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Novavax coronavirus vaccine raises high hopes | Coronavirus | D.W.

Throughout Germany there are long waiting lists to be vaccinated with Nuvaxovid, the vaccine from the US pharmaceutical company Novavax. The interest in it is tremendous, because the protein subunit vaccines work differently from the rest of those approved and available against coronavirus in the European Union so far, both those based on messenger RNA (mRNA) and those of BioNTech/Pfizer. and Moderna, as in viral vectors, such as those of AstraZeneca and Johnson & Johnson.

In late 2021, the EU medicines agency EMA confirmed Nuvaxovid (investigational name NVX-CoV2373) as the fifth approved vaccine in the EU. Germany has ordered a total of 34 million doses of these vaccines from their manufacturer, Novavax, and the first 1.4 million of those doses should already be available.

Alternative for skeptics and push for vaccination

Protein vaccines are a real alternative for those who are still skeptical about the rest of the vaccines available so far, because they have been used for decades to protect against polio, tetanus, hepatitis B or influenza. They also offer very good protection against the coronavirus and cause even fewer side effects than previously approved ones.

Protein subunit vaccines are especially urgently needed to accelerate vaccination campaigns in low-income countries. In many, despite all the promises and international debates, only a fraction of the population is vaccinated. There, these vaccines could make an extremely important contribution, as they are comparatively inexpensive to produce and can be transported and stored much more easily than complex mRNA vaccines.

“Many of our first doses will go to low- and middle-income countries and that has been the goal from the beginning,” Novavax CEO Stanley Erck said when applying for emergency authorization from the EMA last year. In principle, if pharmaceutical companies were to release the patents, protein-based vaccines could also be produced in the so-called “global south”.

How do protein-based vaccines work?

Protein-based anticovid vaccines contain a small particle of the distinctive spike protein, which is also present in the “envelope” of the coronavirus. The immune system responds to these proteins in the vaccine. The immune reaction is much faster because the body, unlike other vaccines, does not have to produce these spike proteins first.

Since the nanoparticles produced by the body in this way, unlike mRNA vaccines, do not contain any genetic material, protein-based vaccines also cause fewer side effects. However, the immune response induced by this type of serum is also weaker.

To increase the immune response to these vaccines, so-called adjuvants are added. In the case of Novavax, nanoparticles of saponins (extracted from the so-called “soap tree”) and phospholipids (components of cell membranes) act as adjuvants.

According to opponents of vaccination, certain adjuvants such as aluminum salts are harmful to health. However, no connection to serious side effects or allergies has been shown in corresponding meta-studies.

Long development process

Before mRNA vaccines celebrated their breakthrough as a result of the coronavirus pandemic, protein-based vaccines were considered a mature technology with a great future, says Carlos Alberto Guzmán, head of the Helmholtz Center’s Department of Vaccinology and Applied Microbiology. , in an interview with DW:

“Protein-based vaccines are well known. They are generally better tolerated and there are no big questions about them. One drawback is that they take longer to develop than vector or mRNA vaccines.” The reason is that it takes time to integrate the building instructions for a spike protein into cells that have been derived from microbes, mammals, insects, or plants. The last few months have shown how complex it is to tailor clean proteins so that they can be produced error-free on a large scale. But once this is achieved, protein-based vaccines are serious alternatives to the already established vector and mRNA vaccines.

How effective are protein vaccines?

According to Novavax, the vaccine should also work against the omicron variant. The immune reaction after two doses of the vaccine remains comparatively low. But, after a third booster dose six months after the second injection, protection against omicron is significantly increased.

The Paul Ehrlich Institute, in charge of research and approval of vaccines and biomedical drugs in Germany, however, reports that there are currently limited data on the efficacy of protein vaccines against omicron and other worrying variants.

In studies conducted in the United States and Mexico in mid-2020, Novavax’s vaccine showed 90.4 percent overall efficacy, similar to BioNTech/Pfizer’s and Moderna’s mRNA vaccines. But that was before delta and omicron variants, which also cause problems for mRNA vaccines, became known.

So the Novavax vaccine will also have to be adapted to the new variants of the virus. According to the pharmaceutical company, a specific injection against omicron is already being developed. Clinical trials are scheduled to begin in late March 2022.

Double protection against SARS CoV-2 and the flu

Conveniently, the Novavax vaccine is a combination vaccine, designed to protect against coronavirus and seasonal flu at the same time. This could prove to be a smart strategy, avoiding the waiting time between the two vaccines.

For Guzmán, “the recent preprint of Novavax’s COVID-19 protein vaccine, NVX-CoV2373, represents a breakthrough. It provides the first evidence that a COVID-19 vaccine can be co-administered with one against seasonal influenza, in two different arms, without undermining its effectiveness.

Syringe inserted into Novavax vaccine vial.

Novavax’s may also have potential as a flu shot.

huge expectations

The expectations generated by Novavax’s protein-based vaccine are enormous. Overall, the company says it has signed supply contracts for a volume of two billion doses, of which 110 million doses in the United States.

Nuvaxovid was initially only administered in Indonesia and the Philippines. Then, at the end of 2021, it was approved in the EU. For the important US market, Novavax did not apply for approval until the end of 2021, almost a year later than planned. So, precisely in the country of origin of this American company, the approval of the injection is still pending.

Whether the US supervisory authorities grant approval depends, among other things, on whether the pharmaceutical company, comparatively small relative to its competitors, can supply its product without restriction. And there are still doubts about it, also in the EU.

In the past, Novavax has drawn attention for failing to deliver on time, German Health Minister Karl Lauterbach noted late last week. However, Germany expects to have four million doses of Nuvaxovid by the end of March.

Other promising candidates

Other vaccine manufacturers, such as Indian pharmaceutical company Biological E and Chinese competitor Clover Biopharmaceuticals, will also submit applications for approval of their protein-based vaccines in the near future. Also preparing to launch are the Anglo-French pharmaceutical giant Sanofi-GlaxoSmithKline, the Canadian company Medicago and the South Korean pharmaceutical group sk bioscience.

In addition, protein-based vaccines are being developed in many countries. In some, like Cuba, Russia and Taiwan, protein-based vaccines have long been a central pillar of national coronavirus immunization campaigns.

(rml/ms)

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