Pfizer to seek approval of vaccine by US FDA

19 Nov


US pharmaceutical giant Pfizer looks set to apply for emergency authorization of its vaccine candidate, which it says was found to be 95 percent effective against the coronavirus.


Pfizer is developing the experimental drug together with Germany's BioNTech.


Pfizer on Wednesday announced the final analysis of a vaccine trial involving more than 40,000 people, among which 170 coronavirus cases were identified.


Eight occurred in volunteers who got the actual vaccine, as opposed to 162 who received a dummy placebo shot.


Also, of the 10 people who developed a severe form of disease, one received the vaccine.


Pfizer says no serious safety concerns were found among the vaccine recipients. It reported fatigue among 3.8 percent of participants and 2 percent suffering headaches, both after getting the second vaccine dose.


Pfizer says it has the required data on the vaccine's safety needed to seek emergency authorization from the Food and Drug Administration within several days.


The FDA will hold advisory meetings to discuss the vaccine ahead of possible authorization. A senior official has told US media that the process will take several weeks.


Pfizer earlier reached a basic agreement with the government of Japan on supplying the country with doses for 60 million people by the end of June 2021.


NHK