EMA gives the green light to Moderna's Covid-19 vaccine

06.01.2021 13:54

The EMA has recommended granting conditional authorization for the marketing of the Covid-19 vaccine Moderna to prevent coronavirus disease in people aged 18 and over. This is the second Covid-19 vaccine that the EMA has recommended for approval.

“This vaccine gives us another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA. “It is a testament to the efforts and commitment of everyone involved that we have this second positive vaccine recommendation just shy of a year since the WHO declared the pandemic.” And further: “As with all medicines, we will continue to use the data on safety and Closely monitor vaccine effectiveness to ensure continued protection of the EU public. Our work will always be guided by scientific evidence and our commitment to protecting the health of EU citizens." According to the EMA, a "very large clinical trial" had shown that the Covid-19 vaccine "Moderna COVID-19" effectively prevented in people aged 18 and over. A total of around 30,000 people were involved in the process. Half received the vaccine and half received dummy injections (placebo). The people did not know whether they had received the vaccine or the dummy injections.

The effectiveness was calculated in around 28,000 people aged 18 to 94 who had no signs of previous infection. The study showed a 94.1% reduction in the number of symptomatic Covid-19 cases among people who received the vaccine (11 out of 14,134 vaccinated people received Covid-19 with symptoms), compared to people who received dummy injections, according to the EMA (185 of 14,073 people) Those who received dummy injections got Covid-19 with symptoms). This means that the vaccine was able to show an effectiveness of 94.1% in the study. The study also showed effectiveness of 90.9% in participants at risk of severe Covid-19, including participants with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection. High effectiveness was also maintained across gender, racial and ethnic groups.