The European regulator announced on Wednesday that it had given the green light to the use from the age of 6 months of the anti-Covid vaccines from Pfizer and Moderna, the first anti-Covid serums to be authorized for children under five in the EU. The European Medicines Agency (EMA) has in parallel also recommended authorizing an adapted vaccine from Moderna targeting the Omicron BA.4 and BA.5 subvariants in addition to the original strain of SARS-CoV-2.
Lower doses
The EMA has “recommended to include use in children aged 6 months to 4 years for Comirnaty”, from Pfizer, and “use in children aged 6 months to 5 years for Spikevax”, from Moderna , the European regulator said in a statement. The doses of both vaccines in these new, younger age groups will be lower, the EMA explained.
In children aged 6 months to 4 years, Comirnaty can be administered as a primary vaccination in three doses. In children aged 6 months to 5 years, Spikevax can be given as a primary vaccination in two doses. The Committee for Medicinal Products for Human Use (CHMP) concluded that “the benefits of Comirnaty and Spikevax in children aged 6 months to 4 and 5 years, respectively, outweigh the risks”, noting that side effects are usually mild or moderate and improved a few days after vaccination.
A pandemic “still ongoing”
Moderna’s adapted vaccine targeting the Omicron BA.4 and BA.5 subvariants is recommended for adults and children from the age of 12 who have already had a primary vaccination against Covid-19. An adapted Spikevax vaccine targeting Omicron BA.1 and the original strain had been licensed in September.
Omicron and its sub-variants have been dominant throughout 2022, quickly taking the place of previous Alpha and Delta variants. The CHMP’s recommendations will now be forwarded to the European Commission, which will make final decisions applicable in all EU member states, the EMA said. The EMA warned last month that the Covid-19 pandemic was “still ongoing” and urged countries to institute vaccine booster programs before winter.