Everything You Need to Know about the Pfizer Vaccine Approval from FDA

There is a new milestone in the fight against COVID-19.

The COVID vaccine developed by Pfizer Inc. and BioNTech SE received full approval by the U.S. Food and Drug Administration (FDA) on Aug. 23, 2021. This is great news as the Delta variant continues to spread across the country.

What does this new development mean for you? Here is everything you need to know about the Pfizer vaccine and its full approval. 

Vaccine Development 

Pfizer’s COVID vaccine, also marketed with the brand name Comirnaty, is developed using messenger RNA (mRNA) methodology to protect against infectious diseases. While the use of mRNA for vaccines is new, the technology has existed for decades. The COVID-19 pandemic has provided the opportunity to take this well-researched technology and put it to good use. 

The mRNA vaccines make a safe, nontoxic “spike protein” that triggers an immune response inside the human body. This immune response, which produces antibodies, helps people gain protection and prevent them from getting seriously ill or hospitalized with COVID-19. 

Status of Approval 

The Pfizer vaccine, which received full FDA approval in Aug. 2021, is considered highly effective, safe and reliable for the prevention of COVID in individuals 16 years of age and older. This vaccine has met the FDA’s highest standard of safety, effectiveness and manufacturing quality required for an approved product. The vaccine, which has been available under the FDA’s emergency use authorization since Dec. 2020, is the first COVID-19 vaccine to receive full FDA approval.

The Pfizer vaccine for individuals 12 to 15 years old continues to be available under FDA’s emergency use authorization EUA), including the administration of an additional dose in certain immunocompromised individuals. Although an EUA is granted during a public health emergency, the approved vaccines have still undergone rigorous and comprehensive safety testing to achieve this status.

Approval Process 

In order to receive the full FDA approval, the Pfizer vaccine went through a rigorous review process. FDA reviewed comprehensive data including longer-term, follow-up data from the Phase 3 trial, where the vaccine’s high efficacy and favorable safety profile were observed up to six months after the second dose. They also reviewed manufacturing and facilities data required for licensure. 

Why it Matters 

The Pfizer’s full FDA approval is an important step in the fight against the pandemic. Scientists and health care experts hope this approval boosts confidence in the vaccine and encourages more people to get vaccinated. The vaccine has shown to be highly effective against COVID, including the Delta variant. The vaccines help prevent severe illness, hospitalization and death. 

Get the Vaccine

Scientific data has shown that COVID-19 vaccines approved by the FDA (whether this approval is a full FDA approval or under EUA) are safe and effective. 

The fully approved vaccine from Pfizer and other vaccines from Moderna and Johnson and Johnson, which currently are available under the FDA’s emergency use authorization, have proven to work against COVID, including the highly contagious Delta variant. 

That’s why BayCare urges everyone who is eligible to get vaccinated. Vaccines, which now are widely available at many county-run sites and local retailers, are the best line of defense against serious complications from a COVID infection.  

To learn more about COVID vaccines and local vaccine sites, visit BayCare.org/Coronavirus/Vaccines.