The proposed expansion will allow the companies to diversify their mRNA vaccine candidate trial further: including people aged from 16-years old (down from the current limit of 18 years old); and people with chronic, stable HIV; Hepatitis C or Hepatitis B infection. The trial will also provide additional safety and efficacy data.
Pfizer and BioNTech announced Saturday they have submitted an amended protocol to the U.S. Food and Drug Administration (FDA) for the expanded trial.
Trials 'proceeding as planned'
Germany’s BioNTech and US-based Pfizer are developing a nucleoside-modified messenger RNA vaccine candidate.
Enrolment in clinical trials is ‘proceeding as planned’ and the companies expect to reach the initial target of 30,000 participants over the coming week.
“The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing,” said Pfizer and BioNTech in a statement on Saturday. “As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.”