The European Medicines Agency (EMA) has recommended the conditional marketing authorisation for COVID-19 Vaccine Moderna (mRNA-1273) that the European Commission granted.
EMA’s human medicines committee has thoroughly assessed the data on the quality, safety and efficacy of the vaccine. This data was provided by a very large clinical trial (NCT04470427) that involves around 30,000 people in total. The vaccine demonstrated a 94.1% efficacy in the trial. The most common side effects were usually mild or moderate and got better within a few days after vaccination. They include 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.
COVID-19 Vaccine Moderna is given as two injections into the arm, 28 days apart.
The vaccine is not currently recommended for children below 18 years of age. However, EMA has agreed with the company on a paediatric investigation plan (PIP) to trial the vaccine in children at a later stage.
According to the PIP, Moderna has started a phase 2/3 trial (NCT04649151) evaluating vaccine candidate mRNA-1273, in adolescent participants, planning to enroll 3,000 US volunteers aged 12 to 17. The randomized, controlled study, conducted in partnership with the Biomedical Advanced Research and Development Authority, will evaluate the vaccine’s safety, efficacy and reactogenicity in healthy adolescents via a two-dose regimen administered 28 days apart.
The European authorities will keep monitoring the safety and effectiveness of the vaccine through the European Union (EU) pharmacovigilance system and additional studies.
The next step involves Moderna, that will deliver the total amount of 160 million doses between the first and the third quarters of 2021. It will add to the 300 million doses of the vaccine distributed by BioNTech/Pfizer, the first vaccine to have been authorised in the EU on 21 December 2020.
Keep following us for further updates and visit our page to discover more about the COVID-19 treatments under evaluation by EMA.