After the official press release of the pharmaceutical corporation Pfizer Inc. and the MedTech company BioNTech SE, it became clear that their joint large-scale clinical trial of a coronavirus vaccine has shown successful data:
- 38 955 participants in the second phase of the study received their second dose of vaccine as of November 8
- The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior infection with the virus
- If regulatory approval or authorization is obtained, the companies currently aim to supply up to 1.3 billion doses globally by the end of 2021
A Plan for Escaping the COVID-19 Crisis
The announcement is particularly notable for the Southeast European technology ecosystem, as the founders of BioNTech SE, the company that developed the vaccine, originate from Turkey.
The third phase of the trial has enrolled 43,538 participants from 6 countries, including 39 U.S. states. Pfizer and BioNTech plan consists of conducting three stages of clinical trials. The first stage took place in the U.S. and Germany in April and it aimed to select which vaccine candidate and dose should be taken for a future clinical study. During the early trials, the BNT162b2 candidate was selected for testing, while the second and third stages of the experiment included the vaccination process and an extensive data recording procedure to record the effect of the drug.
The trial will continue till a total of 164 confirmed COVID-19 cases are accrued and upon which will be made a final analysis for further data and characteristics of the vaccine candidate. Currently, Pfizer and BioNTech are continuing to collect safety data, as they estimate that they will have the required data to submit their vaccine candidate for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) around the third week of November. The EUA is a regulatory tool that could possibly enable the release of the vaccine at the U.S. market, thus accelerating the process of creating a commercial vaccine.
How the Vaccine Works
The candidate vaccine, called BNT162b2, is an mRNA vaccine that does not contain any live virus. The way it works is such that it gives a body’s cells instructions to make viral proteins that can be recognized by the immune system. It contains a small part of the genetic code for the SARS-CoV-2 spike protein. By delivering the mRNA to the body’s cells, the viral protein is expressed and the immune system response is generated against it.
BioNTech: a Hub for MedTech Innovations
The vaccine is a product of BioNTech, a Germany-based company listed in the Nasdaq electronic exchange that was founded in 2008 by husband and wife Uğur Şahin and Özlem Türeci. The two scientists are children of Turkish immigrants. They started as medical researchers, specializing in oncology. In 2001, the couple decided to establish their first business, Ganymed Pharmaceuticals to develop cancer antibodies. The company won funding from MIG and was sold in 2016 to Japan’s Astellas for $1.4B. The next step for Şahin and Türeci was to establish BioNTech which specialty is immunotherapy. According to the company website, its oncology products include individualized and off-the-shelf mRNA-based therapies, chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules. A key area in which BioNTech specializes is the development of multiple mRNA vaccine candidates for a range of infectious diseases alongside its oncology pipeline.
The outbreak of the new coronavirus in January attracted the attention of the founders as they noticed a link between anti-cancer mRNA drugs and mRNA viral vaccines. As a result, the company set up a coronavirus vaccine task force with 500 members of the staff assigned the task of developing a vaccine.
How Pfizer entered the Game
The partnership of BioNTech with Pfizer, one of the largest American pharmaceutical giants, started in March.
According to BBC, Pfizer has a market worth of approximately $186B and made revenues of $51.6B last year. While one of its most popular products is the erectile-dysfunction drug Viagra, Pfizer is also famous for investing in R&D programs.
As stated in the clinical protocol of the trials, BioNTech is the study sponsor responsible for initiating the process of the research conducted by Pfizer. In a nutshell, Pfizer gives researchers secure access to their patient-level data or full CSRs for the purposes of creating a vaccine and provides the MedTech company with its regulatory capabilities, as well as its manufacturing and distribution networks. BioNTech and its partners, on the other hand, are responsible for providing a clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe for the trials. BioNTech and Pfizer have agreed to jointly improve the manufacturing capacity of the COVID-19 vaccine and commercialize it worldwide.
As the trials continue, Pfizer and BioNTech continue collecting data and are looking forward to receiving the green light from the health authorities. According to an official statement by Pfizer, the pharmaceutical company expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.