Novavax Receives Conditional-Marketing Authorization in Europe


As seen on the PR News Wire Monday, December 20, 2021:

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation today to authorize the vaccine (also known as NVX-CoV2373) and is applicable in all 27 European Union (E.U.) member states.

“We welcome today’s European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the E.U.,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank the European Medicines Agency, the Committee for Medicinal Products for Human Use reviewers and the European Commission for their thorough assessment as we look forward to playing a critical role in helping to address the continued threat of COVID-19. We also thank the thousands of clinical trial participants, our partners and Novavax employees worldwide who have contributed to this historic milestone.”

My comments:

This is great news, as there are a lot of people who feel more comfortable with a “traditional” type vaccine, rather than the Mrna type. Also, the World Health Organization granted emergency use listing today. According to their website, the full results from PREVENT-19, Novavax’ pivotal Phase 3 clinical trial of NVX-CoV2373, a recombinant protein nanoparticle vaccine against COVID-19, were published in the New England Journal of Medicine. The paper, ‘Efficacy and Safety of NVX-CoV2373 in Adults in the U.S. and Mexico,’ and it can now be accessed here.

How does Novavax work? They use a trademarked technology:

  • Recombinant Nanoparticle Vaccine Technology: (according to their website) Select genetic sequences to code vaccine antigens, genes are cloned into baculovirus (BV), BC infects Sf9 insect cells. antigens are expressed and purified as multimeric nanoparticles, immunogenic particle with antigens in native configuration are created.
  • Matrix-M is composed of 40 nanometer particles based on saponin extracted from the Quillaja saponaria Molina bark together with cholesterol and phospholipid.”

These sentences needs some help to unpack:

What are the Baculovirus Genes?

Baculovirus are large double-stranded enveloped viruses consisting of circular DNA genomes. Since 1983, when the baculovirus expression system (BES) technology was first used to express human beta interferon in insect cells, the BES has become a versatile and robust eukaryotic expression system for foreign protein expression. In case of Novavax ,the baculovirus infects moth cells and replicates inside them and then these moth cells create a lot of spike proteins. Researchers then extract and purify them.

What does “immunogenic” mean?

Relating to or denoting substances able to produce an immune response.

What are nanoparticles?

Brittanica Dictionary: “Nanoparticles can be classified into any of various types, according to their size, shape, and material properties. Some classifications distinguish between organic and inorganic nanoparticles; the first group includes dendrimers, liposomes, and polymeric nanoparticles, while the latter includes fullerenes, quantum dots, and gold nanoparticles. Other classifications divide nanoparticles according to whether they are carbon-based, ceramic, semiconducting, or polymeric. In addition, nanoparticles can be classified as hard (e.g., titania [titanium dioxide], silica [silica dioxide] particles, and fullerenes) or as soft (e.g., liposomes, vesicles, and nanodroplets). The way in which nanoparticles are classified typically depends on their application, such as in diagnosis or therapy versus basic research, or may be related to the way in which they were produced.”

What is Quillaja saponaria Molina bark?

Wikipedia: Quillaja saponaria, the soap bark tree or soapbark, is an evergreen tree in the family Quillajaceae, native to warm temperate central Chile.

What is saponin?

Wikipedia: Saponins also referred to selectively as triterpene glycosides, are bitter-tasting usually toxic plant-derived organic chemicals that have a foamy quality when agitated in water. They are used in soaps, medicines, fire extinguishers, as dietary supplements, for synthesis of steroids, and in carbonated beverages (root beer foam, for example).

PubMed: Saponins decrease blood lipids, lower cancer risks, and lower blood glucose response.

What are phospholipids?

Sciencing: Phospholipids are molecules with hydrophilic phosphate heads and hydrophobic lipid tails. They comprise cellular membranes, regulate certain cellular processes, and possess both stabilizing and dynamic qualities that can aid in drug delivery.

The Bumbling Biochemist: Bottom line is your immune system learns to recognize that protein so that if it comes back (in the form of the virus), your immune system will have antibodies at the ready to block it from entering cells and, if the virus does get in, it will have T-cells ready to kill the infected cells before the virus can spread in your body and/or call the immune system into high alert. The virally-infected cells will chop up the protein and display pieces of it on their surface, similarly to what we saw with the engulfed nanoparticles. Those matching T-cells which you prepared before will now do their thing, preventing the virus from doing it’s thing!

Read the entire article here:

More information to follow! If you have taken the Novavax vaccine, please let me know how it went.

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