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Vial of vaccine with the Biontech / Pfizer vaccine: Once approved, you can start right away
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After the US pharmaceutical company Moderna, the Mainz company Biontech is now also applying for approval for a corona vaccine in the EU.
According to a message from Biontech, which SPIEGEL has received, the European Medicines Agency Ema has confirmed receipt of the application for conditional marketing authorization.
Biontech and the US company Pfizer had applied for emergency approval from the US Food and Drug Administration (FDA) a good week ago.
In the USA, the responsible FDA committee will meet on December 10th, and a decision will then be made on approval.
In Europe, there are stricter rules for rapid approval than in the USA.
A so-called rolling review process is already running at Ema for the mRNA vaccine from Biontech and Pfizer, which is intended to accelerate the approval process.
Manufacturers can submit data on the quality, harmlessness and effectiveness of a preparation before the complete application for approval.
Conditional approval or approval subject to conditions is possible in the EU if, after an interim analysis, there are "sufficiently convincing data" on safety and efficacy, according to the Paul Ehrlich Institute (PEI), which is responsible for vaccine approval in Germany, at the beginning of November is.
In the communication from Biontech and Pfizer it says: "If the Ema comes to the conclusion that the benefits of the vaccine candidate for protection against Covid-19 outweigh possible risks, the authority will recommend the granting of a conditional marketing authorization." of the vaccine BNT162b2 in Europe before the end of 2020.
Sierk Poetting, CFO and managing director of Biontech, assured that the vaccine should then also be available: "After approval, we can deliver within a few hours," he said in the morning at a press conference of the Ministry of Research and Education.
Special transport system
Experts are concerned that the Biontech vaccine has to be transported at minus 70 degrees and stored for longer.
That makes the logistics complicated.
Biontech and Pfizer have therefore developed a special transport system with specially designed cool boxes.
In the United States, Pfizer has therefore repeatedly carried out dry runs in around 50 vaccination centers over the past few weeks: How to keep the cold chain, how to open the boxes and distribute the vaccine.
YouTube videos were produced for the medical staff.
In Germany, too, there is close contact with the countries in order to organize the vaccine delivery, emphasized Biontech board member Poetting.
The company transports the special boxes, each with 1000 cans, to the distribution centers, from where the responsible authorities take over.
The vaccine is kept cold by dry ice, which is then sufficiently available in the vaccination centers.
If necessary, this could also be replenished by volunteer fire brigades, said Poetting.
Some cities have already spoken about this.
In general, however, keep the vaccine in the refrigerator for five days.
In addition, new formulations are being developed that will allow the vaccine to last longer at refrigerator temperatures.
These should be ready for use as soon as they are vaccinated in general practitioners' practices later in the coming year.
In the final phase III study, the vaccine candidate from Biontech and Pfizer protected the study participants from Covid-19 with an effectiveness of 95 percent.
BNT162b2 must be vaccinated twice.
Seven days after the second vaccination dose, according to the company, he then achieved a vaccination protection of 95 percent.
The effectiveness of the vaccine is consistent across all age and gender groups and across the diverse study population, according to the communication.
The vaccination protection for adults over 65 years was more than 94 percent.
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