Pfizer Inc. (NYSE: PFE) and BioNTech S.E. (NASDAQ: BNTX) provided an update for their coronavirus vaccine that is currently in the late stages of development and testing. Essentially, the vaccine was shown to be well tolerated and it is on track for regulatory review as early as October.
Assuming the firms hit their regulatory target of October, they plan to supply up to 100 million does worldwide by the end of 2020 and roughly 1.3 billion does by the end of 2021.
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, as compared to the BNT162b1 candidate.
The long and short of the analysis is that across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants.
This data came from the ongoing U.S. Phase 1 study evaluating the safety and immunogenicity of varying dose levels of BNT162b1 and BNT162b2 in 195 participants randomized into 13 groups of 15 participants.
In both younger and older adults, BNT162b1 and BNT162b2 elicited similar dose-dependent SARS-CoV-2–neutralizing antibodies, which were substantially elevated after the second dose, showing clear benefit of a two-dose regimen.
Systemic events after administration of BNT162b2 were milder than those with BNT162b1. Overall, after Dose 1, systemic events reported by participants 65 to 85 years old who received BNT162b2 were similar to those reported by those who received placebo.
In terms of the specifics, after the second dose of BNT162b2, only 17% of participants 18 to 55 years old and 8% of participants 65 to 85 years old reported fever, compared to 75% of 18- to 55-year-old participants and 33% of 65- to 85-year-old participants administered a second dose of 30μg of BNT162b1. Severe systemic events (fatigue, headache, chills, muscle pain and joint pain) were reported in small numbers of younger BNT162b2 recipients and were transient and manageable. No severe systemic events were reported by older BNT162b2 recipients. There were no reports of Grade 4 systemic events by any BNT162 recipient.
BioNTech stock traded up about 8% to $71.56 early Friday, in a 52-week range of $12.52 to $105.00. The consensus price target is $77.20.
Pfizer stock was up about fractionally, at $38.81 in a 52-week range of $27.88 to $40.97. The consensus analyst target is $41.85.