The EU’s drug watchdog on Wednesday approved Pfizer and Moderna’s Covid injections for children aged six months and up as fears grow of a winter wave of infections.
At the same time, the European Medicines Agency also approved a separate shot by Moderna, specifically targeting the BA.4 and BA.5 strains of the coronavirus Omicron variant.
The EMA’s human medicines committee “recommended… the use in children aged six months to four years for Comirnaty and use in children aged six months to five years for Spikevax,” the Amsterdam-based watchdog said, referring to Pfizer and Modern’s jabs respectively.
But it said that compared to shots recommended for people aged five years and older, the doses for infants will be lower.
Pfizer’s Comirnaty can be given as a primary vaccination consisting of three doses while Spikevax will consist of two doses.
“For children within these age groups, both vaccines are given as injections in the muscles of the upper arm or thigh,” the EMA said.
Meanwhile it also approved Moderna’s adapted Spikevax booster jab against the new strains of the Omicron variant.
“The bivalent vaccine is recommended for adults and children from 12 years of age who have already had a primary vaccination course against Covid-19,” the EMA said.
The adapted Spikevax vaccine is the second in the 27-nation bloc’s toolbox to fight the highly infectious BA.4 and BA.5 types of the variant.
While the original Covid vaccines that emerged nearly two years ago provide some protection against newer variants, the race has been on to produce jabs that specifically target the milder but more infectious Omicron strains.
Previous “variants of concern” like Alpha and Delta eventually petered out but Omicron and its sub-lineages have dominated throughout 2022.
The BA.4 and BA.5 types have in particular helped to drive new cases of the disease in Europe and the United States in recent months.
The EMA warned last month that while death rates were down the pandemic is “still ongoing” and urged countries to roll out booster programmes before winter, when cases are expected to rise.
The EMA’s recommendations will be sent to the European Commission for a final decision.
