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Pfizer will apply for an emergency marketing authorization for its vaccine in the next few days, as the final results of its clinical trials show 95% efficacy against coronavirus.
According to the pharmacist, the effectiveness of the vaccine, which he developed with the German BioNTech, corresponded to all ages and racial groups without significant side effects, Reuters reports.
The efficacy of the vaccine for those over 65 years of age was greater than 94%.
The final results arrive a week after the publication of the initial ones, which had shown an efficiency of more than 90%. On Monday, Moderna released preliminary data, whose vaccine is also very effective.
The encouraging news about the two vaccines raises hope that the pandemic that has already killed more than 1.3 million people around the world and is wreaking havoc on economies will end.
But as Reuters points out, it will take months for mass vaccinations to begin.
The stages for the preparation of the vaccine.
Preclinical studies
At this stage it is decided which technology will be used, that is, if it will be a “killed vaccine” (one that contains an inactivated virus), a “live” vaccine (that is, a weakened virus), DNA vaccines, RNA vaccines. , etc. Then, cell toxicity is checked to see if it causes an immune response. It is the first procedure performed under the “microscope”
The candidate vaccine is then tested on living organisms, as mentioned above.
Clinical studies
Once it is ensured that the vaccine does not affect the health of an organism, its administration to the human being begins, that is, the stage of clinical studies is entered, which has a total of 4 phases, the most important being phase 3. Currently more than 42 vaccines are in human clinical trials and 10 in phase 3 studies.
Phase 1: The vaccine is given to a small number of people, between 50 and 100 people. In fact, all of these people are healthy, as long as you are not at risk for very serious side effects. After administration, these individuals are monitored for 2-3 months.
Phase 2: If all goes well in Phase 1, the next step is Phase 2, where a greater number of people are selected, around 1,000 volunteers. Here, however, not everyone receives the vaccine, but half and the rest are a placebo placebo vaccine that can usually have all the vaccine components except the basic one (for example, the inactivated virus) that is being tested. Therefore, symptoms and disease progression are compared between those who received the regular vaccine and those who received the placebo.
Phase 3: It is considered the most important since the number of volunteers increases more and even categories of people who suffer from some fairly common diseases such as diabetes, or heart disease, or are older are selected. That is, a representative sample of the population is created.
Usually each phase lasts at least 3 months and of course, unless there is an interruption for some extraordinary reason that needs to be evaluated to continue the process. At the same time, the results of each phase are sent to the approval bodies and specifically to the FDA (America) and Coreper (Europe).
After the approval of the vaccine are the Phase 4 Clinical Studies, in which the pharmaceutical companies that produce it have obtained marketing authorization for the final product, while providing information from doctors and hospitals so that we finally know if the treatment works. if you have side effects or need changes.
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