The European Medicines Agency (EMA) has recommended that Nuvaxovid (also known as NVX-CoV2373) be given conditional marketing authorization to prevent Covid-19 in people aged 18 and over. It is the fifth Covid-19 vaccine and the first Covid-19 protein subunit vaccine recommended by the EMA for registration. The holder of the registration will be Novavax CZ, the company’s Czech subsidiary. Credit: Freepik
Czech Republic, Dec 27 (N) – The EMA’s Committee for Medicinal Products for Human Use (CHMP) thoroughly assessed all the necessary data on the quality, safety and efficacy of the vaccine and recommended that the European Commission grant the vaccine a conditional marketing authorization valid in all EU / EEA countries.
This centralized registration guarantees that the vaccine meets all European standards for quality, safety and efficacy. As with other registered vaccines, its safety and efficacy will continue to be monitored during its registration.
“This vaccine differs from previously registered covid-19 vaccines,” said Irena Storová, director of the Czech State Institute for Drug Control. “It is a so-called protein subunit vaccine, so it is not a vaccine based on mRNA or a viral vector. I believe that expanding the range of available vaccines will support vaccination and thus further mitigate the impact of the pandemic on our society.”
Results from two major clinical studies have shown that Nuvaxovid was effective in preventing Covid-19 in people over 18 years of age. The studies included a total of more than 45,000 participants. In the first study, around 2/3 of the participants received Nuvaxovid and the remaining 1/3 received a placebo (a “dummy treatment”); in another study, half received Nuvaxovid and half received placebo. Study participants did not know whether they received Nuvaxovid or placebo.
The first study, conducted in the United States and Mexico, showed a 90.4% reduction in Covid-19 symptoms seven days after the second dose of Nuvaxovid (14 covid-19 cases out of 17,312 vaccines) compared with placebo. (63 covid-19 cases out of 8,140 people who received placebo). This means that in this study, the efficiency was 90.4%.
A second study in the UK also showed a significant reduction in Covid-19 symptoms in people vaccinated with Nuvaxovid (10 cases out of 7,020 people) compared with people who received placebo (96 cases out of 7,019 people). This means that in this study, the efficiency was 89.7%.
Overall, the results of these two studies indicate that Nuvaxovid is about 90% effective. The original SARS-CoV-2 strain and some of its variants, such as Alpha and Beta, were the most common virus strains at the time of the studies. Limited data are currently available on the efficacy of Nuvaxovid against other SARS-CoV-2 variants, including Omikron.
Although the studies did not include efficacy against the SARS-CoV-2 Omicron variant, Novavax is already evaluating its vaccine against this variant, as with previous variants, and has started developing a vaccine specific to the Omikron variant. (source: https://ir.novavax.com/Novavax-Statement-on-Omicron-Variant-Response).
According to pooled reactogenicity data, in participants aged 18 years and older in two phase 3 studies who received at least one dose of Nuvaxovid or placebo, the most common adverse reactions were injection site sensitivity (75%), injection site pain (62%), and fatigue (53%). Side effects were usually mild to moderate in severity. Overall, the incidence of side effects was higher in adults aged 18 to 65 years than in persons aged 65 and over.
The safety and efficacy of the vaccine will continue to be monitored in all EU member states through the EU Pharmacovigilance System and other studies carried out by pharmaceutical companies and European authorities.
The product information approved by the CHMP for Nuvaxovid will be published in English on the EMA website, where it will later be available in national languages, including Czech. This information will also be available later from the SÚKL database of medicinal products. This information will include a summary of product characteristics for healthcare professionals, a package leaflet for the public and details of the conditions of the vaccine registration.
The EMA assessment report with detailed information on the evaluation of Nuvaxovid and the full risk management plan will be published within a few days. The clinical trial data submitted by the company in the marketing authorization application will also be published on the EMA website.
