The European Medicines Agency (EMA) has recommended that conditional marketing authorization for the Novavax Covid-19 vaccine (Nuvaxovid, also known as NVX-CoV2373) be granted to persons aged 18 years.
Nuvaxovid is the fifth vaccine recommended in the EU to prevent COVID-19.
According to the EMA announcement, Nuvaxovid is a protein-based vaccine and, together with the already approved vaccines, will support vaccination campaigns in EU Member States during a critical phase of the pandemic.
After a thorough evaluation, the EMA Human Medicines Committee (CHMP) concluded that the vaccine data were reliable and met EU criteria for efficacy, safety and quality.
The results of two main clinical trials showed that Nuvaxovid was effective in preventing Covid-19 in people aged 18 years. A total of more than 45,000 people participated in the studies. In the first study, about two-thirds of the participants received the vaccine and the others were given a placebo (placebo) injection. In the other study, participants were equally divided between Nuvaxovid and placebo. People did not know if they were given Nuvaxovid or placebo.
The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic cases of Covid-19 from 7 days after the second dose in people taking Nuvaxovid (14 cases out of 17,312 people) compared to people who received placebo (63 out of 8,140 people). This means that the vaccine was 90.4% effective in this study.
The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic cases of Covid-19 in people taking Nuvaxovid (10 cases in 7,020 people) compared with people taking placebo (96 out of 7,019 people). in this study, the vaccine efficacy was 89.7%.
Overall, the results of both studies show a vaccine efficacy of Nuvaxovid of approximately 90%. The original strain of SARS-CoV-2 and some worrying variants, such as Alpha and Beta, were the most common viral strains circulating when the studies were in progress. There are currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.
The side effects observed with Nuvaxovid in the studies were usually mild or moderate and resolved within two days of vaccination. The most common were injection or tenderness at the injection site, fatigue, muscle aches, headache, general malaise, joint pain, and nausea or vomiting.
The safety and efficacy of the vaccine will continue to be monitored as it is used throughout the EU, through the EU pharmacovigilance system and additional studies by the company and the European authorities.
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