Pfizer, BioNTech to manufacture up to 100 M doses by 2020 end

Pfizer, BioNTech to manufacture up to 100 M doses by 2020 end

The initial results of the Phase 1 and 2 studies, published earlier this month, showed that all 24 participants who received lower dose levels of the BNT162b1 candidate generated antibodies against COVID-19.

Two of Pfizer and BioNTech's potential COVID-19 vaccines have been granted Fast Track status by the FDA, a process created to hasten their development and review.

Companies must request the designation and it is reserved for "any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need", according to the FDA's website.

The companies had recently announced positive preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2. The Canadian company provides lipid nanoparticles (LNP) for the formulation of various mRNA vaccines.

He continued: "We look forward to continue working closely with the FCA throughout the clinical development of this programme, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates".

Pfizer and BioNTech are developing these novel vaccines with pre-clinical and clinical data at the forefront of all decision-making of both companies.

They also expect to make up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by 2021-end, if the vaccine is successful.

The phase 2b/3 trial could start "as soon as later this month", the partners said in a statement this morning, and they are "anticipating enrolling up to 30,000 subjects".

Pfizer and BioNTech are evaluating at least four experimental vaccines in its BNT162 program, all based on an mRNA, or "messenger RNA", technique - which, unlike traditional vaccines, does not use an inactivated virus but rather a portion of the coronavirus' own genetic code to trigger production of antibodies. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer.

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