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Photo by Dado Ruvic (Reuters / Scanpix)
Phase III clinical trials have shown that the COVID-19 vaccine developed by Pfizer and BioNTech is more than 90% effective. This message means that, with the permission of the competent authorities, the market for the first dose could hit the market this year.
According to the Financial Times, the efficacy of the vaccine has been confirmed in phase III clinical trials, in which the vaccine was tested in 43,000 volunteers. After two doses of the vaccine at 28-day intervals, a small number of people infected with the virus allowed independent evaluators to calculate the effectiveness of the vaccine.
These studies are the last stage that companies must go through to apply for a license to distribute their vaccine. Of the more than a dozen companies currently working on the vaccine, Pfizer and BioNTech were the first to complete phase III clinical trials.
For a vaccine to be approved by the US Food and Drug Administration responsible for licensing, the efficacy of the vaccine to be marketed in Class III clinical trials must be at least 50%.
“If the data is positive, Pfizer will request an emergency authorization in the United States in the third week of November, as soon as the safety requirements are met,” said the company’s CEO, Alberto Bourlos, in an open letter in October.
“For me, this is the best possible result. The risk-benefit analysis is clearly in favor of the vaccine, and the vaccine meets all the criteria for rapid development, ”said Ugur Sahin, founder and CEO of BioNTech.
Vaccine companies say the permits could yield $ 50 million by the end of this year. doses of vaccine, and a total of 1.3 billion could be produced next year.
Agreements with Pfizer and BioNTech for $ 100 million vaccine doses and the availability of an additional 500 million. Having already registered with the US, the UK has agreed to buy 30 million of the companies. and the European Union (EU) is currently negotiating dose purchase.
Mr. Sahin said that a fair distribution will be sought in the distribution of vaccines, but added that priority will be given to those markets where the use of the vaccine will be approved.
VŽ has already written that while scientists are developing and testing vaccines, the whole world is preparing for distribution, preparing raw materials for vaccine production, supply chains for distribution, and logistics for storage.
In addition to ongoing negotiations with Pfizer and BioNTech, the EC also approved a third agreement on a potential vaccine in October with one of Johnson & Johnson’s Janssen Pharmaceutical companies, Janssen Pharmaceutica NV, and the EC has already signed agreements with AstraZeneca. and Sanofi-GSK and successfully completed preparatory negotiations with CureVac, BioNTech-Pfizer and Moderna.
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