Ireland is set to get another coronavirus vaccine after the European Medicines Agency gave the green light to the Novavax vaccine.
Under an EU procurement agreement, Ireland can withdraw about 1.1 million doses of vaccine.
This is the fifth vaccine recommended by the European Union to prevent COVID-19.
This is a protein vaccine that, together with already approved vaccines, will support the vaccination campaigns of EU member states during a critical stage of the epidemic.
After a thorough evaluation, EMA’s Committee for Human Medicinal Products (CHMP) unanimously concluded that the vaccine data is reliable and meets EU standards for effectiveness, safety and quality.
Results from two major clinical trials have found that the vaccine called Nuvaxovid is effective in preventing COVID-19 infection in people over the age of 18.
These studies involved a total of 45,000 people. In the first study, about two-thirds of the participants received the vaccine and the others received a placebo (sham); in the other study, participants were evenly divided into Nuvaxovid and placebo groups. People don't know whether they got Nuvaxovid or a placebo.
The first study, conducted in Mexico and the United States, found that people who received Nuvaxovid (14 cases out of 17,312 people) compared with those who received a placebo (63 cases out of 8,140 people) had fewer cases within seven days of the second shot. Symptomatic COVID-19 cases decreased by 90.4%. This means the vaccine was 90.4% effective in the study. A second study in the UK by
also showed similar rates of symptomatic COVID-19 cases in people who received Nuvaxovid (10 cases out of 7,020 people) compared with those who received a placebo (96 cases out of 7,019 people). reduction; in this study, the vaccine was 89.7% effective.
Taken together, the results from the two studies suggest the vaccine is about 90% effective against Nuvaxovid. At the time of the study, the original strain of SARS-CoV-2 and some variants of concern, such as Alpha and Beta, were the most common strains of the virus. Currently, there is limited data on the efficacy of Nuvaxovid against other related variants, including Omicron.
The side effects of Nuvaxovid observed in studies were generally mild or moderate and disappeared within a few days after vaccination. The most common symptoms are tenderness at the injection site, fatigue, muscle pain, headache, general malaise, joint pain, nausea, or vomiting.
The company said that as the vaccine is used across the EU, its safety and effectiveness will continue to be monitored through the EU pharmacovigilance system and additional studies by the company and European authorities.
