A Day After Encouraging Phase I/II Clinical Trial, Pfizer-BioNTech Announces A $1.95 Billion Covid-19 Vaccine Order From U.S. Government

Pfizer Inc. and BioNTech SE today 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, The Wall Street Journal reported.

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.