As early as mid-January 2020, BioNtech began initial animal testing and toxicology studies on SARS-CoV-2. Two months later, a collaboration with Pfizer was announced and Phase 1 and 2/3 studies were conducted in the US and EU in June and July, respectively.
Overview of the current study:
Inclusion criteria for the study include: Participants must be volunteers between 18 and 85 years of age, have a body mass index between 19 kg/m² and 30 kg/m², and weigh at least 50 kg at the first visit. While in phase 1/2 (i.e. phases 1 and 2) exactly 456 participants were tested, in phase 2/3 there were up to 30,000 study participants from more than 150 clinical trial sites worldwide (six of them in Germany) who received a 30 µg dose of the vaccine twice, with a 21-day interval. In the current phase 3 trial, which began on July 27, 43,931 subjects have participated through November 30, 2020. According to the manufacturer, it is estimated that the trial will continue for another two years, until January 29, 2023, in order to observe long-term effects as well.
How does BNT162 work:
The vaccine consists of a messenger RNA, a short segment of genetic material that passes on a task to human cells. The genetic material is enclosed by a layer of fat so that it can safely enter the cells of the human body. The cells are then supposed to produce a version of an immunogen, i.e. antigen, or target protein, i.e. part of the virus, which is supposed to activate the body's own immune response against the SARS-CoV-2 virus. According to the manufacturer, the immune system should be stimulated to produce protective antibodies. As a result, the human immune system should learn to recognize the virus on its own upon contact, thereby preventing subsequent infection. This mRNA vaccine does not contain the SARS-CoV-2 virus and therefore does not pose a risk of infection, according to the manufacturer. It is not yet clear how long the vaccine can be effective.
The vaccine, which is 95% effective, is to be administered twice with a 21-day interval. A technical requirement is to store BNT162 at the -75°C needed for this.
At-risk patients, i.e. elderly people in nursing homes and their staff, are a priority, officials say. Over-80s and healthcare workers were added to the list immediately after. Since hospitals already have the facilities to store the vaccine as needed, it will likely be available for vaccination there first.
Are there side effects?
So far so good, as no serious side effects were reported by the more than 43,000 people who received the vaccine. The only side effects were fatigue at 3.8% of subjects and headache at 2.0%. The exact ingredients of the vaccine have not yet been released to the public.
Prospects for the future:
This vaccine was specifically developed in collaboration between Pfizer and BioNtech. Thus, these manufacturers also have intellectual property over the same. Globally, up to 50 million doses of vaccine are expected to be produced by the end of 2020. By the end of the following year, up to 1.3 billion doses are expected to be produced.