The European Medicines Agency (EMA) continues to strengthen the arsenal of covid vaccines available in the European Union. After an exhaustive evaluation, this Monday gave birth to the conditional commercialization of the fifth vaccine against covid19. It’s about the serum Nuvaxovid, developed by the pharmaceutical company Novavax, which can be administered to all adults over 18 years of age in two doses 21 days apart. According to the conclusion of the EMA Committee for Human Medicines, the data on the vaccine are robust and meet the criteria for efficacy, safety and quality.
It is a protein-based vaccine whose side effects in the studies were generally mild or moderate and disappeared within a couple of days after vaccination. The most common were injection site tenderness or pain, tiredness, muscle pain, headache, general feeling of discomfort, joint pain, and nausea or vomiting. As with the rest of the authorized vaccines (Pfizer-Biontech, Moderna, AstraZeneca and Janssen), the safety and efficacy of the vaccine will continue to be monitored as it is used in the EU, through the EU pharmacovigilance system and further studies by the company and the European authorities.
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The results of the two clinical trials carried out, among more than 45,000 people, have revealed, according to the EMA, that Nuvaxovid is effective in preventing covid19 in people from 18 years of age. In the first study, conducted in Mexico and the United States, about two-thirds of the participants received the vaccine and the rest received a placebo injection, resulting in a 90.4% reduction in the number of symptomatic cases of covid19 to starting 7 days after the second dose in people who received 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.
In a second study, conducted in the UK, participants were split evenly between Nuvaxovid and placebo and offered similar results with a similar reduction in the number of symptomatic cases of covid19 in people who received Nuvaxovid (10 cases out of 7,020 people) in compared to people who received placebo (96 of 7,019 people). In this case, the efficacy of the vaccine was 89.7%. “Together, the results of the two studies show an efficacy of the Nuvaxovid vaccine of around 90% & rdquor;” the EMA noted. At the time of the studies, the variants of concern, such as Alpha and Beta, were the most common virus strains circulating. Currently, the EMA continues, there is limited data on the efficacy of Nuvaxovid against other variants of interest, including omicron.
Reference-www.elperiodico.com