Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently began a global (excluding China) Phase 2/3 safety and efficacy clinical trial for their BNT162b2 mRNA-based vaccine. The companies plan to enroll 44,000 participants and have more than 120 clinical trial sites in four countries, including 39 U.S. states.
The Phase 2/3 trial has enrolled 31,928 adults between 18 and 85 years old, and 19,210 had received their second vaccination as of this week, according to Pfizer. The companies expanded enrollment in the trial from 30,000 to include new populations, including adolescents as young as 16 and people with chronic, stable HIV, Hepatitis C or Hepatitis B infection. “By doing so, we will be able to better understand the potential safety and efficacy of the vaccine in individuals from these backgrounds,” Pfizer said on its website.
In a non-human primate study, BNT162b2 protected rhesus macaques against SARS-CoV-2 infection, according to a news release. Based on data from its Phase 2/3 human trial and on current infection rates, the companies continue to expect a conclusive readout on efficacy by the end of October.