(RxWiki News) The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 vaccine.
This authorization is for the Pfizer-BioNTech COVID-19 Vaccine.
The FDA authorized this vaccine to prevent COVID-19, which is caused by SARS-CoV-2, in those 16 years old and older.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Dr. Stephen M. Hahn in a press release. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization."
It is important to note that an EUA is different from an FDA approval. This authorization came after the FDA reviewed the data and determined that the vaccine may be effective in preventing COVID-19 and that the benefits of getting the vaccine outweigh the known and potential risks.
The vaccine's safety was studied in a trial that included over 37,500 people. About half of these people were given the vaccine, while the other half were given a placebo.
The vaccine was found to be 95 percent effective in preventing COVID-19. After vaccination, eight COVID-19 cases were found in the vaccine group, while 162 cases were found in the placebo group.
Furthermore, of these cases, one case was deemed severe in the vaccine group, while three cases were deemed severe in the placebo group.
At this time, there is not sufficient data available to conclude how long the vaccine can provide protection. Also, there is no data to show whether the vaccine can prevent transmission of the virus from person to person.
The way it works? The vaccine contains a small piece of the virus that causes COVID-19, which allows the body's immune system to learn how to defend itself against the virus.
The vaccine consists of two doses that are given three weeks apart.
Side effects seen in the study were pain at the injection site, feeling tired, headache, muscle and joint pain, chills and fever.
The maker of this vaccine has set up a plan to help monitor the vaccine's safety over the long term. This plan also enables safety concerns to be identified and evaluated in a timely manner.
The EUA for this vaccine was issued to Pfizer Inc.