European Medicines Agency has recommended granting conditional marketing authorization for Moderna's vaccine against COVID-19, authorizing the vaccination for people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorization, as was announced on the EMA’s website.
An extensive clinical trial has illustrated that COVID-19 Vaccine Moderna proved effective at preventing COVID-19 in people from 18 years of age. EMA’s Human Medicines Committee (CHMP) has thoroughly assessed the data on the quality, safety, and efficacy of the vaccine, thus recommending 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,” the report stated.
The trial involved around 30,000 people in total. A half received the vaccine and another half were given placebo injections. People did not know whether they received the vaccine or dummy injections. The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine.
“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,” Emer Cooke, Executive Director of EMA, stated. 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.
COVID-19 Vaccine Moderna is given as two injections into the arm, 28 days apart. The most common side effects of COVID-19 Vaccine Moderna are usually mild or moderate, including 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.