How the FDA's emergency use authorization of a COVID-19 vaccine is different from approval

the Food and Drug Administration authorized emergency use of the nation's first Cove in 19 vaccine late on Friday night. What that means is it sets the stage for what will become the nation's largest vaccination effort. It will take a while for the first shots to roll out. There will be scarce supplies, and initial doses will be rationed. First in line will be health care workers and nursing home residents and staff. Other groups, such as other essential workers and people who are, are at particularly high risk from the coronavirus, such as older adults and people with underlying will come next. It will be probably at least spring before there is an A vaccine for the general population. There are several other vaccines that are in the pipeline and the next one that the FDA will consider it by Madonna and the National Institutes of Health. And that one is up for decision and about another week. If both of those vaccines are able to be used, thehyperfix that 20 million Americans could be vaccinated by the end of December. And then, as you move into January and February Ah, few. You know that that number gets a little bit larger each month until spring, when there it is hoped that there will be additional vaccines available and enough for the general population.

Updated: 9:43 AM CST Dec 12, 2020

Editorial Standards ��

How the FDA's emergency use authorization of a COVID-19 vaccine is different from approval

Updated: 9:43 AM CST Dec 12, 2020

Editorial Standards ��

The Food and Drug Administration on Friday authorized the Pfizer/BioNTech COVID-19 vaccine for emergency use.That's different from the vaccine being approved or licensed by the FDA.Here's how.The emergency use authorization acknowledges that in a time of dire need, the vaccine meets certain requirements to justify its use during the COVID-19 pandemic, including that there are no other adequate, approved or available alternatives. To determine whether to issue an EUA for a product, "the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency."For FDA approval, more data will be required from clinical trials.On Feb. 4, the Department of Health and Human Services determined it was reasonable to allow for the authorization of unapproved products because of the widespread public health risk of COVID-19.The FDA says it expects any company whose vaccines are granted an EUA to continue clinical trials to gather more safety and effectiveness information and seek FDA approval or licensure.

The Food and Drug Administration on Friday authorized the Pfizer/BioNTech COVID-19 vaccine for emergency use.

That's different from the vaccine being approved or licensed by the FDA.

Here's how.

The emergency use authorization acknowledges that in a time of dire need, the vaccine meets certain requirements to justify its use during the COVID-19 pandemic, including that there are no other adequate, approved or available alternatives.

To determine whether to issue an EUA for a product, "the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency."

For FDA approval, more data will be required from clinical trials.

On Feb. 4, the Department of Health and Human Services determined it was reasonable to allow for the authorization of unapproved products because of the widespread public health risk of COVID-19.

The FDA says it expects any company whose vaccines are granted an EUA to continue clinical trials to gather more safety and effectiveness information and seek FDA approval or licensure.

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How the FDA's emergency use authorization of a COVID-19 vaccine is different from approval

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