Novavax Corona vaccine: a protein-based vaccine

Novavax Corona vaccine: a protein-based vaccine

With the mRNA vaccines from BioNTech/Pfizer and Moderna and the vector vaccines from AstraZeneca and Johnson & Johnson, only two different types of vaccine against corona were approved in Germany and the EU for a long time. However, the corona vaccine from the US pharmaceutical manufacturer Novavax (NVX-CoV2373 or Nuvaxovid®) is based on a different technology: It is a protein-based vaccine that is sometimes counted among the dead vaccines. What mode of action makes the coronavirus vaccine unique, how effective is it, what side effects are possible and for whom is it approved?

This is how the Novavax coronavirus vaccine works.

Like other vaccines, the Novavax vaccine is intended to prepare the body for a possible coronavirus infection and thus protect it from a severe course of COVID-19.

The basis of the vaccine is a component of the coronavirus, namely the spike protein, which was produced in insect cell cultures in the laboratory to produce the vaccine. This spike protein is responsible for the docking of SARS-CoV-2 to the human body’s cells; individually, it cannot lead to an infection with the coronavirus in the body. Nuvaxovid® is a recombinant protein vaccine.

The vaccine is the first approved coronavirus vaccine of this type in Germany. While other vaccines contain the blueprint for the spike protein (typical of SARS-CoV-2) in DNA or mRNA, the Novavax vaccine already contains the spike protein. This is, therefore, injected directly and not only produced in the body. The ingredients also include a substance that further strengthens the immune system’s response to the vaccine. This is called an adjuvant.

After administration of the vaccine, the body perceives the protein particles as foreign bodies and sounds the alarm. The immune system then produces antibodies and T cells, and the immune system is trained to fight the pathogen. In the event of later infection with SARS-CoV-2, it can recognize the spike protein and fight the virus to prevent further spread in the body.

The Novavax vaccine also requires two doses, as with the other coronavirus vaccines. There is a gap of 21 days.

 

Is the Novavax vaccine an inactivated vaccine?

Depending on the definition, the vaccine is sometimes counted among the dead vaccines because it does not contain any viruses capable of replication – the Paul Ehrlich Institute also refers to the vaccine as a dead vaccine. According to this definition, however, mRNA and vector vaccines should also be counted among the dead vaccines. In the narrower sense, however, this only includes vaccines that contain killed components of a pathogen, which is not the case with this vaccine.

How effective is Novavax’s protein-based vaccine?

According to results from the first phase 3 study, the protein-based vaccine is said to be 90.4 per cent effective against the original strain of the coronavirus. In a second study, the effectiveness was 89.7 per cent. The protective effect against the British variant Alpha is about 86.3 per cent, according to a registration study carried out in Great Britain. According to the studies, the vaccine is also said to have a high protective effect against other virus variants, but there is still no precise data on the omicron variant.

The protection against severe courses is considered very good (100 per cent); in the study, there were no severe courses among the vaccinated people. The protective effect also sets in quite quickly due to the nature of the vaccine.

According to a corresponding study, the vaccine also showed an effectiveness of 79.5 per cent in the group of 12 to 17-year-olds, and it even protected 82 per cent against the delta variant. The data also indicate good tolerability: Vaccination reactions were lower in adolescents than adults.

 

Novavax vaccine: possible side effects

The vaccine is generally well tolerated. Possible side effects of the Novavax vaccine are comparable to those of other coronavirus vaccines. The most common consequence in the study was pain at the injection site. Tiredness, muscle, joint and headaches, malaise, nausea or vomiting also occurred temporarily in the people taking part in the study.

Rarer side effects (affecting less than 1 in 10 people) included:

Rare side effects affecting less than 1 in 100 people:

Reactions occurred slightly more frequently after the second dose than after the first.

So far, there have been no cases of blood clots. However, the US Food and Drug Administration (FDA) has expressed concern that the vaccine could potentially increase the risk of developing heart muscle inflammation (myocarditis). In an analysis involving a total of 40,000 people, six cases of myocarditis had occurred among those who received the vaccine. In comparison, there was only one case in the placebo group. Whether the vaccine was the trigger and, if so, how high the risk is is currently being examined.

Approval of Nuvaxovid®

On December 20, 2021, the European Medicines Agency (EMA) recommended using the vaccine in the European Union. The European Commission agreed with this recommendation and gave the vaccine conditional approval for people aged 18 and over. On February 3, 2022, the Standing Vaccination Commission (STIKO) followed this recommendation. In June 2022, admission was extended to young people between 12 and 17. Persons under the age of 12 and pregnant and breastfeeding women are initially exempt from the recommendation. The vaccine should be given in two doses at least three weeks apart.

The EMA has tested the vaccine since February 2021 in the so-called rolling review process. In mid-November, the manufacturer applied for conditional market approval in the EU. Novavax had also submitted an application for approval of the vaccine to other countries and to the World Health Organization (WHO). The vaccine was previously approved in Indonesia under the name Covovax™.

Use in Germany and developing countries.

In August 2021, i.e. before the approval was granted, the EU Commission announced that it had approved a contractual purchase guarantee with the manufacturer Novavax. Under this deal, EU member states can buy up to 100 million vaccine doses. Germany initially ordered four million doses, and up to 34 million vaccine doses are planned for 2022.

The vaccine has been available in Germany since the end of February 2022. It should primarily appeal to unvaccinated people who are sceptical about the new mRNA vaccines. So far, however, demand for the vaccine has been lower than expected.

Due to its technology, the vaccine can be transported and stored at refrigerator temperature and could be used particularly well in developing countries. The manufacturer Novavax had announced early on that it would provide 1.1 billion doses for the Covax vaccination program, with the help of which poorer countries should also be supplied with coronavaccines.

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