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.
Click here to read full press release/ article | Ref: Pfizer | Image: Wall Street Journal
The post Pfizer and BioNTech Initiate Rolling Submission of sBLA for the US FDA’s Approval of Comirnaty’s Booster Dose in Individuals Aged 16 Years and Older first appeared on PharmaShots.
