Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announce additional Phase 1 safety and immunogenicity data from their ongoing U.S. study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which has advanced into Phase 2/3 evaluation.
In a Phase 1 study in the U.S. that enrolled 195 participants, at 7 days after a second dose of 30μg, BNT162b2 elicited SARS-CoV-2–neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, In older adults (65-85 years of age), the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in both groups.
The companies previously announced that BNT162b2-vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, compared to the BNT162b1 candidate, and that BNT162b2 demonstrated concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the receptor binding domain (RBD) and against the remainder of the spike glycoprotein that is not contained in the BNT162b1 vaccine candidate.
Further, across all populations, BNT162b2 was well-tolerated, with mild-to-moderate fever in fewer than 20% of the participants.
Systemic events after administration of BNT162b2 were milder than those with BNT162b1. Overall, after Dose 1, systemic events reported by participants 65-85 years old who received BNT162b2 were similar to those who received placebo.
After the second 30μg dose of BNT162b2, only 17% of participants 18-55 years old and 8% of participants 65-85 years old reported fever, compared to 75% of 18-55-year-old participants and 33% of 65-85-year-old participants administered a second dose of 30μg of BNT162b1.
These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30K participants, which has enrolled more than 11K participants thus far.
The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany.
Assuming positive results, Pfizer and BioNTech plan to seek regulatory approval as early as October. If they get the nod, they plan to supply up to 100M doses worldwide by year-end and ~1.3B doses by the end of 2021.
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