) and 21 CFR 601.70. We remind you that to comply with section 505(o), your annual report must also include a report on the status of any study or clinical trial otherwise undertaken to investigate a safety issue. Failure to periodically report on the status of studies or clinical trials required under section 505(o) may be a violation of FDCA section 505(o)(3)(E)(ii) and could result in regulatory action.
POSTMARKETING COMMITMENTS SUBJECT TO REPORTING REQUIREMENTS UNDER SECTION 506B
We acknowledge your written commitments as described in your letter of August 21, 2021 as outlined below:
10. Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry.”
Final Protocol Submission: July 1, 2021
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Study Completion: June 30, 2025
Final Report Submission: December 31, 2025
11. Study C4591007 substudy to evaluate the immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through <30 years of age.
Final Protocol Submission: September 30, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024
12. Study C4591012, entitled “Post-emergency Use Authorization Active Safety Surveillance Study Among Individuals in the Veteran's Affairs Health System Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine.”
Final Protocol Submission: January 29, 2021
Study Completion: June 30, 2023
Final Report Submission: December 31, 2023
13. Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study – Kaiser Permanente Southern California.”
Final Protocol Submission: March 22, 2021
Study Completion: December 31, 2022
Final Report Submission: June 30, 2023
Please submit clinical protocols to your IND 19736, and a cross-reference letter to this BLA STN BL 125742 explaining that these protocols were submitted to the IND. Please refer to the PMC sequential number for each study/clinical trial and the submission number as shown in this letter.
If the information in the final study report supports a change in the label, the final study report must be submitted as a supplement. Please use the following designators to prominently label all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
• Postmarketing Commitment – Correspondence Study Update • Postmarketing Commitment – Final Study Report • Supplement contains Postmarketing Commitment – Final Study Report
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For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product. Label your annual report as an Annual Status Report of Postmarketing Requirements/Commitments and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released. The status report for each study should include:
• the sequential number for each study as shown in this letter; • information to identify and describe the postmarketing commitment; • the original schedule for the commitment; • the status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted); and, • an explanation of the status including, for clinical studies, the patient accrual rate (i.e., number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our website at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm.
POST APPROVAL FEEDBACK MEETING
New biological products qualify for a post approval feedback meeting. Such meetings are used to discuss the quality of the application and to evaluate the communication process during drug development and marketing application review. The purpose is to learn from successful aspects of the review process and to identify areas that could benefit from improvement. If you would like to have such a meeting with us, please contact the Regulatory Project Manager for this application.
Sincerely,
Mary A. Malarkey Marion F. Gruber, PhD Director Director Office of Compliance Office of Vaccines and Biologics Quality Research and Review Center for Biologics Center for Biologics Evaluation and Research Evaluation and Research” Letter to BioNTech: https://www.fda.gov/media/151710/download
Letter to Pfizer: https://www.fda.gov/media/150386/download
Letter to BioNTech: https://www.fda.gov/media/151710/download
Screen shots of FDA Letter to BioNTech mRNA vaccine Approval with additional study conditions August 23, 2021
FDA Emergency Use Authorization Extension for Pfizer mRNA vaccine Letter August 23, 2021
Mining Awareness + 
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