EU medicines agency recommends approval of Moderna’s COVID-19 vaccine for children age 6-11

By Seda Sevencan and Selen Temizer

ISTANBUL (AA) – The EU medicines authority on Thursday recommended Moderna’s COVID-19 vaccine Spikevax for use in children age 6-11.

“A main study in children aged 6 to 11 showed that the immune response to the lower dose of Spikevax (50 µg) was comparable to that seen with the higher dose (100 µg) in 18- to 25-year-olds, as measured by the level of antibodies against SARS-CoV-2,” the European Medicines Agency (EMA) said in a statement.

Common side effects are usually moderate and include pain, redness and swelling at the injection site, tiredness, headache, chills, nausea, vomiting, swollen or tender lymph nodes under the arm, fever, and muscle and joint pain, but they normally improve within a few days of vaccination, it added.

The Spikevax vaccine is already approved for use in adults and children 12 and over.

EMA decisions on vaccines and drugs need approval from the EU Commission.

The vaccines approved for use in the EU so far are produced by BioNTech-Pfizer, Moderna, AstraZeneca, and Johnson and Johnson.