New Crown Outbreak: 13.49 million! Pfizer/BioNTech 2 is granted fast track status by the FDA in the study of mRNA vaccine!

July 15, 2020 // At present, the outbreak of new crown pneumonia is still spreading rapidly around the worldAs of 20 p.mon July 15, 2020, more than 13.495 million cases and more than 582,000 deaths had been confirmed worldwide, according to Baidu's Real-Time Big Data Report on the Outbreak of New Coronavirus PneumoniaPfizer and BioNTech recently jointly announced that two of the four candidate vaccines from the BNT162 mRNA vaccine program (BNT162b1 and BNT162b2) have been granted fast-track (FTD) by the U.SFood and Drug Administration (FDA) and are being clinically developed to prevent new coronaviruses (SARS-CoV-2), which can lead to new coronavirus pneumonia (COVID-19)BNT162b1 and BNT162b2 are the two most advanced candidates in the BNT162 vaccine program and are being evaluated in phase 1/2 clinical studies in the United States and GermanyThe large-scale global 2b/3 safety and efficacy study is expected to begin as early as JulyFast Track is a process designed to promote the development and accelerated review of new drugs and vaccines designed to treat or prevent serious diseases that have the potential to address unmet medical needsThe FDA awarded the FTD as based on preliminary data from current phase 1/2 studies in the United States and Germany, as well as animal immunogenicity studiesOn July 1, 2020, two companies released early data from the ongoing phase 1/2 study of the candidate vaccine BNT162b1 in the United StatesManuscripts are available online in preprinted on this website medRxiv (Phase 1/2 Study to The Safe y and Immunogenicity of a COVID-19 RNA Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report, which is undergoing scientific peer review for publicationEarly data from the BNT162b1 German trial are expected to be released in JulyThe BNT162 vaccine project is evaluating at least four research vaccines, each representing a unique combination of messenger RNA (mRNA) formats and target antigensBNT162b1 and BNT162b2 are nucleoside-modified mRNAs (modRNAs) that are encased in lipid nanoparticlesBNT162b1 encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length echirotoprotein (S) antigen"The FDA's decision to grant fast-track status to these two candidate vaccines marks an important milestone in the development of a safe and effective SARS-CoV-2 vaccine," said Peter Honig, Pfizer's senior vice president of global regulatory affairsWe look forward to working closely with the FDA during the clinical development of this project to assess the safety and effectiveness of these candidate vaccines "We are pleased to receive the FDA's award of our two candidate vaccine fast-track status and look forward to working closely with the FDA and our partner Pfizer to accelerate clinical development," said BioNTech's Chief Medical Officer, Zlem T?reci The vaccine development, called Project Lightspeed, is based on BioNTech's proprietary mRNA technology platform and is supported by Pfizer's global vaccine development capabilities The BNT162 candidate vaccine is undergoing clinical studies and has not yet been approved for distribution anywhere in the world Pfizer and BioNTech are committed to developing these new vaccines, putting preclinical and clinical data at the forefront of all decisions of both companies Subject to regulatory approval, the two companies are expected to launch phase 2b/3 trials as soon as later this month and expect to recruit up to 30,000 subjects If ongoing research is successful and the candidate vaccine is approved by regulators, the two sides now expect to produce up to 100 million doses of the vaccine by the end of 2020 and possibly more than 1.2 billion by the end of 2021 ORIGINAL SOURCE: PFIZER AND BIONTECH GRANTED FDA FAST TRACK FOR TWO INVESTIGATEAL MRNA-BASED CANDIDATE VACCINES AGAINST SARS-COV-2.