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Pfizer, BioNTech Begin Rolling Submission To EMA For SARS-CoV-2 Vaccine Candidate

Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced the initiation of a rolling submission to the European Medicines Agency for BNT162b2, their lead candidate against COVID-19. The companies plan to work with the EMA's Committee for Medicinal Products for Human Use to complete the rolling review process to facilitate the final Marketing Authorization Application.

The companies noted that the CHMP has begun evaluating data generated in pre-clinical trials. The formal MAA submission could be finalized following the rolling review process, pending confirmation from the EMA that the submitted data are adequate.

The BNT162b2 vaccine candidate is based on BioNTech's mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities. The vaccine candidate is currently being evaluated in a global Phase 3 study.

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