After the go-ahead from the European Medicines Agency (EMA), on 23 June, the European Commission approved the extended conditional marketing authorization for Nuvaxovid, Vaccine against the Covid-19 of the American novavax, even in adolescents aged 12-17.
“We are extremely pleased that Nuvaxovid, our vaccine for Covid-19 is now also available for adolescents in Europe,” he said. Stanley C. Erck, president and chief executive officer of Novavax. “Our protein-based vaccine – developed by applying an innovative approach to traditional technology – has demonstrated efficacy and safety in both adolescents and adults,” he added.
The results of the Novavax vaccine study
Authorization is based on results emerged from PREVENT-19, an ongoing pivotal Phase III study of 2247 adolescents 12 to 17 years of age at 73 US sites evaluating the safety, immunogenicity, and efficacy of Nuvaxovid. Over the course of the study, the drug “met its primary efficacy endpoint and demonstrated an overall clinical efficacy of 80% at a time point when the Delta variant it was the predominant strain of SARS-CoV-2 in the United States. Preliminary safety data from the study demonstrated that the vaccine is generally well tolerated,” the company said in a statement.
Serious adverse events were few and balanced and were not considered vaccine related. Local and systemic reactogenicity were generally lower or similar to adults after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise.
Novavax: differences with Pfizer, Moderna, Astrazeneca and J&J
Unlike messenger RNA vaccines (Pfizer e Modern) or viral vector (Astrazeneca e Johnson and Johnson), Novavax is a drug made in the classic way: it directly introduces the protein spike (present on the surface of SarsCov2) causing our body to respond. While Moderna and Pfizer instruct our cell to produce the protein, stimulating our body to produce antibodies.
In detail, the "new" vaccine is formulated a protein basis and contains tiny particles made from a lab-made version of the protein. It also contains an adjuvant, which is a substance that helps strengthen immune responses. After administration, the vaccinated person's immune system will recognize the protein particles as foreign and will respond by producing its own natural defenses (i.e. antibodies and T-cells). In the case of positivity, the immune system will recognize the protein and thus be able to react and reject it.
