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Pfizer and Biontech assume that 50 million doses of vaccines can be produced this year. Image: Shutterstock / Watson
Why is the BNT162b2 result so revolutionary? 7 questions and answers about the vaccine
What is it really about?
On Monday, the US company Pfizer and Germany’s Biontech announced in a press letter that the interim results of an approval study for a phase 3 corona vaccine were positive. What doesn’t sound spectacular at first, it has it all. Because it is the first time in corona vaccine research that such a good result is available in this crucial phase.
Why is the result so innovative?
Biontech and Pfizer have developed a vaccine that researchers say offers more than 90 percent protection against Covid-19. This candidate vaccine, called BNT162b2, has been tested in a clinical study in 43,500 volunteers since the end of July. Half of the test subjects were injected with BNT162b2, the other half a dummy substance. In an interim analysis that was carried out according to plan after infection number 94 was detected, 39,000 test subjects had already been administered a drug. Of the 94 infections, more than 80 occurred in the placebo group. The study will continue until infection number 164 is detected.
Researchers initially expected 60 to 70 percent effectiveness. In their communication, Biontech and Pfizer wrote that their study had shown that 9 out of 10 vaccinated people were protected from Covid-19 infection. However, it is not yet clear whether the high effectiveness of the vaccine is confirmed after evaluating all the results. Independent scientists believe the results are promising.
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What is the vaccine and how does it work?
BNT162b2 from Biontech and Pfizer is a so-called ribonucleic acid vaccine, or RNA for short. RNA is a kind of genetic blueprint. The vaccine contains part of the genetic makeup of the coronavirus. If you enter a human cell, this code is read there. The cell then begins to use the blueprint to produce surface proteins for the coronavirus. These are released into the body and are recognized by the immune system as a foreign antigen. This activates various defense mechanisms and triggers an immune reaction.
The advantage of this technology is that RNA vaccines can be produced on a large scale in a short time. In classical vaccine production, specific viruses must first be cultured before, for example, a flu vaccine can be produced from them.
What are the risks associated with vaccination?
The research team is generally in a good mood, but there are still many unanswered questions. For example, how well the vaccine protects against serious diseases or how long the protection lasts (see point 7). Caution is advised because there are currently no RNA vaccines that are used clinically.
Intramuscular injections can cause local pain or tightening of muscle tissue. The immune reaction can cause fever, chills, tiredness, muscle, joint or headache pain. It is not yet known to what extent these side effects also occur with BNT162b2.
A vaccine can become dangerous if the antibodies that are formed attack healthy body structures. Cases of narcolepsy have been reported with a swine flu vaccine. But such reactions are very rare. According to the researchers, no serious risks have yet been observed.
The building of the Biontech company in Mainz. Image: keystone
What are the next steps now?
Pfizer and Biontech, which are already working together to develop RNA-based vaccines for influenza, are expected to apply for approval of the vaccine from the US Food and Drug Administration by next week. Filing processes are also ongoing in Canada, the UK, and Europe. An expedited approval process is applied to the corona vaccine due to its particular urgency.
In Switzerland, Pfizer submitted an application for approval of the vaccine to the approval authority Swissmedic in mid-October. Swissmedic is handling all requests related to the Covid-19 pandemic faster, but as comprehensively as usual. The approval process is the so-called “rolling submission” process in which pharmaceutical companies continually submit data from the ongoing clinical trial. . According to Swissmedic, an authorization decision will only be made “as soon as all the data on the risk-benefit profile necessary for an evaluation are available and have been evaluated.” Swissmedic is also testing another vaccine being developed by the British company AstraZeneca.
Pfizer and Biontech currently estimate that up to 50 million doses of the vaccine will be produced worldwide this year, enough to vaccinate 25 million people. So up to 1.3 billion cans will be produced in 2021.
Switzerland has already ordered vaccines, but from other companies: first, 4.5 million doses from the American biotech company Moderna, which is also developing an RNA-based vaccine like Pfizer and Biontech. On the other hand, 5.3 million cans are already reserved at AstraZeneca. Since two doses per person are required to achieve vaccine protection, that’s enough for nearly 5 million people, if these vaccines are effective and approved.
So who can get vaccinated?
There will not be extensive vaccination coverage for the population in the foreseeable future. There is still too much information about rare potential side effects missing. Furthermore, it is not yet clear if the vaccine only protects the vaccinated person or if it can also prevent transmission of the virus.
The first to receive the vaccine are the groups that are most at risk for Sars-CoV-2, the so-called risk groups. This especially includes the elderly and people with previous illnesses like diabetes or high blood pressure. Of course, it is not yet clear whether the vaccine can actually prevent serious diseases; it may have been primarily tested in young, healthy volunteers.
The next circle, which would receive the vaccine after the risk groups, is made up of those people who are in close contact with patients at risk, that is, family members and health workers. A third group might include people who maintain public life, such as police officers, teachers, or daycare workers.
How long does the vaccination last?
A good vaccine should work for at least a year. According to the head of Biontech, Ugur Sahin, the vaccine should have an immunization effect of one year, but this is not yet certain. Ultimately, it won’t be clear until the vaccine has been in use for a year.
Based on the results of previous tests, protection by vaccination occurs after about four weeks. Test subjects received two doses of the vaccine three weeks apart, seven days after the second dose they were 90 percent protected. However, protection against SARS-CoV-2 could, similar to vaccination against influenza (flu) viruses, be only partial and may have to be renewed every year or at somewhat longer intervals.
