The expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.
The US Food and Drug Administration (FDA) will have to approve the change in the Phase 3 Covid-19 vaccine trial before it goes into effect.
The Pfizer and BioNTech study is likely to be among the first in the US to report efficacy data from a Phase 3 trial.
In August, the companies announced positive results for the Phase 1 trial of their second Covid-19 vaccine candidate called BNT162b2 or B2, revealing that the latest vaccine candidate has fewer side effects than their first.
The vaccine uses mRNA -- the genetic messenger the body uses to make the DNA code into proteins -- packaged inside a fatty capsule, called a lipid nanoparticle, that allows it to get into cells.
Several vaccines have already begun phase 3 clinical trials in the US, including vaccine candidate AZD1222, co-invented by the University of Oxford and its spin-out company Vaccitech, vaccine candidate mRNA-1273, developed by the US National Institute of Allergy and Infectious Diseases (NIAID) and American biotechnology company Moderna, and vaccine candidate BNT162b2 or B2, developed by Pfizer/BioNTech.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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