BioNTech

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

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

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

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Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the… Read More »Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Pfizer, BioNTech start late-stage study of Covid-19 vaccine

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The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

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Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate… Read More »Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

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Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced… Read More »Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19