BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2 Vaccine Candidate, BNT162b2

Shots:

• The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process to facilitate the final MAA
• BNT162b2 vaccinated participants showed a favorable breadth of epitopes recognized in T-cell responses specific to SARS-CoV-2 spike antigen & BNT162b2 demonstrated concurrent induction of high magnitude CD4+ & CD8+ T cell responses which are TH-1 dominant against RBD and remainder of full spike glycoprotein
• BNT162b2 vaccine candidate (BioNTech’s proprietary mRNA technology and supported by Pfizer) encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S). It is currently being evaluated in an ongoing P-III study with ~37,000 participants enrolled and 28,000 having received their second vaccination at >120 clinical sites worldwide including the US, Brazil, South Africa, and Argentina

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: King’s College London