Pfizer Inc and its German partner BioNTech SE will seek emergency use authorization for a second booster shot of their COVID-19 vaccine for people aged 65 and older, the Washington Post reported on Tuesday.
The submission to the U.S. Food and Drug Administration, anticipated as soon as Tuesday, is expected to include “real world data” collected in Israel, one of the few countries that has authorized a second booster for older people, the report said, citing people familiar with the matter.
Pfizer and BioNtech’s two-dose vaccine has shown to be effective against severe disease and death caused by the heavily-mutated Omicron variant, but less effective in preventing transmission.
Chief Executive Officer Albert Bourla has said there is need for additional booster doses as immunity wanes.
Both the companies did not immediately respond to Reuters request for comment.
(Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli and Amy Caren Daniel)
U.S. FDA has now approved Pfizer’s COVID-19 booster shot for 12- to 15-year-olds