Pfizer, BioNTech dose first US participants in global COVID-19 vaccine trial

Pfizer and BioNTech announced Tuesday that the first subjects have been dosed in the US in a Phase I/II trial for the BNT162 vaccine programme to prevent COVID-19, following dosing of the first cohort in Germany, which was completed last week. "The short, less than four-month timeframe in which we've been able to move from preclinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our…resources, from the laboratory to manufacturing and beyond, in the battle against COVID-19," commented Pfizer CEO Albert Bourla.

The dose-level escalation portion of the trial in the US will enroll up to 360 healthy subjects into two age cohorts, one with participants between 18 and 55 years of age, and another for those ranging from 65 to 85. The companies noted that older adults will only be immunised with a given dose level once testing and dose level of the vaccine candidate show initial evidence of safety and immunogenicity in younger adults.

The companies recently expanded an existing influenza vaccine partnership between the two to include co-developing an mRNA-based coronavirus vaccine. Specifically, the development programme includes four COVID-19 vaccine candidates, each representing a different combination of mRNA format and target antigen. According to Pfizer and BioNTech, the trial's design allows them to test "various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious…to be evaluated in a greater number of volunteers, in a manner that will facilitate the sharing of data with regulatory authorities in real time."

In the meantime, Pfizer says it plans to activate its vast manufacturing network and "invest at risk" in an effort to produce an approved COVID-19 vaccine as quickly as possible. The companies anticipate being able to produce millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. Pfizer-owned sites in Massachusetts, Michigan and Missouri, as well as another in Puurs, Belgium, have been identified as manufacturing sites for COVID-19 vaccine production, with more to be selected. BioNTech also plans to ramp up production capacity, via its existing German mRNA production sites in Mainz and Idar-Oberstein, in order to help bolster global supply.

Pfizer and BioNTech will co-market the vaccine worldwide upon regulatory approval, except in China, where BioNTech already has a partnership with Fosun Pharma for BNT162 for both clinical development and commercialisation.

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