Pfizer submits application for urgent approval
Pfizer and BioNtech will submit an application to the US Food and Drug Administration (FDA) on Friday (November 20) seeking urgent approval for the use of the Covid-19 vaccine.
The vaccine is known as BNT 162B2, the agency said in a statement. The vaccine is likely to be used on high-risk populations in the United States in mid-December.
Pfizer vaccine completed the final data analysis of the third trial before approaching the FDA. The trial began on July 26 in the United States. More than 43,000 volunteers took part in it.
This week, US pharma giant Pfizer and their German partner BioNtech claimed in a final study that the vaccine was 95 percent successful. No side effects have been reported from the use of the vaccine and no safety complications have been observed in adults.
Pfizer will also submit safety data for about 100 children between the ages of 15 months to 15 years with the application.
Pfizer CEO Albert Bauer said in a statement that providing corona vaccine to the world as a representative of the United States is an important milestone for us. Now we have a complete picture of the effectiveness and protection of the vaccine. There is also confidence about the possibility of this vaccine.
Meanwhile, another US drug company, Moderna, has also completed a third phase trial of their coronavirus vaccine. The company claims that their vaccine will protect them from 94.5% corona. This month they will apply for approval to use the vaccine.
A source told CNN that on December 8, 9 and 10, the FDA's Vaccine and Related Biological Advisory Committee will hold a group meeting with outside experts. The agency may make a decision on urgent approval of the use of the vaccine at the end of the December 10 meeting.