Pfizer/BioNTech File for 2nd Covid Vaccine Booster

Pfizer and BioNTech have submitted an FDA Emergency Use Authorization application for a second booster dose in adults 65 years of age and older who have received an initial booster of any of the authorized or approved Covid-19 vaccines. The submission is based on two real-world data sets from Israel that evaluated the vaccine dose during a period when the Omicron variant was the predominant strain. “Both data sets showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness,” the companies say. The Israeli data from over 1.1 million adults 60 years of age and older who were eligible for an additional (fourth dose) booster showed that their rates of infection were two times lower and rates of severe illness were four times lower compared to those who received only one booster dose.