Pharmaceutical companies Pfizer and BioNTech expect to obtain US approval to market their corona vaccine this month. The companies claim that their vaccine is effective in treating patients. These concern preliminary results of the Phase Three trials of a corona vaccine.
This research has been conducted with more than 44,000 test subjects. Of these, 94 people were eventually infected with the coronavirus. The most notable finding is that the vast majority of this group, more than 90 percent, were given a placebo instead of the real vaccine.
Efficacy higher than expected
The efficacy of 90 percent is higher than had previously been expected. Pfizer will submit a request to the American Food and Drug Administration (FDA) to take it to the market later this month. This authority requires a vaccine to be at least 50 percent effective before it can be approved. Given that there are also no known significant safety risks, this means that the vaccine will almost certainly be approved.
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In Europe, the vaccine must be approved by the European Medicines Agency (EMA). The EMA is already closely tracking the preliminary results of the vaccine and expects to be able to approve the vaccination as soon as all the data from the research has been received.
The companies still need to study how it works with people who have been infected in the past. The expectation is that the disease will have a milder course in those cases.
Pfizer and BioNTech estimate that they will have 100 million doses of the vaccine ready by the end of the year. In 2021, production capacity will be scaled up to around 1.3 billion vaccines. The pharmaceutical companies have an agreement with the European Commission to supply at least 200 million vaccines. There is still an option open for an additional 100 million doses.
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