W:Emergency Use Authorization facts for kids

An Emergency Use Authorization (EUA) is a special permission given by the Food and Drug Administration (FDA) in the United States. It allows certain medicines or medical products to be used quickly during emergencies, even if they haven't gone through the full, long approval process yet. This helps people get important treatments faster when there's a serious health threat.

An EUA is not the same as full approval. It just means the FDA believes the product might be effective and that its benefits during an emergency are greater than its risks.

How EUAs Are Used

EUAs are often used during big health crises like pandemic influenza (flu outbreaks) or new diseases. They help get important tools, like medicines or tests, to people when they are needed most.

For example, EUAs have been used for things like:

• Medicines to fight serious diseases.
• Tools to help diagnose illnesses quickly.
• Products to protect against chemical, biological, radiological, or nuclear (CBRN) threats.

The FDA looks at all the available science to decide if a product "may be effective." This is a lower standard than the full "effective" standard needed for regular approval. It means they have a good reason to believe it will work, based on the information they have.

An EUA ends when the emergency is over, or when the product gets full approval through the normal process.

Laws Behind EUAs

The rules for EUAs come from a law called the Federal Food Drug and Cosmetic Act. This law has been updated over the years by other important laws, such as:

• The Project Bioshield Act of 2004.
• The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.
• The 21st Century Cures Act of 2016.

These laws help the FDA decide when and how to issue EUAs to keep people safe during emergencies.

What Products Can Get an EUA?

EUAs can be given for different types of products:

• Drugs: Like medicines you take.
• Devices: Like medical equipment or diagnostic tests.
• Biological products: Like vaccines or blood products.

An EUA can allow the use of a product that hasn't been approved yet, or it can allow a new, unapproved way to use a product that is already approved for something else.

Sometimes, a product might only have been tested in animals, not humans. This is called the "animal efficacy rule." In certain emergencies, an EUA can allow these products to be used in humans if there's no other option and the benefits outweigh the risks.

EUAs are only active during a declared public health emergency. The Secretary of Health and Human Services (HHS) makes this declaration.

EUAs During Pandemics

EUAs have been very important during recent pandemics.

Swine Flu Pandemic (2009)

In 2009, during the 2009 swine flu pandemic, the FDA issued EUAs for:

• Certain strong antiviral drugs to treat the flu.
• Special tests to quickly identify the swine flu virus.

This helped doctors and public health officials respond faster to the outbreak.

COVID-19 Pandemic (2020)

When the COVID-19 pandemic started in 2020, the Secretary of HHS declared a public health emergency. This allowed the FDA to use EUAs for many products related to COVID-19.

Some examples of products that received EUAs during the COVID-19 pandemic include:

• COVID-19 testing kits to find the virus.
• Medicines like remdesivir to treat the illness.
• Convalescent plasma, which uses blood from people who recovered from COVID-19.
• Pfizer–BioNTech COVID-19 vaccine and Moderna's mRNA vaccine (mRNA-1273) to prevent the disease.

It's important to know that some EUAs can be changed or even stopped if new information comes out. For example, the EUA for a medicine called hydroxychloroquine was later stopped for COVID-19 treatment because studies showed it wasn't effective for that use. Also, the EUA for bamlanivimab (a special antibody treatment) was revoked when it was found to be less effective on its own against new virus variants.