German regulatory authority signs off on first clinical trial of Pfizer, BioNTech's BNT162 vaccine programme for COVID-19

Pfizer and BioNTech announced Wednesday that the Paul-Ehrlich-Institut has approved a Phase I/II trial of the BNT162 vaccine programme to prevent COVID-19 infection. The news comes on the heels of a recent expanded partnership between the two companies to co-develop an mRNA-based coronavirus vaccine.

The companies indicated that four vaccine candidates, stemming from BioNTech's COVID-19-focused Lightspeed project, are slated to enter clinical development, with two of the candidates including a nucleoside modified mRNA (modRNA), while one includes a uridine-containing mRNA (uRNA) and the fourth utilises self-amplifying mRNA. They said the larger spike sequence of the novel coronavirus is included in two of the vaccines, while the smaller optimised receptor-binding domain from the spike protein, which is thought to be "most important for eliciting antibodies that can inactivate the virus," is included in the other two.

The dose escalation portion of the trial will include approximately 200 healthy subjects between the ages of 18 to 55 years. Aside from determining the optimal dose for further testing, as well as safety and immunogenicity, the study will also evaluate the effects of repeated immunisation for three of the four vaccine candidates that use uRNA or modRNA. In addition, Pfizer and BioNTech said that subjects deemed to be at higher risk for severe COVID-19 infection will be enrolled in the second part of the study.

Albert Bourla, chief executive at Pfizer, remarked "now that the work in Germany can commence, we are looking forward to and actively preparing for the potential start of this…clinical study programme in the US in the near future." Meanwhile, BioNTech is also collaborating with partner Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.

For related analysis, see ViewPoints: COVID-19 vaccines in focus.

 

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