Covid-19: Will Novavax’s Nuvaxovid vaccine be commercialized?

The Nuvaxovid vaccine is based on recombinant protein technology, using fragments of the Sars-Cov-2 spike protein produced in the laboratory.

Nuvaxovidthe vaccine developed by Novavax against the Covid-19, approaches the standard marketing in Europe. The Committee for Medicinal Products for Human Use gave a positive opinion regarding the extension of the shelf life from 9 to 12 months and the standard marketing authorisation. Initially, in December 2021, the European regulatory body had granted a conditional authorization to respond to public health emergencies.

Alvar Paz, general manager and head of commercial strategy for Europe of the company, commented that this opinion represents an important step in ensuring access to the vaccine for European patients, especially in view of the upcoming autumn vaccination programme. As the continent is facing the management of the endemic phase, immunization remains a key priority.

The Nuvaxovid vaccine is based on recombinant protein technology, using fragments of the protein spike in Sars-Cov-2 produced in the laboratory and the adjuvant Matrix-M, which facilitates the activation of the innate immune defenses to enhance the immune response.

The Committee’s favorable opinion is based on several studies conducted on a large population. A study published in the New England Journal of Medicine in February 2022 it involved 29,582 adults in the United States and Mexico, demonstrating a 90.4% effectiveness in preventing Covid-19 cases. A second UK study involving 15,139 adults showed 89.8% effectiveness. In both cases, adverse effects were mild or moderate and short-lived.

Furthermore, a study on adolescents aged between 12 and 18, called Prevent-19, highlighted the effectiveness of the vaccine also in this age group, including the delta variant. Adverse events observed were generally mild and transient, such as injection site tenderness, fatigue and headache.

The next step will be the approval of Nuvaxovid by the European Commissionwhich will lead to the availability of the vaccine on the European market, offering an additional option for vaccination against Covid-19.