European Commission approves Moderna’s COVID-19 vaccine

Following the European Medicines Agency (EMA) recommending a conditional marketing authorisation, the European Commission (EC) has approved Moderna’s COVID-19 vaccine. The vaccine will be available for people 18 years of age or older.  

The EMA’s human medicines committee (CHMP) assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the EC. 

The vaccine works using messenger RNA (mRNA) which has instructions for making the coronavirus Spike (S) protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells. When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the S protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells to attack it.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of the EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by the World Health Organization (WHO). As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.”

A large blind clinical trial has shown that Moderna’s COVID-19 vaccine was effective at preventing COVID-19 in people from 18 years of age. The trial involved around 30,000 people in total. Half received the vaccine and half were given placebo injections. The vaccine is administered as two injections into the arm, 28 days apart. 

Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection. The trial showed a 94.1 percent reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received placebo injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1 percent efficacy in the trial.

The trial also showed 90.9 percent efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection. The high efficacy was also maintained across genders, racial and ethnic groups.