BioNTech, Pfizer initiate rolling submission to European Medicines Agency for COVID-19 vaccine candidate

October 6, 2020  –  Pfizer Inc. (New York, NY) and BioNTech SE announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19.

BioNTech and Pfizer plan to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate the final Marketing Authorization Application (MAA).

The formal MAA submission could be finalized following the rolling review process, pending demonstration of vaccine efficacy and safety and confirmation from the EMA that the submitted data are adequate. The vaccine candidate will remain subject to the EMA’s diligent standards for quality, safety and efficacy.

The EMA’s decision to start a rolling review follows the encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2.

A combination of an antibody and T cell response is believed to be important in eliciting protection against viral infection and disease.

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