Sarah Bennett
The Food and Drug Administration (FDA) is responsible for overseeing the review of the safety and efficacy of candidate vaccines and determining whether or not to approve them for use. The FDA's full approval process varies depending on the product, and companies must follow a standard set of steps for development and testing before filing an application for a vaccine. The FDA commonly seeks input from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) during vaccine reviews, but the final decision rests with the FDA. The FDA may also provide emergency use authorization (EUA) to expedite the availability of medical products during a public health emergency. An EUA can be revised or revoked by the FDA at any point as the agency evaluates the most current needs and available data.
| Characteristics | Values |
|---|---|
| Frequency of FDA vaccine approval revocation | Not specified |
| FDA's authority to revoke approvals | The FDA can revoke approvals at any point |
| Instances of FDA revoking approvals | Hydroxychloroquine for COVID-19, monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines, EUAs for COVID-19 drugs and biological products |
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What You'll Learn
- The FDA can revoke Emergency Use Authorizations (EUAs)
- The FDA does not have to request input from VRBPAC for vaccine approval decisions
- The FDA's full approval process varies depending on the product
- The FDA commonly seeks input from the Vaccines and Related Biological Products Advisory Committee (VRBPAC)
- The FDA can engage in post-market surveillance of approved vaccines
The FDA can revoke Emergency Use Authorizations (EUAs)
The FDA established its EUA program in 2004 in response to threats of bioterrorist attacks, including anthrax. Since then, EUAs have been used for H1N1 (swine flu), Ebola, avian flu, Middle Eastern Respiratory Syndrome (MERS), and other major public health threats. EUAs in these instances included tests, an anthrax vaccine, antiviral treatments, and personal protective equipment.
The FDA may revoke an EUA when it determines that doing so is appropriate to protect the public health or safety. For example, the FDA issued an EUA for hydroxychloroquine during the first phase of the COVID-19 pandemic. However, when it became clear that the treatment posed a risk but did not offer significant benefits, the FDA retracted the EUA.
Information on terminated and revoked EUAs can be found in archived information on the FDA website.
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The FDA does not have to request input from VRBPAC for vaccine approval decisions
The FDA is responsible for overseeing the review of the safety and efficacy of candidate vaccines and determining whether or not to approve them for use. The FDA commonly seeks input from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) during vaccine reviews. VRBPAC is an external expert advisory committee that reviews and evaluates scientific data on the safety and effectiveness of vaccines, providing independent advice to the FDA Commissioner. It is managed by the FDA's Center for Biologics Evaluation and Research (CBER).
While the FDA typically seeks input from VRBPAC, it is important to note that the FDA does not have to request input from VRBPAC for vaccine approval decisions. The FDA Commissioner has the discretion to bypass advisory committee recommendations and make decisions independently. The FDA Commissioner's role in vaccine approvals includes using VRBPAC recommendations when weighing approvals and other regulatory decisions about vaccines. However, the final decision rests with the FDA, and they are not legally bound to follow the committee's recommendations.
In recent years, there have been instances where the FDA has made vaccine policy changes without seeking input from VRBPAC. For example, the Trump administration decided on the seasonal influenza vaccine composition without external input. Similarly, FDA leaders announced that updated COVID-19 vaccines would need to undergo new placebo-controlled trials for approval, a decision made without VRBPAC's input.
It is worth mentioning that the FDA has the authority to grant Emergency Use Authorization (EUA) for medical products, including vaccines, during public health emergencies. An EUA can be granted when no approved alternatives exist, and the benefits outweigh the risks. The FDA can revoke an EUA at any time as it evaluates current needs and data. For instance, during the COVID-19 pandemic, the FDA issued and later retracted an EUA for hydroxychloroquine when it was found to pose risks without significant benefits.
The FDA's full approval process for vaccines involves companies filing a "biologics license application" (BLA). This process includes research and discovery, pre-clinical testing, and clinical development stages. The FDA may also engage in post-market surveillance of approved vaccines and revisit approval decisions if new evidence warrants it.
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The FDA's full approval process varies depending on the product
The FDA's full approval process can take years and varies depending on the product. For instance, vaccines and therapeutics (treatments, therapies, or drugs) require companies to file a "biologics license application" (BLA). Before filing a BLA for a vaccine, companies must conduct research and testing in a standard set of steps. The first is the research and discovery stage, where scientists conduct laboratory research, often on animals, to test their vaccine candidate. Next is the pre-clinical stage, where researchers perform additional lab testing in animals to gather information on the vaccine's potential performance in humans. Finally, there is the clinical development stage, where the company compiles the results of their pre-clinical testing and manufacturing technology and submits them to the FDA for assessment.
The FDA also has an expedited approval process for drugs that meet certain criteria. The first of these sped-up procedures is the Fast Track process, which is meant to motivate the development and approval of medications for unmet treatment areas. Applicants seeking Fast Track designation must produce a product that fills an unmet need, such as providing therapy for a condition with no existing treatment. To receive Fast Track designation, the drug developer must apply for the designation, and the FDA will deliver a decision within 60 days. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and review process. There have been incredible, life-saving drugs to come out of the fast-track approval process, including several HIV medications and treatments for several types of cancer.
Another expedited approval process is the Breakthrough Therapy designation, which is for drugs intended to treat serious or life-threatening diseases or conditions where there may be preliminary clinical evidence that the drug may demonstrate substantial improvement over existing therapies. The FDA will generally decide whether to grant a Breakthrough Therapy designation within 60 days of receiving the application.
The FDA also has a Priority Review process, which is granted to drugs that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. Additionally, drugs that can provide a diagnosis or prevention of a disease where there is currently none may be eligible for Priority Review. The FDA will attempt to direct additional resources to the evaluation of these applications to ensure that they are reviewed within six months.
Finally, the Accelerated Approval process is for drugs that fill an unmet need for patients with serious conditions. This process allows the FDA to approve a drug based on a surrogate endpoint, an endpoint that is reasonably likely to predict clinical benefit but is not itself a direct measurement of that benefit. For example, if a drug received accelerated approval based on tumor reduction size, a follow-up confirmatory trial would need to show that the drug had a significant survival benefit compared to a placebo. If the confirmatory trial doesn't show such a benefit, the drug would need to be withdrawn from the market.
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The FDA commonly seeks input from the Vaccines and Related Biological Products Advisory Committee (VRBPAC)
VRBPAC consists of a core of 15 voting members, including the Chair. The FDA Commissioner selects the members of VRBPAC, and they can be replaced at the Commissioner's discretion. The VRBPAC charter requires that the committee be terminated after two years unless it is renewed, and agencies have the discretion to rewrite the charters to adjust the rules under which the committees function.
The FDA does not have to request input from VRBPAC for vaccine approval decisions, and the final decision rests with the FDA. The FDA evaluates the safety, effectiveness, benefits, and risks of vaccine candidates, as well as manufacturing and facility information, before recommending a vaccine for approval. The FDA has the discretion to adjust the pace of its review process, placing high-priority candidate vaccines on a faster track and lower-priority vaccines on a slower track.
The FDA may also engage in post-market surveillance of approved vaccines to track their safety, effectiveness, and possible side effects. It can revisit approval decisions if new evidence warrants it and can seek to remove a vaccine from the market if significant safety concerns or other issues are identified.
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The FDA can engage in post-market surveillance of approved vaccines
The Food and Drug Administration (FDA) is the regulatory authority that has oversight of the safety, effectiveness, and quality of vaccines used in the United States. The FDA's evaluation process is rigorous and comprehensive, but ongoing surveillance of vaccines after FDA approval is necessary to identify uncommon adverse events or long-term complications. The FDA may engage in post-market surveillance of approved vaccines to track their safety, effectiveness, and possible side effects. This is done through various surveillance systems, such as the Vaccine Adverse Event Reporting System (VAERS), the FDA BEST (Biologics Effectiveness and Safety) program, and the FDA Sentinel Program. In certain cases, the FDA may require the manufacturer to conduct post-marketing studies to further assess known or potential serious risks. These studies are sometimes called Phase 4 of development.
The FDA can also provide emergency use authorization (EUA) for vaccines under certain circumstances, such as during the COVID-19 pandemic. An EUA can be revised or revoked by the FDA at any point as the agency evaluates the most current needs and available data. For example, during the first phase of the COVID-19 pandemic, the FDA issued an EUA for hydroxychloroquine, but later retracted it when it became clear that the treatment posed a risk and did not offer significant benefits. Similarly, there are revoked EUAs for COVID-19 drugs and biological products, as well as medical devices, in vitro diagnostics, personal protective equipment, decontamination systems, and other devices.
The FDA works with vaccine manufacturers to develop a lot release protocol, which is a template of tests to be conducted on each lot of the vaccine post-approval. FDA investigators examine and evaluate the facility and operation for compliance with FDA regulations. Once a manufacturing process is developed that ensures the vaccine can be produced reliably and consistently, and the preclinical and clinical development programs have been successfully completed, companies submit a Biologics License Application (BLA) to the FDA. The BLA includes preclinical and clinical data and information, as well as details of the manufacturing process and facilities. The FDA's scientific team evaluates all the scientific data and information included in the BLA to determine whether to approve a vaccine.
The FDA could seek to remove a vaccine from the market if significant safety concerns or other issues, such as concerns about manufacturing practices, are identified. However, there is a process that must be followed, and without new information and sufficient evidence of harms or other concerns, there would likely be legal challenges to any attempt to remove an existing approved vaccine. The FDA's decision-making process for vaccine approvals considers the benefits and risks for the intended population who will receive the vaccine, as well as the diseases to be prevented.
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Frequently asked questions
The FDA does not commonly revoke vaccine approvals. However, the FDA can revoke an Emergency Use Authorization (EUA) at any point. An EUA is a tool the FDA can use to expedite the availability of medical products, including vaccines, during a public health emergency.
The FDA oversees the review of the safety and efficacy of candidate vaccines. Companies file what is called a "biologics license application" (BLA) for vaccines and therapeutics. Before filing a BLA, the development and testing of the vaccine must follow a standard set of steps, including research and discovery, pre-clinical, and clinical development stages.
The FDA may grant an EUA when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh the potential risks. An EUA is only in effect for as long as the public health emergency for which it was declared. The FDA upholds its strict standards for safety and efficacy even when issuing an EUA, but the timeline for approval is condensed.
