FDA approval of Pfizer vaccine
Image from cnbc.com
September 8, 2021
On Aug. 23, the Pfizer COVID-19 vaccine received full Food and Drug Administrations (FDA) approval. This vaccine is recommended for individuals of 16 years of age and up; however, it continues to be available for individuals 12 to 15 years of age.
Since December of 2020, the Pfizer vaccine has been available under Emergency Use Authorization \for individuals of 16 years or older and on May 10, the authorization was extended to those 12 to 15 years of age.
Even though the vaccine is available for those who are 12 to 15 years of age, the vaccine only gained FDA approval for those who are 16 years of age or older. The vaccine went through three processes: concept, pivotal clinical trial and then the vaccine received it’s approval.
To gain FDA approval, the vaccine has to go through a lengthy process. This process included an analysis of the drug’s benefits as well as the risks associated with the vaccine. The FDA also looked at all of the clinical trials from the drugmaker; however, a majority of this analysis was already complete when the FDA granted emergency use for the vaccine.
Along with analyzing the drug’s benefits, risks and looking at all of the clinical trials from the drugmaker, the FDA also looked at the data on how people reacted to the vaccine six months after people received full vaccination. The FDA also inspected manufacturing facilities.
Now that Pfizer has gained FDA approval, it’s likely that people will begin to see more vaccine requirements put in place. The Defense Department has already announced that all service members are now required to get the vaccine. Most public universities are also requiring students to be vaccinated to attend courses on campus. Federal workers will also be required to either sign a form stating that they have been vaccinated or else the workers will have to get tested weekly, distance themselves from others and will be required to wear a mask.
Health officials are hoping now that there is full FDA approval, it will make those hesitant feel more comfortable about receiving the vaccine. The FDA is calling this a key achievement for public health.
