Frankfurt For their corona immunization, some people are waiting for vaccines that are based on different technologies than the previously available vaccines. Now the corona vaccine from the US manufacturer Novavax has received approval in the EU. Following a corresponding recommendation from the EU medicines authority Ema, the EU Commission granted the vaccine conditional marketing authorization on Monday, as announced by EU Commission President Ursula von der Leyen.
The Novavax vaccine is the fifth vaccine approved in the EU, but it comes with a significant delay. Production issues have significantly delayed the development of this vaccine and the approval process. The responsible commission of experts at Ema had issued the recommendation after an extraordinary meeting. The “EU criteria for effectiveness, safety and quality” have been met, announced the Ema.
The Novavax vaccine is already approved in Indonesia and the Philippines. Last Friday, the World Health Organization approved the vaccine Covovax, which is manufactured by the Serum Institute of India under a Novavax license and is to be used primarily in the Asia-Pacific region. In terms of material, this is completely identical to the Novavax vaccine, which is to be used in the EU under the name Nuvaxovid.
Further alternatives to the four previously approved vaccines could follow next year. This is also linked to the hope that some people will still be vaccinated after all. These are the most important questions and answers:
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How does the Novavax vaccine work?
According to the Paul Ehrlich Institute (PEI), Nuvaxovid consists of virus-like particles that contain the spike protein of the coronavirus. The body recognizes the proteins as foreign and the immune system is activated – specific antibodies and T cells are formed.
This means that you are better prepared for a real infection. mRNA preparations, for example, work differently. Here, body cells are stimulated with the help of snippets of genetic material to produce the spike protein themselves in order to trigger an immune response.
How well does Novavax’s new vaccine work?
In a pivotal study by Novavax, its effectiveness in terms of disease was 90 percent. This means that 90 percent fewer diseases occurred among the subjects in the vaccinated group than among the subjects in a control group. Two doses were given three weeks apart.
However, the results mainly relate to the alpha variant, which has been almost completely displaced by Delta in Germany. According to experts, the new Omikron variant will soon have a strong influence on the infection process. According to its own information, Novavax has already started work on a modification that is geared towards the Omikron variant.
When will the Novavax vaccine be available in Germany?
It is not yet clear. The European Commission signed a supply contract with Novavax in August this year. The prerequisite for ordering up to 100 million doses is the approval of the vaccine by the European Medicines Agency. There is also an option for 100 million more cans that can be activated, which means that deliveries could extend into 2023.
Why do some people wait for certain vaccines?
Some seem to have greater reliance on vaccines made by classical methods. For example, there is a distrust of the new mRNA technology on which the vaccines from Moderna and Biontech / Pfizer are based.
There are concerns that these could cause previously unknown long-term damage. Football national player Joshua Kimmich (FC Bayern), for example, initially explained his vaccination with “a few concerns, especially about the lack of long-term studies”. After emotional debates and a corona infection, he recently announced that he would be vaccinated after all. Experts believe it is almost impossible that the approved vaccines will cause long-term effects that are still unknown.
When it comes to alternatives to the approved vaccines, the term dead vaccine is often used. What’s behind it?
According to the Federal Ministry of Research, inactivated vaccines contain pathogens that have been killed, i.e. no longer able to reproduce. They can also contain only components or individual molecules of these pathogens. Examples are vaccines against hepatitis A and influenza.
The body cannot differentiate between the dead vaccine and the pathogen and activates a targeted immune system that protects against a real infection. For some people who have so far refused to be vaccinated, this approach sounds “more natural” than, for example, the one with mRNA vaccines.
However, the term is not used uniformly. In the narrower sense, Novavax is not a dead vaccine, as there are no real virus parts in the vaccine.
Which vaccines against Covid-19 could come soon?
Several products are already being assessed in the so-called rolling review process of Ema, although not all parts of the approval application have yet been submitted. The vaccines from the manufacturers Sinovac and Valneva (France), for example, contain killed coronaviruses.
With agency material
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