Pfizer and BioNTech have submitted a request to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional 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 2 real-world data sets from Israel analyzed at a time when the Omicron variant was circulating. The first data set included over 1.1 million adults 60 years of age and older with no known history of SARS-CoV-2 infection and who were eligible for an additional booster dose. Among those who received a second booster dose of the Pfizer-BioNTech COVID-19 vaccine at least 4 months after the first booster, the rates of confirmed infections and severe illness were 2 and 4 times lower, respectively, when compared with individuals who received only 1 booster dose.

The second data set included results from an ongoing, open-label, nonrandomized clinical trial among health care workers 18 years of age and older at a single study center in Israel who had received 3 doses of the Pfizer-BioNTech COVID-19 vaccine (ClinicalTrials.gov Identifier: NCT05231005). Results showed that among the 154 participants who received a fourth dose of the vaccine at least 4 months following the initial booster, neutralizing antibody titers increased approximately 7-fold to 8-fold at 2 and 3 weeks, compared with 5 months after the third dose. 

Additionally, an 8-fold and 10-fold increase in neutralizing antibody titers against the Omicron variant was observed at 1 and 2 weeks, respectively, after the fourth dose compared with 5 months after the third dose. There were no new safety concerns reported in individuals who received a fourth dose of the vaccine.

While not included in the EUA submission, the Companies stated in a press release that “emerging evidence, including data from Kaiser Permanente Southern California, 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.”

The Pfizer-BioNTech COVID-19 vaccine is authorized for use in individuals 5 years of age and older and is approved in those 16 years of age and older.

Reference

Pfizer and BioNTech submit for US Emergency Use Authorization of an additional booster dose of their COVID-19 vaccine for older adults. News release. Pfizer Inc. and BioNTech SE. March 15, 2022. Accessed March 16, 2022. https://www.globenewswire.com/news-release/2022/03/15/2403974/0/en/Pfizer-and-BioNTech-Submit-for-U-S-Emergency-Use-Authorization-of-an-Additional-Booster-Dose-of-their-COVID-19-Vaccine-for-Older-Adults.html