Pfizer/BioNTech has submitted data to the European Union's medicines regulator for the approval of its coronavirus vaccine for children aged five to 11, following a similar step in the United States.

The vaccine makers announced last month that trial results had shown their jab was safe and created a "robust" immune response in that age group.

The European Medicines Agency said it will review data related to the vaccine, known as Comirnaty, including results from an ongoing clinical study.

Pfizer/BioNTech said the study involved 2,268 children ages five to 11 and data has been submitted to the EMA with a view to securing "Conditional Marketing Authorisation in the European Union".


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Professor Brian MacCraith, chair of Ireland's Covid-19 taskforce, hailed it as a "significant development".

The pharma groups also revealed: "The same data have been submitted to the US Food and Drug Administration and will be filed with other regulatory authorities in the coming weeks."

The US Food and Drug Administration has scheduled an 26 October meeting to review the data, before giving its opinion on whether authorisation should be granted.

The vaccine is currently not allowed for the five to 11 age group. It has, however, been authorised for use in children over the ages of 12 years in both the United States and European Union.

Inoculating young children is seen as key to keeping schools open and helping to end the pandemic.

Children in the 5-11 age group in the Pfizer trial received a two-dose regimen of 10 micrograms, compared with 30 micrograms for older age groups. The shots were given 21 days apart.

The Pfizer vaccine is already being administered to adolescents over 12 in several countries, as well as to adults around the globe.

Pfizer and BioNTech are also trialling their vaccine on infants aged six months to two years, and on children aged two to five.

Initial data for these groups may come before the end of the year.

Israel has already given special authorisation to vaccinate children aged 5-11 who are "at significant risk of serious illness or death" from Covid-19, using the Pfizer jab at the lower dosage.