Pfizer and BioNTech announced on Saturday (Sep 12) that they will expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants.
Enlarging the Phase 3 trial of their Covid-19 vaccine by 50% which could allow the companies to collect more safety and efficacy data and to increase the diversity of the study’s participants.
Expanding the trial will likely make it easier for the company to demonstrate whether the company’s Covid-19 vaccine candidate, BNT162b1, is effective against SARS-CoV-2, the virus that causes Covid-19.
The companies have submitted an amended protocol to the U.S. Food and Drug Administration which will have to approve the change before it goes into effect.
“The companies continue to expect that a conclusive readout on efficacy is likely by the end of October,” the press release said.
Pfizer and BioNTech study is likely to be among the first in the U.S. to report efficacy data from a Phase 3 trial.
“Enrollment in the trial has been proceeding as planned and the company expects to reach its initial target of up to 30,000 participants next week. The proposed 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 (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.” Pfizer said in its statement.
On July22, Pfizer Inc. and BioNTech SE announced that they have signed a $1.95 billion agreement with the U.S. Department of Health and Human Services and the Defense Department to secure hundreds of millions of doses of a Covid-19 vaccine which Americans would receive for free.
Under the deal, the U.S. government would receive 100 million doses of BNT162, the Covid-19 vaccine candidate jointly developed by Pfizer and BioNTech, and can acquire up to 500 million additional doses.
On Jul 20, -BioNTech SE and Pfizer Inc. announced encouraging initial data from their Phase I/II clinical trial of Covid-19 vaccine candidate, BNT162b1, being conducted in Germany. The open-label, non-randomised, non-placebo-controlled, dose-escalation trial is part of the companies’ global mRNA-based Covid-19 vaccine programme.
BNT162b1 is a lipid nanoparticle formulated, nucleoside-modified messenger RNA encoding a SARS-CoV-2 receptor binding domain (RBD) antigen.
Preliminary results from the trial included findings from a total of 60 healthy adults aged 18 to 55. Of the 60 participants, 12 subjects each received 1µg, 10µg, 30µg or 50µg of BNT162b1 on day one and day 22. The remaining 12 participants were administered with a single injection of 60µg.
BNT162b1 was found to have induced high, dose-dependent SARS-CoV-2-neutralising titers and RBD-binding IgG concentrations following the second dose. Furthermore, the product for the first time demonstrated a concurrent stimulation of high level CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD
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