Q: Is an approval (or biologics license approval) different from an emergency use authorization? Does it change the availability of COVID-19 vaccines?
A: Emergency use authorizations (EUAs) can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing or treating a disease. In determining whether to issue an EUA for a product, after the FDA receives an application, it evaluates the data submitted, conducts its own analyses and assesses any known or potential risks and any known or potential benefits.
For COVID-19 vaccines that received EUAs from the FDA, the agency evaluated data submitted by the manufacturers about the COVID-19 vaccine’s safety and effectiveness, and conducted its own analyses, before reaching each decision. The agency found the data to be clear and compelling to support the use of these vaccines for the prevention of COVID-19. Emergency use authorization is a tool that the FDA can use in a declared public health emergency, like the pandemic that we are in now, to more rapidly make potentially life-saving products available under very specific conditions.
An FDA-approved vaccine has undergone the agency’s standard process for reviewing medical products, including vaccines, drugs and medical devices. The FDA’s review process for a vaccine relies upon the submission of a Biologics License Application (BLA) by the manufacturer. A BLA is a comprehensive submission that is submitted to the agency and must meet very specific requirements. For the COVID-19 vaccines, a BLA builds on the data and information that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process and inspections at the sites at which the vaccine is made. The FDA’s review of a BLA is among the most comprehensive in the world. We conduct our own analyses of the information in the BLA to make sure the vaccines are safe and effective and meet our standards for approval. The FDA also inspects the facilities that are involved in the manufacturing of the product.
An application for approval for a COVID-19 vaccine provides the FDA with a wealth of data and information, such as information about safety and effectiveness in the population who will receive the vaccine.
Q: How long will it take to approve COVID-19 vaccines?
A: Each review of a COVID-19 vaccine for approval is unique, and the amount of time it takes may be different. Having safe and effective approved COVID-19 vaccines is a top priority for the FDA. The process involves incredible expertise and attention to detail, which is critical to ensuring that the FDA’s rigorous standards are met.
Our team is reviewing tremendous amounts of data. Vaccine applications have the equivalent of hundreds of thousands of pages of data and other information – more than what is submitted as part of an EUA. When a BLA comes in, we have to make sure there is accurate safety and effectiveness information and manufacturing data. We also conduct inspections and develop testing protocols to make sure that every lot of vaccine that is released meets rigorous quality standards.
We fully support the quality and rigor of our review process. We conduct our own analyses of the information in the BLA to make sure the vaccines are safe and effective and meet our standards for approval. We must be able to stand behind our decision once we approve these vaccines, so we and the public can feel confident that the vaccines they receive are safe and effective. Americans expect that of the agency.
Q: How important is it to make sure approved vaccines are available versus other public health measures? Do you have the resources to do this quickly?
A: Evaluating the data with the goal of approving safe and effective vaccines is a top priority for the FDA. We are aligning resources to not only prioritize COVID-19 vaccines but also support our broad public health mission. We recognize the pressing need and public health imperative of approving vaccines, and are expediently conducting a high-quality review. We are using “sprint teams,” which include staff members from across all the offices in the FDA, to help support the experts in the Center for Biologics Evaluation and Research in doing their vaccine work, including review of applications submitted for approval.
We recognize that an approved vaccine may encourage more people to get the vaccine. We firmly believe that everyone should get their COVID-19 vaccine now. For those who have waited until there is more information available on the safety and effectiveness of a vaccine, the FDA has been carefully monitoring the safety and effectiveness of all COVID-19 vaccines that the agency has authorized under EUA, and the data strongly support the use of the vaccines.
We also realize that for some, FDA approval of a COVID-19 vaccine may bring additional confidence and encourage them to get the vaccine. We are committed to prioritizing our review, but we are also committed to following our rigorous processes. We are moving as quickly as we can while following our rigorous review process, so we and the public can feel confident that the vaccines they receive are safe and effective.
A: Emergency use authorizations (EUAs) can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing or treating a disease. In determining whether to issue an EUA for a product, after the FDA receives an application, it evaluates the data submitted, conducts its own analyses and assesses any known or potential risks and any known or potential benefits.
For COVID-19 vaccines that received EUAs from the FDA, the agency evaluated data submitted by the manufacturers about the COVID-19 vaccine’s safety and effectiveness, and conducted its own analyses, before reaching each decision. The agency found the data to be clear and compelling to support the use of these vaccines for the prevention of COVID-19. Emergency use authorization is a tool that the FDA can use in a declared public health emergency, like the pandemic that we are in now, to more rapidly make potentially life-saving products available under very specific conditions.
An FDA-approved vaccine has undergone the agency’s standard process for reviewing medical products, including vaccines, drugs and medical devices. The FDA’s review process for a vaccine relies upon the submission of a Biologics License Application (BLA) by the manufacturer. A BLA is a comprehensive submission that is submitted to the agency and must meet very specific requirements. For the COVID-19 vaccines, a BLA builds on the data and information that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process and inspections at the sites at which the vaccine is made. The FDA’s review of a BLA is among the most comprehensive in the world. We conduct our own analyses of the information in the BLA to make sure the vaccines are safe and effective and meet our standards for approval. The FDA also inspects the facilities that are involved in the manufacturing of the product.
An application for approval for a COVID-19 vaccine provides the FDA with a wealth of data and information, such as information about safety and effectiveness in the population who will receive the vaccine.
Q: How long will it take to approve COVID-19 vaccines?
A: Each review of a COVID-19 vaccine for approval is unique, and the amount of time it takes may be different. Having safe and effective approved COVID-19 vaccines is a top priority for the FDA. The process involves incredible expertise and attention to detail, which is critical to ensuring that the FDA’s rigorous standards are met.
Our team is reviewing tremendous amounts of data. Vaccine applications have the equivalent of hundreds of thousands of pages of data and other information – more than what is submitted as part of an EUA. When a BLA comes in, we have to make sure there is accurate safety and effectiveness information and manufacturing data. We also conduct inspections and develop testing protocols to make sure that every lot of vaccine that is released meets rigorous quality standards.
We fully support the quality and rigor of our review process. We conduct our own analyses of the information in the BLA to make sure the vaccines are safe and effective and meet our standards for approval. We must be able to stand behind our decision once we approve these vaccines, so we and the public can feel confident that the vaccines they receive are safe and effective. Americans expect that of the agency.
Q: How important is it to make sure approved vaccines are available versus other public health measures? Do you have the resources to do this quickly?
A: Evaluating the data with the goal of approving safe and effective vaccines is a top priority for the FDA. We are aligning resources to not only prioritize COVID-19 vaccines but also support our broad public health mission. We recognize the pressing need and public health imperative of approving vaccines, and are expediently conducting a high-quality review. We are using “sprint teams,” which include staff members from across all the offices in the FDA, to help support the experts in the Center for Biologics Evaluation and Research in doing their vaccine work, including review of applications submitted for approval.
We recognize that an approved vaccine may encourage more people to get the vaccine. We firmly believe that everyone should get their COVID-19 vaccine now. For those who have waited until there is more information available on the safety and effectiveness of a vaccine, the FDA has been carefully monitoring the safety and effectiveness of all COVID-19 vaccines that the agency has authorized under EUA, and the data strongly support the use of the vaccines.
We also realize that for some, FDA approval of a COVID-19 vaccine may bring additional confidence and encourage them to get the vaccine. We are committed to prioritizing our review, but we are also committed to following our rigorous processes. We are moving as quickly as we can while following our rigorous review process, so we and the public can feel confident that the vaccines they receive are safe and effective.
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