Pfizer and BioNTech Plan to Initiate U.S. COVID-19 Vaccine Trial

Pfizer and Germany-based BioNTech are collaborating on a messenger RNA vaccine against SARS-CoV-2, the novel coronavirus that causes COVID-19. The two companies have already begun Phase I/II clinical testing in Germany. The companies now plan to start testing in the U.S. once the U.S. Food and Drug Administration (FDA) gives approval.

In Germany, 12 patients out of a target population of 200 have been dosed with the BNT162 vaccine candidate. They began dosing on April 23. The trial is in healthy subjects from the ages of 18 to 55, targeting a dose range of 1 ug to 100 ug to determine the best dose for further studies in addition to evaluating the safety and immunogenicity of the vaccine.

Pfizer is scaling up manufacturing to be able to churn out millions of doses by the end of the year, with the possibility, according to company chief executive officer Albert Bourla, to produce “hundreds of millions” in 2021 if the clinical trials are a success.

Pfizer is also studying an antiviral drug against COVID-19. The company, in its first-quarter report yesterday, noted, “Preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2. Consequently, Pfizer will continue to perform preclinical confirmatory studies, including further antiviral profiling and assessment of the suitability of the lead molecule for IV administration clinically. In parallel, the company is also investing in materials that aim to accelerate the start of a potential clinical study of the lead molecule to third-quarter 2020, three or more months in advance of earlier estimates, subject to positive completion of the preclinical confirmatory studies.”