The designation will provide for an expedited pathway for regulatory review of the preventative medication, which could come later this year.
The U.S. Food and Drug Administration (FDA) granted Fast Track designation to COVID-19 vaccine candidates under development by Pfizer and Germany’s BioNTech. The designation will provide for an expedited pathway for regulatory review of the preventative medication, which could come later this year.
The FDA designation covers two of the companies’ four investigational vaccine programs under development against the novel coronavirus, BNT162b1 and BNT162b2. Those two programs are the most advanced candidates under development by the two companies and are currently in an ongoing Phase I/II study.
BNT162b1 and BNT162b2 are both nucleoside-modified RNAs, formulated in lipid nanoparticles. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.
Earlier this month, BioNTech and Pfizer released early data from the study of BNT162b1 that showed neutralizing antibodies were observed at 1.8- to 2.7-times the level of those found in patients who recovered from COVID-19. That data is undergoing peer review as the companies prepare for publication. The FDA’s decision to grant Fast Track designation was based on that preliminary data released earlier this month, the companies said this morning.
Peter Honig, head of Global Regulatory Affairs at Pfizer, said the FDA’s decision to grant Fast Track designation to the vaccine program is an important milestone in the fight against the pandemic. BioNTech Chief Medical Officer Özlem Türeci echoed the sentiment. Türeci said the designation is important as the two companies are diligently working on a vaccine program as they seek to expedite a clinical path toward potential approval. A Phase IIb/III program is expected to begin this month with 30,000 patients. The goal is to prove that people who are dosed with the vaccine are at least 50% less likely to become infected – a threshold set by the FDA.
The vaccine programs are being developed in a program called Project Lightspeed, the company’s accelerated development program for COVID-19, which is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities. The two companies forged an agreement to develop the mRNA vaccine candidate in March while the vaccine candidate was still in the preclinical phase.
Last week, BioNTech Chief Executive Officer Ugur Sahin predicted that, if the late-stage research goes smoothly, the vaccine could be ready for regulatory approval by the end of 2020, with about 100 million doses ready for immediate use. By the end of 2021, Sahin said the companies could manufacture about 1.2 billion doses of the vaccine candidate. Sahin speculated that billions of vaccines will have to be delivered across the globe before there is sufficient immunity against COVID-19. The novel coronavirus has infected approximately 13 million people across the globe. The largest outbreak has been in the United States with more than 3.3 million diagnosed patients. The virus has killed 569,679 people, according to the Johns Hopkins COVID-19 dashboard.
