Pfizer (PFE) announced on Friday that it will apply for urgent use of the COVID-19 vaccine in the United States in the third week of November once the safety milestone is achieved.
The US Food and Drug Administration requires at least two months of safety data before permitting emergency use of the experiment. Coronavirus vaccine.
Pfizer, which is developing vaccine candidate BNT162b2 at BioNTech SE (BNTX) in Germany, said it would continue testing until the final point of analysis, even if it was declared effective in the early stages. The company expects to reach a safety milestone in the third week of November.
“As I said before, we are working at the speed of science, which means we can know if our vaccine is effective by the end of October,” said the CEO. Albert Bula writes in an open letter.
BNT162b2 vaccine candidate is based on BioNTech mRNA Technology Supported by Pfizer’s global vaccine development and manufacturing capabilities. Vaccine candidates are currently being evaluated in a global phase 3 trial.
Earlier this month, Pfizer and BioNTech said they had begun rolling submissions of the COVID-19 vaccine to the European Medicines Agency.
Last month, the two companies said they would seek regulatory review of BNT162b2 as early as October 2020. With regulatory approval or approval, we plan to administer up to 100 million doses worldwide by the end of 2020, approximately 1.3 doses. 1 billion doses by the end of 2021.
Contact for comments and feedback: email@example.com