COVID-19 Q&A: Emergency use authorization

COVID-19 vaccines from Pfizer, Moderna, and Johnson & Johnson have all received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and are considered safe and effective at preventing serious illness and even death from COVID-19.

The following is information found on the FDA’s website. It has been edited for length and clarity. Visit the FDA link to read the full Q&A and learn more about each vaccine.

What is an EUA?

An emergency use authorization is a process that helps make needed medications and vaccinations available during emergencies. An EUA does not affect vaccine safety, because it does not impact development, such as research, clinical studies, and the analysis of side effects and adverse reactions. Instead, it speeds up manufacturing and administrative processes.

Are the COVID-19 vaccines rigorously tested?

Yes. All vaccines follow the same testing processes, whether they are approved for emergency use or through a typical license. Clinical trials evaluated investigational COVID-19 vaccines in tens of thousands of study participants to generate the scientific data and other information needed to determine safety and effectiveness. These clinical trials are conducted according to the rigorous standards set forth by the FDA.

Currently, millions of Americans have safely chosen to take the COVID-19 vaccine.

What safety and effectiveness data are required by the FDA for an EUA request for a COVID-19 vaccine?

COVID-19 vaccines undergo a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA undertakes a comprehensive evaluation of this information after it is submitted to them by a vaccine manufacturer.

FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine to issue and EUA for a vaccine for which there is adequate manufacturing information to ensure quality and consistency.

What are the plans for continued monitoring of COVID-19 vaccines authorized by FDA for emergency use?

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.

FDA also expects manufacturers who receive an EUA to continue their clinical trials for additional safety and effectiveness information.

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.

Post-authorization safety monitoring during the COVID-19 pandemic vaccination program aims to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist. There are multiple, complementary systems in place with validated analytic methods that can quickly detect signals for possible vaccine safety problems.

The U.S. government – in partnership with health systems, academic centers, and private sector partners – uses 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.

How is it that COVID-19 vaccines have been developed so quickly?

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.

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 they can invest aggressively in development and allowing faster distribution of an eventual vaccine.

Recognizing the urgent need for safe and effective vaccines, FDA is using its various authorities and expertise to facilitate quicker development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness.

How does a COVID-19 vaccine go from authorized for emergency use to licensed?

The FDA expects the manufacturer who gets an EUA for a vaccine to continue to collect data in any ongoing trials for as long as feasible to obtain additional safety and effectiveness information. The manufacturer is expected to work toward submission of a Biologics License Application (BLA) as soon as possible.

How long will it take for a vaccine to be approved, or to get to a BLA?

There is no general timeline for the submission of a BLA to FDA after issuance of an EUA or completion of clinical trials, but the FDA generally tries to make a decision within six months.

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