Of the 52 vaccines being tested on humans in clinical trials, there are three main types. Some people use dead or weakened viruses to bring coronavirus genes into cells and produce an immune response. Others contain fragments from coronaviruses or even complete proteins, but do not have genetic material to activate the immune system. Finally, genetic vaccines use genetic material to make the human body produce proteins from the virus, and then the immune system recognizes the virus and attacks it.
Biotechnology (Nasdaq stock code: BNTX) And partner Pfizer (New York Stock Exchange: PFE) They are creating a genetic vaccine candidate and announcing the mid-term results of their phase 3 clinical trial, which makes all mankind feel optimistic. However, although this vaccine called BNT1
Company history and supporters
BioNTech was established in 2008 to maximize the concept of personalized medicine. The company’s basic idea is that each cancer patient’s tumor is unique, and by analyzing the genetic characteristics of the tumor, scientists can create gene-based therapies to limit the spread of this cancer or even destroy this specific condition.
Not just fantasy. In 2017, all 13 patients who received gene-based personalized treatment for advanced advanced melanoma had enhanced immunity against their tumor mutations. In essence, they are immune to the spread of their cancer. Other vaccines against rabies and flu have provided protection, but the benefits gradually fade after a year.
In addition to COVID-19, the company’s current goals include skin cancer, HIV, tuberculosis, seasonal influenza, and many undisclosed rare or infectious diseases.In addition to Pfizer, BioNTech also has some impressive partnerships, including Regeneration element (Nasdaq stock code: REGN), Bill and Melinda Gates Foundation, University of Pennsylvania and Genentech.
Before developing its COVID-19 vaccine candidate, the company did not conduct any treatments in its phase 3 trials. The management now has 9 full-time candidates, and 5 candidates developed with partners, starting the first phase of the trial from the end of this year or the first half of 2021. To date, BioNTech’s revenue has been the result of stock issuance, grants and manufacturing contracts, not the sale of any approved drugs. It seems this might change.
Partnership and profit
BioNTech and Pfizer just let investors learn about the Phase 3 trial data of their COVID-19 vaccine candidate as early as possible. The candidate demonstrated 90% efficacy among participants who received the vaccine twice, three weeks apart. This is far beyond the high end expected. This summer, the National Institutes of Health (NIH) determined that to stop this pandemic, vaccines need to be at least 70% effective or at least 80% effective without any other measures (such as wearing masks and social distancing). Understandably, the market is excited about 90% efficiency, and it is also exciting to reach an agreement between the government and partners to obtain the dose after regulatory approval.
In July, the US government agreed to purchase approximately 600 million doses in two doses on the standard two-dose schedule, at a price of approximately US$39. Although prices may change once the urgent pandemic demand ends, Pfizer does confirm that other developed countries will not get lower prices than the US government for the same quantity of products. Japan hopes to host the postponed 2020 Olympics, so it has signed 120 million doses of vaccine. The UK has agreed to take 30 million doses in the next two years, but it cannot be ignored. The European Union signed an agreement for 300 million doses on Wednesday.
And there may be more transactions in the future. Company executives said that people will continue to need to be vaccinated to maintain immunity in the herd, as well as in the case of virus mutations. For its part, BioNTech will also profit from the Asian vaccine market. In March, the management and Fosun Pharma signed an agreement to distribute the vaccine in China. BioNTech received an advance payment of US$135 million and will share future profits in the country.
What will happen now?
First, the company needs to complete two months of data collection after the second dose of vaccine. According to the current schedule, this means that they will reach this milestone in the third week of November. Thereafter, the partner should apply to the US Food and Drug Administration (FDA) for an emergency use authorization (EUA). Although the EUA allows the distribution of vaccines to those who need it most, there are still some unknowns. First, no one in the trial had a serious COVID-19 case. Therefore, it is not yet clear how this therapy prevents the most serious consequences. It is not known exactly how long the vaccine can prevent infection.
Another unknown is how to distribute the vaccine. Since it is a gene-based product, it needs to be stored at extremely low temperatures-minus 94 degrees Fahrenheit. Pfizer and BioNTech will work with the U.S. government to use dry ice to transport vaccine vials to keep them cool. The vaccine can be stored in this deep-frozen state for up to six months, but once it reaches the destination, the vaccine can only be stored between 36 and 46 degrees Fahrenheit for up to five days. The obstacle to reaching the destination will be to ensure that the patients who need it most can get the vaccine within those five days and receive the follow-up dose accurately three weeks later.
Currently, these companies expect to produce 50 million doses of vaccine by the end of the year and 1.3 billion doses by the end of 2021. Next year seems to be going all out to produce vaccines and sell them all over the world. Although the two companies have expressed interest in Covax, the World Health Organization (WHO) initiative is to ensure early access to vaccines in underdeveloped countries, but they have not yet signed. In fact, these companies have not received funding from anyone. Although this approach may seem risky at first, it frees them from the constraints of politics and bureaucracy and is able to charge fair market prices for the products they work hard to develop.
In the past few years, BioNTech has proven its scientific superiority. Now, with Pfizer’s partners and a global call to action, the two companies seem to be ready to deliver vaccines to the world. Since hundreds of millions of doses have been pre-sold and a distribution agreement has been reached in China, and plans to sell more than 1 billion doses next year, BioNTech seems to be nowhere to be found.