Shots:

• The sBLA is based on P-III trial for Comirnaty (third booster dose) administered b/w 4.8 - 8mos.- following the completion of 2 dose in 306 participants aged b/w 18-55 yrs.
• The P-III trial showed that third booster dose induces robust neutralizing Abs against wild-type strain @1mos.- following PD3 with a median follow-up time of 2.6mos. post-booster- 99.5% of patients had a four-fold response after the third dose compared to 98.0% after the second dose with favorable safety and tolerability profile
• The sBLA submission is expected to be complete at the end of Aug’21 & companies plans to submit the data with the EMA and other regulatory authorities globally in the coming wks.

| Ref: Pfizer | Image: Wall Street Journal