Pfizer and BioNTech’s COVID-19 vaccines to have their development fast tracked by the FDA

pharmafile | July 14, 2020 | News story | Manufacturing and Production, Research and Development COVID-19, Vaccine, coronavirus 

The FDA has granted Pfizer and BioNTech’s COVID-19 vaccine candidates Fast Track status to speed up their development and review.

The FDA has selected the two most advanced of their four mRNA based vaccines known as BNT162b1 and BNT162. They were fast tracked due to data from Phase 1 and 2 studies that are ongoing in Germany.

BNT162b1 was tested in 45 health adults between the ages of 18 and 55, with 24 receiving two lower dose injections, 12 receiving a high dose, and nine others receiving two placebo dosages. After 28 days, all those on a lower dosage showed elevated numbers of antibodies capable of binding with COVID-19.

Peter Honig, Senior Vice President, Global Regulatory Affairs at Pfizer, said: “The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2.

“We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”                                                                                 

Özlem Türeci, Chief Medical Officer at BioNTech, also commented: “We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward.”

These vaccines are part of the companies’ ‘Project Lightspeed’ vaccine, which is based on Biotech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities. The companies currently want to manufacture up to 100 million doses by the end of 2020 and more than 1 billion doses by the end of 2021.

Conor Kavanagh

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