Pfizer and BioNTech Initiate Rolling Submission to European Regulator for COVID-19 Vaccine

Pfizer Inc. (New York, NY, USA) and Biopharmaceutical New Technologies (BioNTech Mainz, Germany) have initiated a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19.

The BNT162b2 vaccine candidate is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. It encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is a target of virus neutralizing antibodies. The vaccine candidate is currently being evaluated in a global Phase 3 study ongoing at more than 120 clinical sites worldwide including the US, Brazil, South Africa and Argentina. To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.

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. Preliminary data from the Phase 1/2 portions of the study have demonstrated that BNT162b2 was well tolerated with mild to moderate adverse events in all age groups. The vaccine candidate generated dose level-dependent immunogenicity, as measured by receptor binding domain (RBD)-binding IgG concentrations and SARS-CoV-2 neutralizing titers. In addition, BNT162b2-vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, and BNT162b2 demonstrated a concurrent induction of high magnitude CD4+ and CD8+ T cell responses which were TH-1 dominant against the RBD and the remainder of the full spike glycoprotein.

A combination of an antibody and T cell response is believed to be important in eliciting protection against viral infection and disease. 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). As part of the rolling review, the CHMP has begun evaluating data generated in pre-clinical trials. 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.

“It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles. We will continue to have regular and open dialogue with the EMA throughout the rolling review process,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

“A global crisis the magnitude of COVID-19 has completely transformed the vaccine development and review process,” said Peter Honig, M.D., Senior Vice President and Head of Worldwide Safety and Regulatory of Pfizer. “We are making every effort to develop a safe and effective vaccine following the guidance of regulatory agencies and are proud to take this historic step with the European Medicines Agency for our COVID-19 vaccine candidate, BNT162b2.”

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