Pfizer-BioNTech Seek FDA Approval For Second COVID-19 Booster In Elderly Population

Pfizer Inc PFE and BioNTech SE BNTX filed an application with the FDA seeking emergency use authorization for a second booster shot of their COVID-19 vaccine for people aged 65 and older.

An analysis of data from over 1.1 million adults 60 years and older showed rates of confirmed infections were two times lower, and severe illness was four times lower in people who received an additional booster dose administered at least four months after the third dose compared to those with one booster dose.

The submission to the FDA also includes data collected in Israel, where a second booster is authorized for many people over age 18.

Also Read: Pfizer-BioNTech's COVID-19 Shot Moderately Effective Against Omicron In Kids Aged 5 to 15, CDC Study Shows.

Among the 154 (out of 700) participants who received the fourth dose, neutralizing antibody titers increased approximately 7-fold to 8-fold at two and three weeks compared to five months after the third dose. 

Additionally, there was an 8-fold and 10-fold increase in neutralizing antibody titers against the omicron variant at one and two weeks after the additional booster dose, respectively.

Price Action: PFE shares closed 0.08% lower at $52.21, and BNTX stock closed 4.53% lower at $145.04 during after-hours trading on Tuesday.

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