The Pfizer-BioNTech COVID vaccine has become the first to receive full FDA approval for people aged 16 years and above.
On Monday, the US Food and Drug Administration (FDA) granted full approval to the Pfizer vaccine. Thus, making it the first COVID-19 vaccine approved by the FDA. According to the statement, the vaccine will be marketed as Comirnaty and be available for those aged 16 years and older.
Acting FDA Commissioner, Dr. Janet Woodcock called the approval a huge milestone in the fight against COVID-19.
While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.
Dr Janet Woodcock, acting FDA Commissioner
In December of last year, United States became the first country to approve the Pfizer vaccine. The decision came after FDA granted it an emergency use authorization (EUA). In the face of emergencies such as a pandemic, life-saving medical products generally receive a EUA. However, it is not the same as full approval. FDA’s EUA for Pfizer vaccine was based on the vaccine’s clinical trial results that included over 40,000 participants.
For full approval, the FDA conducted a further assessment of the trial data. They followed the study participants for four to six months. Not only did they assess the vaccine’s safety and effectiveness, but also its manufacturing process.
Greater Confidence in Vaccines?
Since the emergency use authorization, more than 92 million people in the US have received the Pfizer vaccine. However, more than 30% of the country’s eligible population has yet to become vaccinated. Health officials believe that a full FDA approval can likely garner greater confidence in the vaccine and fight vaccine hesitancy among people. Moreover, schools and offices may likely make vaccination mandatory as they begin to open.
The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.
Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research
The full approval currently only applies to people aged 16 years and above. For children aged 12 to 15 years, the vaccine continues to be available under a EUA. However, the data is still unclear for children under 12 years. Pfizer is expected to announce their decision for younger age groups by September.
Source: FDA
