https://orf.at/stories/3236901/
(German)
Novavax applies for EU approval The US pharmaceutical company Novavax has applied for market approval in the European Union for its CoV vaccine.
The Amsterdam-based EU Medicines Agency (EMA) announced on Wednesday that it had already started testing.
A decision could be made within a few weeks as part of an accelerated procedure, "if the data presented are sufficiently reliable and complete to demonstrate the effectiveness, safety and quality of the vaccine," it said. It would be the first protein-based vaccine against Covid-19 to be approved.
The vaccine is a dead vaccine, which contains killed components of the novel coronavirus for immunization. In contrast to the manufacturers Biontech / Pfizer and Moderna, who produce their vaccines on the basis of the new mRNA technology, Novavax uses a very traditional method.
The agent thus arouses interest in people who have reservations about immunization with mRNA vaccines or vector vaccines.
So far, four vaccines against Covid-19 have been approved in the European Union, two of which are mRNA vaccines (Biontech and Moderna) and two are vector vaccines (AstraZeneca and Johnson & Johnson).
90 percent overall effectiveness in phase 3 study In the crucial phase 3 study with 30,000 patients, the Novavax vaccine showed an overall effectiveness of around 90 percent.
However, the intended approval dragged on because Novavax had to contend with production problems. The vaccine received emergency approval this month in the Philippines and Indonesia. The US approval application is planned for the end of the year.
The EU has secured up to 200 million cans from the company. Novavax uses the “spike protein” from SARS-CoV-2 for its vaccine and reproduces it en masse in insect cells. After the vaccination, the human immune system uses it to generate antibodies against the protein and can thus fight off Covid 19 disease. Because the vaccine - unlike the Biontech Pfizer vaccine, for example - can be stored at refrigerator temperature, the agent is considered a beacon of hope for poorer countries.