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June 01, 2021

How does full FDA approval differ from an emergency use authorization?

Moderna became the second pharmaceutical to submit a Biological License Application to U.S. regulators for its COVID-19 vaccine

Moderna announced Tuesday that it has begun the rolling submission process for full approval of its COVID-19 vaccine in adults from the U.S. Food and Drug Administration.

The manufacturer will continue to submit data from its Phase 3 clinical trials to U.S. regulators in support of its request for full approval, Moderna CEO Stéphane Bancel said.

Study results will be submitted by the company on a rolling basis over the coming weeks with a request for a priority review within six months. Once the rolling submission process is complete, the FDA will notify Moderna once it is formally accepted for review.

Moderna is the second pharmaceutical to submit a Biological License Application to the FDA for its COVID-19 vaccine. Last month, Pfizer began submitting data from its late-stage clinical trials to U.S. regulators for full approval of its own coronavirus vaccine.

But how does a full approval from the FDA differ from an emergency use authorization?

An emergency use authorization is used by the FDA to provide quick access to medical products, such as vaccines, that can be used when there are no other adequate, approved or available options during a public health emergency.

The FDA will make a product available based upon the best available evidence, without waiting for all of the data to be processed, if the product's benefits outweigh the risks.

An emergency use authorization remains in effect until the end of the public health emergency. Only FDA-approved vaccines would be allowed to remain on the market once the public health emergency concludes.

The FDA expects vaccine manufacturers who receive an emergency use authorization to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval.

When a manufacturer seeks full approval from the FDA, it must submit a comprehensive Biological License Application. A BLA consists of preclinical and clinical data and information, as well as details of the manufacturing process and facilities.

Full approval from the FDA requires all late-stage clinical trial data to be reviewed after all three phases are complete. The agency must determine whether the data and other information show that the drug is safe and effective for its intended use, and that the product can be made according to federal quality standards.

When a product is approved, it means the FDA has determined that the drug is effective for its intended use and its benefits outweigh the risks when used, based upon an entire body of evidence. It also means that the FDA has assured product quality and consistency. 

The product then must be properly labeled with risks and benefits, as well as its correct use, in order to share information with physicians and patients. Manufacturers are then permitted to market the approved product directly to consumers.

COVID-19 vaccinations receiving full approval from the FDA could increase public confidence and lead to a decline in vaccine hesitancy, according to the New York Times

It also could make it easier for businesses, schools, government agencies and the U.S. military to require employees, students and service members to be vaccinated. The Equal Employment Opportunity Commission said last December that employers could mandate COVID-19 vaccinations.

The FDA authorized Moderna's vaccine for use in adults last December after the two-dose regimen was found to be safe and highly effective in a Phase 3 trial

Moderna's vaccine uses mRNA technology to strengthen the immune system's response to the coronavirus. It can be stored at regular refrigerator temperatures, either for a month at 35-46 degrees Fahrenheit or for up to six months at -4 degrees.

Last week, the drugmaker reported that its two-dose COVID-19 vaccine is highly effective and safe for adolescents. Moderna said it will submit its late-stage clinical trial data to U.S. regulators this month for an emergency use authorization, with hopes of becoming the second vaccine available to teenagers in the U.S.

The FDA authorized Pfizer's vaccine last month for adolescents ages 12-15. Pfizer plans to seek authorization for children ages 2-11 in September.

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