Pfizer Inc. and BioNTech SE today announced the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose for 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 analyzed at a time when the Omicron variant was widely circulating. These data showed evidence that an additional mRNA booster increases immunogenicity and lowers rates of confirmed infections and severe illness.

An analysis of Israeli Ministry of Health records was conducted for more than 1.1 million adults 60 years of age and older who had no known history of SARS-CoV-2 infection and were eligible for an additional (fourth dose) booster. These data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least four months after an initial booster (third) dose compared to those who received only one booster dose.

Emerging evidence suggests that effectiveness against both symptomatic COVID-19 and severe disease caused by Omicron wanes 3 to 6 months after receipt of an initial booster (third) dose. Thus, additional booster doses may be needed to ensure individuals remain adequately protected. The data being reviewed by the FDA suggests that an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least 4 months after an initial booster dose could restore antibody titers to peak post-third dose titer levels, improve protection against both infection and severe disease in individuals 60 years of age and older and have a similar safety profile to that of previous doses.