Pfizer and BioNTech Reports P-II/III Trial Results of Omicron BA.4/BA.5-Adapted Bivalent Booster for COVID-19
Shots:
- The P-II/III trial to evaluate Omicron BA.4/BA.5-Adapted Bivalent Booster (30µg) in 900 healthy volunteers aged ≥12yrs.
- The results showed ~4-fold higher neutralizing Ab titers against Omicron BA.4/BA.5 sublineages over original COVID-19 vaccine in individuals aged ≥55yrs., increased 13.2-fold from pre-booster levels in adults aged ≥55yrs. & 9.5-fold in adults aged 18-55yrs. over 2.9-fold increase who received the original booster vaccine & higher immune was observed. The safety & tolerability profile remains favorable & similar to the original COVID-19 vaccine
- The companies will share the results with the EMA & other global health authorities shortly. The US FDA has authorized a booster dose for use in patients aged ≥5yrs. in emergencies
Ref: Globenewswire | Image: Pfizer
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