As the pandemic drags on into a bleak and indeterminate future, so does the question of its origins. The consensus view from 2020, that in the likeliest scenario SARS-CoV-2 emerged naturally, through a jump from bats to humans (maybe with another animal between), persists unchanged. But suspicions that the outbreak started from a laboratory accident remain, shall we say, endemic. For months now, a steady drip of revelations has sustained an atmosphere of profound unease.https://products.gobankingrates.com/pub/4676bc08-11ad-4872-8fef-ffbda36ebb37?targeting[keyword]=news-tech
The latest piece of evidence came out this week in the form of a set of murkily sourced PDFs, with their images a bit askew. The main one purports to be an unfunded research grant proposal from Peter Daszak, the president of the EcoHealth Alliance, a global nonprofit focused on emerging infectious diseases, that was allegedly submitted to DARPA in early 2018 (and subsequently rejected), for a $14.2 million project aimed at “defusing the threat of bat-borne coronaviruses.” Released earlier this week by a group of guerrilla lab-leak snoops called DRASTIC, the proposal includes a plan to study potentially dangerous pathogens by generating full-length, infectious bat coronaviruses in a lab and inserting genetic features that could make coronaviruses better able to infect human cells. (Daszak and EcoHealth did not respond to requests for comment on this story.)
The document seems almost tailor-made to buttress one specific theory of a laboratory origin: that SARS-CoV-2 wasn’t simply brought into a lab by scientists and then released by accident, but rather pieced together in a deliberate fashion. In fact, the work described in the proposal fits so well into that narrative of a “gain-of-function experiment gone wrong” that some wondered if it might be too good to be true. Central figures in the coronavirus-origins debate were involved: Among Daszak’s listed partners on the grant were Ralph Baric of the University of North Carolina at Chapel Hill, an American virologist known for doing coronavirus gain-of-function studies in his lab, and Shi Zhengli, the renowned virus hunter from the Wuhan Institute of Virology. (Shi Zhengli has not responded to a request for comment. A UNC spokesperson responded on behalf of Baric, noting that “the grant applicant and DARPA are best positioned to explain the proposal.”)
There is good reason to believe the document is genuine. The Atlantic has confirmed that a grant proposal with the same identifying number and co-investigators was submitted to DARPA in 2018. The proposal that circulated online includes an ambitious scheme to inoculate wild bats against coronaviruses, carried out in concert with the National Wildlife Health Center, a research lab in Wisconsin. A spokesperson for the U.S. Geological Survey, which oversees the center, acknowledged this connection and affirmed the identifying number and co-investigators, noting that the agency’s involvement in the project ended with DARPA’s rejection of the grant proposal. “This is the proposal that was not funded,” USGS Acting Public Affairs Chief Rachel Pawlitz said after reviewing the PDF. She could not, however, vouch for the document in its entirety.
Jared Adams, DARPA’s chief of communications, said in an emailed statement that the agency was not at liberty to discuss proposals submitted as part of its emerging-pathogenic-threat program, which was launched in January 2018, and that DARPA has never funded “any activity or researcher associated with EcoHealth Alliance or Wuhan Institute of Virology.” An article about the proposal published yesterday in The Intercept points to a tweet by Daszak last weekend, before the PDF was widely shared, that refers obliquely to the release of unfunded grant proposals.
For anyone looking for the great, final vindication of the lab-leak hypothesis, this document will leave you wanting. Does the SARS-CoV-2 pandemic have an unnatural origin? The answer hasn’t changed: probably not. But we have learned something quite disturbing in the past few days, simply from how and when this information came to light.
The pandemic-origins debate is a big, confusing mess—but it’s an important mess, so bear with us. The hottest news in the leaked proposal concerns the researcher’s plan to sift through a large trove of genomic-sequence data drawn from samples of bat blood, feces, and other fluids, in search of (among other things) new kinds of “furin cleavage sites.” When these are encoded into just the right spot on the spike protein of a coronavirus, they allow that spike to be opened up by an enzyme found in human cells. According to the proposal, “high-risk” versions of these sites, once identified, would then be introduced via genetic engineering into SARS-like coronaviruses.
Why does this matter? We’ve long known that the presence of such a site in SARS-CoV-2 increased its pathogenic power, and we also know that similar features have not been found in any other SARS-like coronavirus (though we may find them in the future). For lab-leak proponents, these facts—combined with certain details of the furin cleavage site’s structure—strongly hint at human intervention. As the science journalist Nicholas Wade argued in an influential lab-leak-theory brief last spring, this genetic insertion “lies at the heart of the puzzle of where the virus came from.” The virologist David Baltimore even told Wade that the structure of the SARS-CoV-2 furin cleavage site was “the smoking gun for the origin of the virus.” (Baltimore later walked back his claim.)
As many scientists have since pointed out, the mere presence of the furin cleavage site is not dispositive of a Frankenstein experiment gone wrong. For example, the same genetic feature has come about, quite naturally and independently, in plenty of other, more distantly related coronaviruses, including those that cause the common cold. According to a “critical review” co-authored by 21 experts on viruses and viral evolution that was posted as a preprint in July, “simple evolutionary mechanisms can readily explain” the site’s presence in SARS-CoV-2, and “there is no logical reason” why it would look the way it does if it had been engineered inside a lab. “Further,” the authors wrote, “there is no evidence of prior research at the [Wuhan Institute of Virology] involving the artificial insertion of complete furin cleavage sites into coronaviruses.”
“The move would make it the first Covid vaccine to go from emergency use authorization to full FDA approval.”
With that in mind, it is worth a reminder that both Pfizer and Moderna stopped the clinical trials the FDA was using in their review:
The Moderna and Pfizer vaccine tests were conducted, as customary, with a control group; a group within the trial who were given a placebo and not the test vaccine. However, during the trial -and after the untested vaccines were given emergency use authorization- the vaccine companies conducting the trial decided to break protocol and notify the control group they were not vaccinated. Almost all the control group were then given the vaccine.
Purposefully dissolving the placebo group violates the scientific purpose to test whether the vaccine has any efficacy; any actual benefit and/or safety issues. Without a control group there is nothing to compare the vaccinated group against.According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose:
[…] “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.
“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”
He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study. “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.
People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots.
Just so we are clear, the final FDA authorization and approval for the vaccines are based on the outcome of these trials. As noted in the example above, the control group was intentionally lost under the auspices of “the right thing to do”, so there is no way for the efficacy, effectiveness or safety of the vaccine itself to be measured.
There’s no one left within the control group, of a statistically valid value, to give an adequate comparison of outcomes for vaxxed -vs- non-vaxxed. This is nuts. That NPR article is one to bookmark when people start claiming the vaccination is effective.
How can the vaccine not be considered effective when there is no group of non-vaccinated people to compare the results to?
Good grief, the entire healthcare system is operating on a massive hive mindset where science, and the scientific method, is thrown out the window in favor of ideological outcomes and self-fulfilling prophecies.
The fact that the researchers and doctors, apparently under the payroll of the pharmaceutical companies that have a vested financial interest in the vaccine outcome, lost the control group on purpose is alarming.
Of course, Big Pharma will promote the vaccine as beneficial, and the controlled media will promote that message with a complete disconnect from the clinical trial details, and the FDA will grant approval on results that were intentionally constructed to produce only one outcome.
As noted by Dr. Malone, the commonsense therapeutic approach should be the primary focus, not vaccination, for ongoing healthcare systems as the COVID-19 variants will continue to evolve. Ultimately, the natural immunity process will be of greater overall benefit than vaccinations which will require continual boosters to deal with the ever-evolving variants (a similar approach to dealing with reoccurring and evolving flu strains). Dr. Malone provided support for his position with concurrence from the leading U.K. Vaccinologist in Great Britain, Sir Andrew Pollard
In essence, both Dr. Andrew Pollard (Director of the U.K. Oxford Vaccine Group), and Dr. Malone state that variants of the COVID-19 virus will continue to spread throughout the population regardless of vaccine status; and the virus will continue to evolve into more infectious but less deadly or pathogenic strains.
There simply is no way to vaccinate the population and stop the spread of COVID variants, because the vaccinated will contract and spread the virus just like the non-vaccinated. The vaccine approach should be targeted to the elderly and those most at risk.
Specific to the position of Dr. Malone – given the untested nature of the vaccine itself; no one knows the long-term side-effects; the benefit of the vaccine should be weighed against the individual’s current health status. Elderly populations with lower immune responses should be the target for vaccination; they are the most at risk. However, younger -less at risk- individuals will likely benefit more from therapeutic treatment after exposure *if* they experience any symptoms at all.
The problem is…. this commonsense approach is less favorable to the interests of the pharmaceutical industry and the healthcare systems that are controlled by the financial mechanisms inside the business of healthcare. Big Pharma would obviously make less money from a smaller target population for vaccination; ergo the therapeutic approach is a threat to the preferred approach of those who operate the business model. This is the overarching political battle.
The influence of the massive pharmaceutical corporations, inside the institutions of government controlled healthcare on a global basis, is massive. This outlook is the origin of the vaccinate push and vaccine narrative as the *only* and *best* solution. Anyone who raises a point, any point, in opposition to the mandated mass vaccine approach then becomes a target to be isolated, marginalized, ridiculed and removed.
On Monday, the FDA announced that it had approved the Pfizer-BioNTech COVID-19 vaccine for the prevention of the disease in individuals 16 years of age and older, but the rushed nature of their announcement raises questions.
Liberal media hacks rejoiced and gleefully spread the news they had been waiting for since Trump left office and the vaccine magically transformed into their only hope for mankind.
“Time for mandates!” They exclaimed, in some form or another, as they feverishly began plotting how they could now call for conservatives to be held down while a needle gets jammed in their arm.
And how convenient, just in time for booster shots!
The tyrants in Biden’s regime also jumped at the news and immediately said they would force all active-duty military members to get the jab. They are expected to implement even more draconian restrictions now that the FDA has given the experimental and highly controversial mRNA vaccine their ‘blessing.’
But wait just one second.
Just a few months ago when Trump was in charge, these same bootlickers were singing a completely different tune. They sounded the alarm about the vaccine being rushed and corners being cut so it could be distributed more quickly.
Now Biden fraudulently holds office and they follow along mindlessly like sheep as the FDA skips out on conducting crucial clinical trials and ignores mounting data that suggests the vaccine is less effective than natural immunity.
Perhaps they should have stuck to their guns, but mindless compliance is the liberal default.
Over the past few years the FDA has drasticallychanged the process to approve new drugs and biologics and have only accelerated since the China-virus was unleashed upon the world. New submissions for experimental treatments are being approved in record time, taking just months when they used to average over 3 years.
Even the inventor of the mRNA technology is speaking out against their rash decision.
According to a study by JAMA, the Journal of American Medical Association, treatments that get submitted for review are now subject to far less scrutiny and clinical trials than they have been in the past, with most now passing after being tested on just one control group.
This has enabled the agency to fast-track the passage of the Pfizer shot, despite awful results that have seen the vaccinated spread the virus as much – if not more – than those who have recovered naturally.
Even the CDC had to flip-flop again and admit as much.
Unbelievably, the FDA also turned over the responsibility to conduct necessary vaccine trials on some of the most important subgroups, like pregnant women, to the manufacturer. Several mandatory studies that should have taken place before full approval still need to be conducted and it will be up to Pfizer to ensure their completion and report the results.
Authors: By Joe Hoft Published August 24, 2021 at 9:00am
The FDA claimed last year their ‘rigorous testing means final vaccine approval in 2024!’ Then it was approved yesterday.
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 The final formulated product will be manufactured, filled, labeled and packaged at Pfizer . The diluent, 0.9% Sodium Chloride Injection, USP, will be manufactured at (b) (4) (b) (4) (b) (4) Page 2 – STN BL 125742/0 – Elisa Harkins 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. DATING PERIOD The dating period for COVID-19 Vaccine, mRNA shall be 9 months from the date of manufacture when stored between -90ºC to -60ºC (-130ºF to -76ºF). The date of manufacture shall be no later than the date of final sterile filtration of the formulated drug product (at , the date of manufacture is defined as the date of sterile filtration for the final drug product; at Pfizer , it is defined as the date of the Following the final sterile filtration, , no reprocessing/reworking is allowed without prior approval from the Agency. The dating period for your drug substance shall be when stored at We have approved the stability protocols in your license application for the purpose of extending the expiration dating period of your drug substance and drug product under 21 CFR 601.12. FDA LOT RELEASE Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER). BIOLOGICAL PRODUCT DEVIATIONS You must submit reports of biological product deviations under 21 CFR 600.14. You should identify and investigate all manufacturing deviations promptly, including those associated with processing, testing, packaging, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA 3486 to the Director, Office of Compliance and Biologics Quality, electronically through the eBPDR web application or at the address below. Links for the instructions on completing the electronic form (eBPDR) may be found on CBER’s web site at https://www.fda.gov/vaccines-blood-biologics/report-problem-centerbiologics-evaluation-research/biological-product-deviations: Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) Page 3 – STN BL 125742/0 – Elisa Harkins 10903 New Hampshire Ave. WO71-G112 Silver Spring, MD 20993-0002 MANUFACTURING CHANGES You must submit information to your BLA for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of COVID-19 Vaccine, mRNA, or in the manufacturing facilities. LABELING We hereby approve the draft content of labeling including Package Insert, submitted under amendment 74, dated August 21, 2021, and the draft carton and container labels submitted under amendment 63, dated August 19, 2021. CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, please submit the final content of labeling (21 CFR 601.14) in Structured Product Labeling (SPL) format via the FDA automated drug registration and listing system, (eLIST) as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ default.htm. Content of labeling must be identical to the Package Insert submitted on August 21, 2021. Information on submitting SPL files using eLIST may be found in the guidance for industry SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guida nces/UCM072392.pdf. The SPL will be accessible via publicly available labeling repositories. CARTON AND CONTAINER LABELS Please electronically submit final printed carton and container labels identical to the carton and container labels submitted on August 19, 2021, according to the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/providing-regulatory-submissions-electronic-format-certain-humanpharmaceutical-product-applications. All final labeling should be submitted as Product Correspondence to this BLA STN BL 125742 at the time of use and include implementation information on Form FDA 356h. ADVERTISING AND PROMOTIONAL LABELING Page 4 – STN BL 125742/0 – Elisa Harkins You may submit two draft copies of the proposed introductory advertising and promotional labeling with Form FDA 2253 to the Advertising and Promotional Labeling Branch at the following address: Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Ave. WO71-G112 Silver Spring, MD 20993-0002 You must submit copies of your final advertising and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)). All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)). ADVERSE EVENT REPORTING You must submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80), and you must submit distribution reports at monthly intervals as described in 21 CFR 600.81. For information on adverse experience reporting, please refer to the guidance for industry Providing Submissions in Electronic Format —Postmarketing Safety Reports for Vaccines at https://www.fda.gov/regulatory-information/search-fdaguidance-documents/providing-submissions-electronic-format-postmarketing-safetyreports-vaccines. For information on distribution reporting, please refer to the guidance for industry Electronic Submission of Lot Distribution Reports at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation /Post-MarketActivities/LotReleases/ucm061966.htm. 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. Page 5 – STN BL 125742/0 – Elisa Harkins 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 Page 6 – STN BL 125742/0 – Elisa Harkins 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 Page 7 – STN BL 125742/0 – Elisa Harkins 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 Page 8 – STN BL 125742/0 – Elisa Harkins 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 Page 9 – STN BL 125742/0 – Elisa Harkins 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 Page 10 – STN BL 125742/0 – Elisa Harkins 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 Page 11 – STN BL 125742/0 – Elisa Harkins 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.