FDA approves first COVID-19 vaccine – All you need to know

Pfizer-BioNTech COVID-19 vaccine has become the first COVID-19 vaccine to be approved by the US Food and Drug Administration (FDA) on August 23, 2021. Read all you need to know.

Created On: Aug 25, 2021 15:29 IST
Pfizer-BioNTech COVID-19 vaccine, Source: Reuters
Pfizer-BioNTech COVID-19 vaccine, Source: Reuters

First FDA approved COVID-19 vaccine: Pfizer-BioNTech COVID-19 vaccine has become the first COVID-19 vaccine to be approved by the US Food and Drug Administration (FDA) on August 23, 2021. The vaccine will be marketed as Comirnaty for the public for preventing COVID-19 infection in individuals 16 years old and above. The FDA's approval of Pfizer’s COVID-19 vaccine is expected to instill additional confidence among the public that the vaccine meets the high standards for safety, efficacy, and quality of the FDA.

The Pfizer-BioNTech COVID-19 vaccine received Emergency Use Authorization (EUA) on December 11, 2020, for individuals 16 years old and above. On May 10, 2021, the EUA was extended across individuals between 12 and 15 years old. The vaccine also continues to be under EUA for administration in immunocompromised individuals.

All vaccines approved by FDA undergo a standard process for reviewing the safety, effectiveness, and quality. The FDA utilizes data and information provided by the manufacturer of a vaccine in the Biologics License Application (BLA).

What is Comirnaty?

Comirnaty is the new brand name of Pfizer-BioNTech’s COVID-19 vaccine. It is the first COVID-19 vaccine that has received FDA approval to be administered against COVID-19 infection. Comirnaty contains messenger RNA (mRNA), which is a genetic material that instructs human cells to clone one of the spike proteins of the COVID-19 virus. This helps the human body to build an immune response when exposed to the actual coronavirus.

The formulation of Comirnaty is same as the Pfizer’s original vaccine. The mRNA in the vaccine does not alter the genetic material of the individual receiving the vaccine shot. The vaccine is administered in two doses regimen, with an interval of three weeks from the first dose.

How did FDA approve Comirnaty?

The FDA puts all vaccines under its standard process of screening their safety, effectiveness, and quality and analyzes the data provided by the manufacturer of the vaccine in the Biologics License Application (BLA).

In the case of the Comirnaty vaccine, Pfizer has submitted the BLA that contains extensive data and information that supported the Emergency Use Authorization (EUA). The data comprises preclinical and clinical trials information, data about the manufacturing process, vaccine testing results, inputs from the inspection visits of the vaccine manufacturing units.

The FDA analyzed data from approximately 20,000 vaccine and 20,000 placebo recipients aged 16 years and above who did not show COVID-19 infection within a week of receiving the second dose.

The safety of the vaccine was further evaluated from a total of 44,000 individuals aged 16 years old and above. These included 22,000 individuals who received the vaccine and 22,000 individuals who received a placebo.

The results from the trials showed that the Pfizer-BioNTech vaccine, now known as Comirnaty, was 91 per cent effective in preventing COVID-19.

After analyzing the BLA submitted by Pfizer for its COVID-19 vaccine, the FDA successfully ascertained the safety and efficacy of the vaccine and was convinced that the vaccine meets FDA’s standards.

What is BLA?

BLA, known as the Biologics License Application (BLA), is a comprehensive document that the manufacturer of the vaccine submits to the FDA with detailed specific requirements.

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