In the continued absence of "potent drugs", the "competition" for vaccine development of new coronavirus vaccines continues to accelerate.
On May 5, Pfizer and German biotech company BioNTech announced the completion of the first clinical trials in the United States for the administration of the new crown mRNA vaccine to subjects.
The trial is part of the BNT162 vaccine program for the new coronavirus pneumonia (Covid-19) and is part of a global development program where the first doses in the German study group were completed last week.
The aim of this study was to determine the safety, immunogenicity and optimal dose levels of four mRNA vaccine candidates evaluated in a serial study.
The clinical trial will enroll 360 healthy subjects in two age groups (18-55 years and 65-85 years). The first subjects to be immunized in the first phase of the study will be healthy adults aged 18-55.
Once a candidate vaccine at a given dose level has been tested and prima facie evidence of safety and immunogenicity is provided for young people, it can only be immunized with a candidate vaccine at a given dose level.
Locations, where the drug is currently administered to participants, include the Grossman School of Medicine at New York University and the University of Maryland School of Medicine.
Pfizer and BioNTech's development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen.
The design of the trial allows for the simultaneous evaluation of various mRNA candidates in order to identify the safest and potentially most effective candidates among a large number of volunteers in a manner that will facilitate real-time data sharing with regulatory agencies.
"With our unique and robust clinical study program underway, starting in Europe and now the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most," said Albert Bourla, Chairman and CEO, Pfizer.
The short, less than four-month timeframe in which we've been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against Covid-19, Bourla said.
"It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period. We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against Covid-19," said CEO and Co-founder of BioNTech, Ugur Sahin.
During the clinical development phase, BioNTech will provide the clinical supply of the vaccine through its GMP-certified mRNA production facility in Europe.
In terms of capacity, Pfizer and BioNTech say they are working to scale up production for global supply.
The breadth of Pfizer's plan to activate its extensive manufacturing network and make venture capital investments should allow for the production of millions of doses of the vaccine by 2020, rising to hundreds of millions by 2021.
Pfizer's manufacturing sites in three U.S. states (Massachusetts, Michigan, and Missouri) and Pouls, Belgium, have been identified as hubs for the production of the vaccine.
BioNTech and Pfizer will work together to commercialize the vaccine globally, subject to regulatory approval (excluding China, where BioNTech and Fosun Pharma have collaborated on the clinical development and commercialization of BNT162).
On March 17, 2020, the two sides announced the start of cooperation on the vaccine. According to previously announced details from both parties, the collaboration leverages BioNTech's technology platform and Pfizer's strengths in vaccine development, regulation, global manufacturing, and distribution networks.
Under the terms of the agreement, Pfizer will pay BioNTech an upfront payment of $185 million, which includes a cash payment of $72 million and an equity investment of $113 million.
BioNTech is eligible for up to $563 million in future milestone payments (a potential total consideration of $748 million). Pfizer and BioNTech will share the R&D costs equally.
Pfizer will provide 100% of the R&D costs early on and BioNTech will reimburse Pfizer for 50% of the R&D costs during the commercialization of the vaccine.
On the Chinese side, Fosun got the rights to develop and commercialize the vaccine in China.
On March 15, Fosun Pharmaceuticals announced that it has been licensed by BioNTech to exclusively develop and commercialize a vaccine product against Covid-19 based on its proprietary mRNA technology platform in China.
Under the agreement, Fosun Pharma is responsible for the regional clinical trials, marketing applications, and sales of the vaccine in China, and will bear the corresponding costs and expenses.
BioNTech will be responsible for providing technical materials and preclinical study data for clinical trial applications in the region, supporting clinical trials in the region, and supplying products for related clinical trials and marketing.
Fosun Pharmaceutical Industries will pay BioNTech up to $85 million in license fees (including down payments, clinical development registrations, and sales milestone payments) and a sales commission of 35% of the annual gross profit of the product over the agreed sales commission period.
At the same time, Fosun Pharmaceuticals subsidiary intends to subscribe for an additional 1,580,777 shares of common stock issued by BioNTech for approximately $50 million.
mRNA is a nucleic acid molecule that carries genetic information into the body. mRNA vaccines import genetic information into the body, causing cells to produce antigens that induce the body to produce neutralizing antibodies and stimulate T-cell responses to fight viruses through the dual mechanism of humoral and cellular immunity.
Compared with conventional vaccines, mRNA vaccines are relatively easy to synthesize and produce, have strong immunogenicity, do not require additional adjuvants, and are safe in the face of major outbreaks.
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