Pfizer and BioNTech say they will apply on Friday to the US Food and Drug Administration for the emergency use of their Covid-19 vaccine.
In a joint statement, the companies said they are ready to start distributing the drug “within hours after authorization” and that the regulator’s approval could “enable use of the vaccine in high-risk populations in the US by the middle to end of December 2020.”
The vaccine, which is based on new mRNA technology which draws on the genetic code of the corona virus to train the body’s immune system, has been found to be 95-per-cent effective in clinical trials.
The developers say no serious safety concerns have been observed.
Pfizer and BioNTech expect to supply up to 50 million vaccine doses globally in 2020, increasing to up to 1.3 billion doses in 2021.
Approval in Europe is pending and a process known as a rolling review is underway with the EU regulator.