Pfizer and BioNTech Vaccines Were Granted FDA Fast Track Designation Against SARS-CoV-2 (COVID-19)
A large Phase 2b/3 safety and efficacy study may begin as early as July 2020
Pfizer (PFE) and BioNTech (BNTX) announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed against SARS-CoV-2 (COVID-19) received Fast Track designation from the U.S. Food and Drug Administration (FDA).
BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the United States and Germany.
The Fast Track designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as on animal immunogenicity studies.
Results for BNT162 Program
On July 1, 2020 the companies released early data from the ongoing U.S. Phase 1/2 study for the BNT162b1. The manuscript is available on the online preprint server medRxiv and is concurrently undergoing a scientific peer-review for potential publication.
Early data from the German trial of BNT162b1 are expected to be released this month.
The BNT162 program is evaluating at least four experimental vaccines each of which represent a unique combination of messenger RNA (mRNA) format and target antigen.
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.
From Pfizer and BioNTech
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 continuing to work 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, said, “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.”
The Project Lightspeed vaccine development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities.
The BNT162 vaccine candidates are still in clinical trials and are not currently approved for distribution anywhere in the world. Pfizer and BioNTech are committed to developing these novel vaccines with pre-clinical and clinical data at the forefront of all decision-making of both companies.
Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects. If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.
The Stock, BioNTech
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|Market Cap.||$18.22 billion|
As stated above, the BNT162 program is evaluating at least four experimental vaccines; they each represent a unique combination of mRNA format and target antigen. This is the same approach used by Moderna (MRNA). The truth of the matter is we are all crossing our fingers for all these firms to succeed; however, no one can swear as to which one will come out on top.
Vaxart (VXRT) is a small cap firm with the first oral vaccine; it is administered in tablet form and continues to outperform for several reasons including the following:
- The US government has selected Vaxart for its Operation Warp Speed.
- The firm stated that its oral COVID -19 vaccine candidate would be involved in a non-human primate challenge study.
- Vaxart’s COVID-19 vaccine is the only oral COVID-19 vaccine.
- Vaxart will be added to the broad market Russell today, Monday, July 13, 2020.
- Vaxart signed a memorandum of understanding with Attwill Medical Solutions Sterilflow, LP (AMS) affirming the parties’ intent to establish AMS as a resource for lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine. AMS will be assigning dedicated resources and equipment for the scale up and commercial production of the vaccine upon entering a formal agreement. The firms hope that they will be able to produce a billion, or even more, COVID-19 vaccine doses per year.
Vaxart is a clinical-stage biotechnology company focused on developing oral tablet vaccines designed to generate mucosal and systemic immune responses that protect against a wide range of infectious diseases and have the potential to provide sterilizing immunity for diseases such as COVID-19.
Vaxart believes that a room temperature stable tablet vaccine is easier to distribute, store and administer than injectable vaccines and may provide significantly faster response to a pandemic than injectable vaccines, enabling a greater portion of the population to be protected.
Vaxart’s development programs include oral tablet vaccines that are designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV).
|Price Now||$10.73 UP $2.75|
|Market Cap.||$796.74 million|
The above news makes us feel like the government and investors are convinced that this firm has strong scientific fundamentals that enabled the creation of an oral COVID-19 vaccine, which has an advantage over injectable vaccines. Like the other COVID-19 vaccines one cannot know which might succeed in crossing the finish line to being granted US as well as other countries’ authorities’ approvals.
We are hopeful that all these firms’ vaccines will get approved because we need them all.
We will do our best to get the information and the inspiration about each of them.
There is still more learn and to say about this subject.