Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) announce additional Phase 1 data on safety and immunogenicity from their ongoing US study of the BNT162 mRNA-based vaccine program against SARS-CoV-2, which is advanced in Phase 2/3 evaluation.
In a Phase 1 study in the US that enrolled 195 participants, 7 days after a second dose of 30μg, BNT162b2 attracted SARS-CoV-2 neutralizing geometric mean titers (GMTs) in younger adults (18-55 years) ) that were 3.8 times the GMT of a panel of 38 sera from SARS-CoV-2 conquering patients, In older adults (65-85 years), the vaccine candidate drew a neutralizing GMT 1.6 times the GMT of the same panel, proving strongly immunogenicity in both groups.
The companies previously announced that BNT162b2 vaccinated human participants displayed a favorable range of epitopes, recognized in T-cell responses specific to the SARS-CoV-2 spike antigen, compared to the BNT162b1 candidate, and that BNT162b2 demonstrated simultaneous induction of CD4 + and CD8 + with high magnitude T cell responses against the receptor binding domain (RBD) and against the rest of the spike glycoprotein not contained in the candidate for vaccine BNT162b1.
Furthermore, across all populations, BNT162b2 was well tolerated, with mild to moderate fever in less than 20% of participants.
Systemic events after BNT162b2 administration were milder than those with BNT162b1. Overall, after dosing 1, systemic events reported by participants 65-85 years of age receiving BNT162b2 were similar to those receiving placebo.
After the second 30μg dose of BNT162b2, only 17% of participants aged 18-55 years and 8% of participants aged 65-85 reported fever, compared with 75% of 18-55 year olds participants and 33% of 65- 85-year-old participants administered a second dose of 30μg BNT162b1.
These results inform the selection of the BNT162b2 candidate for the pivotal Phase 2/3 worldwide study in up to 30K participants, which has so far enrolled more than 11K participants.
The companies continue to analyze data from the Phase 1 trial in the US and Germany.
If positive results are assumed, Pfizer and BioNTech plan to arrange October approval. When they get the nod, they plan to deliver up to 100M doses worldwide by the end of the year and ~ 1.3B doses by the end of 2021.
PFE + 1.5%, while BNTX increases 8% premiere.
Earlier: Pfizer / BioNTech pivot to new COVID-19 vaccine candidate with better security profile (Aug. 20)
