The US Food and Drug Administration (FDA), the federal agency of the Department of Health and Human Services, has given full approval to the Covid Pfizer / BioNTech vaccine.
Pfizer is the first vaccine to receive full FDA approval and is expected to be the only one. The vaccine will be marketed as Comirnaty, the FDA announced today.
"While this and other vaccines have met the FDA's strict scientific standards for emergency use authorization, after the FDA approved the Covid-19 vaccine, the public can be confident that this vaccine meets the FDA's gold safety standard. , the effectiveness and quality of production we require for an approved product. ”
Why did it get full approval now and why was it used before?
Before vaccine makers apply for full approval, they first apply for emergency use status in cases where the risk of a disease is high. Emergency use procedures are shorter than those for full approval.
In cases where the benefits of a product, in this case the vaccine, outweigh the possible side effects, the vaccines are allowed to be used, although they are not fully approved.
The FDA worked around the clock and conducted its own vaccine analyzes in addition to company analyzes, said Dr. Peter Marks, director of the FDA Center for Biological Assessment and Research, during Monday's conference.
"We also made risk-benefit assessments based on real-world data that have emerged since the vaccine was used in hundreds of millions of people globally."
