EMA to decide on use of Moderna Covid vaccine for children under 12

The European Union's drug regulator expects to decide in about two months on whether to allow the use of Moderna's Covid-19 vaccine in children aged six to 11 years, it said on Wednesday, after the United States drug-maker sought approval.

"The current timeline for evaluation foresees an opinion in approximately two months, unless supplementary information or analysis is needed," the European Medicines Agency (EMA) said in a statement.

Anyone over the age of 12 is currently eligible for the Covid-19 vaccine in the Republic, and 89 per cent of those have been fully inoculated, according to the Covid-19 data hub. Some 90.5 per cent of people aged over 12 have received at least one vaccine dose.

Booster shots are also being rolled out to people aged over 60 and to frontline healthcare workers.

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Moderna said on Tuesday it had applied for European authorisation for use of a 50-micrograms dose of its shot in the six-11 years age group, weeks after it delayed a similar filing with US regulators.

The company had in October said its vaccine generated a strong immune response in children in that age group.

The EU had in July authorised the vaccine for use in teenagers aged 12 to 17 years, but several countries including Sweden have paused its use for people aged 30 or younger due to rare heart-related side-effects.

Inflammations

Germany's vaccine advisory committee on Wednesday recommended that people aged under 30 be vaccinated only with the Biontech/Pfizer Covid-19 vaccine, as it showed a lower number of heart inflammations in younger people than the Moderna vaccination.

The committee, known as Stiko, also recommended that pregnant women, independent of their age, be inoculated only with the Biontech/Pfizer vaccine as well.

Stiko based its recommendation on new safety data from the Paul Ehrlich Institute, Germany’s authority in charge of vaccines, and new international data.

Germany is the latest EU country to recommend limiting use of the Moderna vaccine on younger people.

France's public health authority this week recommended people under 30 be given Pfizer's vaccine when available instead of the Moderna jab. Finland and Sweden have also limited use of the Moderna shot. – Reuters