Moderna announced on Tuesday that it has begun a rolling submission process to fully approve the U.S. Food and Drug Administration’s adult COVID-19 vaccine.

Moderna CEO Stéphane Bancel will continue to submit data from its phase 3 clinical trial to US regulators to support its request for full approval Say.

The company will roll over the research results in the next few weeks and require a priority review within six months. Once the rolling submission process is completed, the FDA will notify Moderna after it has officially accepted the review.

Moderna is the second pharmaceutical company to submit a COVID-19 vaccine bio-licensing application to the FDA.Last month, Pfizer began to submit late-stage clinical trial data to US regulators Fully approve your own coronavirus vaccine.

But what is the difference between FDA’s full approval and emergency use authorization?

Emergency use authorization is FDA uses it to provide quick access to medical products, Such as vaccines, can be used when there are no other adequate, approved or available options during a public health emergency.

If the benefits of the product outweigh the risks, FDA will provide the product based on the best available evidence without waiting for all data to be processed.

The emergency use authorization remains valid until the end of the public health emergency. Once the public health emergency is over, only vaccines approved by the FDA will be allowed to remain on the market.

The FDA hopes that vaccine manufacturers with emergency use authorization will be able to Continue their clinical trials To obtain additional safety and effectiveness information and seek approval.

When the manufacturer seeks Obtained full FDA approval, It must submit a comprehensive biological license application. The BLA includes preclinical and clinical data and information, as well as detailed information on manufacturing processes and facilities.

The FDA’s full approval requires the review of all late-stage clinical trial data after all three phases are completed. The agency must determine whether the data and other information indicate that the drug is safe and effective for its intended use and that the product can be manufactured in accordance with federal quality standards.

When the product is approved, it means that the FDA has determined that the drug is effective for its intended use, and its benefits outweigh the risks when used. Based on a set of evidenceThis also means that the FDA guarantees product quality and consistency.

The risks and benefits of the product and its proper use must then be properly labeled in order to share information with doctors and patients. Then allow manufacturers to sell approved products directly to consumers.

The COVID-19 vaccination that is fully approved by the FDA may increase public confidence and lead to a reduction in vaccine hesitation, according to New York Times.

It can also make it easier for businesses, schools, government agencies, and the US military to require employees, students, and military personnel to be vaccinated.Equal Employment Opportunity Commission Said last December Employers can mandate COVID-19 vaccination.

U.S. Food and Drug Administration License Moderna’s vaccine Used in adults after discovering a two-dose regimen in December last year Safe and efficient in Phase 3 trials.

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

Last week, the drugmaker reported that its two doses of COVID-19 vaccine were Very effective and safe for teenagers. Moderna said it will submit its late-stage clinical trial data to US regulators this month for emergency use authorization, hoping to become the second vaccine available to US teenagers

FDA authorizes Pfizer’s vaccine last month Suitable for teenagers aged 12-15.Pfizer Project Seek authorization For children aged 2-11 years in September.