Pfizer/BioNTech's Updated Omicron Adapted COVID-19 Shot Increases Neutralizing Antibodies Above Pre-Booster Levels

Pfizer Inc PFE and BioNTech SE BNTX have announced early data from a Phase 2/3 trial evaluating the safety, tolerability, and immunogenicity of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels, with similar responses seen across individuals aged 18 to 55 years of age and those older than 55 years of age. 

FDA and European Medicines Agency approved a 30-µg booster dose of the Omicron BA.4/BA.5-adapted vaccine for ages 12 years and older.

Wednesday, the FDA granted Emergency Use Authorization for a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5-11 years. 

A comparison of responses in individuals older than 55 who received the bivalent vaccine or the original vaccine showed that a 30-µg booster dose of the Original Pfizer-BioNTech COVID-19 Vaccine elicited more limited increases in the neutralizing antibody response against the Omicron BA.4/BA.5 variants. 

The Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated, with early data indicating a favorable safety profile similar to the original vaccine.

Additional data measuring responses at one-month post-administration of the Omicron BA.4/BA.5 bivalent vaccine booster are expected in the coming weeks.

Additionally, the companies have initiated a similar Phase 1/2/3 trial investigating the Omicron BA.4/BA.5-adapted bivalent vaccine among children six months through 11 years of age. 

Price Action: BNTX shares are down 2.19% at $133.66, and PFE stock is down 0.60% at $41.78 during the market session on the last check Thursday.