Biontech Corona vaccine: procedure, distribution, manufacturer – Coronavirus Vienna

The European Medicines Agency (EMA) is now advising on the approval of the corona vaccine for the Mainz-based company Biontech and its US partner Pfizer in the European Union. This means that after Christmas, corona vaccines could finally start in Austria and other EU countries.

In response to pressure from several EU countries, the EMA has advanced its review of the vaccine approval by eight days. The Committee for Medicinal Products for Human Use (CHMP) of the EU authority based in Amsterdam is checking on Monday afternoon whether it recommends the Biontech vaccine.

To do this, it evaluates the quality, safety and efficacy of the vaccine based on the laboratory data presented by the manufacturer and the results of clinical tests. Unlike Britain and the US, which only granted temporary emergency approval for the Biontech vaccine, in the EU it is a one-year conditional marketing authorization, requiring a more stringent testing procedure.

If the committee cannot reach an agreement, it will meet again on December 29. However, if the EMA committee recommends approval as expected, the EU Commission will decide together with the member states.

Vaccinations with the Biontech vaccine are scheduled to start in the EU from December 27. The EU ordered the vaccination doses jointly. The number of doses that each Member State is entitled to purchase depends on the size of its population.

The Biontech vaccine is based on what is known as mRNA technology. MRNA stands for messenger ribonucleic acid, also known as messenger RNA.

With mRNA vaccines, pathogens or their components are not required as with conventional vaccines. Rather, some cells in the body receive parts of the virus’ genetic information in the form of RNA with the vaccine – the blueprint for individual virus proteins, also known as antigens, is delivered. Antigens activate the immune system to generate the protective immune response against the pathogen.

An advantage of the Biontech vaccine is the simple structure of the RNA, which makes it possible to produce many millions of doses of vaccine in a few weeks. However, the Biontech vaccine must be transported and stored at very low temperatures of around minus 70 degrees. The freezers that are commonly used in hospitals are not enough for this.

Scientist Ugur Sahin and his wife Özlem Türeci, both children of Turkish immigrants, founded Biontech in 2008 together with Vienna-born cancer researcher Christoph Huber. Before the corona pandemic, the Mainz-based company’s around 1,500 employees were working on new immunotherapies for cancer patients based on mRNA technology.

In distributing its corona vaccine, Biontech will benefit from a partnership with the US pharmaceutical giant Pfizer, which the two companies had originally concluded with a view to flu vaccines, in 2018. Under the impression of the corona pandemic and the global search for an antidote, the two companies expanded their cooperation again in March.

With its crown vaccine, Biontech has become a major player in the pharmaceutical industry in a very short time. The preparation has already been approved in the UK, Switzerland, the US, Canada, Israel and some other countries.

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