BioNTech & Pfizer’s BNT162b2 Now Under Rolling Submission Status by EMA: Means COVID-19 Vaccine Could Get Approved Faster

BioNTech & Pfizer’s BNT162b2 Now Under Rolling Submission Status by EMA Means COVID-19 Vaccine Could Get Approved Faster

The COVID-19 vaccine candidate known as BNT162b2 may be getting closer to registration (e.g. approval) as the European Medicines Agency (EMA) has accepted the initiation of a rolling submission from partners Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX), the original developer of the RNA-based vaccine program. The EMA decision was made possible thanks to encouraging preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. In summary, because the combination of antibody and T cell response is believed to be important in eliciting protection against viral infection and disease, EMA considered and accepted this approach to reviewing the submission. Now the two companies, Pfizer and BioNTech, will engage 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). CHMP is now analytically diving into this preclinical clinical trials data. The recent BioNTech press release notes that a formal MAA submission could be ...

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