EMA gives the green light to Novavax – How protein vaccines can help fight the pandemic

A vial of vaccine from Novavax (picture alliance / ASSOCIATED PRESS)
With the EMA’s recommendation for Novavax, five corona vaccines could soon be approved in Germany. For the time being, the EU Commission has to confirm the release. Novavax may also have the potential to induce some non-vaccinated people who have doubts about the mRNA technology to vaccinate.

But it wasn’t just Novavax who worked on a protein vaccine. SanofiPasteur could soon follow suit. What are the benefits of the additional vaccines? An overview.

The corona vaccines previously approved in Germany contain genetic information on the production of the corona spike protein. This is made in our body cells. Novavax, in turn, consists of genetically engineered spike proteins from the coronavirus – the spike protein is therefore produced outside the body. About a dozen are combined in a nanoparticle and act as a kind of artificial virus for the immune system. In order for this to work well, the vaccine also contains an enhancer, a chemical from the soap bark tree.

Novavax corona vaccine prior to approval

There are basically three advantages: Firstly, there has been long experience with protein vaccines, for example vaccinations against the flu, hepatitis B or whooping cough. Some people hesitate about the previous vaccinations because they are new and contain mRNA. Protein vaccines could therefore offer an alternative for people with reservations, especially since studies to date have shown them to be somewhat more tolerable.

They are also easier to use because they are easier to store – a normal refrigerator will do. This is why the Covax international vaccination campaign is also hoping for protein vaccines that would be easier to distribute globally. In addition, their production could also be taken over in the global south. Novavax has already promised Covax over a billion doses.

More information about the coronavirus:

What do we know about its effectiveness?

A study in England found the Novavax vaccine to be 83 percent effective. At that time, however, the alpha variant of SARS-CoV-2 was on the way. A parallel study in South Africa showed an effectiveness of only around 50 percent against the beta variant. In the middle of the year, Novavax also released data from the United States and Mexico that showed an effectiveness of more than 90 percent. It is not yet known what the effectiveness of the Delta and Omikron variants will be. Novavax may also have to be adapted to these variants.

First protein vaccine for Europe: EMA receives application for approval from Novavax

The data from Novavax have convinced the responsible authorities in Indonesia, the vaccine has already received approval there. Novavax is not the only company that has developed a protein vaccine, and Sanofi Pasteur is already in active contact with the EMA. In some other countries mass vaccination campaigns are already running, for example in Cuba with its own protein vaccine. The number of infections there has been falling significantly since mid-September. It remains to be seen whether this is actually related to the vaccination campaign. Russia and China also use protein vaccines and have already passed them on to other countries. The problem: Most of the time, there are no fully published data on effectiveness and safety.

So far, only the data from the studies are known about Novavax – and whether there are any rare side effects will only be shown in the application. There is now a lot of data and information about mRNA vaccines. At Novavax, this experience has to be gained first.

Protein vaccine technology is well established, but it must be adapted in any case. It is easy to send the instructions for the spike proteins in bioreactors full of insect or hamster cells or to integrate them into tobacco plants. But whether it works depends on the details. For example, if the cells produce the protein too quickly, they may die.

In addition, the protein still has to be purified and the process adapted to the individual case. In this respect, it was clear from the start that the protein vaccines would not be the first to be ready. How high the practical hurdles are was shown by the manufacturer Novavax, which repeatedly struggles with quality problems, even though it was supported by the USA with 1.6 billion dollars. And Sanofi Pasteur also had to completely rewrite the vaccine after unexpected problems with effectiveness.


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