USFDA approves first COVID-19 Vaccine

On August 23, 2021, the U.S. Food and Drug Administration approved the first COVID-19 vaccine.

The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed for the prevention of COVID-19 disease in individuals 16 years of age and older.

The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.

EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety, and effectiveness of medical products.

For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA).

A BLA is a comprehensive document that is submitted to the agency providing very specific requirements.

The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

The vaccine contains messenger RNA (mRNA), which is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19.

The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19.

The mRNA in the vaccine is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. The approved vaccine has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.