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US Food and Drug Administration (FDA) is globally respected for its scientific standards of vaccine safety, effectiveness and quality. [ cite ?]
SOURCE: https://en.wikipedia.org/wiki/Food_and_Drug_Administration "... The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed[4] and veterinary products....The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from household pets to human sperm donated for use in assisted reproduction. ...The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Stephen M. Hahn, MD is the current commissioner, as of December 2019.[5] ... The FDA has its headquarters in unincorporated White Oak, Maryland.[6] The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico.[7] In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.[8] ..."
The agency provides scientific and regulatory advice to vaccine developers and undertakes a rigorous evaluation of the scientific information through all phases of clinical trials, which continues after a vaccine has been approved by FDA or authorized for emergency use. FDA recognizes the gravity of the current public health emergency and the importance of facilitating availability, as soon as possible, of vaccines to prevent COVID-19 - vaccines that the public will trust and have confidence in receiving.
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.
Yes. Clinical trials are evaluating investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed by FDA to determine safety and effectiveness.
These clinical trials are being conducted according to the rigorous standards set forth by the FDA. [ARE THESE "rigorous standards" SET FORTH - IN DOCUMENTS THAT ARE AVAILABLE TO THE PUBLIC - TO READ? ]
Initially, in phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response in people.
In the absence of safety concerns from phase 1 studies, phase 2 studies include more people, where various dosages are tested on hundreds of people with typically varying health statuses and from different demographic groups, in randomized-controlled studies.
These studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine.
In phase 3, the vaccine is generally administered to thousands of people in randomized, controlled studies involving broad demographic groups (i.e., the population intended for use of the vaccine) and generates critical information on effectiveness and additional important safety data.
This phase provides additional information about the immune response in people who receive the vaccine compared to those who receive a control, such as a placebo.
[ At what point, are persons - who test negative for the SARS-COV-2 presence - Given the vaccine AND then deliberately and methodically exposed to the virus? ]
[ That is, does the vaccine act as a "prophylactic"? - 'preventing' the infective "life cycle" of the SARS-COV-2 virus - from taking place? ]
[ Specifically, is a human - after "vaccination" - "immune" to subsequent infection by the SARS-COV-2 virus? And, if "Yes" - for how long? ]
COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer. Who has collected this information? Is the data "collected" - for subsequent FDA "review" - available to the public?
For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. [ In the "risk-reward analysis" - are all eventualities calculated? And, if so - is the methodology published? What role does "profit" play? And, how is "tort" reflected in the analysis - of responsibility - for UN-considered - and UN-foreseen circumstances? ]
An EUA request for a COVID-19 vaccine can be submitted to FDA - based on a final analysis of a phase 3 clinical efficacy trial or an interim analysis of such trial, i.e., an analysis performed - before the planned end of the trial - once the data have met the "pre-specified success criteria" for the study’s primary efficacy endpoint.
From a safety perspective, FDA expects an EUA submission will include all "safety data" accumulated from phase 1 and 2 studies conducted with the vaccine, with an expectation that phase 3 data will include a median follow-up of at least 2-months (meaning that at least half of vaccine recipients in phase 3 clinical trials have at least 2 months of follow-up) after completion of the full vaccination regimen. [ How is this enforced? ]
In addition, FDA expects that an EUA request will include a phase 3 "safety database" of well over 3,000 vaccine recipients, representing a high proportion of participants enrolled in the phase 3 study, who have been followed for serious adverse events and adverse events of special interest for at least one month after completion of the full vaccination regimen. [ What ensures the vaccine "developer" - has not "cherry picked" the "trial participants? - for reporting ONLY 3,000 participants - who had "good" or "adequate results? - That is, are records maintained - and scrutinized - on ALL Study participants?]
Part of FDA’s evaluation of an EUA request for a COVID-19 vaccine includes evaluation of the chemistry, manufacturing, and controls information for the vaccine.
Sufficient data should be [ must be ] submitted to ensure the quality and consistency of the vaccine product.
FDA will use all available tools and information, including records reviews, site visits, and previous compliance history, to assess compliance with current good manufacturing practices. [ Please cite the basis for the "current good manufacturing practices" - that must be followed. And, does the "inspector" bear legal responsibility for any "failures to comply" reports missing?]
The FDA staff are "career scientists" and "physicians" who have globally recognized expertise in the complexity of vaccine development and in evaluating the safety and effectiveness of all vaccines intended to prevent infectious diseases. [ citations and examples please? Who has recognized - these "FDA staff" - to have "globally recognized expertise"...? How is the "recognition" - of their "expertise" - been assured - beyond, being "employed" by the FDA? ]
These FDA professionals are committed to "decision-making" based on scientifically driven evaluation of data. [Is the "methodolgy" used, documented and published?]
FDA staff are like your family - they are fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are also directly impacted by the work that they do, and are exactly who you want making these important public health decisions for the United States. [ Who employs and pays "FDA staff " - and, how are they evaluated? What "consequences' - if any - do they face - for being "wrong" - AND, what protects them - from "retribution" - by "political appointees"?]
FDA expects vaccine manufacturers to include in their EUA requests a plan for active follow-up for safety, including deaths, hospitalizations, and other serious or clinically significant adverse events, among individuals who receive the vaccine under an EUA, to inform ongoing benefit-risk determinations to support continuation of the EUA. [ Please cite the requirements specification for "the plan" required: its contents and any format required. For example, companyies - that develop USA Military Software & systems - must provide a series of documents - in accordance with Military Specifications. Typically, examples are cited - which indicate the "Level Of Detail" required - and, they exemplify what was accepted previously.]
FDA also expects manufacturers who receive an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue licensure (approval). [ What are the consequences - for FAILURE to do this "expected" activity?]
Post-authorization vaccine safety monitoring is a federal government responsibility shared primarily by FDA and the U.S. Centers for Disease Control and Prevention (CDC), along with other agencies involved in healthcare delivery. ["Shared Responsibility" - can be confusing and difficult - for those persons charged to perform a duty. For example, performance of "digging a hole" - under "shared responsibility' - can easily result - in a shallow and mis-shapen result.]
Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist.
There will be multiple, complementary systems in place with validated analytic methods that can rapidly detect signals for possible vaccine safety problems.
[ Please specify the "complementary systems" -which will exist, 'containing' specific analytic methods which will "rapidly detect" "signals" for "vaccine safety problems". Who will be responsible for the creation and implementation of the means identified? And, what will be the consequences for failure of the mission? ]
The U.S. government has a well-established post-authorization/post-approval vaccine safety monitoring infrastructure that will be scaled up to meet the needs of a large-scale COVID-19 vaccination program. [ Please identify where is this "infrastructure" located? Who staffs and manages it mission? etc. ]
The U.S. government – in partnership with health systems, academic centers, and private sector partners – will use multiple existing vaccine safety monitoring systems to monitor COVID-19 vaccines in the post-authorization/approval period.
Some of these systems are the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD), the Biologics Effectiveness and Safety (BEST) Initiative, and Medicare claims data. [ SOURCE: https://en.wikipedia.org/wiki/Vaccine_Adverse_Event_Reporting_System "...VAERS has limitations, including unverified reports, misattribution, underreporting, and inconsistent data quality.[2] CDC cautions that it is generally not possible to find out from VAERS data if a vaccine caused the adverse event, or how common the event might be.[3] ... Litigation related to vaccines and autism has led to an increase in VAERS reports filed by plaintiff's attorneys. A 2006 article in Pediatrics found that most VAERS reports related to thimerosal, and many related to autism, were filed in connection with litigation, leading the authors to caution that inappropriate reliance on VAERS data may be a source of bias.[10] The study's lead author stated: "Lawyers are manipulating this system to show increases [in vaccine-related adverse events] that are based on litigation, not health research."[11] Paul Offit, chief of infectious disease at Children's Hospital of Philadelphia, wrote: Public health officials were disappointed to learn that reports of autism to VAERS weren't coming from parents, doctors, nurses, or nurse practitioners; they were coming from personal-injury lawyers ... For the lawyers, VAERS reports hadn't been a self-fulfilling prophecy; they'd been a self-generated prophecy.[11] ..." ]
FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website. [ Who takes responsibility for ensuring ... understanding ... ability to access ... ?]
In public health emergencies, such as a pandemic, the development process may be atypical.
For example, as demonstrated by the response to the COVID-19 pandemic, the U.S. government has coalesced government agencies, international counterparts, academia, nonprofit organizations and pharmaceutical companies to develop a coordinated strategy for prioritizing and speeding development of the most promising vaccines.
In addition, the federal government has made investments in the necessary manufacturing capacity at its own risk, giving companies confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. [ How does a federal government - experience "risk" - in a political environment?]
However, efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety. [ In fact, this is still to be determined, reported etc. In such a "politicized" environment, it is the Public's general perception {that} ANY FDA staffer - citing "problems" - with the development methods employed - and, any "corners cut" - will be "dealt with". ]
Recognizing the urgent need for safe and effective vaccines, FDA is utilizing its various authorities [Please cite the "various authorities" utilized.] and expertise to facilitate the expeditious development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness.
Early in a public health crisis, FDA provides clear communication [and tax-payer dollars] to the pharmaceutical industry pertaining to the scientific data and information needed to ensure development of vaccines [ limiting manufacturer losses] and works quickly to provide advice on their proposed development plans and assessment of the data that are generated. [ Have pre-assurances been issued - and, entire productions (of interim stock batchs) been purchased? ]
FDA "whistle" "blower" :: https://www.nytimes.com/2020/10/06/us/politics/whistle-blower-rick-bright.html