The authorization is for the prevention of COVID-19 in people 18 years and over.
This is the second COVID-19 vaccine that the European Medicines Agency (EMA) has recommended for authorization, following a positive review for the Pfizer-BioNTech candidate on December 21, 2020.
EMA’s human medicines committee (CHMP) said it has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorization be granted by the European Commission.
This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns, said the agency.
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, executive director, 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 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.”
Trial evaluation
A very large clinical trial showed that COVID-19 Vaccine Moderna was effective at preventing COVID-19 in people from 18 years of age, noted the EU agency.
“The trial showed a 94.1% 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 dummy 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% efficacy in the trial.
“The trial also showed 90.9% 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.”
Moderna’s vaccine is given as two injections into the arm, 28 days apart.
The EMA said the most common side effects with the vaccine were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting.
“The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and by European authorities.”