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Partner companies BioNtech and Pfizer want to request emergency approval from the US pharmaceutical authorities The EMA in Euroa could give the green light for approval in mid-December.
Washington.
The Mainz BioNtech company [US09075V1026] and the US pharmaceutical giant Pfizer [US7170811035] have applied for emergency approval for their corona vaccine from the US Food and Drug Administration, both companies reported Friday in a joint message. Delivery of the vaccine, called BNT162b2, could begin later this year, if approved, BioNtech had already announced.
BioNtech and Pfizer are the first Western manufacturers to publish promising study results and apply for emergency approval from the FDA. The companies had previously announced that the vaccine would offer 95 percent protection against Covid-19 disease. The vaccine works equally well in all age groups and other demographic differences and shows virtually no serious side effects, the companies announced after their final analyzes.
The FDA must now review the application. It was initially unclear how long that might take. However, the American experts were sure that there could be an audit result before the end of the year. An expedited approval process is applied to corona vaccines due to their particular urgency.
BioNtech and Pfizer are already continuously submitting data to the European Medicines Agency (EMA) and in other countries. With this lamination process, manufacturers can convey to individual parts the quality, safety and effectiveness of a preparation even before the full application for approval. However, they have not yet submitted a full application for approval to the EMA, as is the case with the FDA. However, a first vaccine could be approved in Europe as early as the second half of December, the head of the EU Commission, Ursula von der Leyen, said on Thursday, referring to information from the EMA.
After approval, existing doses must be distributed “evenly” according to the company. “One country will not achieve everything.” The EU has already signed a framework agreement to purchase 300 million doses of the vaccine from BioNtech and Pfizer. Austria can count on around two per cent of the amount of this framework agreement.
Speed of light
BioNtech had already started developing the BNT162b2 vaccine in the “Lightspeed” project in mid-January. The phase 3 study, crucial for its approval, began in several countries in late July.
The preparation is a so-called mRNA vaccine, which is based on a new mechanism. It contains genetic information about the pathogen, from which the body produces a virus protein, in this case the surface protein with which the virus enters cells. The goal of vaccination is to stimulate the body to produce antibodies against this protein to intercept viruses before they enter cells and multiply.
An advantage of mRNA vaccines is that they can be produced much faster than conventional vaccines. BioNtech and Pfizer expect to provide up to 50 million doses of vaccines worldwide this year and up to 1.3 billion doses next year. However, the vaccine must be stored at minus 70 degrees. Pfizer has extensive experience in refrigerated storage and vaccine transportation and already has a corresponding global infrastructure, the companies said.
Austrians in the founding team of BioNTech
BioNtech was founded in 2008 by Sahin, his wife Özlem Türeci, and Austrian cancer researcher Christoph Huber. Two years ago, the company signed a collaboration agreement with Pfizer that was expanded to include a search for vaccines in March this year in the face of the coronavirus pandemic.
In addition to BioNtech / Pfizer, several other pharmaceutical companies are currently working on advanced-stage corona vaccines, including Johnson & Johnson, Astrazeneca, and Sanofi-GSK. Countries such as Russia, China, and more recently Bahrain have already launched vaccines with restrictions and are already vaccinating parts of the population with them. How well these vaccines actually protect and what side effects they may have is currently largely open.
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