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In the fight against the corona pandemic, hopes are directed towards new vaccines against the virus. On Monday, the European Medicines Agency (EMA) finally recommended approval of the corona vaccine from the Mainz company Biontech and its US partner Pfizer in the European Union. Ensuring the safety of vaccination has always been the top priority, said EMA chief Emer Cooke. After Christmas, corona vaccines could finally start in Austria and other EU countries, because final approval from the EU Commission is just a matter of form. According to the head of the EU Commission, Ursula von der Leyen, the corresponding decision should be taken tonight.
Admission and distribution process
The EMA had carried its review of the vaccine approval under pressure from several EU countries for eight days. The Committee for Medicinal Products for Human Use (CHMP) evaluated the quality, safety and efficacy of the vaccine based on laboratory data provided by the manufacturer and the results of clinical tests. Unlike the UK and the US, which only granted temporary emergency approval for the Biontech vaccine, the EU was concerned about a one-year conditional marketing authorization, which requires a more stringent testing procedure.
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.
MRNA technology vaccine
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.
Promotion to the great player
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 also 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.
“A happy day”
Federal Chancellor Sebastian Kurz (ÖVP) welcomed the first approval and spoke of a “pleasant day after ten months of hard fight against the corona pandemic” in a statement. If the EU gives the green light, Austria “will start distributing the first vaccines quickly from 27 December”.
The delivery of around 10,000 doses of vaccines before the New Year should benefit Vienna and Lower Austria; the first large batch (more than 240,000 doses of vaccines announced for January) will apparently be divided among the federal states according to the population key. These vaccination doses, two are always required, will be used in nursing homes and nursing homes according to the Austrian vaccination strategy. The next delivery will then be made with 200,000 cans from the manufacturer Moderna, as the EMA will issue a recommendation on January 6. This will allow the immunization of healthcare workers in hospitals, ordinations, etc. and from high-risk groups. The third batch of vaccines should come from AstraZeneca and is the highest with around two million doses of vaccine. This begins the second phase of the vaccination plan: vaccinations for all people over 65 years of age and those with systemic risk in the areas of education, security, justice and critical infrastructure. The rest of the population will continue in summer.
